DOI: 10.1111/j.1471-0528.2010.02544.x www.bjog.

org

Urogynaecology

Randomised prospective single-blinded study comparing inside-out versus outside-in transobturator tapes in the management of urodynamic stress incontinence: 1-year outcomes from the E-TOT study
M Abdel-fattah,a I Ramsay,b S Pringle,c C Hardwick,c H Ali,c D Young,d A Mostafaa
a Division of Applied Health Science, University of Aberdeen, Aberdeen, UK b Department of Obstetrics & Gynecology, NHS Forth Valley, Stirling, UK c Department of Obstetrics & Gynecology, Southern General Hospital, Glasgow, UK d Department of Statistics and Modelling Science, University of Strathclyde, Glasgow, UK Correspondence: Dr M Abdel-fattah, Second Floor, Aberdeen Maternity Hospital, Foresterhill, Aberdeen AB25 2ZD, UK. Email m.abdelfattah@abdn.ac.uk

Accepted 10 February 2010. Published Online 12 April 2010.

Objective To compare the inside-out versus outside-in routes

for transobturator tape insertion for urodynamic stress incontinence, and to identify independent risk factors for failure at 1 year.
Design Prospective single-blinded randomised trial. Setting Tertiary urogynaecology centre. Population A cohort of 341 women undergoing transobturator

tape procedures between April 2005 and April 2007.

Methods Women were randomised to tension-free vaginal

tape-obturator (TVT)-O for the inside-out route (n = 170) and transobturator tape (TOT)-ARIS for the outside-in route (n = 171). Participants completed validated symptom-severity, quality-of-life and sexual-function questionnaires before and after surgery. In addition, they completed the patient global impression of improvement questionnaire (PGI-I) and standard 1-hour pad test postoperatively.
Main outcome measures The primary outcome was the patient-

Results A total of 341 women were recruited: 171 women to the outside-in (TOT-ARIS) group and 170 to the inside-out (TVT-O) group; 299 completed the 1-year follow up. The patient-reported success rate was 80% with no statistically signicant differences between the groups (outside-in 77.6% versus inside-out 81.2%; OR 1.25; 95% CI 0.71, 2.20; P = 0.54). The objective cure rate was 91% with no statistically signicant difference between the groups (outside-in 88% versus insideout 94%; OR 2.21; 95% CI 0.85, 5.75; P = 0.157). Previous incontinence surgery (OR 1.41; 95% CI 1.18, 1.91; P = 0.029) and preoperative urgency incontinence (OR 1.78; 95% CI 1.21, 3.91, P = 0.048) were signicant risk factors for failure of transobturator tape at the 1-year follow up. Conclusions There are no signicant differences in patient

reported and objective cure rates between inside-out and outside-in transobturator tapes. Quality of life and sexual function signicantly improved following surgery. Both previous incontinence surgery and preoperative urgency incontinence are associated with signicantly lower patient-reported cure rates.
Keywords ARIS , tension-free vaginal tapes, transobturator tape,

reported success rate reported on the PGI-I scale. Secondary outcomes included objective cure rate and improvement in Kings Health Questionnaire scores.

TVT-O, urodynamic stress incontinence.

Please cite this paper as: Abdel-fattah M, Ramsay I, Pringle S, Hardwick C, Ali H, Young D, Mostafa A. Randomised prospective single-blinded study comparing inside-out versus outside-in transobturator tapes in the management of urodynamic stress incontinence: 1-year outcomes from the E-TOT study. BJOG 2010;117:870878.

