Safety and Efficacy of Retropubic or
Transobturator Midurethral Slings in a
Randomized Cohort of Turkish Women
Tufan Tarcan Naside Mangir Ahmet Sahan Yiloren Tanidir
Muhammed Sulukaya Yalcin İlker
Department of Urology, Marmara University School of Medicine, Istanbul , Turkey

status. Patients with a poorer subjective cure rate were

those with mixed urinary incontinence, whose preopera-
tive SEAPI and OAB-V8 scores were significantly higher.

Conclusion: MUS surgery is highly effective and could safe-
ly be performed in a cohort of Turkish women with SUI in

subspecialty centers by experienced surgeons. There is no
significant difference between RP or TO applications in
terms of safety and efficacy. Further studies with long-term
follow-up data are required. © 2014 S. Karger AG, Basel

Introduction
Urinary incontinence (UI) is a common condition
which has a negative impact on the physical, social and
psychological well-being of patients. The type and clinical
presentation of UI varies mainly with ageing [1] among

other possible factors [2] . Stress UI (SUI) is more com-
mon in younger women while mixed UI (MUI) and ur-
gency UI are more common in elderly women. MUI is

more bothersome than pure SUI [3] and population-
based studies have demonstrated that MUI has a greater

impact on health-related quality of life compared to SUI
[4] .

Key Words
Urinary incontinence · Midurethral sling · Vaginal mesh ·
Vaginal tape

Abstract
Objective: The aim of this study was to evaluate the safety

and efficacy of retropubic (RP) or transobturator (TO) mid-
urethral slings (MUS) in a prospective randomized cohort of

Turkish women. Patients and Methods: A total of 54 wom-
en with urodynamic stress urinary incontinence (SUI) were

randomized to undergo either RP or TO MUS between Au-
gust 2006 and February 2013 in a tertiary referral center by

a single surgeon. All patients had history, physical examina-
tion, urodynamic evaluation and quality of life assessments.

The validated Turkish versions of the SEAPI, ICIQ-SF and
OAB-V8 questionnaires were used. The Advantage ® RP and
the Obtryx ® TO MUS Systems were used for all RP and TO

procedures. Results: Twenty-seven patients were random-
ized to each group. The median follow-up was 48.5 ± 21.8

months. The median hospital stay was 24.0 ± 4.8 h and me-
dian operative time was 35.0 ± 19.9 min. The overall objec-
tive and subjective cure rates were 92.6 and 79.6%, respec-
tively. The quality of life of all patients significantly in-
creased after the operation compared to their preoperative

Received: April 24, 2014
Accepted after revision: June 2, 2014
Published online: August 20, 2014

Internationalis
Urologia

Tufan Tarcan, MD, PhD
Marmara University Medical School
Fevzi Çakmak M. Mimar Sinan C. No:41
TR–34899 Pendik, Istanbul (Turkey)
E-Mail bilgi @ tufantarcan.com

www.karger.com/uin

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450

Surgical treatment of SUI was revolutionized by Ulm-
sten and Petros [5] in 1995 through the introduction of

the tension-free vaginal tape (TVT) procedure, which has
gained widespread acceptance in the last 20 years [6] ,

mostly due to the high success rates and relative simplic-
ity of the procedure that allows greater numbers of sur-
geons to perform it. After TVT a variety of other retropu-
bic (RP) and transobturator (TO) tapes were introduced

which made midurethral sling (MUS) procedures less in-
vasive and safer [7] .

There has been a multitude of randomized controlled
trials designed to evaluate the comparative efficacy of RP

and TO routes for MUS insertion. Recently, a meta-anal-
ysis of these randomized controlled trials revealed similar

efficacy profiles for both procedures, although rates of
bladder perforations, pelvic hematomas and de novo
storage lower urinary tract symptoms were significantly
lower in TO procedures [8] .
Nowadays, female pelvic floor surgeons are facing the
fact that synthetic mesh materials used in the pelvic floor
are not invariably safe. Indeed, the serious and irreversible

complications associated with these meshes seen in long-
term follow-up have led to litigations against manufactur-
ers and surgeons, which are apparently increasing [9] .

