Objective
To assess the efficacy of transobturator tapes in the management of women with urodynamic mixed urinary incontinence (UI).
Study Design
A secondary analysis of a prospective randomized study; 83 women with mixed UI on urodynamics and predominant stress UI symptoms were recruited and randomly assigned to undergo “outside-in” or inside-out transobturator tapes. Preoperative assessment included urodynamic assessment and completion of validated symptom severity and quality of life (QoL) questionnaires. The primary outcome was patient-reported success rates at 1-year as assessed by the Patient Global Impression of Improvement (very much/much improved). Secondary outcomes included changes in preoperative urgency/urgency incontinence, changes in QoL scores and comparison between the 2 types of transobturator tapes.
Results
Seventy-seven women completed 1-year follow-up (outside-in [n = 42] vs inside-out [n = 35]). The patient-reported success rate and objective cure rate were 75% and 90%, respectively. At 1-year follow-up; 40 women (52%) and 31 women (57.4%) reported cure in their preoperative urgency and urgency incontinence, respectively. A total of 74% reported ≥10 point improvement in QoL scores.
Conclusion
In women with urodynamic mixed incontinence and predominant stress UI, transobturator tapes were associated with good patient-reported success rate at 1 year. Urgency/ urgency incontinence are cured in over 50% of women.
Urinary incontinence (UI) is a common condition worldwide particularly in women and is often associated with a negative impact on their social, physical and psychologic well-being. In working class women, UI is associated with negative effects on their productivity and some will avoid employment because of fear of embarrassing situations. Jahanlu and Hunskaar recently assessed 1274, originally continent, women at age of 41-45 years over a 10-year period. A total of 40.3% of this cohort developed new onset UI; 49.8%, 18.3%, and 20.3% for stress (SUI), urgency (UUI), and mixed urinary incontinence (MUI), respectively. The relative incidence increased with advancing age, and MUI was most common in women above the age of 60 years. Women with MUI report a significantly higher negative impact on their life styles than women with SUI only. MUI is a complex problem and a difficult one to treat; successful outcome associated with treatment depends on alleviation of both SUI and overactive bladder (OAB) symptoms.
Midurethral tension-free vaginal tapes are now the most common operations performed for SUI. Retropubic tension-free vaginal tapes (TVT; Ethicon, Edinburgh, UK), originally described by Ulmsten et al, is widely accepted worldwide as the gold standard surgical treatment for SUI. TVT has gained a wide popularity because of their lower perioperative morbidity and shorter learning curve when compared with the previous gold standard procedure (colposuspension), whereas achieving a similar success rate. Furthermore, it has been shown to retain a long-term patient reported success rate of 77% at 11 years. A number of studies have assessed its efficacy in women with MUI; however, they were predominantly retrospective studies. Kulseng-Hanssen et al showed that in 1113 women with MUI, TVT was an appropriate treatment, with women complaining of predominant SUI having the best results. Prospective studies had relatively small poulations to be able to draw robust conclusions.
Transobturator TVT are newer and have been shown to be noninferior to retropubic TVT in women with SUI with long-term follow-up. Transobturator tapes are inserted in a more horizontal plane than retropubic TVT, which could be of particular relevance to women with MUI as theoretically this may reduce the chances of postoperative urgency. Despite its potential, a very limited number of studies have assessed the efficacy of transobturator tapes in women with MUI and have reached contradicting results indicating a clear gap in the literature.
The aim of our study is to evaluate the success of transobturator tapes in the management of women with MUI as assessed by patient reported outcomes, objective cure rates, changes in quality of life (QoL), and sexual function at 1-year follow-up.
Materials and Methods
A secondary analysis of a prospective single-blinded randomised study performed in a tertiary urogynecology center in UK in the period between April 2005 and April 2007. The study was approved by the local research ethics committee and the study protocol was registered on the public domain www.clinicaltrials.gov in March 2005. Eighty-three women with urodynamic MUI and predominant SUI symptoms were randomly assigned to undergo either the “outside-in” TOT -ARIS (Coloplast Corp, Minneapolis, MN) or “inside-out” TVT-O (Ethicon Inc, Somerville, NJ), using opaque sealed envelopes. Both ARIS and TVT-O are made of macroporous, monofilament type-1 polypropylene mesh. These women were a part of a large randomized trial and were a preplanned subgroup analysis in our published protocol.
Inclusion and exclusion criteria
Women were included if they were having primary or secondary continence surgery and had failed pelvic floor muscle training (PFMT) and bladder retraining. Women were excluded if they had predominant bothersome OAB symptoms, neuropathic bladder, comorbidities such as multiple sclerosis or diabetes, concomitant surgery, or uterovaginal prolapse (POP-Q ≥ stage 2).
Preoperative assessment
The preoperative assessment included a detailed history, pelvic examination, urodynamic assessment, and completion of the King’s Health Questionnaire (KHQ), Birmingham Bowel Urinary Symptom Questionnaire (BBUSQ-22), and Pelvic Organ Prolapse/Incontinence Sexual Function Questionnaire (PISQ-12). Procedures were performed as originally described ; postoperative voiding assessment was performed using a standard protocol and satisfactory voiding was defined as postvoiding residual urine volume <100 mL and voided volume ≥250 mL.
Postoperative assessment at 12 months
The postoperative assessment at 12 months was performed by an independent clinician who was blinded to the type of surgery. The above parameters were reassessed with the addition of Patient Global Impression of Improvement (PGI-I), international consultation on Incontinence Questionnaire-Short form (ICIQ-SF) questionnaires, and International Continence Society (ICS) standard 1-hour pad test.
Measurable outcomes
The primary outcome was the “patient-reported success” assessed by PGI-I as “Very Much Improved” or “Much Improved.” Secondary outcomes were cure of preoperative urgency/urgency incontinence (defined as 2-point improvement on urgency question of BBUQ-22), impact on women’s QoL (changes in KHQ scores), and impact on sexual function (changes in PISQ-12 total score) and objective cure defined as negative pad test (≤1 g gain). We also compared both routes of transobturator tapes as a secondary outcome.
Statistical analysis
Between-group comparisons for categorical variables were performed using χ 2 or Fisher’s exact tests. Pre- and postscores were compared using Wilcoxon tests and between-group comparisons of scores were performed using Mann-Whitney tests. All analyses were performed using SPSS version 17 (SPSS, Chicago, IL) at a significance level of 5%.
Results
Eighty-three women were recruited ( Figure ): “outside-in” n = 42 (51%) vs “inside-out” n = 41 (49%). Seventy-seven women (93%) completed the 12-month follow-up and Table 1 shows their preoperative characteristics. Sixty-three women (72%) undertook the ICS pad test; 14 women preferred to complete the questionnaires at home including 2 women who were only contactable at 18 and 21 months postoperatively.
| Characteristic | Total cohort | Inside-out TVT-O | Outside-in ARIS |
|---|---|---|---|
| n = 35 (45.5%) | n = 42 (54.5%) | ||
| Age, y: mean ± SD (range) | 55.14 ± 10.970 (34–77) | 53.80 ± 11.809 (34–77) | 56.21 ± 10.258 (37–76) |
| BMI ≥30 kg/m 2 | 33 (44.0%) | 14 (41.2%) | 19 (46.3%) |
| MUCP <30 cm H 2 O | 20 (27.0%) | 11 (32.4%) | 9 (22.5%) |
| Previous hysterectomy | 32 (41.6%) | 14 (40.0%) | 18 (42.9%) |
| Previous continence surgery | 13 (16.9%) | 9 (25.7%) | 4 (9.5%) |
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