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Efficacy and safety of ginger-salt-indirect moxibustion for urge urinary incontinence after stroke: Protocol for a pilot multicentre randomised controlled trial

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Abstract

Introduction Ginger-salt-indirect moxibustion is widely applied to treat urge urinary incontinence after stroke, which is a common complication in stroke survivors. Moxa cone moxibustion and moxa box moxibustion are the main techniques of ginger-salt-indirect moxibustion. Our previous study had shown that ginger-salt-indirect moxibustion using moxa cones was feasible and effective for urination disorders post-stroke. This pilot study aims to assess the feasibility of conducting research to evaluate the efficacy and safety of ginger-salt-indirect moxibustion for patients with post-stroke urge urinary incontinence. Methods and analysis This is a multicentre, prospective, single-blinded, pilot randomised controlled trial. 120 eligible patients will be randomly allocated to three groups. Treatment group A (n=40) will receive moxa cone moxibustion and routine care; treatment group B (n=40) will receive moxa box moxibustion and routine care; control group (n=40) will only receive routine care for stroke recovery. The entire moxibustion treatment will consist of a total of 28 sessions during the course of 4 weeks. The primary outcome measure will be the increase in mean volume per void assessed at week 4 from the first moxibustion session (baseline). Secondary outcome measures will include mean frequency of urination per day and quality of life assessments measured by completion of the Incontinence Quality of Life Questionnaire and Barthel Index. All outcome measures will be assessed at baseline and at 4 and 16 weeks from baseline. Adverse events in the three groups will be recorded to assess the safety of moxibustion. Ethics and dissemination Research ethics was approved by the Research Ethical Committee of Beijing Hospital of Traditional Chinese Medicine Affiliated to the Capital Medical University (ref: 2013BL-094). Written informed consent will be obtained from all participants. Study results will be published in peer reviewed journals. Trial registration number ISRCTN 44706974.
Efcacy and safety of ginger-salt-
indirect moxibustion for urge urinary
incontinence after stroke: protocol
for a pilot multicentre randomised
controlled trial
Linpeng Wang,
1
Lichen Wang,
1
Guangxia Shi,
1
Lin Zeng,
2
Yi Yang,
1
Tao Zhang,
1
Huilin Liu
1
To cite: Wang L, Wang L,
Shi G, et al. Efficacy and
safety of ginger-salt-indirect
moxibustion for urge urinary
incontinence after stroke:
protocol for a pilot
multicentre randomised
controlled trial. BMJ Open
2014;4:e006326.
doi:10.1136/bmjopen-2014-
006326
Prepublication history for
this paper is available online.
To view these files please
visit the journal online
(http://dx.doi.org/10.1136/
bmjopen-2014-006326).
Received 7 August 2014
Revised 19 September 2014
Accepted 24 September 2014
1
Acupuncture and
Moxibustion Department,
Beijing Hospital of Traditional
Chinese Medicine affiliated to
Capital Medical University,
Beijing, China
2
Research Center of Clinical
Epidemiology Affiliated to
Peking University, Beijing,
China
Correspondence to
Dr Huilin Liu;
lhlxwy@aliyun.com
ABSTRACT
Introduction: Ginger-salt-indirect moxibustion is
widely applied to treat urge urinary incontinence after
stroke, which is a common complication in stroke
survivors. Moxa cone moxibustion and moxa box
moxibustion are the main techniques of ginger-salt-
indirect moxibustion. Our previous study had shown
that ginger-salt-indirect moxibustion using moxa cones
was feasible and effective for urination disorders post-
stroke. This pilot study aims to assess the feasibility of
conducting research to evaluate the efficacy and safety
of ginger-salt-indirect moxibustion for patients with
post-stroke urge urinary incontinence.
Methods and analysis: This is a multicentre,
prospective, single-blinded, pilot randomised controlled
trial. 120 eligible patients will be randomly allocated to
three groups. Treatment group A (n=40) will receive
moxa cone moxibustion and routine care; treatment
group B (n=40) will receive moxa box moxibustion and
routine care; control group (n=40) will only receive
routine care for stroke recovery. The entire moxibustion
treatment will consist of a total of 28 sessions during
the course of 4 weeks. The primary outcome measure
will be the increase in mean volume per void assessed
at week 4 from the first moxibustion session
(baseline). Secondary outcome measures will include
mean frequency of urination per day and quality of life
assessments measured by completion of the
Incontinence Quality of Life Questionnaire and Barthel
Index. All outcome measures will be assessed at
baseline and at 4 and 16 weeks from baseline. Adverse
events in the three groups will be recorded to assess
the safety of moxibustion.
Ethics and dissemination: Research ethics was
approved by the Research Ethical Committee of Beijing
Hospital of Traditional Chinese Medicine Affiliated to
the Capital Medical University (ref: 2013BL-094).
Written informed consent will be obtained from all
participants. Study results will be published in peer
reviewed journals.
Trial registration number: ISRCTN 44706974.
INTRODUCTION
Urinary incontinence (UI) is dened by the
International Continence Society (ICS) as
involuntary leakage of urine that causes
hygienic or social problems.
1
The prevalence
of UI after stroke varies from 3279% at
admission,
24
25% at hospital discharge, and
15% after 1 year.
4
Urge urinary incontinence
(UUI) is a common type of UI
5
that occurs
after stroke. It is characterised by involuntary
leakage of urine accompanied or preceded
by urgency.
1
The results of a previous review
6
suggested
that there were three major causes of UI
after stroke: detrusor hyperreexia caused by
infarction; stroke-related cognitive or lan-
guage decits; and bladder hyporeexia with
resultant overow incontinence. UUI can be
caused by detrusor overactivity due to the
loss of inhibitory neurones after stroke.
