Christopher F. Maher, a Barry A. O Reilly, a Peter L. Dwyer, a Marcus P. Carey, a Anne Cornish, a Philip Schluter b

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1 BJOG: an International Journal of Obstetrics and Gynaecology June 2005, Vol. 112, pp DOI: /j x ubovaginal sling versus transurethral for stress urinary incontinence and intrinsic sphincter deficiency: a prospective randomised controlled trial Christopher F. Maher, a Barry A. O Reilly, a eter L. Dwyer, a Marcus. Carey, a Anne Cornish, a hilip Schluter b Objective To compare the pubovaginal sling and transurethral in the treatment of female stress urinary incontinence (SUI) and intrinsic sphincter deficiency (ISD). Design A prospective randomised controlled trial comparing two surgical treatments for SUI and ISD. Setting Tertiary referral urogynaecology unit in Australia. opulation Women with SUI and ISD who were suitable for either surgical technique. Methods Forty-five women with SUI and ISD were randomly allocated the pubovaginal sling or transurethral (n ¼ 23). Subjective and objective success rates, patient satisfaction and cost measurements at six months and one year following surgery were the primary outcome measures. A telephone questionnaire survey was performed at a mean follow up period of 62 months (43 71). Main outcome measure Comparison of success rates, complications and costs. Results The symptomatic and patient satisfaction success rates were similar following the sling and with the objective success rate being significantly greater ( < 0.001) following the sling (81% vs 9%). had significantly lower morbidity but was more expensive than the sling ( < 0.001). Response rate at 62 months follow up was 60% in both groups with the sling group reporting better continence success (69% vs 21%) and satisfaction rates (69% vs 29%, ¼ 0.057). Conclusions The pubovaginal sling was more effective and economical than transurethral for the treatment of SUI and ISD. However, transurethral remains an appropriate treatment in selected cases of SUI and ISD. INTRODUCTION The medium to long term success rate of primary continence surgery in women with stress urinary incontinence (SUI) is consistently reported at over 85%. A small number of these women have intrinsic sphincter deficiency (ISD) 1 for which there is no standardised definition. ISD has been diagnosed by either a low maximum urethral closure pressure (MUC), a low leak point pressure on subtracted cystometry or an open bladder neck at rest in the absence of a bladder contraction during video urodynamics. Women with ISD have an increased failure rate after surgery. 2,3 Sand et al. 4 found that women under 50 years of age undergoing a Burch colposuspension with an MUC 20 cm H 2 O had a failure rate three times higher than those a Urogynaecology Unit, Mercy Hospital for Women and Royal Women s Hospital, Melbourne, Australia b School of opulation Health, University of Queensland, Australia Correspondence: Dr B. O Reilly, Department Obstetrics and Gynaecology, Cork University Hospital, Cork, Ireland. D RCOG 2005 BJOG: an International Journal of Obstetrics and Gynaecology with SUI and a normal MUC. These authors suggested that the suburethral sling should be the treatment of choice in women over 50 years old with low urethral pressure stress incontinence. 5 Other workers have reported success rates of 80 85% in women undergoing a sling procedure for ISD. 6,7 eriurethral bulking agents are minimally invasive alternatives to suburethral slings in the management of ISD. Although the cure rate appears lower, these agents carry lower morbidity, shorter procedure and hospitalisation times and a quicker recovery. 8,9 (Uroplasty, Minneapolis, Minnesota, USA) is a vulcanised silicone microimplant (polydimethylsiloxone) suspended in a povidine gel designed to provide urethral bulking for the treatment of SUI. Initial evaluation of the reported success rates of 48 74% at three months to three years. While the pubovaginal sling remains a credible and important option for SUI secondary to ISD, alternative less invasive and cheaper treatment options are attractive to patients, clinicians and health economists. As has not been subjected to the rigorous evaluation of a randomised controlled trial, we have completed this study to compare the pubovaginal sling and transurethral in the treatment of SUI secondary to ISD.

