Key Words: urinary incontinence, suburethral slings

Transcription

1 Evaluation of Transobturator Tension-Free Vaginal Tapes in the Surgical Management of Mixed Urinary Incontinence: 3-Year Outcomes of a Randomized Controlled Trial Mohamed Abdel-Fattah,*, Laura R. Hopper and Alyaa Mostafa From the University of Aberdeen, Aberdeen, United Kingdom Abbreviations and Acronyms MUI ¼ mixed urinary incontinence MUS ¼ mid urethral sling OAB ¼ overactive bladder QoL ¼ quality of life RCT ¼ randomized controlled trial RP-TVT ¼ retropubic tension-free vaginal tape SUI ¼ stress urinary incontinence TO-TVT ¼ transobturator tension-free vaginal tape UI ¼ urgency incontinence Accepted for publication July 16, Study received local research ethics committee approval. * Correspondence: Division of Applied Health Sciences, University of Aberdeen, Second Floor, Aberdeen Maternity Hospital, Foresterhill, Aberdeen AB25 2ZD United Kingdom (telephone: ; FAX: ; m.abdelfattah@abdn.ac.uk). Financial interest and/or other relationship with Astellas, AMS, Bard and Pfizer. Nothing to disclose. Editor s Note: This article is the fourth of 5 published in this issue for which category 1 CME credits can be earned. Instructions for obtaining credits are given with the questions on pages 276 and 277. Purpose: We evaluate the clinical effectiveness of transobturator tension-free vaginal tape procedures in the surgical management of mixed urinary incontinence in women at 3-year followup. Materials and Methods: In this secondary analysis of a prospective, single-blind, randomized controlled trial 83 of 341 women (24%) with mixed urinary incontinence were randomized to undergo an outside-in (ArisÒ transobturator sling system 42) or inside-out (TVTÔ-O 41) transobturator tension-free vaginal tape procedure. Patients were contacted by postal questionnaire at a minimum of 3 years postoperatively. The primary outcome was the patient reported success rate, defined as very much improved/much improved on the PGI-I (Patient Global Impression of Improvement). Secondary outcomes included improvement in quality of life, impact on preoperative urgency/urgency incontinence and repeat surgical treatment for stress urinary incontinence. Outcomes at 3 years were compared between groups (outside-in vs inside-out) and to 1-year outcomes. Analysis was performed using SPSSÒ version 20 with significance levels set at p ¼ Results: A total of 66 women with mixed urinary incontinence completed the 3-year followup (outside-in 35 vs inside-out 31). In each group 2 women underwent further continence surgery. The patient reported success rate was 73.8% with no significant differences between the groups (OR 1.035, 95% CI 0.342e3.134, p ¼ 0.951). Overall 34 (50.1%) and 26 women (56.5%) reported cure of preoperative urgency and urgency incontinence, respectively, and 52 women (86.7%) had a clinically significant improvement in quality of life (18 points or more in total KHQ [King s Health Questionnaire] score) compared to baseline. Conclusions: Transobturator tape procedures are associated with a good (73.8%) patient reported success rate at a minimum of 3 years of followup in the surgical management of mixed urinary incontinence in women with predominant stress urinary incontinence symptoms. Nearly half of the women reported cure of urgency/urgency incontinence. Key Words: urinary incontinence, suburethral slings MIXED urinary incontinence is the second most common type of urinary incontinence and is specifically more common with advancing age. MUI is considered more difficult to treat due to the need to mutually manage stress urinary incontinence and overactive bladder symptoms, with the latter often being unpredictable with evidence of flaring and remission of symptoms over time. 1 Of all incontinent women in the EPICONT study 114 j /14/ /0 THE JOURNAL OF UROLOGY 2014 by AMERICAN UROLOGICAL ASSOCIATION EDUCATION AND RESEARCH,INC. Vol. 191, , January 2014 Printed in U.S.A.