Introduction
Midurethral tension-free vaginal tape has been the mainstay in the treatment of female urodynamic stress incontinence (USI) over the last decade. It is well established that the

advent of tension-free vaginal tape (TVT; Ethicon Inc., Somerville, NJ, USA)1 has revolutionised anti-incontinence surgery, with an emphasis on mesh/tape reinforcement at the midurethral level, creating a hammock that supports the urethral closure mechanism at times of increased

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intra-abdominal pressure. Several methods of suburethral tape insertion have been described, but these are mainly divided into the following groups: the retropubic approach, such as TVT and SPARC [American Medical Systems (AMS) Inc., Minnetonka, MN, USA]; the transobturator approach, that is the inside-out route using TVT-O2; and the outside-in route,3 using devices such as ARIS (Coloplast Corp., Minneapolis, MN, USA) or MONARC (AMS). The principal of transobturator procedures is for the tape to be inserted tension-free in a horizontal plane underneath the midurethra and between the two obturator foramina. In the outside-in approach, described by Delorme in 2001,3 the tape is inserted percutaneously, is tunnelled around the inferior pubic ramus and is then guided by the surgeons nger into the suburethral vaginal incision. In 2003, De Leval2 described a modied approach in which the tape is inserted in the reverse route, with a winged guide for the protection of the bladder and the urethra: the insideout approach. Two meta-analyses4,5 have shown the transobturator tapes to be non-inferior to retropubic TVT in the management of USI in short-term follow up (112 months), with the advantages of fewer bladder injuries and less voiding dysfunction, although with an increased incidence of groin pain. The use of transobturator tape is the rst choice for the surgical treatment of USI in an increasing number of urogynaecology units in Europe and the USA,6 although the choice of the surgical approach and tape material is predominately according to the surgeons preference, presumably due to the lack of robust comparative studies between the two approaches. A few previous studies710 have attempted to compare the two transobturator approaches, but they were all underpowered, and the majority used inadequate randomisation, such as alternate assignment.7,8 Nevertheless, the authors in two of these studies8,9 concluded that adequately powered randomised studies are required if we are to draw rm and robust conclusions as to whether either of these two approaches is superior to the other. The E-TOT (Evaluation of Transobturator Tapes) Study aim to compare the two surgical approaches of transobturator tape insertion in the management of female USI: the inside-out route (using the TVT-O tape) and the outside-in route (using the ARIS tape). We have previously reported on the short-term outcomes;11 in this article we present the patient-reported outcomes, objective cure rates, and changes in quality of life and sexual function at 1 year. In addition, we report on a multivariate analysis for the prediction of independent risk factors of transobturator tape failure at the 1-year follow up.

Methods
This single-blinded prospective randomised study was conducted in an urogynaecology tertiary centre, and was

approved by the South Glasgow Research Ethics Committee. The study protocol was registered in the public domain (www.clinicaltrials.gov) in March 2005. All women admitted for a transobturator tension-free vaginal tape procedure as the sole procedure in the period between April 2005 and April 2007 were invited to participate in the study, and signed an informed consent form. Procedures were performed as originally described,2,3 using TVT-O and TOT-ARIS for the inside-out and outside-in approaches, respectively. Intraoperative cough stress test and cystoscopy were not performed in either study arm. This is in line with a number of studies in the literature reporting the low rates of lower urinary tract injuries with transobturator tapes and the recommendation for the omission of intraoperative cystoscopy.2,12,13 Women diagnosed with USI from preoperative urodynamics or with mixed incontinence, but with predominantly bothersome stress incontinence, were eligible to take part. Women with previous incontinence surgery were included. All women had failed or declined pelvic oor muscle training (PFMT). Women were excluded if they were unwilling to participate in the randomisation process, had predominant overactive bladder symptoms, or had specic co-morbidities such as known neurological conditions (e.g. multiple sclerosis), diabetes, pelvic organ prolapse ( stage 2 POP-Q) and/or concomitant surgery at time of transobturator tape insertion. The preoperative assessment included a detailed history taking, a pelvic examination and an urodynamic assessment. All patients completed the Kings Health Questionnaire (KHQ),14 Birmingham Bowel Urinary Symptom (BBUSQ22)15 and Pelvic Organ Prolapse/Incontinence Sexual Function Questionnaire (PISQ-12).16 A postoperative pain assessment was performed at discharge by asking the patient to grade any groin/leg pain as none, minimal, mild, moderate or severe and on a 10-point Likert scale, where 10 was considered to be severe pain. The postoperative assessment at 1 year was performed by an independent clinician who was blinded to the type of surgery: the above parameters were re-assessed with the addition of Patient Global Impression of Improvement (PGI-I)17 and International Consultation on Incontinence Questionnaire Short Form (ICIQSF)18 questionnaires, and a standard 1-hour pad test. The primary outcome measure at 1 year was the patientreported success rate, dened as Very Much Improved or Much Improved on the PGI-I. Secondary outcomes included: improvement in quality of life (10 points improvement on the total KHQ score), objective cure rate (negative standard 1-hour pad test), patient-reported success on ICIQ-SF, dened as Never leak or Leak once or less/week, patients overall satisfaction on a 10-point Likert scale (scores 8 were considered as Satised) and improvement in sexual function (PISQ-12 scores).