7
Detrusor overactivity is characterised by invol-
untary detrusor contractions during the
lling and storage phase.
178
When intra-
detrusor pressure generated by abnormal
Strengths and limitations of this study
First pilot study to evaluate the feasibility of con-
ducting research to assess the efficacy and
safety of ginger-salt-indirect moxibustion as
treatment for urge urinary incontinence after
stroke.
Multicentre, randomised controlled trial with
pragmatic design.
Interventions conducted by certified acupunctur-
ists according to the STRICTOM and good clin-
ical practice guidelines (GCP).
Lack of blinding of acupuncturists and partici-
pants due to the nature of moxibustion.
Wang L, et al.BMJ Open 2014;4:e006326. doi:10.1136/bmjopen-2014-006326 1
Open Access Protocol
detrusor contractions exceeds sphincter pressure, UI
occurs.
7
UI is a strong prognostic indicator for stroke
recovery, which is associated with high rates of mortal-
ity,
910
disability
11
and increasing admission to institu-
tional care.
12
Micturition disorders may result in urinary
infection, nephritis, fungal dermatitis,
13
and even bed-
sores. Typical symptoms, including frequent micturition,
nocturia and urgency, could lead to impaired quality of
life
14
and heavy economic burden.
15 16
Initial treatments for UUI after stroke recommended
by ICS are behavioural therapy and pharmacotherapy.
1
Behavioural therapies, including healthy bladder habits
and training techniques, are aimed at changing patient
lifestyle and at teaching patients to control urgency and
enhance continence ability.
17
For habit modication,
patients are given guidance on how to re-establish a
healthy voiding schedule, eliminate bladder irritants
from the diet, manage uid intake and bowel regularity,
control weight, and give up smoking.
1824
Training tech-
niques consist of bladder training, urgency control tech-
niques, pelvic muscle exercises, delayed voiding, and
multicomponent behavioural training.
17
Behavioural
interventions are applied in the primary care setting,
with or without pharmacotherapy.
2527
Among these
strategies, behavioural training and bladder training
have the strongest evidence of efcacy for the treatment
of UUI.
2831
Antimuscarinic drugs can reduce urgency and
improve bladder function by controlling detrusor
muscle overactivity through inhibition of M2 and M3
muscarinic bladder receptors.
3234
Several meta-analyses
have shown that the most widely used antimuscarinic
drugs have signicant clinical benets on UUI.
3538
However, use of antimuscarinic agents is complicated by
dose convenience, drug contraindication, and nancial
concerns.
39
A Cochrane systematic review
40
concluded
that no studies designed to manage UI after stroke in
secondary care had been rigorously conducted so far.
Although there are clinical guidelines for the manage-
ment of UI after stroke,
1
to date there is insufcient
good quality evidence to support current clinical prac-
tices.
41
More available therapies and well-designed
studies are required to provide further evidence for
management of UUI after stroke.
Moxibustion is a therapy that uses ignited materials
(usually moxa) to heat selected points of the skin
surface. This therapy is widely used for chronic de-
ciency diseases
42
and is commonly indicated for UUI.
43
The mechanism of action of moxibustion combines
thermal, radiation and pharmacological effects of the
materials used, acting on the meridian system.
44
Following the theory of Traditional Chinese Medicine
(TCM), kidney qi regulates voiding function and ensures
voluntary urination. Deciency of kidney qi is known to
be the primary pathogenesis of UI according to
ZhuBingYuanHouLun(a famous ancient TCM litera-
ture). Ginger and salt are typically used on Shenque
(CV8) acupoint to warm, tonify and nourish the kidney
qi, thereby controlling the bladder and regulating
voiding function.
Moxa cone moxibustion and moxa box moxibustion
are primary techniques of ginger-salt-indirect moxibus-
tion, which are commonly used in clinical practices in
China. Moxa cone moxibustion involves a moxa cone
burning directly on the ginger slice and providing
thermal stimulus to the skin surface. Moxa box moxibus-
tion facilitates manipulations and reduces adverse reac-
tions by using the moxa box device with moxa sticks
inside over the ginger slice. Results of our previous
study
45
showed that ginger-salt-partitioned moxibustion
with moxa cone could reduce mean daytime and night-
time voiding frequency in the treatment of urination dis-
orders post-stroke. In addition, we also observed that
ginger-salt-indirect moxibustion with moxa cones could
increase mean volume per void of UI after stroke in an
unpublished study. Our previous studies, together with
results from an earlier Cochrane review,
40 45
suggest
ginger-salt-indirect moxibustion may be worth investigat-
ing with more rigorous study design.
METHODS
Objectives
This pilot study aims to evaluate the feasibility of research
to assess the efcacy and safety of ginger-salt-indirect
moxibustion for the treatment of UUI after stroke.
Recruitment
This is a multicentre, single-blinded, pilot randomised
controlled trial. The research consists of three sequential
parts (gure 1): a recruitment period before randomisa-
tion, a treatment period of 4 weeks, and a follow-up
period of 12 weeks. One hundred and twenty eligible
participants will be recruited from acupuncture wards of
three hospitals according to the inclusion and exclusion
criteria. During the rst visit, potentially qualied
patients will be provided with detailed information
about this study, including the research objective, study
procedure, potential benets and risks. If a patient
shows willingness to participate, they will be required to
voluntarily sign a written informed consent. This will be
followed by baseline assessment and randomisation.
