The safety and efficacy of the "inside-out" trans-obturator TVT in elderly versus younger stress-incontinent women: a prospective study of 353 consecutive patients.

Abstract

To analyze the safety and efficacy of the trans-obturator tension-free vaginal tape (TVT-O) in elderly versus younger stress-incontinent women.
Ninety-seven consecutive elderly, aged 70 and older, and 256 younger women (mean age 75 and 55 years, respectively) who underwent TVT-O for urodynamically confirmed stress urinary incontinence (SUI) were prospectively enrolled. Concomitant pelvic organ prolapse (POP) repair was performed in 90% of the elderly and 70% of the younger women. The surgical procedures, as well as all pre- and postoperative clinical and urodynamic evaluation, were performed in one university-affiliated medical center. Main outcome measures were operative complications, early and late postoperative morbidity, postoperative urodynamically confirmed SUI (symptomatic, or asymptomatic), persistent, or de novo overactive bladder (OAB) and bladder outlet obstruction (BOO).
Mean follow-up of the patients was 30 ± 17 months (range 3-58 months). Early and late postoperative morbidity was similar in both groups, except for significantly more cases of postoperative recurrent UTI's among elderly women (13.7% vs. 6.2%). The incidence of persistent urodynamically confirmed overt SUI was similar in both age groups (5%). However, asymptomatic urodynamic SUI was significantly more common among elderly patients (19% vs. 3.7%, P<0.05). The incidence of persistent OAB was similar in elderly and younger patients (68% and 62%, respectively), while de novo OAB was significantly more common in elderly patients (11.9% vs. 4.7%, P<0.05).
TVT-O is safe and efficient for both elderly and younger stress-incontinent women. However, elderly patients are in increased risk for postoperative recurrent UTI's as well as de novo OAB.

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Neurourology and Urodynamics
The Safety and Efficacy of the “Inside-Out” Trans-Obturator TVT
in Elderly Versus Younger Stress-Incontinent Women: A
Prospective Study of 353 Consecutive Patients
Asnat Groutz,*Aviad Cohen, Ronen Gold, David Pauzner, Joseph B. Lessing, and David Gordon
Urogynecology and Pelvic Floor Unit, Department of Obstetrics and Gynecology, Lis Maternity Hospital, Tel Aviv Sourasky
Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
Objectives: To analyze the safety and efficacy of the trans-obturator tension-free vaginal tape (TVT-O) in elderly ver-
sus younger stress-incontinent women. Methods: Ninety-seven consecutive elderly, aged 70 and older, and 256 younger
women (mean age 75 and 55 years, respectively) who underwent TVT-O for urodynamically confirmed stress urinary
incontinence (SUI) were prospectively enrolled. Concomitant pelvic organ prolapse (POP) repair was performed in 90%
of the elderly and 70% of the younger women. The surgical procedures, as well as all pre- and postoperative clinical and
urodynamic evaluation, were performed in one university-affiliated medical center. Main outcome measures were oper-
ative complications, early and late postoperative morbidity, postoperative urodynamically confirmed SUI (symptomatic,
or asymptomatic),persistent,or de novo overactive bladder (OAB) and bladder outlet obstruction (BOO). Results: Mean
follow-up of the patients was 30±17 months (range 3--58 months). Early and late postoperative morbidity was similar
in both groups, except for significantly more cases of postoperative recurrent UTI’s among elderly women (13.7% vs.
6.2%). The incidence of persistent urodynamically confirmed overt SUI was similar in both age groups (5%). However,
asymptomatic urodynamic SUI was significantly more common among elderly patients (19% vs. 3.7%, P<0.05). The
incidence of persistent OAB was similar in elderly and younger patients (68% and 62%, respectively), while de novo
OAB was significantly more common in elderly patients (11.9% vs. 4.7%, P<0.05). Conclusions: TVT-O is safe and
efficient for both elderly and younger stress-incontinent women. However, elderly patients are in increased risk for
postoperative recurrent UTI’s as well as de novo OAB. Neurourol. Urodyn. © 2010 Wiley-Liss, Inc.