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A sample-size calculation showed that with 80% power and assuming a 90% success rate (both objective and patient-reported) for TVT-O,3 140 women were needed in each arm to detect a 10% difference in the success rate between the two procedures. With an anticipated drop-out rate of 20% over 3 years we aimed to recruit 168 women to each arm. Women were assigned to either procedure by random allocation (computer generated), and allocation was concealed using opaque sealed envelopes, which were opened by the nursing staff on the morning of the operation. Women were informed about the type of operation if they wished, for ethical considerations, but they were instructed not to disclose this information to the clinician at follow up. Catergorical variables were compared between groups using the chi-square test, or using Fishers exact test if small numbers made the chi-square analysis invalid. Data were tested for normality using the AndersonDarling test. Within-group comparisons of quantitative variables were subsequently analysed using paired Students t test or Wilcoxon test, and two-sample Students t test or Mann Whitney U test were used on between-group data. Factors associated with failure were assessed univariately in a logistic regression model, and those signicantly associated with failure were entered in a multivariate model to determine the independent predictors. All analyses were performed using spss v16 at a signicance level of 5%.

form the basis of the analysis. No woman assigned to one arm asked to change her operation or withdrew from the study prior to the operation: reasons for non-attendance are listed in Figure 1. Thirteen women repeatedly failed to attend their follow-up appointments or to send back their 1-year follow-up questionnaires. On checking their hospital and study records, none of these women were re-referred to the hospital for any urogynaecology complaint; nine of these 13 women were objectively cured on postoperative urodynamics at 6 months, and the other four failed to attend the 6-month follow-up visit. All were excluded from this analysis.

Patient-reported outcomes
Of the 292 women (97.7%) who completed the PGI-I questionnaire, 80% (n = 232) showed a successful outcome, with no statistically signicant difference between the two groups (outside-in 77.6% versus inside-out 81.2%; OR 1.25; 95% CI 0.71, 2.20; P = 0.54). Table 2 shows other parameters of patient-reported outcomes and overall satisfaction at 1 year.

Objective outcomes
A total of 230 women (77%) underwent a standard 1-hour pad test at 1-year follow up (Table 2): 210 were negative (91%), with no statistically signicant difference between groups (outside-in 88% versus inside-out 94%; OR 2.21; 95% CI 0.85, 5.75; P = 0.157). The other 69 patients requested to avoid further hospital trips, but participated in the completion of postoperative questionnaires.

Results
A total of 344 women were eligible for the study, and 341 women were recruited (outside-in route n = 171; insideout route n = 170). There were no signicant differences in the patient characteristics between the groups (Table 1). A total of 299 women (88%) completed the 1-year follow up (TOT-ARIS n = 147 versus TVT-O n = 152), and

Perioperative complications
No major complications occurred in either arm (Table S1): signicantly more vaginal angle perforations occurred in the outside-in group than the inside-out group (17 versus 3; P = 0.001); otherwise, there was no statistically

Table 1. Patient characteristics Outside-in (ARIS) n = 171 (%) Mean age Mean BMI (kg/m2) Mixed group (n = 83) Previous incontinence surgery (n = 46) MUCP 30 cm H2O (n = 59) Previous hysterectomy (n = 88) Previous anterior repair (n = 25) Previous anti-muscarinic treatment (n = 61) BMI, body mass index; MUCP, maximum urethral closure pressure. 52.1 28.9 43 (24.6) 18 (10.5) 32 (18.7) 48 (28.1) 10 (5.85) 32 (18.7) Inside-out (TVT-OTM) n = 170 (%) 51.5 28.1 40 (23.6) 28 (16.5) 27 (15.8) 40 (23.6) 15 (8.8) 29 (17)