Design
Randomisation and allocation concealment
The randomisation scheme is provided by the Research
Center of Clinical Epidemiology Afliated to Peking
University Third Hospital in China. Statistical experts
will use the block randomisation method (block size of
6) of the SAS package (V.9.1.3; SAS institute Inc, Cary,
North Carolina, USA) to form the random allocation
sequence. Then computer-generated opaque sealed
envelopes, each with the serial number outside and
group number inside, will be produced. The envelopes
will be kept in a secure locked drawer making it inaccess-
ible to all study personnel. After baseline assessments,
2Wang L, et al.BMJ Open 2014;4:e006326. doi:10.1136/bmjopen-2014-006326
Open Access
the envelopes will be opened sequentially by an inde-
pendent researcher in front of the participants to
ensure adequate concealment. Participants will be allo-
cated to three groups according to the group number
printed inside the envelopes.
Blinding
Due to the nature of moxibustion, it is difcult to
ensure the therapists or participants are blinded to the
treatment allocation. Data managers and statisticians will
be blinded throughout the trial. During the interven-
tion, therapists and data managers will be requested not
to communicate with each other about the allocation.
Blinded telephone interviewers will collect the follow-up
materials to evaluate the long term effect of moxibustion
at 16 weeks after the baseline.
Participants
Sample size
Because this is a pilot study, a power calculation to deter-
mine the sample size was not conducted. Sample size
calculation was performed based on estimates of the
number of participants we would expect to recruit
within 24 months. We therefore plan to recruit ve parti-
cipants per month, according to our previous trial. A
sample size of 40 per group and a total number of 120
will be included, which is larger than the minimum of
12 per group suggested for pilot studies.
46
Outcomes of
this pilot study will help calculate the appropriate
sample size for further randomised clinical trials.
Inclusion criteria
1. Male or female, aged 4075 years
2. Inpatients with UUI after stroke, according to the
diagnosis criteria of the American Stroke Association
and the ICS
3. 4th to 48th week after stroke onset
4. Normal consciousness, communication ability and
recognition
5. Written informed consent.
Exclusion criteria
1. UUI caused by spinal injury, multiple sclerosis or
hyperplasia of the prostate gland
2. Chronic urinary retention or UI before stroke onset
3. Stress UI, mixed UI and chronic urinary tract infection
4. Insufciency of heart, liver, kidney organs
5. Participants in another clinical trial.
Discontinuation criteria
Reasons for discontinuation of treatment may include,
but are not limited to, the following:
1. Participants decision to discontinue treatment at any
time for any reason
2. Investigators determination to discontinue treatment
for the patients safety and best interests at any time
3. Non-compliance of participants with the study pro-
cedure (eg, study visits)
4. Concomitant therapy that could affect the study
results during the trial
5. Detection of protocol violations at any time.
Figure 1 Trial flowchart.
Wang L, et al.BMJ Open 2014;4:e006326. doi:10.1136/bmjopen-2014-006326 3
Open Access
Intervention
Ginger-salt-indirect moxibustion is formulated on the
basis of descriptions in the ancient literature and our
clinical experience. Moxibustion will be manipulated by
certied acupuncturists with at least 20 yearsclinical
experience. All treatment details will be standardised
between practitioners by guiding videos and relative
training before the rst acupuncture session.
Interventions will be performed in accordance with the
STRICTOM
47
and good clinical practice guidelines
(GCP).
Treatment group A
Participants in treatment group A will receive moxa
cone moxibustion and routine care once a day for
4 weeks. The procedure for each session as it is used in
normal practices is as follows (gure 2). Participants are
asked to lie on a bed in a supine position and remove
clothing to fully expose the navel in a temperature con-
trolled room (2530°C). A certain amount of salt is put
on the navel to cover Shenque (CV8) acupoint and is
covered by a fresh slice of ginger (30 mm in diameter
and 45 mm in thickness). Then a moxa cone ( pure
wormwood bre in material, 15 mm in diameter and
30 mm in length; Tongrentang Inc, China) is placed on
the fresh ginger slice and lit by the therapist. Once the
moxa cone is burnt out, the therapist removes the whole
moxa cone and replaces it with another one. The tech-
nique requires the participant to experience a sensation
of heat but no painful burning sensation. If participants
feel pain or a burning sensation, the ginger slice with
burning moxa cone will be removed immediately and
reset after several minutes. Each session requires three
units of moxa cone. The therapist is required to observe
the patient carefully and quickly remove the burning ash
to avoid injury. Because this study is designed to evaluate
moxibustion treatment as it is used in normal practice,
the moxibustion group will also receive the usual care
provided to the control group.
Treatment group B
Participants in treatment group B will receive moxa box
moxibustion and routine care once a day for 4 weeks.
The manipulations are generally similar to those in treat-
ment group A. The only difference is that the double-
hole moxa box (13×8×8.5 cm) with two moxa sticks
(pure wormwood bre, 15 mm in diameter and 70 mm
in length; Tongrentang Inc, China) in the holes will be
placed on the fresh ginger slice (gure 3). The moxa
sticks will be ignited from the bottom. If patients feel
pain, the therapist will remove the lid with the moxa
sticks for several minutes. Each session requires three
units of moxa sticks.
Control group
According to pragmatic design, the control group will
receive routine therapies for stroke recovery. These
include control of blood pressure, inhibition of platelet
aggregation, routine physiotherapy, occupational
therapy, and glucose control treatment. It will be sug-
gested to the participants in this group that they main-
tain their normal lifestyle, including diet, exercise and
workload. Moreover, participants will be encouraged to
inform the researchers of any new treatments performed
after entry into the trial.
Outcome measures
Primary outcome measure
The primary outcome measure will be the increase in
mean volume per void at week 4 from the baseline.
