A prospective multicenter randomized comparative study between the U- and H-type methods of the TVT SECUR procedure for the treatment of female stress urinary incontinence: 1-year follow-up.

Abstract

No studies have been published comparing the U- and H-type methods of the TVT SECUR (TVT-S) procedure.
Our aim was to compare the efficacy and safety of the two types of TVT-S for female stress urinary incontinence (SUI).
Women with urodynamic SUI were enrolled in this 12-mo multicenter randomized study.
Subjects were randomly allocated to either the U- or H-type method of TVT-S.
Pre- and postoperative evaluations included a standing stress test, the Sandvik questionnaire, the Incontinence Quality of Life (I-QOL) questionnaire, and the International Consultation on Incontinence Questionnaire-Female Lower Urinary Tract Symptoms (ICIQ-FLUTS). Patients' satisfaction and complications were evaluated. Objective and subjective cures were defined as no leakage on the stress test and responses on the Sandvik questionnaire, respectively. We compared the surgical outcomes between the two methods.
Of 285 women, 144 had the U-type method and 141 had the H-type method. Objective cure rates were 87.5% for the U-type method and 80.1% for the H-type method (p=0.091). Subjective cure rates were 77.1% for the U-type method and 75.7% for the H-type method (p=0.786). Improvement in I-QOL and domain scores of the ICIQ-FLUTS (filling and incontinence sum, QOL score), and patients' satisfaction favored the U-type method. There were three cases of intraoperative vaginal wall perforation, one case of increased bleeding, and three cases of temporary postoperative retention. A power calculation was not performed, and some baseline characteristics were not balanced between the two methods.
Both methods of TVT-S provided comparable cure rates for female SUI. However, QOL and treatment satisfaction favored the U-type method.
The protocol of this study was not registered.

Full text

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Platinum Priority – Female Urology – Incontinence
Editorial by Elisabetta Costantini and Massimo Lazzeri on pp. 980–982 of this issue
A Prospective Multicenter Randomized Comparative Study
Between the U- and H-type Methods of the TVT SECUR Procedure
for the Treatment of Female Stress Urinary Incontinence: 1-Year
Follow-Up
Kyu-Sung Leea, Young-Suk Leea, Ju Tae Seob, Yong Gil Nac, Myung-Soo Chood, Joon Chul Kime,
Jun Hyoung Seof, Jong Min Yoong, Jeong Gu Leeh, Duk Yoon Kimi, Eun Sang Yooj,
Kweon Sik Mink, Jae Yup Hongl, Jeong Zoo Leem,*
aDepartment of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
bCheil General Hospital & Women’s Healthcare Center, Kwandong University College of Medicine, Seoul, Korea
cChungnam National University Hospital, Chungnam National University College of Medicine, Daejeon, Korea
dAsan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
eHoly Family Hospital, The Catholic University of Korea College of Medicine, Seoul, Korea
fCHA Medical Center, Pochon Cha University College of Medicine, Pochon, Korea
gDaehang Hospital, Seoul, Korea
hKorea University Anam Hospital, Korea University College of Medicine, Seoul, Korea
iDaegu Catholic University Medical Center, Daegu Catholic University College of Medicine, Daegu, Korea
jKyungpook National University Hospital, Kyungpook National University School of Medicine, Daegu, Korea
kPaik Institute of Clinical Research, Inje University College of Medicine, Busan, Korea
lBundang Cha Hospital, Pochon CHA University College of Medicine, Seongnam, Korea
mPusan National University Hospital, Pusan National University School of Medicine, Busan, Korea
EUROPEAN UROL OG Y 57 (2010) 973–979
available at www.sciencedirect.com
journal homepage: www.europeanurology.com
Article info
Article history:
Accepted February 10, 2010
Published online ahead of
print on February 19, 2010
Keywords:
Female stress urinary
incontinence
Randomized comparative study
TVT SECUR
Abstract
Background: No studies have been published comparing the U- and H-type
methods of the TVT SECUR (TVT-S) procedure.
Objective: OuraimwastocomparetheefficacyandsafetyofthetwotypesofTVT-S
for female stress urinary incontinence (SUI).
Design, setting, and participants: Women with urodynamic SUI were enrolled in
this 12-mo multicenter randomized study.
Intervention: Subjects were randomly allocated to either the U- or H-type method
of TVT-S.