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344 were eligible for the study

3 women declined to take part due to the length/process of follow-up

341 Recruited & Randomised

Allocated to Inside-Out (TVT-O ) (n = 170) Received allocated intervention (n = 170)

Allocated to Outside-In (ARIS) (n = 171) Received allocated intervention (n = 171)

Completed 6 month Follow-up (n = 160)

Withdrawn (n = 6) Untraceable (n = 1) Repeated failure to attend (n = 3)

Completed 6 month Follow-up (n = 157)

Withdrawn (n = 8) Untraceable (n = 4) Repeated failure to attend (n = 2)

Completed 1-Year Follow-up (n = 152)

Unplanned Pregnancy (n = 1) Prolapse surgery (n = 1) Untraceable (n = 1) Repeated failure to attend (n = 5)

Completed 1-Year Follow-up (n = 147)

Moved abroad (n = 1) Receiving Chemotherapy for Ovarian CA (n = 1) Repeated failure to attend (n = 8)

Figure 1. Flow chart of patient recruitment and follow up.

signicant difference between the two groups. The median postoperative pain scores were comparable (4 outside-in versus 6 inside-out). De novo detrusor overactivity occurred in 5.3% (n = 16), with no statistically signicant difference between the groups.

although there were no differences between the two routes of insertion.

Impact on sexual function

In total, 199 women (65%) completed a valid PISQ-12 questionnaire pre and postoperatively; the others did not complete the questionnaire preoperatively for a variety of reasons, or had more than two missing items and therefore invalidated the questionnaire (Table S2). A total of 172 (94%) showed improvement in total PISQ-12 scores, whereas 13 patients (4.3%) showed deterioration, and four patients (1.4%) showed no change in total PISQ-12 scores. All 12 parameters and the total score were assessed (Table S2): the overall improvement in the PISQ-12 score was signicant (P < 0.001, Wilcoxon test), but there was no signicant difference between the median improvement in the outside-in versus inside-out routes (3.0 versus 4.5 respectively, P = 0.346).

Impact on quality of life

A total of 299 women completed the pre and postoperative KHQ: the total KHQ score showed a median improvement of 33.6 points (2985). Signicantly more women in the inside-out group showed 10 or more points of improvement in the total KHQ score at 1-year follow up, compared with the outside-in group (88% versus 77.6%, respectively; P = 0.034; 95% CI 1.093, 3.757). However, analysis of the nine domains as well as the total KHQ scores (Table 3) showed that all KHQ domains, except general health, showed clinically and statistically signicant improvement following transobturator tape procedures,

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Table 2. Objective and patient-reported success rates for the whole cohort and comparing outside-in (TOT-ARIS) versus inside-out (TVT-OTM) Outside-in ARIS (n = 143) Success (%) PGI-I* Standard ICS 1-hour pad test** Satisfaction scale*** ICIQ-SF**** 111/143 (77.6) Cured 96/109 (88.1) Success 113/141 (80.1) 99/147 (67.3) Inside-out TVT-OTM (n = 149) Success (%) 121/149 (81.2) Cured 114/121 (94.2) Success 109/141 (77.3) 110/152 (72.4) 1.25 (0.71, 2.20) 2.21 (0.85, 5.75) 0.84 (0.48, 1.50) 1.27 (0.78, 2.08) 0.54 0.157 0.662 0.412 OR (95% CI) P

ICIQ-SF, International Consultation on Incontinence Questionnaire short form; PGI-I, patient global impression of improvement. *Success: very much improved or much improved. **Cure: Pad gain 1 gram. ***Success: score 8/10. ****Success: never leaked or leak a few drops once or less/week.