Mean volume per void is one of the main quantitative
indicators recorded in bladder diaries or frequency
volume charts.
17 31 4850
It is calculated by dividing the
total volume of voluntary urination by the total fre-
quency of voluntary urination, based on 72 h frequency
volume chart data. The increase in mean volume per
void objectively reects an improvement in bladder cap-
acity and detrusor stability in the urine lling and
storage period. In a previous study, we observed that
mean volume per void increased in the
ginger-salt-indirect moxibustion group compared to the
control group, the difference being statistically signi-
cant. Consequently, we selected the increase in mean
volume per void at week 4 from baseline as the primary
outcome. We will also assess the increase in mean
volume per void at week 16 from baseline to evaluate
long term efcacy.
Secondary outcome measures
1. The mean frequency of urination per day, including
voluntary and incontinence urination.
2. Quality of life assessments measured by completion
of the Incontinence Quality of Life Questionnaire
(I-QOL)
51
and the Barthel Index (BI).
52
The average frequency of urination per day is composed
of mean frequency of voluntary and incontinent urin-
ation, which represents the severity of frequent mictur-
ition and UI, respectively. This is strongly linked to the
stability of the bladder and detrusor. Questionnaires for
quality of life assessment will be completed based on the
objective condition and subjective sensation of the
participants.
All outcome measures will be assessed before the base-
line, and at 4 and 16 weeks from the baseline.
Adverse events
Adverse events (AEs) are dened as negative or unin-
tended clinical manifestations following the treatment.
Participants will be instructed to report any abnormal
reactions to the clinical research team at any time. In
addition, study investigators will collect information
about abnormal reactions weekly by visiting the partici-
pants. All details of related and unexpected AEs, such as
time of occurrence, degree of AE, and suspected causes,
will be recorded on Case Report Forms (CRFs). The
common AEs related to moxibustion include allergy,
4Wang L, et al.BMJ Open 2014;4:e006326. doi:10.1136/bmjopen-2014-006326
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burn and infection.
53
AEs will be classied into ve
grades: mild (asymptomatic or mild symptoms; clinical
or diagnostic observations only; intervention not indi-
cated); moderate (minimal, local or non-invasive inter-
vention indicated); severe (severe or medically
signicant but not immediately life-threatening; hospital-
isation or prolongation of hospitalisation indicated);
very severe (life-threatening consequences; urgent
intervention indicated); death related to AEs.
Participants with mild and moderate AEs will receive
symptomatic treatment and will be closely followed up
by the research team. Severe AEs will be reported to the
Research Ethics Committee within 48 h. The Research
Ethics Committee will offer medical advice to the
research team and determine whether the patient is eli-
gible for further treatment.
Figure 2 Moxa cone moxibustion.
Figure 3 Moxa box moxibustion.
Wang L, et al.BMJ Open 2014;4:e006326. doi:10.1136/bmjopen-2014-006326 5
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Data management
Before recruitment, the whole research group, including
therapists, data administrators and outcome assessors,
will participate in a training seminar about research con-
tents and data management. Baseline characteristics of
participants will be recorded on CRFs by a research
assistant. Data collection of urination and questionnaires
will be conducted by a researcher who remains blinded
to the group allocation at the baseline, 4 and 16 weeks
from the baseline. Occupational caregivers will be
trained to identify UI and voluntary urination.
Caregivers will collect urine following voluntary urin-
ation and measure it with a pot-shaped urine collector
with scales. They will be trained to record accurate
voiding time, voluntary urinary volume and UI episodes
on a 72 h frequencyvolume chart ( gure 4). The
record will be started at 8:00 and last for 72 h. If care-
givers failed to collect urine in time, they will note
voiding time and specic reasons on the chart. The
blinded researcher will complete the urination section
on CRFs according to the 72 h frequencyvolume charts
handed in by caregivers.
Two independent researchers blinded to the group
allocation will enter the data on an Excel spreadsheet
after the completion of the CRFs separately. Another
independent researcher will compare the two datasets
for check-up. If different data entry is discovered, data
will be compared with the original CRFs to verify incon-
sistency. All modication will be marked on the CRFs.
Research data will be gathered and saved, abiding by the
Data Protection Act 1998. Paper les will be kept in a
locked ling cabinet. Electronic documents will be
stored in a password protected computer, with access
restricted to the principal investigator. All research docu-
ments will be preserved for at least 5 years after
publication.
Statistical analysis
Data analysis will be performed in a blinded pattern by sta-
tisticians of the Research Center of Clinical Epidemiology
Afliated to Peking University Third Hospital in China.
Statistical analyses will be conducted on an
intention-to-treat basis using the SPSS statistical package
programme (V.18.0). Missing data will be replaced in
accordance with the principle of the last observation
carried forward. A value of p<0.05 will be considered statis-
tically signicant with a two-sided test. Baseline character-
istics including gender, age and previous duration are
described as n (%) for categorical data and mean±SD for
continuous data. To compare the differences among
groups, we will perform analysis of variance for normally
distributed data, the Kruskal-Wallis test for abnormally dis-
tributed data, and the χ
2
test for categorical data.
Comparisons between two groups will be conducted using
the Bonferroni method of post hoc multiple comparisons.
Ethical considerations
This study adheres to the principles of the Declaration
of Helsinki and has been approved by the Research
Ethical Committee of Beijing Hospital of TCM Afliated
to Capital Medical University (ref: 2013BL-094). We will
conduct the research in the following hospitals: Beijing
TCM Hospital Afliated to Capital Medical University,
Beijing Huguosi Hospital of TCM and China
Rehabilitation Research Center. Each participant will
sign written informed consents voluntarily.