Measurements: Pre- and postoperative evaluations included a standing stress test,
the Sandvik questionnaire, the Incontinence Quality of Life (I-QOL) questionnaire,
and the International Consultation on Incontinence Questionnaire-Female Lower
Urinary Tract Symptoms (ICIQ-FLUTS). Patients’ satisfaction and complications
were evaluated. Objective and subjective cures were defined as no leakage on the
stress test and responses on the Sandvik questionnaire, respectively. We compared
the surgical outcomes between the two methods.
* Corresponding author. 305 Gudeok-Ro, Seo-Gu, Pusan 602-739, South Korea. Tel. +82 51 240 7350;
Fax: +82 51 255 7133.
E-mail address: toohotman@hanmail.net (J.Z. Lee).
0302-2838/$ – see back matter # 2010 European Association of Urology. Published by Elsevier B.V. All rights reserved.doi:10.1016/j.eururo.2010.02.018

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1. Introduction
Since tension-free vaginal tape (TVT) was introduced as a
minimally invasive surgery for stress urinary incontinence
(SUI), there has been an effort to develop a safer and less
invasive procedure to avoid blind passage of the needle
through the retropubic region. With this aim in mind,
Delorme [1] described the transobturator tape (TOT). In a
recent review [2] that compared TVT and TOT, the
occurrence of bladder perforation, pelvic hematoma, and
storage symptoms was significantly less common in
patients treated with TOT. However, TOT carried risks of
groin pain or neurovascular injury in the obturator region
[2]. Single-incision midurethral slings (MUS), the TVT
SECUR (TVT-S; Gynecare, Menlo Park, CA, USA), the MiniArc
(American Medical Systems, Minnetonka, MN, USA), and
the Mini-Sling (ProSurg, San Jose, CA, USA), were developed
to minimize those risks by the short course of the devices.
The TVT-S consists of PROLENE mesh, 8 cm in length, with
ends coated with an absorbable fleece material that
provides fixation. The system can be fixed in a U-shaped
(U) position into the connective tissue of the urogenital
diaphragm or in a hammock (H) position into the obturator
internus muscle.
To date, no study has been published that compares the
U- and H-type methods. We conducted this study to
compare the efficacy and safety of the two methods of the
TVT-S in women with SUI.
2.Materials and methods
2.1.Design
This 12-mo multicenter randomized trial involved 13 experienced
surgeons (performed >15 cases of TVT-S before this trial) at 13 hospitals.
Participants received detailed information about the study procedure
and provided written consent before study entry. This study was
performed in accordance with the principles of the Declaration of
Helsinki.
2.2. Participants
Women ?18 yr of age with urodynamic SUI or mixed urinary
incontinence (MUI) with a predominance of SUI were eligible for
inclusion. Women who had pelvic organ prolapse (POP) stage ?2 on the
POP quantification system [3], the intention to have more children, or a
neurologic disease were excluded.
2.3. Procedure
Consenting patients were randomly allocated to either the U- or H-type
method in the operating room. Under local (and/or light sedation),
spinal, or general anesthesia, surgery was performed according to the
Results and limitations: Of 285 women, 144 had the U-type method and 141 had the
H-type method. Objective cure rates were 87.5% for the U-type method and 80.1% for
the H-type method (p = 0.091). Subjective cure rates were 77.1% for the U-type method
and 75.7% for the H-type method (p = 0.786). Improvement in I-QOL and domain scores
of the ICIQ-FLUTS (filling and incontinence sum, QOL score), and patients’ satisfaction
favored the U-type method. There were three cases of intraoperative vaginal wall
perforation, one case of increased bleeding, and three cases of temporary postoperative
retention. A power calculation was not performed, and some baseline characteristics
were not balanced between the two methods.
Conclusions: Both methods of TVT-S provided comparable cure rates for female SUI.
However, QOL and treatment satisfaction favored the U-type method.
Trial registration: The protocol of this study was not registered.
# 2010 European Association of Urology. Published by Elsevier B.V. All rights reserved.
Fig. 1 – (a) U-shaped position and (b) hammock (H) position of the TVT SECUR system.
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manufacturer’s instructions. For the U-type method, the inserters were
introduced into the paraurethral space orienting to 458 from the sagittal
midline and advanced upward until the back edge of the pubic bone was
reached, creating a U-shaped sling (Fig. 1a). For the H-type method, the
inserters were introduced into the obturator internus muscle parallel to
the floor creating a hammock-shaped sling (Fig. 1b). An important
technique was to remove the handle gently while carefully inserting the
device into the connective tissue, so the ideal tension would be applied
to the mesh without allowing it to loosen. Cystoscopic examination was
performed in the U-type method. A urethral catheter was introduced
only in the case of postoperative retention.