2 798 C.F. MAHER ET AL. Fig. 1. Flowchart of participants through trial. METHODS All patients underwent standardised history, physical examination, urine culture and multichannel urodynamics. Vaginal prolapse was assessed in the left lateral position and graded using a modified Baden Walker classification. 14 Bladder neck mobility was assessed visually with the patient in the left lateral position with a Sim s speculum before and during coughing. The bladder neck was graded as hypermobile, normal or rigid. 15 Urodynamic assessment was performed using subtracted dual-channel cystometry at a filling rate of 100 ml/minute with simultaneous pressure flow studies. Urethral pressure measurements were made with the patient in the sitting position at rest and during coughing, with the bladder empty and again at cystometric capacity. Bladder and urethral pressures were measured with a dual sensor 7-French microtransducer catheter (Gaeltec, Scotland) as described by Asmussen and Ulmsten. 16 Abdominal pressure measurement was recorded with a singlesensor 7-French catheter placed vaginally. The diagnosis of voiding dysfunction was made if the maximal urinary flow rate was less than 15 ml/second on two occasions with a voided volume greater than 150 ml and residual urine greater than 100 ml. Between August 1997 and December 2000, all women with USI and ISD diagnosed by a MUC 20 cm H 2 O who failed to respond to conservative treatments were invited to participate in this study. Women were excluded if they required prolapse surgery, had undergone a sling procedure or were unsuitable for general anaesthesia. rior to surgery, validated questionnaires [the Short Urinary Distress Inventory (SUDI) 17 and Incontinence Impact Questionnaire (IIQ) 18 ] were completed and a 1-hour pad test 19 was performed. Uroplasty (Netherlands) provided free of charge to women without health insurance. The pubovaginal sling was performed as described by McGuire et al. 7 A combined abdominal vaginal approach was performed in which an 11- to 12-cm sling was harvested from the rectus sheath. The sling was positioned suburethrally at the proximal urethra and secured to the rectus sheath without tension. A Stamey suprapubic catheter was placed under cystoscopic vision at the end of the procedure. Table 1. Demographic data and pre-operative assessments. The values are presented as n (%) or median [range]. Medians were compared with Wilcoxon s rank-sum test and proportions were compared with the Fisher s exact test. (n ¼ 23) Age (years) 65 [34 84] 63 [43 81] BMI (kg/m 2 ) 30 [21 37] 29 [21 47] Menopausal 12 (52) 10 (46) arity 3 [0 4] 3 [0 6] revious surgery* 18 (78) 18 (81) Abdominal hysterectomy 5 5 Vaginal hysterectomy/repair Retropubic continence surgery 2 2 Needle suspension 2 1 Other 2 1 MUC 17 [0 20] 18 [2 20] Hypermobile bladder neck 2 (9) 3 (14) Voiding dysfunction 1 (5) 0 Detrusor instability 2 (11) 10 (50) ad test (ml) 16 [5 47] 21 [4 56] SUDI score 56 [0 100] 64 [11 100] SIIQ score 57 [0 100] 41 [0 95] * Some patients had more than one previous operation.

3 Table 2. eri-operative details. The values are presented as median [range]. Medians were compared using Wilcoxon rank-sum test. (n ¼ 23) Theatre time (minutes) 22 [10 41] 60 [35 105] < Inpatient stay (days) 1 [1 2] 4 [3 8] < Blood loss (ml) [ ] < Duration of 1 [0 7] 5 [2 42] < catheterisation (days) Return to normal activity (days) 28 [0 35] 4 [0 42] < Transurethral injections were performed under general anaesthesia. The (volume ml) was introduced using a 23.5-French 0 urethroscope with a prelubricated 16-French gauge needle. vials were discharged using a ratchet gun. Injections were placed transurethrally beginning approximately 1 cm distal to the bladder neck in equal aliquots at 2 o clock, 10 o clock and 6 o clock until the bladder neck was closed. A 5-French infant feeding tube drained the bladder post-operatively overnight. All surgery was performed under the supervision of consultant urogynaecologists, D or MC. All surgeons had extensive prior experience with transurethral injectables and slings. In the group, catheters were removed on day one and the patient discharged if the residual was less than 100 ml on bladder scanning. In the pubovaginal sling group, the suprapubic catheter was clamped on day three with patients allowed to void spontaneously. atients were then discharged as appropriate. Women were reviewed at six weeks, six months and at six monthly intervals and underwent standardised history and examination. atient satisfaction was scored on a visual analogue scale from 0 to At six months, the 1-hour pad test, multichannel urodynamics, validated questionnaires and a voiding diary (noting number of incontinent episodes over one week) were completed. Subjective success was defined as women with no or occasional (less than once a week) stress incontinence. Objective success was defined as no urinary leakage due to SUI on repeat urodynamic studies. Women with continuing stress incontinence following the were offered a top-up injection. Long term follow up was not included in the original study design, but we routinely follow up patients involved in clinical trials and felt that the long term follow up of patients treated surgically for stress incontinence would be an important secondary analysis. Costings based on the daily cost of a hospital bed in the state of Victoria, Australia, in 1998 (AU$500/day) and the operating theatre costs were determined by standardised Australian government charges (theatre cost for the sling was AU$1000, AU$350 and the disposable cost of