DISCUSSION
Placebo or sham control is encouraged in clinical trials to
avoid bias.
54
To our knowledge, no consensus has been
established to recommend valid placebo or sham methods
of moxibustion so far. Sham moxibustion is impractical for
blinding purposes because of the common knowledge of
moxibustion among Chinese patients. Owing to the pref-
erence for moxibustion, non-compliance of Chinese
patients will make it difcult to use standard therapies as
control treatment. For pragmatic purposes, we set a usual
care group as a blank control group, rather than a certain
effective therapy or a sham device.
In regard to the evaluation instruments, we selected a
72 h frequencyvolume chart to record urination details,
and I-QOL together with BI to assess quality of life. The
frequencyvolume chart and bladder diary is highly
recommended in clinical trials by ICS.
1
Frequency
volume charts record the time and volume of each
voiding, as well as the incontinence episodes. ICS sug-
gested that frequencyvolume charts should be recorded
for at least 24 h.
1
A minimum of 72 h was required to
ensure reliability for diary parameters.
48 5558
Thus, we
will use a 72 h frequencyvolume chart to alleviate
burdens for patients and improve compliance.
59 60
As for the assessment of quality of life, I-QOL is strongly
recommended to assess the effect of UI on patient quality
of life.
61
Previous research
51
has afrmed the reliability
and validity of I-QOL as an incontinence-related QOL
instrument in neurogenic UI patients. The items of I-QOL
focus on three dimensions, namely social embarrassment,
avoidance behaviour, and psychosocial impact. BI is added
to evaluate patientsactivities of daily living, which is recog-
nised as a valid and reliable outcome measurement for
stroke survivors.
52
Figure 4 72 h frequencyvolume chart.
6Wang L, et al.BMJ Open 2014;4:e006326. doi:10.1136/bmjopen-2014-006326
Open Access
One limitation of this pilot study is that we will be unable
to prevent therapists and participants from knowing the
group allocation because of the characteristics of moxibus-
tion. To minimise the bias, therapists will receive profes-
sional training and strict quality control. In order to
homogenise the psychological effects, participants are
informed that the effects of the two moxibustion techni-
ques are uncertain. The words placeboor controlwill be
avoided. Similar strategies have been applied in previous
trials.
62 63
Non-compliance of the control group is another
limitation of this pilot trial. It may lead to a high dropout
rate. Participants will be provided with 150 Renminbi
(RMB) as nancial compensation to improve compliance.
This study is the major sub-project focusing on stroke
recovery, which is sponsored and funded by the National
Administration of TCM of China. This protocol
describes the rst pilot randomised controlled trial
evaluating the feasibility of conducting research to assess
the efcacy and safety of ginger-salt-indirect moxibustion
on UUI after stroke. Results of this preliminary study will
provide essential information for the design of subse-
quent large scale trials. Further trials will focus on the
assessment of urodynamic parameters and evaluation of
efcacy and safety of moxibustion on UUI after stroke.
Acknowledgements We acknowledge State Administration of Traditional
Chinese Medicine of China for agreeing to sponsor this study. The authors
also would like to thank Ines Janowicz for the English language editing, and
the reviewers for their helpful comments on this manuscript.
Contributors LPW and HLL conceived this study and prepared the initial
protocol. LW drafted the manuscript and participated in the design of the
study. GXS, YY, LZ, TZ participated in revising the protocol. LZ plans for the
statistical analysis. LPW and HLL made amendments to the trial protocol. All
authors read and approved the final manuscript.
Funding The trial is sponsored and funded by special project for the national
clinical research bases construction of traditional Chinese medicine belonging
to the State Administration of Traditional Chinese Medicine of the Peoples
Republic of China, grant number: JD2X2012152.
Competing interests None.
Patient consent Obtained.
Ethics approval Research ethics approval was attained from the Research
Ethical Committee of Beijing Hospital of Traditional Chinese Medicine
Affiliated to Capital Medical University (ref: 2013BL-094).
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement The results of this pilot study will be disseminated
via peer reviewed publications and conference presentations. All of the data
are available.
Open Access This is an Open Access article distributed in accordance with
the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license,
which permits others to distribute, remix, adapt, build upon this work non-
commercially, and license their derivative works on different terms, provided
the original work is properly cited and the use is non-commercial. See: http://
creativecommons.org/licenses/by-nc/4.0/
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Open Access

Supplementary resources (2)

... The economic burden resulting from managing OAB in Hong Kong will be huge in the foreseeable future. Moreover, OAB can also cause severe social impact and lead to impaired quality of life for those sufferers [6]. ...
Article
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Background: Overactive bladder (OAB) is defined as "urgency, with or without urge incontinence, usually with frequency and nocturia". Acupuncture is one of the most popular alternative treatment methods for OAB. Little established evidence is available to support the effectiveness of acupuncture for OAB. This study is a pioneer randomized, double-blinded, sham-controlled trial to assess the effectiveness and safety of acupuncture in the elderly population with overactive bladder in Hong Kong. Methods/design: This is a randomized, double-center, patient and outcome assessor blinded, sham-controlled trial. The study sample size is 100 patients. Eligible subjects aged between 60 to 90 years old will be recruited into this study. All subjects will be randomly allocated into the active acupuncture group or sham acupuncture group in a 1: 1 ratio. Participants who are allocated into the active acupuncture group will receive a standardized 30-min real acupuncture treatment session for a total of 16 sessions on the top of standard routine care, whilst those who are randomized to the sham acupuncture arm will receive sham acupuncture in addition to standard routine care. Non-penetrating needles will be utilized as sham acupuncture. The primary outcome measure is the 7-day voiding diary and the secondary outcome measures are urine nerve growth factor (NGF) level, the Incontinence Impact Questionnaire (IIQ-7), Urogenital Distress Inventory (UDI-6) and OAB Symptom Score (OABSS). All outcome measures will be collected at baseline, the end of treatment and 3 months after treatment completion. Discussion: The objectives of this study include (1) to evaluate the effectiveness and safety of acupuncture treatment in patients with OAB on reduction in the frequency of incontinence episodes as derived from a 7-day voiding diary, (2) to evaluate whether acupuncture treatment could improve subjective symptoms in patients with OAB and (3) to examine the feasibility of using NGF as a biomarker for overactive bladder and test correlation with the effectiveness of acupuncture intervention. The finding of this study will provide preliminary evidence on the effectiveness and safety of acupuncture for treatment of OAB. Trial registration: Chinese Clinical Trial Registry, ChiCTR-INR-16010048 . Registered on 29 Nov 2016.