2.4.Assessments
Baseline evaluation included each participant’s demographics, medical
and surgical histories, obstetric and gynecologic histories, pelvic
examination, and urodynamic study. The urodynamic study was
performed according to the International Continence Society standards
[4]. At baseline and postoperative 12-mo visits, patients were assayed
using the standing stress test, the Sandvik questionnaire [5], the
Incontinence Quality of Life (I-QOL) questionnaire [6], the International
Consultation on Incontinence Questionnaire-Female Lower Urinary
Tract Symptoms (ICIQ-FLUTS) [7], the Incontinence Visual Analogue
Scale (I-VAS; 0, no incontinence; 10, extremely severe incontinence) [8],
and a 3-d voiding diary. One week after surgery, uroflowmetry and
postvoid residuals were measured. Patients described urgency sensation
associated with each micturition in the voiding diary using the Urinary
Sensation Scale (USS; 1, no urgency, to 5, urgency incontinence) [9].
Urgency episodes were defined as the number of micturition-associated
urgencies with a USS score ?3. We asked the patients to describe (1) if
the surgery was beneficial, (2) if the surgery was satisfactory, (3)
whether they would undergo the surgery again if necessary, and (4)
whether they would recommend the surgery to others. Preoperative
patients’ most important goal for the surgery were collated, and
postoperative goal achievement (GA) was assessed using a Likert scale
(0, not at all achieved; 5, completely achieved). Successful achievement
was defined as a score of 4 or 5.
Operation time, estimated blood loss (EBL; calculation, total volume
to volume of prefilled water in the suction chamber), immediate
postoperative pain VAS (0, no pain; 10, excruciating pain), and
perioperative complications were evaluated.
The primary end point was the cure rate at the 12-mo postoperative
visit. Objective and subjective cures were defined as no leakage on the
stress test and responses on the Sandvik questionnaire, respectively.
2.5.Statistical methods
The center applied a stratified permuted block randomization method.
Patients who had a standing stress test at baseline and the 12-mo
postoperative visits consisted of the efficacy set. The safety set consisted
of all participants who received the study procedure. We compared the
continuous or ordinal variable between the two methods using the
student t test or Mann-Whitney U test according to the normality of
distribution. Comparison of nominal variables was performed using the
chi-square test. Postoperative change was analyzed using the paired t
test or Wilcoxon signed rank test. The Bonferroni correction was applied
where necessary. SAS software v.9.1.3 (SAS Institute Inc, Cary, NC, USA)
was used, and a p value <0.05 was considered statistically significant.
Fig. 2 – Participation diagram.
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3.Results
Of the 330 women enrolled, 285 (144 in the U group and
141 in the H group) were included in the efficacy analysis
(Fig. 2). Table 1 shows the participants’ demographics.
Age, menopausal status, percentage of women with
detrusor overactivity (DO), and number of urgency
episodes were not balanced between the groups. The
mean duration of the surgery was 17.0 ? 9.7 min, and the
mean duration of hospital stay was 1.0 ? 1.2 d without a
significant difference between the groups. The mean EBL
was 44.0 ? 80.3 ml (U, 41.8 ? 38.7 vs H, 39.0 ? 64.4;
p = 0.674). The mean pain VAS was 2.4 ? 2.0 (U, 2.5 ? 2.1
vs H, 2.3 ? 1.8; p = 0.530).