Key words: elderly; stress urinary incontinence; surgical outcomes; TVT-O
INTRODUCTION
People all over the world are living longer. By 2050, one
of every five people living in the United States will be aged
65 or older, and the total number of older Americans is
expectedtobe82million.1Similarly,the2050lifeexpectancyof
American women at birth is expected to be 85.6.2Advanced
age is associated with age-related physiologic changes and
increased incidence of co-morbidity. It is also associated with
increased prevalence of urinary incontinence, with an early
prevalencepeakduringmidlife(prevalence30--40%),andasub-
sequent steady increase in later life (prevalence 30--50%).3--5
Type and clinical presentation of urinary incontinence may
vary with aging. Stress urinary incontinence (SUI) is more
common in younger women, while mixed stress and urge
incontinence predominates in the older age group.5,6Urinary
incontinence among elderly women may also be associated
withimpairedbladderemptyingcausedbydetrusorunderactiv-
ityand/orbladderoutletobstruction(BOO).7Theseconcomitant
factors, along with some other age-related co-morbidities,
may adversely affect the management of elderly incontinent
patients.
Surgical intervention is considered to be the most efficient
and durable approach for the treatment of SUI. A wide variety
of surgical techniques have been described, among which the
mid-urethral sling procedures have gained worldwide popular-
ity. Data regarding the safety and efficacy of these procedures
in elderly women are scarce. The present study was con-
ducted to assess the safety and medium-term effectiveness
of the “inside-out” trans-obturator tension-free vaginal tape
(TVT-O) procedure in elderly versus younger stress-incontinent
women.
METHODS
A total of 353 consecutive women who underwent TVT-O
procedure (GYNECARE TVT Obturator System, Somerville, NJ)
for urodynamically proven SUI were prospectively enrolled. The
studyprotocolwasapprovedbythelocalhospitalHelsinkicom-
mittee. Elderly patients were defined as being 70 years of age
and older. Of the study population 97 (27%) were classified
as elderly (mean age 75±4.1; range, 70--90) and 256 (73%) as
younger patients (mean age 55±8.6; range, 31--69).
All patients underwent a full clinical and urodynamic evalu-
ation before surgery. Physical examination was undertaken in
the lithotomy and standing positions. Diagnosis of pelvic organ
prolapse (POP) was established by using the POP Quantification
(POP-Q). Indications for surgical prolapse repair were stage 2--4
prolapse.Themethods,definitions,andunitsoftheurodynamic
evaluationconformedtothestandardsproposedbytheInterna-
tional Continence Society.8Stress test was performed at 150ml
and at every additional 50ml until SUI was demonstrated, or
maximum cystometric capacity was attained. Urodynamic SUI
was defined as the involuntary loss of urine during increased
intra-abdominal pressure, without a change in the detrusor
pressure. Patients with POP that did not demonstrate urody-
namic overt SUI, were re-examined with a fitted ring pessary.
Heinz Koelbl led the review process.
Conflict of interest: none.
∗Correspondence to: Dr. Asnat Groutz, Urogynecology and Pelvic Floor Unit, Lis
Maternity Hospital, Tel Aviv Sourasky Medical Center, 6 Weizman Street, Tel Aviv,
Israel. E-mail: agroutz@yahoo.com
Received 13 February 2010; Accepted 15 June 2010
Published online in Wiley InterScience
(www.interscience.wiley.com).
DOI 10.1002/nau.20976
© 2010 Wiley-Liss, Inc.

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Groutz et al.
Urodynamic occult SUI was defined as the involuntary loss of
urine during Valsalva maneuver after prolapse reduction and
in the absence of simultaneous detrusor contractions. BOO was
categorized by the Blaivas--Groutz nomogram.9
Surgical intervention was tailored according to clinical and
urodynamic findings: Stress-incontinent women with normal
pelvic anatomy underwent TVT-O only, whereas those with
POP, and either overt or occult SUI, underwent combined TVT-
O and prolapse repair. All surgical procedures were carried
out by one of three experienced urogynecologists (A.G., R.G.,
D.G.). The TVT-O procedure was performed in strict accordance
with the method described by Jean de Leval, the technique
initiator.10Intra-operative urethro-cystoscopy was not rou-
tinely performed.
Patients were closely followed-up during their hospital stay.