... Adverse events (AEs) are defined as negative or unintended clinical manifestations following the treatment [57]. Our investigators will collect information regarding AEs every 3 days. ...
Article
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Background The incidence of cerebral infarction has been growing year by year in China and around the world. According to clinical observation, acupuncture utilizing the “waking up the spirit” needling method is widely used in patients with cerebral infarction, though the underlying mechanisms remain unclear. Additionally, a number of studies have begun to focus on the relationship between cerebrovascular reserve (CVR) and cerebral infarction. The present study aims to investigate whether CVR is one of potential mechanisms underpinning this effect of acupuncture on patients with cerebral infarction. Methods This is a single-centre, prospective, single-blinded, randomized controlled pilot study. Sixty eligible patients will be randomized into an intervention group (waking up the spirit acupuncture) and a control group (hand and foot 12-meridian acupuncture) in a 1:1 ratio. All treatments will be conducted once a day on weekdays followed by a 2-day rest period on the weekend, over a total treatment course of 2 weeks. The primary outcome measures are cerebrovascular reserve (CVR) capacity and Breath-holding Index (BHI) which will be evaluated at baseline and 2 weeks after the first acupuncture treatment, and the secondary outcome measures are National Institutes of Health Stroke Scale (NIHSS) and Barthel Index scores which will be used to further evaluate the efficacy of the intervention. Discussion Cerebrovascular reserve is an independent risk factor for the occurrence, progression, and recurrence of cerebral infarction that requires attention. This trial aims to investigate whether acupuncture utilizing the waking up the spirit needling method can improve CVR capacity in patients with acute cerebral infarction, thus reducing NIHSS scores and preventing further progression of the disease. Furthermore, data and evidence gained from this study will be utilized in the development of future research projects regarding the effects of acupuncture in patients with acute cerebral infarction. Trial registration ISRCTN, ID: ISRCTN99117074. Registered on 20 April 2016. Electronic supplementary material The online version of this article (doi:10.1186/s13063-017-2013-5) contains supplementary material, which is available to authorized users.
Article
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BackgroundsPostoperative urinary retention (POUR) is one of the most common complications after hemorrhoidectomy. The best treatment for POUR is prevention and should be involved in the whole perioperative period. Moxibustion has been used to treat urinary retention for thousands of years, and clinical studies have also proved its effects. We try to carry out a randomized, controlled, prospective study to observe whether prophylactic moxibustion could effectively reduce the incidence of POUR of hemorrhoidectomy in 24 h.Methods This study is a single-center, evaluator-blinded, randomized, and controlled trial. Participants who meet the inclusion and exclusion criteria in this RCT will be randomly assigned to either the treatment group (moxibustion) or the control group (tamsulosin hydrochloride) in a 1:1 ratio according to a computer-generated randomization list. Both moxibustion and tamsulosin will be used 1, 10, and 24 h after operation, respectively. The outcomes of occurrence of POUR, time to first urination, catheterization rate, urinary tract infection, length of hospitalization, and adverse effects will be recorded.DiscussionThe findings of the study will help to explore the preventive efficacy of prophylactic moxibustion against POUR of hemorrhoidectomy in 24 h.Trial RegistrationCHiCTR, CHiCTR2000039350, registered 24 October, 2020, http://www.chictr.org.cn/showproj.aspx?proj = 63204.