The aim of this study was to evaluate the safety and ef-
ficacy of RP and TO MUS surgeries in a prospective ran-
domized cohort of Turkish women with SUI or stress-
predominant MUI.

Patients and Methods
A total of 54 women with urodynamic SUI were randomized to
undergo either RP or TO MUS operations between August 2006
and February 2013. The study protocol was approved by the local
Ethics Committee of Marmara University School of Medicine
(MAR.YC.2007.0082). All patients signed a detailed informed
consent form. Inclusion criteria were urodynamically proven SUI,
which included pure urodynamic SUI and stress-predominant
MUI [urodynamic SUI plus overactive bladder (OAB) symptoms

with or without urodynamic detrusor overactivity (DOA)]. Exclu-
sion criteria were neurogenic bladder, previous anti-incontinence

surgery and the presence of urogenital prolapse greater than or
equal to stage 3.

The preoperative assessment included history, physical exami-
nation, including cough and Q tip testing, 24-hour pad test, uri-
nalysis and culture and urodynamic assessment. Urodynamic as-
sessment included filling and voiding cystometry with a pressure

flow study. Filling cystometry was performed with room tempera-
ture saline at a rate of 40 ml/min via an 8-Fr double lumen filling

catheter. All of the urodynamic investigations in this study were
performed according to the International Continence Society

(ICS) ‘good urodynamic practice’ guidelines [10] and the ICS ter-
minology was used for all definitions [11] . Urodynamic SUI was

defined as involuntary loss of urine during increased intra-abdom-
inal pressure, without a change in detrusor pressure. MUI was de-
fined as the existence of urodynamic SUI together with symptoms

of urgency or urgency UI with or without DOA. The degree of
pelvic organ prolapse was evaluated with the pelvic organ prolapse
quantification (POP-Q) system. Objective measurement of UI was
performed preoperatively by a 24-hour pad test in all patients and
repeated postoperatively only for uncured patients. A visual analog
scale in which 0 represents ‘no pain’ and 10 represents ‘worst pain
possible’ was used to evaluate pain at 1 and 24 h after surgery.
Health-related quality of life was evaluated with validated
Turkish versions of ICIQ-SF [12] and SEAPI questionnaires [13] .

Two forms were completed by each patient during the preopera-
tive evaluation and postoperative months 1 and 12. OAB symp-
toms were also evaluated by a recently validated Turkish version

of OAB-V8 [14] .

The objective cure rate was defined as no leakage of urine dur-
ing a cough stress test, which was performed in lithotomy position

with a filled bladder (200–300 ml). The bladder volume was con-
firmed by a hand-held ultrasound bladder scanner (BladderScan ®

BVI 6100, Verathon Medical Europe, IJsselstein, The Nether-
lands). The subjective cure rate was defined by the patient’s global

impression of her continence status. Subjective and objective cure
rates were evaluated at months 1 and 12 after surgery.
Randomization was performed using a computer-generated
randomization scheme. All the operations were performed by an

experienced surgeon in strict accordance with the methods previ-
ously described [15, 16] . The Advantage ® RP MUS System (Bos-
ton Scientific, Natick, Mass., USA) was used for all of the RP and

TheObtryx ® TO MUS System (Boston Scientific) for all of the TO

procedures. Intraoperative urethrocystoscopy was routinely per-
formed in all of the RP operations.

Statistical analyses were performed with SPSS version 17.0 soft-
ware (SPSS Inc., Chicago, Ill., USA). Along with descriptive analy-
sis, categorical data were evaluated with χ 2

test and quantitative

data were evaluated with either the Student t test for normally dis-
tributed data or the Mann-Whitney U test when the data did not

show a normal distribution.

Results
Considering the preoperative patient characteristics in

the RP and TO groups, there was no statistically signifi-
cant difference between the 2 groups in terms of age, body

mass index, previous pelvic surgery and childbearing sta-
tus. All patients had a clinical diagnosis of SUI or stress-
predominant MUI.