Special attention was taken in evaluating and documenting
early postoperative morbidity. Postoperatively, the patients
were scheduled for evaluation at 1, 3, 6, and 12 months, and
annually thereafter. Each visit comprised of medical history,
focused questioning regarding the occurrence and severity
of lower urinary tract symptoms, pelvic examination with a
full bladder, stress test, uroflow and post void residual urine
volume. Urodynamic evaluation was routinely undertaken 3
months after surgery. Patients, who developed lower urinary
tract symptoms after this time, underwent a full clinical evalu-
ation,includingrepeatedurodynamics,atpresentation.Patients
who developed postoperative recurrent urinary tract infections
(UTIs), or de novo overactive bladder (OAB) also underwent
urethro-cystoscopy to exclude iatrogenic injury. Recurrent UTI
was defined as at least three episodes of UTI, with at least one
documented by culture, in the last 12 months. OAB was defined
as urinary urgency, with or without urge incontinence, usually
with frequency and nocturia. All pre- and postoperative data
were prospectively documented and stored in a computerized
data base.
Main outcome measures were procedure-related complica-
tions, early and late postoperative morbidity, postoperative
urodynamically confirmed persistent SUI (symptomatic or
asymptomatic), persistent, or de novo OAB, and BOO. Surgical
safetyandefficacywerecomparedbetweenelderlyandyounger
patients. Results were analyzed statistically by Student’s t-test
and χ2test. Values of P<0.05 were considered significant. Data
arepresentedasmean±SD,orpercentageaccordingtothevari-
ables.
RESULTS
Of 353 eligible patients, 17 (2 elderly and 15 young) were
lost for further follow-up after the first visit at 1-month post-
operatively. All other 336 patients (95 elderly and 241 young)
were available for a complete postoperative clinical and uro-
dynamic analysis. Mean follow-up of the patients was 30±17
months (range 3--58 months). Clinical characteristics of elderly
versus younger patients are presented in Table I. The vast
majority of the elderly patients were community-dwelling,
cognitive-healthy women. Overall, 35 (10%) of the patients had
previouslyundergonehysterectomyand12(3%)hadundergone
anti-incontinence procedures. OAB was reported by 56% of the
elderlyand57%oftheyoungerpatients.ConcomitantPOPrepair
was required in 87 (90%) elderly (90% of whom had stage 3--
4 POP) and 180 (70%) younger patients (59% of whom had stage
3--4 POP).
Early postoperative morbidity was similar in elderly and
younger patients (Table II). Mean hospital stay was 5.4±2 ver-
Neurourology and Urodynamics DOI: 10.1002/nau
TABLE I. Patient’s Characteristics
Age≥70 years
(N=97) (27%)
Age<70 years
(N=256) (73%)Mean±SD or N (%) (N=353)
Age (years)
Parity
Estrogen replacement therapy
Previous hysterectomy
Previous incontinence surgery
Concomitant OAB
Concomitant POP
75±4.1
2.8±1.6
2 (2%)
14 (14%)
2 (2%)
54 (56%)
87 (90%)
55±8.6
3.1±1.4
21/177 (12%)
21 (8%)
10 (4%)
145 (57%)
180 (70%)
OAB, over active bladder; POP, pelvic organ prolapse.
sus 4.6±2.7 days for elderly and younger patients, respectively.
MostpatientswhounderwentTVT-Oonlyweredischargedfrom
hospital the day after the procedure. However, 53 (55%) of the
elderly and 88 (34%) of the younger patients also had con-
comitant vaginal hysterectomy with anterior and/or posterior
colporrhaphies that required longer hospitalization. Incidence
of early postoperative fever, UTI, and blood loss was all simi-
lar in both age groups. Three (3%) of the elderly and 13 (5%) of
the younger patients had immediate postoperative voiding dif-
ficulties necessitating catheterization for more than 7 days. No
loosening procedure of the tape was undertaken. All resumed
spontaneous voiding within 3 weeks postoperatively. Seven
(7%) of the elderly and 28 (11%) of the younger patients had
protracted postoperative thigh pain with spontaneous resolu-
tion within 1--3 months. Other early postoperative morbidity
included one case of cardiac arrhythmia and one case of facialis
in elderly patients, and two cases of pneumonia in younger
patients.
An analysis of late postoperative morbidity and outcome
resultswasrestrictedtothesubsetof95elderlyand241younger
patientswithatleast3monthsfollow-up(mean30±17;range,
3--58 months). Vaginal erosion of the prolene tape was diag-
nosed in two (2.1%) of the elderly and five (2.1%) of the younger
patients. All cases were diagnosed within 6 months postoper-
atively. Most (five cases) were midline erosions. The patients
were treated by local excision of the eroded tape, with subse-
quent complete healing. Recurrent UTIs occurred in 13 (13.7%)
elderlyand15(6.2%)youngerpatients.Iatrogeniclowerurinary
tract injury was excluded by postoperative urethro-cystoscopy.