Article
Background: Urinary incontinence can affect 40% to 60% of people admitted to hospital after a stroke, with 25% still having problems when discharged from hospital and 15% remaining incontinent after one year.This is an update of a review published in 2005 and updated in 2008. Objectives: To assess the effects of interventions for treating urinary incontinence after stroke in adults at least one-month post-stroke. Search methods: We searched the Cochrane Incontinence and Cochrane Stroke Specialised Registers (searched 30 October 2017 and 1 November 2017 respectively), which contain trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, CINAHL, ClinicalTrials.gov, WHO ICTRP and handsearched journals and conference proceedings. Selection criteria: We included randomised or quasi-randomised controlled trials. Data collection and analysis: Two review authors independently undertook data extraction, risk of bias assessment and implemented GRADE. Main results: We included 20 trials (reporting 21 comparisons) with 1338 participants. Data for prespecified outcomes were not available except where reported below.Intervention versus no intervention/usual careBehavioural interventions: Low-quality evidence suggests behavioural interventions may reduce the mean number of incontinent episodes in 24 hours (mean difference (MD) -1.00, 95% confidence interval (CI) -2.74 to 0.74; 1 trial; 18 participants; P = 0.26). Further, low-quality evidence from two trials suggests that behavioural interventions may make little or no difference to quality of life (SMD -0.99, 95% CI -2.83 to 0.86; 55 participants).Specialised professional input interventions: One trial of moderate-quality suggested structured assessment and management by continence nurse practitioners probably made little or no difference to the number of people continent three months after treatment (risk ratio (RR) 1.28, 95% CI 0.81 to 2.02; 121 participants; equivalent to an increase from 354 to 453 per 1000, 95% CI 287 to 715).Complementary therapy: Five trials assessed complementary therapy using traditional acupuncture, electroacupuncture and ginger-salt-partitioned moxibustion plus routine acupuncture. Low-quality evidence from five trials suggested that complementary therapy may increase the number of participants continent after treatment; participants in the treatment group were three times more likely to be continent (RR 2.82, 95% CI 1.57 to 5.07; 524 participants; equivalent to an increase from 193 to 544 per 1000, 95% CI 303 to 978). Adverse events were reported narratively in one study of electroacupuncture, reporting on bruising and postacupuncture abdominal pain in the intervention group.Physical therapy: Two trials reporting three comparisons suggest that physical therapy using transcutaneous electrical nerve stimulation (TENS) may reduce the mean number of incontinent episodes in 24 hours (MD -4.76, 95% CI -8.10 to -1.41; 142 participants; low-quality evidence). One trial of TENS reporting two comparisons found that the intervention probably improves overall functional ability (MD 8.97, 95% CI 1.27 to 16.68; 81 participants; moderate-quality evidence).Intervention versus placeboPhysical therapy: One trial of physical therapy suggests TPTNS may make little or no difference to the number of participants continent after treatment (RR 0.75, 95% CI 0.19 to 3.04; 54 participants) or number of incontinent episodes (MD -1.10, 95% CI -3.99 to 1.79; 39 participants). One trial suggested improvement in the TPTNS group at 26-weeks (OR 0.04, 95% CI 0.004 to 0.41) but there was no evidence of a difference in perceived bladder condition at six weeks (OR 2.33, 95% CI 0.63 to 8.65) or 12 weeks (OR 1.22, 95% CI 0.29 to 5.17). Data from one trial provided no evidence that TPTNS made a difference to quality of life measured with the ICIQLUTSqol (MD 3.90, 95% CI -4.25 to 12.05; 30 participants). Minor adverse events, such as minor skin irritation and ankle cramping, were reported in one study.Pharmacotherapy interventions: There was no evidence from one study that oestrogen therapy made a difference to the mean number of incontinent episodes per week in mild incontinence (paired samples, MD -1.71, 95% CI -3.51 to 0.09) or severe incontinence (paired samples, MD -6.40, 95% CI -9.47 to -3.33). One study reported no adverse events.Specific intervention versus another interventionBehavioural interventions: One trial comparing a behavioural intervention (timed voiding) with a pharmacotherapy intervention (oxybutynin) contained no useable data.Complementary therapy: One trial comparing different acupuncture needles and depth of needle insertion to assess the effect on incontinence reported that, after four courses of treatment, 78.1% participants in the elongated needle group had no incontinent episodes versus 40% in the filiform needle group (57 participants). This trial was assessed as unclear or high for all types of bias apart from incomplete outcome data.Combined intervention versus single interventionOne trial compared a combined intervention (sensory motor biofeedback plus timed prompted voiding) against a single intervention (timed voiding). The combined intervention may make little or no difference to the number of participants continent after treatment (RR 0.55, 95% CI 0.06 to 5.21; 23 participants; equivalent to a decrease from 167 to 92 per 1000, 95% CI 10 to 868) or to the number of incontinent episodes (MD 2.20, 95% CI 0.12 to 4.28; 23 participants).Specific intervention versus attention controlPhysical therapy interventions: One study found TPTNS may make little or no difference to the number of participants continent after treatment compared to an attention control group undertaking stretching exercises (RR 1.33, 95% CI 0.38 to 4.72; 24 participants; equivalent to an increase from 250 to 333 per 1000, 95% CI 95 to 1000). Authors' conclusions: There is insufficient evidence to guide continence care of adults in the rehabilitative phase after stroke. As few trials tested the same intervention, conclusions are drawn from few, usually small, trials. CIs were wide, making it difficult to ascertain if there were clinically important differences. Only four trials had adequate allocation concealment and many were limited by poor reporting, making it impossible to judge the extent to which they were prone to bias. More appropriately powered, multicentre trials of interventions are required to provide robust evidence for interventions to improve urinary incontinence after stroke.
Article
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The research on indications of acu-moxibustion is very important for effectively guiding clinical practice. In the present paper, the authors retrieved domestic literature about researches on the disease-spectrum or indications of acu-moxibustion therapy in recent 10 years, and made a bibliometrics analysis according to the described research methods, publishing year, quantity and their proportionate relationship. A total of 18 qualified original papers involving 414 illnesses or clinical conditions were included in the present paper. Among the 414 kinds of clinical conditions or illnesses, 72 were considered to be suitable candidates for acu-moxibustion therapy, including functional dyspepsia, herpes zoster, irritable bowel syndrome, gastrointestinal dysfunction, scapulohumeral periarthritis, cervical syndrome, dyssomnia, acne (cyst type), chronic urticaria, regional neurodermatitis, pain, itching, etc. which belong to illness-spectrum grade-I. Generally, the acu-moxibustion therapy is, in clinical effects, relatively poorer for structural diseases which are attributed to grade-II or grade-III type. Nevertheless, the diversity of clinical indications of acu-moxibustion has been confirmed nowadays. Current studies on illness-spectrum are of certain uniformity and comprehensiveness, but need further extending and perfecting, and need more standardized methods corresponding to principles of the evidence-based medicine.