There was also no statistically significant difference

between the 2 groups regarding preoperative measure-
ments in terms of urodynamic findings of maximum flow

rate, presence of DOA and postvoid residual volume.
Also, the total preoperative scores of OAB-V8, ICIQ-SF
and SEAPI were statistically indifferent between the
groups.

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The median follow-up was 48.5 ± 21.8 months. The

median hospital stay was 24. 0 ± 4.8 h and median opera-
tive time was 35.0 ± 19.9 min. The overall objective and

subjective cure rates were 92.6 and 79.6%, respectively.

Concurrent pelvic organ prolapse surgery (vaginal cysto-
cele or rectocele repair without mesh) was performed in

14.3% of patients. There was no statistically significant
difference between RP and TO procedures in terms of
hospital stay and objective cure rate. The RP group had a
slight but significant increase in operative time and the
subjective cure rate was better in the TO group compared
to the RP group.
The postoperative 24-hour pad test of the 4 patients

who were stress test positive at postoperative month 1 re-
vealed a mean of 59.7 g (min 30 g, max 90 g) in 24 h (data

not shown). The patients with a feeling of being ‘not
cured’ were mostly those with a preoperative diagnosis of
MUI who had significantly higher preoperative scores of
OAB-V8 and SEAPI compared to the ‘cured’ ones. On
multivariate analysis none of these factors proved to be
associated with a poorer outcome.
The quality of life of all patients undergoing MUS
surgery increased significantly after the operation, and
in the subgroup of patients with MUI this increase was
less prominent ( fig. 1 ). The pre- and postoperative
SEAPI scores of all patients and patients with MUI were
20.2 ± 1.5 and 5.6 ± 1.4 (p = 0.0001) and 22.7 ± 2.3 and
12.6 ± 2.8 (p = 0.02), respectively. Likewise pre- and

postoperative ICIQ-SF scores of all patients and pa-
tients with MUI were 13.8 ± 0.7 and 3.9 ± 0.9 (p =

0.0001) and 13.9 ± 1.0 and 7.6 ± 1.8 (p = 0.01), respec-
tively.

No patients required mesh removal or urethrolysis,

and only 2 patients in the RP group required postopera-
tive clean intermittent catheterization for 6 weeks. De

novo urgency developed in 2 (11.1%) and 1 (6.7%) pa-
tients with SUI in the RP and TO groups, respectively. Of

those patients with a preoperative diagnosis of MUI,
postoperative anticholinergic treatment was prescribed
in 4 (44.4%) and 2 (16.7%) patients in the RP and TO
groups, respectively. We did not have any cases of bladder
perforation or pelvic hematoma.

Discussion

Despite some minimal variances on reported out-
comes of RP and TO tapes, there is no doubt that both of

the techniques have very high cure rates. The reported
objective cure rates after MUS surgery are between 70 and

90%, changing according to definition of cure and follow-
up time [17–19] . Our objective cure rates appear to be

slightly higher than these values and also some of the pre-
viously reported randomized studies on Turkish women

[20] in which objective cure rates at 12 months were 89
and 87% for RP and TO tapes, respectively.
Reporting pelvic floor research study outcomes based
on multiple objective and subjective measures has been
recommended [21] . This is vital to accurately assess the

true effect of an intervention. Our study represents an ex-
ample of this where there is a significant difference be-
tween objective and subjective cure rates at 1-month fol-
low-up in the RP group, but not in the TO group. Nilsson

et al. [22] reported objective and subjective cure rates for

26
Preoperative SEAPI
24
22
20
18
16
14
12
SEAPI score
10
8
6
4
2
0
All patients
Postoperative SEAPI

Patients with MUI
16
Preoperative ICIQ
14
12
ICIQ-SF score 10
8
6
4
2
0
All patients
Postoperative ICIQ

Fig. 1. Pre- and postoperative quality of life Patients with MUI
scores of all patients and patients with
MUI.