Of the 87 elderly patients who underwent concomitant POP
repair, 10 (11%) developed recurrent stage 2 POP, and 8 (9%)
othershadrecurrentstage3--4POP.Ofthe180youngerpatients
who underwent concomitant POP repair, 22 (12%) developed
recurrent stage 2 POP, and 6 (3%) others had recurrent stage 3--
4 POP.
Functional outcome analysis is presented in Table III. The
incidenceofpersistentpostoperativeurodynamicallyconfirmed
SUI was similar in both age groups (5%). However, incidence of
TABLE II. Early Postoperative Morbidity
Age≥70 years
(N=97) (27%)
Age<70 years
(N=256) (73%)Mean±SD or N (%) (N=353)
Hospital stay (days)
Catheter >7 days
Fever
Persistent pain
Other complications
5.4±2
3 (3%)
4 (4%)
7 (7%)
4.6±2.7
13 (5%)
13 (5%)
28 (11%)
Pneumonia: 2 Cardiac arrhythmia: 1,
facialis: 1

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TVT-O in Elderly Versus Younger Women
3
TABLE III. Outcome Results
Elderly patients
(N=95)
Young patients
(N=241)Mean±SD or N (%)
Follow up (months)
Vaginal erosion
Recurrent UTI’s
Persistent urodynamic SUI
Symptomatic
Asymptomatic
Persistent OAB
De novo OAB
Bladder outlet obstruction
Uroflowmetry
Voided volume (ml)
Maximum flow rate (ml/sec)
Post void residual volume (ml)
27±17
2 (2.1%)
13 (13.7%)∗
31±16
5 (2.1%)
15 (6.2%)
5 (5.3%)
18 (19%)∗
36/53 (68%)
5/42 (11.9%)∗
0
13 (5.4%)
9 (3.7%)
84/135 (62%)
5/106 (4.7%)
3 (1.2%)
274±89
16.2±9.5
102±81
331±97
21.3±8.6
71±58
SUI, stress urinary incontinence; OAB, over active bladder; UTI, urinary tract
infection.
∗P<0.05.
urodynamic SUI in clinically asymptomatic patients was sig-
nificantly higher among elderly versus younger patients (19%
vs. 3.7%, P<0.05). The incidence of persistent OAB was simi-
lar in elderly and younger patients (68% and 62%, respectively),
while de novo OAB was significantly more common in elderly
patients (11.9% vs. 4.7%, P<0.05). All cases of de novo OAB
underwent urethro-cystoscopy to exclude intra-vesical pathol-
ogy. Three (1.2%) of the younger patients, versus none of the
elderly, had symptoms and pressure-flow studies suggesting
BOO. All cases were classified as moderate obstruction by the
Blaivas--Groutznomogram.9Thepatientsweretreatedbytrans-
vaginal excision of the tape, with complete resolution of the
obstruction.Unfortunately,thesepatientsalsodevelopedrecur-
rent SUI thereafter.
DISCUSSION
Age-related medical morbidity, as well as impaired blad-
der function may adversely affect management and outcomes
of stress-incontinent elderly women. Aging is associated
with increased incidence of detrusor overactivity, and a sub-
stantial number of stress-incontinent elderly women also
have urge incontinence. Aging may be also associated with
detrusor underactivity and impaired bladder emptying.5--7
These features, accompanied by reduced compliance to con-
servative therapy, may adversely affect outcome results of
any anti-incontinence intervention. Nevertheless, the surgical
management of these women is the same as younger stress-
incontinent patients.
Data regarding the safety and efficacy of mid-urethral slings
for the treatment of stress-incontinent elderly women are
scarce. Few studies examined the efficacy of the traditional
retro-pubictensionfreevaginaltape(TVT)inolderpopulations.