AU$3000). Outcomedatawereanalysedonanintention-to-treat basis. Sample size was determined on the basis of a 48% UBOVAGINAL SLING VERSUS TRANSURETHRAL MACROLASTIQUE 799 success rate for the 11 and a 90% success rate for the pubovaginal sling, 6 and a two-sided significance level of a ¼ 0.05 and a study with statistical power of 80%. Using a two-group continuity corrected m 2 test, the sample size required in each group to fulfil these specifications was 23. Due to the small sample numbers and skewed nature of the data, non-parametric statistical methods were employed. Median and range values were used to report demographic and peri-operative measures of location and spread, whereas medians and interquartile ranges (IQR) were used to report post-operative measures. Wilcoxon s rank-sum test and Fisher s exact test were used to compare continuous and discrete variables between groups, respectively. Spearman s correlation coefficient was used to measure correlation between two continuous variables. A 0.05 was used to define significance in all statistical comparisons. All terminology conforms to the recommendations of the International Continence Society unless otherwise stated. 19 Institutional ethics committee approval was obtained prior to commencement of the study. RESULTS Forty-five women consented to participate and were randomly allocated using computer randomisation software to either the transurethral (n ¼ 23) or the pubovaginal sling procedure (Fig. 1). There were no differences between the two groups in any variables except that detrusor overactivity was more common in the sling group than in the group (Table 1). Operating time, blood loss, inpatient days, duration of catheterisation and time to resume normal activities were all lower following the than after the pubovaginal sling (Table 2). Short term follow up One woman in each group failed to return or complete any review, one in the arm suffering dementia and one in the sling arm who refused to return Table 3. ost-operative outcomes at six months. Data are presented as n (%) or median [range]. (n ¼ 21) Subjectively cured 17 (77) 19 (90) 0.41 atients satisfied 13 (60) 7 (81) 0.41 (self-report) Objectively cured 2 (9) 17 (81) < Median SUDI score 14 [0 100] 11 [0 44] 0.65 Median SIIQ score 5 [0 85] 9 [0 85] hour pad test (g) 5 [0 57] 2 [0 20] 0.57 MUC (cm H 2 O) 20 [9 46] 26 [5 57] 0.83

4 800 C.F. MAHER ET AL. despite claiming a successful operation (Fig. 1). The median length of short term follow up was 12 months after the and 15 months after the sling ( ¼ 0.64). The subjective and objective success rates and satisfaction ratings are shown in Table 3. Only the objective cure rate showed a statistically significantly higher rate for sling compared with. Following surgery, there was a significant reduction in the pre-operative 1-hour pad test, SUDI and IIQ scores compared with baseline within each group (typically < 0.01, data not shown). There were no significant differences in the change. One woman developed de novo bladder overactivity following the sling. Voiding dysfunction was seen in one woman following the and four after the sling (5% vs 21%, ¼ 0.33). One woman in the sling group continues with long term clean intermittent selfcatheterisation. Following the, 5 of 22 required a top-up transurethral injection. Two (9%) women following underwent further continence surgery including a sling and transurethral collagen injection and one (5%) following the sling required a tension-free vaginal tape. Other complications included two urinary tract infections following the and three after the sling and one incisional hernia following the sling. re-operative bladder neck hypermobility was not an independent risk factor for objective cure in either the ( ¼ 0.15) or sling group ( ¼ 0.58). There was no significant difference in the pre- and post-operative change in MUC between the two groups and MUC values correlated poorly with successful objective outcome in either group. The average cost per patient for the (including reoperations) was significantly greater (AU$4410) than for the sling (AU$3500) ( ). Long term follow up Subjective follow up was repeated by telephone questionnaire approximately five years after surgery. The telephone questionnaire referred to overactive bladder (OAB) symptoms of frequency, nocturia and urgency, as well as Table 4. Subjective long term follow up. value was obtained using Fisher s exact test. Symptom (n ¼ 14) (n ¼ 13) Frequency 4 (29) 2 (15) 0.65 Nocturia 4 (29) 3 (23) 1.00 Urgency 7 (50) 4 (31) 0.44 Urge incontinence 7 (50) 4 (31) 0.44 Stress incontinence 4 (29) Voiding difficulty 1 (7) 2 (15)* 0.60 Satisfied with surgery 4 (29) 9 (69) * Both requiring intermittent self-catheterisation. urge and stress incontinence, voiding difficulty, further surgery and satisfaction with the initial surgery. Attempts were made to contact all patients but only a 60% response rate was recorded (14 in the group and 13 in the sling group). The median duration from surgery in these two groups was 61 months (range months). Results are presented in Table 4. DISCUSSION procedures are generally recommended for women with SUI complicated by ISD. 2 4 High success rates for sling procedures need to be weighed against potentially increased post-operative morbidity including voiding dysfunction and bladder overactivity. 