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RP transvaginal tape to be 90 and 77%, respectively, at the

11-year follow-up, and no difference in objective and sub-
jective cure rates was observed in a meta-analysis of SUI

treatments, including TO tapes [8] .
Our findings demonstrated that the subjective cure

rate in patients undergoing RP MUS is significantly low-
er than the objective cure rate, which is not apparently the

case in the TO group. The subjective cure rate is a wom-
an’s subjective comprehension of her general urinary sta-
tus and this may be affected by many factors besides sur-
gical success. Our secondary analysis showed that the pa-
tients with a feeling of being ‘not cured’ were mostly those

with mixed UI who had significantly higher OAB and
SEAPI scores preoperatively. The multivariate analysis

failed to show any significant factor other than being op-
erated with an RP route.

The most common complications associated with

transvaginal meshes are bladder/vaginal perforation, he-
matoma, postoperative storage lower urinary tract symp-
toms and urinary retention [8, 23, 24] . The rate of mesh

removal in population-based studies was reported to be
approximately 4%, of which 60% was due to mesh erosion
[25, 26] . In our patient population we did not observe any

complications or mesh erosions requiring secondary in-
tervention in short-term follow-up.

The main potential advantage of the TO technique
over the RP technique is that it avoids the risk of bladder
injuries [15, 27] , hence routine cystoscopy after TO MUS
procedures is not recommended. Although we are aware

of few cases of bladder perforation reported to occur dur-
ing TO needle insertion [28] , since large series revealed

negligible bladder perforation in TO groups [29] we did
not perform routine cystoscopy in the TO arm in our
study population.
In 2008 and 2011 the FDA issued two public health
statements, the latter being more alarming, announcing

to the public that although complications related to trans-
vaginal surgical mesh placement for pelvic organ pro-
lapse or SUI were rare, they might result in serious com-
plications which are sometimes irreversible [30] . This was

followed by growing numbers of legal actions and liti-
gations against both manufacturers and surgeons [31] .

Although this discussion is mainly related to the use of
synthetic nonabsorbable mesh materials for transvaginal
treatment of pelvic organ prolapse, MUS surgeries using
the same synthetic mesh material are certainly included

in the FDA’s warning. Conclusively, the American Uro-
logical Association released a position statement on the

use of a vaginal mesh for treatment of SUI. While they

agreed with the FDA statement they highlighted the lev-
el 1 evidence showing the equivalency or superiority of

synthetic polypropylene mesh slings to other surgical
techniques without a significant increase in adverse
events in 10 years of follow-up [32] .
In this context, the main conclusion of this article
would be that MUS surgery is a highly effective option in
the surgical treatment of SUI and can safely be performed

by experienced surgeons, resulting in a significant im-
provement in patient quality of life. However, we would

like to highlight the importance of in-depth patient coun-
seling to cover all other treatment alternatives and pos-
sible irreversible short- and long-term risks associated

with the use of a synthetic mesh material before surgery.
Also, these operations should only be performed if the

surgeon has adequate subspecialty training on the proce-
dure and management of complications [9] . Since not all

synthetic devices are equal, only those meshes that have

been tested in carefully controlled clinical trials with ad-
equate safety, efficacy and adverse event data should be

used [9] . A nationwide registry of used meshes is also im-
portant in order to establish the true incidence of prob-
lems associated with meshes.

The major limitation of this study is related to the rel-
atively low number of patients recruited over a wide range

of time. This can partly be explained by the fact that there
is a perception among urologists/gynecologists that the
MUS procedure is relatively simple to perform, and belief
that it can be performed with any of the monofilament
macroporous polypropylene meshes in any women with

a positive stress test, which might have led to a low num-
ber of referred patients to our department. Indeed, refer-
rals were made mainly after complications. Another obvi-
ous limitation is that our results can only be validated in

a short-term follow-up. Also, this study is unable to pro-
vide data on the effect of SUI surgery on sexual function

or a standardized classification of the complications.

Conclusions

MUS surgery is highly effective and can be safely per-
formed, resulting in a significant improvement in quality

of life in a Turkish cohort of women with SUI. In short-
term follow-up there was no obvious difference between

RP and TO routes in terms of safety and efficacy. The

subgroup of patients with MUI experienced a less prom-
inent improvement in quality of life. Despite the ongoing

mesh debate, this operation is still one of the best alterna-
tives for treatment of SUI and can be safely performed in

subspecialty centers by experienced surgeons.

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