Table 3. Kings Health Questionnaire scores comparing pre and postoperative scores for the whole cohort, and comparing inside-out TVT-OTM versus outside-in TOT-ARIS KHQ domain Median P Difference between pre- and postoperative score (approx. 95% CI) Median difference (prepost) Outside-in 0.89 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001 (0.000, (50.00, (41.67, (41.67, (27.78, (13.00, (16.67, (37.50, (30.73, 0.000) 66.70) 50.00) 50.00) 33.33) 19.83) 25.00) 45.83) 36.42) 0.00 66.67 50.00 50.00 22.22 0.00 16.67 41.67 35.19 Inside-out 0.00 66.67 50.00 50.00 33.33 2.00 16.67 50.00 35.65 0.695 0.771 0.624 0.637 0.104 0.7 0.976 0.099 0.419 (0.001, ()0.01, ()16.67, ()16.67, ()11.11, ()0.33, (0.00, ()16.67, ()8.03, 0.003) 0.00) 0.00) 0.00) 0.00) 0.00) 0.00) 0.00) 3.70) P Difference between operative approach (approx. 95% CI)

Pre General health Incontinence impact Role limitation Physical limitation Social limitation Personal relationships Sleep/energy Severity measure Average KHQ 25.00 100.00 66.67 66.67 33.33 32.00 50.00 75.00 57.10

Post 25.00 33.33 0.00 0.00 0.00 0.00 16.67 16.67 14.78

KHQ, Kings Health Questionnaire.

Analysis of risk factors for failure

Univariate analysis of preoperative risk factors for patientreported failure of transobturator tapes (on PGI-I) showed that a body mass index (BMI) of greater than 30, previous incontinence surgery, nocturia more than once per night and urgency incontinence were signicant factors for failure (Table 4). On multivariate analysis previous incontinence surgery and urgency incontinence were the only independent risk factors for patient-reported failure at 1 year (Table 4).

Discussion
The E-TOT results showed no signicant differences in the patient-reported outcomes, objective outcome and most of the perioperative complications between the outside-in

route (TOT-ARIS) and the inside-out route (TVT-O) transobturator tapes. The objective cure rates and patientreported success rates of transobturator tapes in the whole cohort were 91.3 and 80%, respectively, with no statistically signicant difference between the inside-out and outsidein approaches. These results are in agreement with the previous smaller studies comparing both procedures.710 Lipais et al.7 compared inside-out TVT-O and outside-in MONARC in a randomised study, and reported a nonsignicant difference in both patient-reported and objective cure at the 1-year follow up. However, their study was limited by the fact that it included only one surgeon, the randomisation was inadequate (using alternate assignments) and the study was under-powered. Our results were also comparable with the initial case series reports for the outside-in TOT-ARIS, showing 83% success at 6 months,1

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Table 4. Regression analysis of various risk factors for failure of transobturator tapes Characteristics Univariate analysis Outcome of treatment Cured (%) Age (years) 60 (n = 221) >60 (n = 56) BMI (kg/m2) <30 (n = 177) 30 (n = 105) MUCP (cm H2O) 30 (n = 44) 31 (n = 233) Preoperative urodynamics USI group (n = 217) Mixed group (n = 75) History of previous incontinence surgery Primary surgery (n = 248) Secondary surgery (n = 44) Type of operation TVT-O group (n = 149) TOT-ARIS group (n = 143) Preoperative symptoms Nocturia (n = 139) No nocturia (n = 143) Normal frequency <8/day (n = 76) Frequency 8/day (n = 208) No urgency incontinence (n = 142)** Urgency incontinence (n = 140)*** No urgency (n = 130)** Urgency (n = 152)*** Failed (%) P Multivariate analysis Adjusted OR (95% CI) P

176 (79.6) 45 (80.4) 149 (84.2) 76 (72.4) 28 (63.6) 189 (81.1) 176 (81.1) 56 (74.7) 202 (81.5) 30 (68.2) 121 (81.2) 111 (77.6) 102 120 64 160 120 103 108 116 (73.4) (83.9) (84.2) (76.9) (84.8) (73.6) (83.1) (76.3)