Article
When designing a clinical trial an appropriate justification for the sample size should be provided in the protocol. However, there are a number of settings when undertaking a pilot trial when there is no prior information to base a sample size on. For such pilot studies the recommendation is a sample size of 12 per group. The justifications for this sample size are based on rationale about feasibility; precision about the mean and variance; and regulatory considerations. The context of the justifications are that future studies will use the information from the pilot in their design.
Article
Overactive bladder (OAB) is a symptom-based syndrome characterized by the presence of urgency, which is defined as a sudden and compelling desire to void that cannot be postponed. OAB may significantly impact of quality of life. Numerous treatment options exist for OAB, including behavioral therapies such as pelvic floor muscle rehabilitation, bladder training, and dietary modification, as well as traditional therapies such as pharmacological therapy and neuromodulation. Behavioral therapies are considered the mainstay of treatment for urinary incontinence in general. However the efficacy of these noninvasive strategies for OAB treatment has not been well addressed in the literature. This article presents an overview of current evidence with attention to the clinical relevance of findings related to lifestyle modification, bladder training, and pelvic floor muscle training. Initial evidence suggests that obesity, smoking, and consumption of carbonated drinks are risk factors for OAB but there is less support for the contributory role of caffeine or the impact of caffeine reduction. The evidence supporting bladder training and pelvic floor muscle training is more consistent and a trend towards combining these therapies to treat OAB appears positive. Given the prevalence of OAB and growing support for the efficacy of behavioral treatments it is important and timely to augment existing evidence with well-designed multicenter trials.
Article
Context.— Urinary incontinence is a common condition caused by many factors with several treatment options.Objective.— To compare the effectiveness of biofeedback-assisted behavioral treatment with drug treatment and a placebo control condition for the treatment of urge and mixed urinary incontinence in older community-dwelling women.Design.— Randomized placebo-controlled trial conducted from 1989 to 1995.Setting.— University-based outpatient geriatric medicine clinic.Patients.— A volunteer sample of 197 women aged 55 to 92 years with urge urinary incontinence or mixed incontinence with urge as the predominant pattern. Subjects had to have urodynamic evidence of bladder dysfunction, be ambulatory, and not have dementia.Intervention.— Subjects were randomized to 4 sessions (8 weeks) of biofeedback-assisted behavioral treatment, drug treatment (with oxybutynin chloride, possible range of doses, 2.5 mg daily to 5.0 mg 3 times daily), or a placebo control condition.Main Outcome Measures.— Reduction in the frequency of incontinent episodes as determined by bladder diaries, and patients' perceptions of improvement and their comfort and satisfaction with treatment.Results.— For all 3 treatment groups, reduction of incontinence was most pronounced early in treatment and progressed more gradually thereafter. Behavioral treatment, which yielded a mean 80.7% reduction of incontinence episodes, was significantly more effective than drug treatment (mean 68.5% reduction; P=.04) and both were more effective than the placebo control condition (mean 39.4% reduction; P<.001 and P=.009, respectively). Patient-perceived improvement was greatest for behavioral treatment (74.1% "much better" vs 50.9% and 26.9% for drug treatment and placebo, respectively). Only 14.0% of patients receiving behavioral treatment wanted to change to another treatment vs 75.5% in each of the other groups.Conclusion.— Behavioral treatment is a safe and effective conservative intervention that should be made more readily available to patients as a first-line treatment for urge and mixed incontinence.
Article
Background Despite the common use of urinary diaries to assess lower urinary tract symptoms (LUTS), a standardised validated diary does not exist. Objective To develop a validated urinary diary, using the psychometric validation protocol used in previous International Consultation on Incontinence Questionnaire (ICIQ) modules. Design, setting, and participants We invited 400 consecutive patients attending the urology department for assessment of LUTS to complete a urinary diary (developed and validated for content in a previous study), and the ICIQ Male or Female LUTS questionnaire. Outcome measurements and statistical analysis To establish construct validity, the urinary diary was compared with known theories from published literature; to establish criterion validity, the diary was compared with questionnaire responses and/or urodynamic observations. Optimal diary duration was tested by comparing the 4-d diary against shorter durations. Patients completed a second diary after 2–3 wk for test-retest analysis, and a subset receiving sacral nerve stimulation completed the diary before and after treatment for analysis of responsiveness. A variety of statistical tests were used for different stages of the study. Results and limitations The urinary diaries and ICIQ LUTS questionnaires were completed by 264 patients. Construct validity was established for two of three tested hypotheses. Criterion testing showed good agreement between questionnaire and diary recordings of nocturia (κ = 0.653; p < 0.001; 92.2%) and incontinence (κ = 0.351; p < 0.001; 64.5%), whereas good agreement (κ = 0.378; p < 0.001; 69.2%) was observed between urodynamically proven incontinence and diary reports (n = 104). Diary recordings of urgency showed weak agreement with questionnaire responses (κ = −0.215; p < 0.001; 36%) and urodynamic observations (κ = −0.105; p = 0.256; 43.7%). The 3-d diary explained at least 94% of the total variance of the 4-d diary. A second diary for test-retest analysis was returned by 59 patients, demonstrating fair to excellent agreement (Spearman correlations: 0.49–0.88). Pre- and post-treatment analysis, on pilot testing, showed that the diary is responsive to change. Conclusions Using the ICIQ psychometric validation methodology, a bladder diary was developed for the assessment of LUTS and shown to be valid, reliable, and responsive to change. The 3-d diary has been accepted as the ICIQ bladder diary. Patient summary In this study, patients and clinicians developed and tested a diary in which patients can record their urinary symptoms. The resulting 3-d diary is called the ICIQ bladder diary and is available for adult men and women with urinary symptoms.