Table 1 – Baseline characteristics
VariablesTotal (n = 285)U type (n = 144)H type (n = 141)
p value
Age, yr, mean ? SD
BMI, mean ? SD
Parity, mean ? SD
Menopausal status
Symptom duration, yr, mean ? SD
Stamey symptom grade
1
2
3
Urodynamic parameters
VLPP, cm H2O, mean ? SD
ISD, VLPP ?60 cm H2O
MUCP, cm H2O, mean ? SD
DO
Mixed incontinence
Urethral hypermobility
Voiding diary parameters
Frequency/24 h, mean ? SD
Nocturia/24 h, mean ? SD
Urgency episode/24 h, mean ? SD
54.2 ? 9.1 (32–85)
24.0 ? 3.0 (17.3–39.1)
2.6 ? 1.1 (0–9)
65.1%
5.8 ? 5.3 (0.3–33.0)
55.4 ? 9.1 (35–79)
24.1 ? 3.1 (18.2–39.1)
2.7 ? 1.2 (0–6)
72.1%
6.0 ? 5.6 (0.5–33.0)
53.0 ? 8.9 (32–85)
23.9 ? 2.9 (17.3–31.7)
2.6 ? 1.1 (1–9)
57.8%
5.6 ? 5.0 (0.3–30.0)
0.0136*
0.9384*
0.9900*
0.0125y
0.9801*
0.6515*
–
–
–
34.3%
53.0%
12.7%
36.1%
50.8%
13.1%
32.2%
55.4%
12.4%
89.6 ? 25.3 (13–170)
11.4%
46.5 ? 21.2 (11–117)
13.5%
38.4%
61.2%
89.8 ? 24.5 (15–170)
9.8%
46.3 ? 21.5 (11–117)
18.2%
42.5%
59.2%
89.4 ? 26.2 (13–165)
13.0%
46.8 ? 20.9 (11–114)
8.6%
34.3%
63.3%
1.0000*,§
0.7815y,§
0.7821*
0.0189y
0.2143y
0.5068y
9.0 ? 2.8 (4–22)
1.2 ? 1.1 (0–6)
2.4 ? 3.2 (0–22)
9.0 ? 2.6 (4–22)
1.3 ? 1.2 (0–6)
2.9 ? 3.4 (0–13)
9.1 ? 2.9 (4–22)
1.2 ? 1.1 (0–5)
1.9 ? 3.0 (0–22)
1.0000*
0.8327*
0.0211*
BMI = body mass index; DO = detrusor overactivity; ISD = intrinsic sphincter deficiency; MUCP = maximum urethral closing pressure; VLPP = Valsalva leak
point pressure.
*Mann-Whitney U test.
yChi-square test.
§Bonferroni correction.
Table 2 – Comparisons of the changes in outcome measures between the U- and H-type methods
VariablesTotal U-type methodH-type method
p value
Preop Postop PreopPostopPreopPostopU vs Hy
I-QOL
Avo/Lim
Psychosocial impacts
Social embarrassment
ICIQ-FLUTS
Filling sum
Voiding sum
Incontinence sum
Sexual function score
QOL score
I-VAS
Voiding diary parameters
Micturition/24 h
Nocturia
Urgency episode/24 h
Uroflowmetry parameters
Qmax
PVR
41.8
43.3
34.7
71.3*
71.9*
74.9*
41.8
43.4
33.9
75.3*
76.0*
79.6*
41.8
43.2
35.5
67.2*
67.7*
70.0*
0.022
0.021
0.015
6.18
2.58
8.55
1.74
7.77
6.82
3.60*
1.74*
3.46*
0.87*
3.46*
1.36*
6.20
2.91
8.76
1.81
7.90
6.90
3.18*
1.86*
2.82*
0.81*
2.80*
1.03*
6.15
2.23
8.33
1.66
7.64
6.75
4.04*
1.61*
4.12*
0.94*
4.15*
1.69*
0.022
0.276
0.006
0.421
0.007
0.056
9.03
1.25
2.37
7.97*
0.68*
1.22*
8.99
1.28
2.88
8.02*
0.68*
1.40*
9.07
1.23
1.86
7.92*
0.69*
1.04*
0.218
0.615
0.329
25.7
18.0
24.3
20.1
24.8
18.2
23.7
20.6
26.6
17.8
25.0
19.6
0.576
0.306
Avo/Lim = avoidance and limiting behavior; ICIQ-FLUTS = International Consultation on Incontinence Questionnaire-Female Lower Urinary Tract Symptoms;
I-QOL = Incontinence Quality Of Life questionnaire; PVR = postvoid residuals; Qmax= maximum flow rate; QOL = quality of life; I-VAS = Incontinence Visual
Analogue Scale.
*p < 0.05; comparison between pre- and postoperative, Wilcoxon signed rank test, or paired t test with Bonferroni correction.
yComparison between U- and H-type methods, Mann-Whitney U test, or t test.
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3.1.Efficacy
The overall objective cure rate was 83.9% (239 of 285);
87.5% (126 of 144) for U versus 80.1% (113 of 141) for H
(p = 0.091). The overall subjective cure rate was 76.4% (217
of 284); 77.1% (111 of 144) for U versus 75.7% (106 of 140)
for H (p = 0.786). Table 2 summarizes the postoperative
changes in the outcome measures and the comparison of
the changes between groups. The improvement in all
domain scores of the I-QOL questionnaire was greater in the
U group. Filling, incontinence, andQOL domain scores of the
ICIQ-FLUTS were significantly further improved in the U
group. There was no difference in the improvement in
voiding diary parameters and I-VAS between groups.