Sevestreetal.11analyzedaseriesof76elderlystress-incontinent
womenwhounderwentTVT.Therewerenomajorpostoperative
complications, however, 13.7% of the patients had postopera-
tive persistent SUI and 18.4% had urge incontinence. De novo
urgency without incontinence was detected in 21% of the
patients. The investigators concluded that although the rate of
de novo urgency appeared to be significant, TVT is safe and
efficient in elderly populations. In another study, pre- and post-
operative quality of life parameters were compared in a small
seriesof21elderlyand46youngerstress-incontinentpatients.12
At postoperative follow-up of 3--24 months, SUI was improved
in91%oftheyoungerand80%oftheelderlypatients.Qualityof
lifeparameters,includingincontinenceimpact,rolelimitations,
physical limitations, social limitations, emotions and severity
measures, were all significantly improved in both age groups.
In another study, carried out in our medical center, a large
series of 157 elderly and 303 consecutive younger patients who
underwent TVT was analyzed.13Incidence of early postopera-
tive morbidity was similar in both age groups. However, several
cases of significant age-related morbidity were noted among
elderly patients: two cases of pulmonary embolism, two cases
of cardiac arrhythmia, one case of severe pneumonia, and one
case of deep vein thrombosis. All major age-related complica-
tions occurred in elderly patients who underwent concomitant
prolapse repair. We therefore speculated that some age-related
complications were due to the larger surgical intervention as
wellaslongerhospitalizationassociatedwithconcomitantpro-
lapse repair. Outcome analysis of that series was restricted to
123 elderly and 208 younger women with at least 12 months
follow-up. Results were similar in both age groups except for
a significantly higher incidence of postoperative de novo urge
incontinence among elderly women (18% vs. 4%, P<0.05).
The blind penetration of the retro-pubic space by the classic
TVT applicators may cause some major injuries.14An alterna-
tive surgical approach, in which the mid-urethral tape is passed
throughtheobturatorforamens,eitherinside-outoroutside-in,
was therefore developed. Several studies confirmed the safety
and efficacy of these trans-obturator procedures.15--19A recent
French registry data on 984 TVT-O procedures revealed periop-
erative morbidity rate of 2.2% and postoperative complication
rate of 5.2%.19The most common complication was residual
pain (2.7%). The other complications of paravesical hematoma,
urinary retention, vaginal erosion and re-intervention had an
incidence of less than 1%. However, to date, there are almost
no data regarding the safety and efficacy of these procedures
in elderly patients. Chen et al.20investigated potential risk
factors associated with failure of TVT-O in a small series of
54 women, 11 of whom were ≥60 years. Overall, the sur-
gical procedure failed in 6 (11%) patients, 4 of whom were
≥60 years. The investigators concluded that “only age and
previous anti-incontinence surgery were significant risk fac-
tors for surgical failure.” Contrary to these findings, results
of our series demonstrate similar failure rates in elderly and
younger patients. These outcome results are similar to the pre-
vious data reported by our group regarding the efficacy of
retro-pubic TVT in elderly women.13The incidence of persis-
tent postoperative urodynamically confirmed SUI was similar
in both age groups (5%). However, incidence of urodynamic SUI
in clinically asymptomatic patients was significantly higher
among elderly patients (19% vs. 3.7%, P<0.05). We speculate
that this finding may reflect an intuitive surgical tendency to
leave the tape very loose in elderly patients in order to pre-
ventpostoperativevoidingdifficulty.Thisspeculationisfurther
supported by the finding that none of our elderly patients had
postoperative BOO. The clinical implication of urodynamic SUI
in asymptomatic women is unclear. It is quite possible that
these women will develop overt SUI at a later date. The inci-
dence of persistent OAB was similar in elderly and younger
patients (68% and 62%, respectively), while de novo OAB was
significantly more common in elderly patients (11.9% vs. 4.7%,
P<0.05). High rates of de novo OAB or urge incontinence
were also reported in elderly patients who underwent retro-
pubic TVT.11,13There was no serious early or late postoperative
morbidity among our patients. The only significant late mor-
bidity in elderly compared to younger women was recurrent
UTI’s (13.7% vs. 6.2%, respectively, P<0.05). However, it should
Neurourology and Urodynamics DOI: 10.1002/nau

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Groutz et al.
be noted that the vast majority of our elderly patients were
community-dwelling, cognitive-healthy women. The safety of
anti-incontinence surgical procedures in frail elderly patients
needs further investigation.
CONCLUSIONS
In conclusion, TVT-O is safe and efficient for both elderly and
younger stress-incontinent women. However, elderly patients
are in increased risk for postoperative recurrent UTI’s as well as
de novo OAB.
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