45 (20.4) 11 (19.6) 28 (15.8) 29 (27.6) 16 (36.4) 44 (18.9) 41 (18.9) 19 (25.3) 46 (18.5) 14 (31.8) 28 (18.8) 32 (22.4) 37 23 12 48 22 37 22 36 (26.6) (16.1) (15.8) (23.1) (15.2) (26.4) (16.9) (23.7)

1.000

1.31 (0.54, 3.15)

0.546

0.028*

0.52 (0.27, 1.09)

0.068

0.223

1.21 (0.50, 2.88)

0.667

0.306

1.06 (0.51, 2.18)

0.875

0.041*

1.41 (1.18, 1.91)

0.029*

0.540

1.46 (0.77, 2.77)

0.242

0.044* 0.243 0.028* 0.195

0.59 (0.30, 1.17) 0.93 (0.39, 2.17) 1.78 (1.21, 3.91) 1.07 (0.50, 2.30)

0.136 0.869 0.048* 0.849

USI, urodynamic stress incontinence. *Signicant (P < 0.05). **Never/occasionally on Birmingham Bowel Urinary Questionnaire-22. ***Most of the time/all the time on Birmingham Bowel Urinary Questionnaire-22.

and 80.5% success at 1 year.12 Similarly, the success rate for the inside-out TVT-O was comparable with those reported in the literature by De Leval (91%),3 and later by Lee et al. (86.8%).13 In our study, patient-reported outcomes were assessed using a number of validated instruments, but they have all shown lower cure rates than objective cure rates assessed by the standard 1-hour pad test. This reinforces the ndings of other studies showing a lack of correlation of objective tests, especially the pad test, with the symptoms of the patients.1921 The perioperative complication rates were not signicantly different between the groups, except for a higher rate of vaginal angle perforation associated with the outside-in TOTARIS, which was attributed mainly to the need for more dissection with this technique. Similar ndings were reported

by But et al.,9 but are considered to be of limited clinical signicance. A number of studies have suggested a high risk of postoperative groin pain with the inside-out TVT-O treatment, with a range of 1524%, and with as many as 4.7% of patients complaining of long-term pain.22,23. But et al.9 found the inside-out TVT-O treatment to be signicantly more painful than the outside-in MONARC treatment during the operation, and for up to 6 hours postoperatively. In agreement with our results, they did not show signicant differences in pain level at discharge, but the duration of pain was higher in the inside-out TVT-O group (mean 21.6 days versus 7.5 days, P = 0.033). It is well recognised that special emphasis should be focused on a womans quality of life (QoL) following surgery.24 The KHQ has been validated in different languages,

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and Kelleher et al.25 have shown that a minimum of a ve-point improvement in KHQ scores is required to demonstrate any improvement in QoL, with ten points representing a clinically signicant improvement. Our study conrmed a clinically signicant improvement in QoL for the vast majority of women (83%) following the insertion of transobturator tapes. All domains apart from general health showed signicant improvements, with no difference between both groups, in agreement with the work of others.8 Lee et al.8 assessed the QoL of 100 women, alternatively assigned to inside-out TVT-O versus outside-in TOT-ARIS, using the Incontinence Quality of Life questionnaire (I-QoL) with 1-year follow up. All parameters showed signicant improvement after the operation, with no signicant difference between groups. Interestingly, Domingo et al.21 have shown a deterioration in QoL scores in 93 women 1 year after transobturator tape insertion, despite the 97% objective cure rates on the cough stress test. A total of 199 women were sexually active before and after the study and completed the questionnaires with up to just two items missing. The vast majority of women showed an improvement in sexual function in all parameters directly related to the cure of urinary incontinence, such as coital incontinence, fear of incontinence during intercourse, avoidance of sexual intercourse and negative emotions. Parameters indirectly related to incontinence such as frequency of intercourse, variety of activities, sexual excitement, dyspareunia and partner-related parameters did not show any signicant improvements. One previous study26 compared the sexual function 3 months after inside-out TVT-O (n = 34) versus outside-in Obtape (Porges), and showed an overall improvement in sexual function following both operations. Several studies have assessed sexual function following retropubic TVT, with the majority suggesting an overall improvement in sexual function after surgery,2730 whereas two articles have suggested no signicant difference before and after surgery,31,32 and another two articles have found that more women experienced a worsening of symptoms than an improvement.33,34 An analysis of risk factors from the E-TOT study data at 1 year conrmed urge incontinence and previous incontinence surgery to be independently associated with the failure of transobturator tapes, based on objective and patientreported outcomes. We found a preoperative urodynamics diagnosis of mixed incontinence was not a signicant risk factor for failure, although a history of urge incontinence was. Our results are different from those of Houwert et al.,35 who found previous incontinence surgery, mixed incontinence symptoms and detrusor overactivity (DO) to be significant risk factors of failure for midurethral slings. This difference may have arisen from a failure of the detection of preoperative DO by the urodynamics in our study, or might have resulted from the lack of randomisation in their study.