Women in the U group reported higher rates of satisfaction,
willingness to have surgery again, and willingness to
recommend the surgery (Fig. 3). Of the 108 women who
had MUI at baseline, 41.5% (U, 45.8% vs H, 37.0%; p = 0.383)
reported that their urgency incontinence was cured after
surgery.
Patients’ goals for the surgery consisted of five catego-
ries, and most were related to symptom relief (Table 3).
After surgery, the median point of GA was 4.5 (U, 4.5 vs H,
4.0; p = 0.123). And 81% (U, 83.8% vs H, 78.2%; p = 0.546)
reported that their goal was achieved successfully.
3.2.Complications and additional procedures
Three cases of lateral vaginal wall perforation occurred
during the H-type method. All cases were repaired
immediately, and there were no wound complications.
A woman in the H group received 2 pt of blood due to
postoperativedizzinessand
(500 ml). After transfusion, her symptom was relieved,
and no hematoma or intravaginal bleeding was found on
physical and pelvic examination. Postoperative retention
occurred in two U-group and three H-group cases. All of
them recovered their normal voiding after 1 or 2 d with an
indwelling urethral catheter.
De novourgencywas reported in7.3% (U, 7.0%vs H,7.6%;
p = 0.858), and none of them reported de novo urgency
incontinence. No women complained of postoperative
dyspareunia.
Eleven women, six U-group and five H-group cases,
received the tape plication procedure for persistent or
recurrentSUI.Ofthose,twoU-groupcaseshadanadditional
H-type method of TVT-S, and three U-group cases had MUS
(two TVT and one TOT). Mesh erosion and bladder or
urethral injuries were not reported during the study period.
intraoperativebleeding
4. Discussion
This is the first randomized study comparing the U- and H-
type methods of the TVT-S. We found that cure rate was
comparable between the two methods 12 mo after surgery.
However, outcomes regarding QOL and satisfaction were in
favor of the U-type method. We believe that the higher cure
rate of the U-type method, even though it did not reach
statistical significance, would affect the results.
Reported cure rates of TVT-S are similar to ours, ranging
from 78% to 100% [10–12]. Meschia et al [11] in particular
reported 79% and 77% success rates in the H- and U-type
methods, respectively. Another single-incision sling, MiniArc,
was reported as having a 69–91% cure rate [13,14]. Our
result is also comparable with those of conventional MUS
whose 1-yr cure rate is 85–93% [15,16].
Our study population showed heterogeneous character-
istics in terms of the MUI, intrinsic sphincter deficiency
(ISD), and urethral hypermobility (UH). Moreover, there
were unbalanced baseline characteristics regarding age,
menopausal status, DO, and number of urgency episodes.
Therefore, we conducted subanalysis comparing cure rates
according to those variables and found that they did not
change the cure rates significantly. However, according to
the subanalysis by the presence of UH, the subjective cure
rate was lower in the H group among women with UH (U,
86.5% vs H, 72.4%; p = 0.033). This result was different from
the study conducted by Martan et al [17], which reported
thatinthegroupofwomenwithlargerUHitmightbebetter
to place the tape in the H position. The other results were
also inconsistent with existing data in which MUI, ISD, and
DO were reported as negative impact factors [18,19]. Those
Fig. 3 – Patients’ 12-mo perception of treatment benefit, satisfaction,
willingness to have retreatment, and willingness to recommend.
Table 3 – Patient-reported goals and goal achievement (n = 220)
Category
n (%)PGA (median, quartile)
Symptom relief
Stress incontinence
Frequency
Urgency
Nocturia
Weak stream
Pelvic discomfort
Activity/exercise
Quality of life
Coping behavior
Sexual function
152 (69.1%)
140 (63.6%)
6 (2.7%)
2 (0.9%)
1 (0.5%)
1 (0.5%)
2 (0.9%)
47 (21.4%)
12 (5%)
8 (4%)
1 (0.5%)
4.5 (4, 5)
4.5 (4, 5)
4.5 (4, 4.5)
4 (4, 4)
0.5
2.5
3.25 (2, 4.5)
4.8 (4, 5)
5 (4, 5)
4.7 (2.5, 5)
5
PGA = Patient-reported goal achievement.
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