20,21 Risk factors associated with ISD including increasing age and a history of previous surgeries have encouraged many clinicians to seek minimally invasive alternatives treatments to the sling. Transurethral is a simple and safe procedure with minimal morbidity and has been recommended as an ideal treatment for SUI and ISD. 10 We are aware of no other prospective randomised controlled trial comparing the pubovaginal sling and transurethral in women with SUI and ISD. A recent systematic review of efficacy of highlighted the low methodological quality of available studies and stressed the importance of randomised clinical trials to establish efficacy. 22 Our study confirmed that the is associated with reduced morbidity when compared with the sling, including significantly decreased operating time, blood loss, hospital stay and a quicker return to normal activity. While the subjective, patientdetermined and objective evaluations were all greater in the sling group, the objective evaluation was the only parameter in which the sling demonstrated a statistically superior outcome to the in the short term. Within each group, there was a significant improvement in outcome as documented by the 1-hour pad test and validated urinary incontinence questionnaires. The small sample size of this trial limits the possibility of statistical significant differences in the other outcome measures. In our population of women with SUI, approximately 10 20% have ISD, which makes recruitment for trials such as this a lengthy process. The short term subjective and patient-determined success rates we reported for are similar to that in the literature, which ranges from 48% to 74% The 10% objective success rate we reported is very low. Koelbl et al. 12 reported a 59% success rate using a 300-mL clinical stress test as the objective testing criteria, whereas another recent study followed patients for one year after transurethral and demonstrated a subjective improvement in 76% of patients with an objective improvement based on urodynamic Valsalva leak point pressures of 45%. 23 Our low objective success rate may be explained simply by the

5 UBOVAGINAL SLING VERSUS TRANSURETHRAL MACROLASTIQUE 801 rigorous full urodynamic objective evaluation that was applied. An alternative explanation is poor procedural technique, but we feel this is unlikely given that our subjective success rate is similar to that in the literature and all surgeons had significant experience with other transurethral agents and prior to commencing the study. Our median reimplantation rate for of 22% is similar to that reported, which ranges from 12% to 35% Our 90% subjective and 81% objective success rates using the pubovaginal sling are consistent with the literature 6,7 but lower than the 100% success rate reported by Sand et al. 24 Our voiding dysfunction rate of 20% following the sling is higher than that reported by Sand et al. 24 but similar to other authors. 20,21 ost-operatively, de novo detrusor overactivity was similar in both groups at six months. Despite randomisation, pre-operative detrusor overactivity occurred in half of the slings and only 10% of the group. This difference can only be explained by the small sample size and would have been avoided with stratification of detrusor overactivity. Long term follow up after five years revealed no symptoms of stress incontinence in the sling group and no new OAB symptoms, whereas the group had a worse subjective outcome with 28% reporting persistent SUI. Overall continence rate (both stress and urge) was 70% in the sling group compared with only 22% in the group. This poor long term continence rate in the group was perhaps predictable in view of the high (90%) incidence of persisting SUI when repeat urodynamics was performed at short term follow up. However, this long term follow up was a secondary analysis performed using our unvalidated departmental standardised symptom questionnaire. This study has limitations in that blinding is impossible and so inherent bias regarding postoperative care and discharge was unavoidable. At the commencement of this study, pubovaginal slings and injectables were considered the treatments of choice in women with SUI and ISD. These remain options in the surgical management among many clinicians, but more recently there have been rapid developments in the less invasive suburethral slings with little morbidity compared with the traditional pubovaginal sling and randomised comparison of these with injectables will be studied in future research. References 1. Urinary Incontinence Guidelines anel. Urinary Incontinence in Adults. Clinical ractice Guidelines. Rockville, Maryland: Agency for Health Care olicy and Research, ublic Health and Human Services, 1992 (AHCR publication ). 2. McGuire EJ. Urodynamic findings in patients after failure of stress incontinence operation. rog Clin Biol Res 1981;78: Hilton, Stanton SL. Urethral pressure measurement by microtransducer: the results in symptom-free women and those with genuine stress incontinence. Br J Obstet Gynaecol 1983;90: Sand K, Bowen LW, angamiban R, Ostegard DR. The low pressure urethra as a factor in failed retropubic urethropexy. Obstet Gynecol 1987;69: Bowen LW, Sand K, Ostegard DR, Franti CE. Unsuccessful Burch retropubic urethropexy: a case-controlled urodynamic study. Am J Obstet Gynecol 1989;160: Blaivas JG, Jacobs BZ. ubo-vaginal sling for the treatment of complicated stress urinary incontinence. J Urol 1991;145: McGuire EJ, Bennett CJ, Konnak JA, Sonda L, Savastano JA. Experience with pubo-vaginal slings for urinary incontinence at the University of Michigan. J Urol 1987;138: Malizia Jr A, Reiman H, Myers R, Sande J, Barham SS, Benson Jr R. Migration and granulomatous reaction after periurethral injection of poltef (Teflon). JAMA 1984;251: Kreder KJ, Austin C. 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