The E-TOT study has a number of strengths, including the adequate randomisation and concealment, and the successful recruitment of the target population size. The study was adequately powered to detect differences in the patient-reported and objective cure rates between the two transobturator approaches. No women withdrew their consent for the study or opted to change the treatment that they were assigned to: we believe that the main reason for this was the womens perception that both surgical approaches are not hugely different, and are used to achieve the same nal outcome of a suburethral transobturator tape. The study centre is the only urogynaecology referral centre in the region, and therefore it is unlikely that women lost to follow up have been referred to another unit for management of complications or recurrence. We could have applied last observation carried forward (LOCF) for these women, but that does not exclude dissatisfaction or recurrence that did not require referral to hospital, and therefore we decided to exclude them from the analysis. The procedures were performed by two urogynaecologists and three general gynaecologists who were all experienced in both types of operations, having performed at least 20 of each procedure prior to the study. The varying experience involved in our study ensures the results of the study can be generalisable for all surgeons. However, there are a few limitations: to comply with the ethical committees recommendation, we were unable to blind the patients for the type of operation, and the follow-up period was also short, at just 1 year. Long-term follow up is required, and is underway to ascertain the validity of these results in the long term.

Conclusion
This randomised study has shown no signicant differences in objective and patient-reported cure rates between inside-out (TVT-O) and outside-in (ARIS) transobturator tapes. Womens quality of life and sexual function signicantly improved following the insertion of transobturator tapes, with no signicant differences between groups. Transobturator tapes in women with previous incontinence surgery and/or preoperative urge incontinence are associated with signicantly lower cure rates.

Disclosure of interests
IR is a member of the European advisory board for Coloplast. All authors received travel grants from different pharmaceutical companies to attend medical conferences.

Contribution to authorship
MA-f and IR conceived the idea and the initial design, and obtained the ethics approval and funding. All authors participated in designing the study, performing the procedures

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and collecting data. MA-f and AM inputted the data under the supervision of IR. DY, AM and MA-f analysed the data. MA-f wrote the article, and all authors had input and approved the nal version.

Details of ethics approval

Approval was obtained from the West of Scotland Research Ethics Committee, 1st Floor, Tennent Institute, 38 Church Street, Glasgow, G11 6NT, UK: A randomised trial comparing TVT-O & TOT in surgical management of USI (urodynamic stress incontinence); ref. R050005.
8

Funding
The study was funded by a grant from Henry Smith Charity. Refs: 20050062 & 20050933.
10

Acknowledgements
The authors thank the Henry Smith Charity for their generous grant that enabled this study to be completed, Sister Archibald for performing the 1-year follow up and all the patients involved in the study.

11

12

Supporting information
The following supplementary materials are available for this article: Table S1. Perioperative complications and postoperative pain assessment by allocated group. Table S2. (PISQ-12) scores comparing pre and postoperative scores for the whole cohort. Additional Supporting Information may be found in the online version of this article. Please note: Wiley-Blackwell are not responsible for the content or functionality of any supporting information supplied by the authors. Any queries (other than missing material) should be directed to the corresponding author. j
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