2 TRANSOBTURATOR TAPES FOR MIXED URINARY INCONTINENCE % reported experiencing MUI. 2 Women with MUI often report that their symptoms are more troublesome in terms of quality of life compared to women with other types of urinary incontinence. 2,3 There is evidence of a reduction in the productivity of working women with MUI and in severe cases urinary incontinence can lead to social isolation. 4,5 There is currently a lack of evidence on the best management strategy for MUI. Standard practice is to offer women surgical treatment for SUI, most commonly mid urethral sling, if OAB symptoms are well controlled. TO-TVT is theoretically more advantageous in women with MUI compared to RP-TVT due to the more horizontal insertion and less obstructive nature. We have previously shown a patient reported success rate of 75% and an objective cure rate of 90% in women with MUI after insertion of TO-TVT at 1-year followup. 6 There is a paucity of data on long-term outcomes of TO-TVT in general and particularly in women with MUI. 7 A recent systematic review called for RCTs with a long-term followup to determine the effectiveness of MUS in women with MUI. 7 In this study we bridge a gap in the current literature and evaluate patient reported outcomes of 2 types of TO-TVT in women with MUI at a minimum of 3 years of followup. We also compare the results to 1-year outcomes to determine late onset failures. METHODS This is a secondary analysis of a prospective single-blind RCT, the E-TOT (Evaluation of Transobturator Tapes) study, performed at a tertiary urogynecology referral center in Scotland between April 2005 and April A total of 341 women with SUI were recruited and randomized to receive outside-in (TOT-Aris 42) or inside-out (TVT-O 41) TO-TVT. Of these women 83 had MUI symptoms (ie SUI and urgency with or without urinary incontinence) and predominant SUI symptoms, and formed the basis of this secondary analysis (see figure). Ethical approval was received from the local research 41 allocated and received inside-out Completed 1 year follow-up n=35 Loss to follow-up n=4 Withdrawals n=2 Completed 3-year follow-up n=31 Loss to follow-up n=4 83 patients with MUI recruited and randomised 42 allocated and received outside-in Completed 1 year follow-up n=42 Completed 3-year follow-up n=35 Loss to follow-up n=7 CONSORT flow diagram of recruited patients and followup ethics committee and the trial protocol was registered at Inclusion and Exclusion Criteria Women were included in this secondary analysis if they had MUI with predominant SUI symptoms (predominant symptoms were self-determined by participants). All women underwent primary or secondary continence surgery after a trial of conservative management. Women were excluded from the study if they had predominant OAB symptoms, were undergoing concomitant surgery, had comorbidities such as multiple sclerosis or diabetes, or had pelvic organ prolapse (pelvic organ prolapse quantification system stage 2 or greater) on examination. Randomization and Allocation Concealment Randomization was computer generated and allocation was concealed using sealed opaque envelopes. Women were not blinded to allocation. However, they were asked not to disclose this information at followup. Preoperative Assessment This evaluation included history, clinical examination and urodynamic assessment. Women completed several questionnaires preoperatively including the KHQ, PISQ-12 (Prolapse Incontinence Sexual Function Questionnaire) and BBUQ-22 (Birmingham Bowel Urinary symptom Questionnaire). Postoperative Assessment at 3 Years Women were contacted by mail at a minimum of 3 years of followup and were asked to complete the same questionnaires as they did preoperatively, with the addition of the PGI-I, patient satisfaction on a 10-point visual analog scale, the ICIQ-SF (International Consultation on Incontinence Questionnaire-Short Form) and questions eliciting whether they had received any further conservative, medical or surgical treatment for urinary incontinence/pelvic organ prolapse. The same assessment was previously performed at 1 year and the results were reported. 6 Outcome Measures The primary outcome was the patient reported success rate as defined by very much improved/much improved on PGI-I, with all other responses classified as failures. Secondary outcomes included impact on QoL and sexual function (defined as 18 points or more improvement in total KHQ score and improvement in PISQ-12 score compared to baseline, respectively), cure rates of postoperative urgency and UI (defined as 2 or more points improvement on the relevant question in BBUQ-22, eg improvement from all of the time to occasionally), and patient satisfaction (defined as a score of 8 or greater on a 10-point visual analog scale). Analysis of Data Statistical analysis was performed using SPSS version 20. Between group comparisons were made for categorical variables using the chi-square or Fisher s exact test where appropriate. Comparisons of between group improvements in KHQ and PISQ-12 scores were performed using the Mann-Whitney test. The 3-year postoperative scores were compared with baseline scores using the Wilcoxon

3 116 TRANSOBTURATOR TAPES FOR MIXED URINARY INCONTINENCE Table 1. Baseline characteristics of patients Whole Cohort Outside-In Inside-Out p Value Mean SD pt age Mean SD kg/m 2 body mass index Mean SD parity No./total No. previous hormone replacement therapy (%) 15/66 (23) 6/35 (17) 9/31 (29) 0.25 No./total No. previous incontinence surgery (%) 10/66 (15) 3/35 (9) 7/31 (23) 0.11 No./total No. previous hysterectomy (%) 28/66 (42) 15/35 (46) 13/31 (39) 0.57 No./total No. previous anterior repair (%) 7/66 (11) 2/35 (5) 5/31 (16) 0.24 No./total No. previous antimuscarinics (%) 46/66 (69) 25/35 (71) 21/31 (68) 0.75 signed rank test. The 1 and 3-year outcomes were compared for the entire cohort using McNemar s test for categorical outcomes. RESULTS A total of 66 (79.5%) women with MUI completed a minimum of 3 years of followup (median 41 months, IQR 36-44). Compared to 1-year results, 11 women were lost to followup in the outside-in (7) and insideout (4) groups. The figure shows the CONSORT (CONsolidated Standards of Reporting Trials) flow diagram. There were 4 women (6%) who underwent further continence procedures (3 in postoperative year 1) and were analyzed as failures in this study. Baseline patient characteristics are shown in table 1. More women in the inside-out group had previously undergone continence surgery (outsidein 3 vs inside-out 7, p ¼ 0.11). Patient Reported Success Rate This outcome was defined by very much/much improved on PGI-I, and was 73.8% with no significant differences between groups (outside-in 73.5% vs inside-out 74.2%, OR 1.04, 95% CI 0.34e3.13, p ¼ 0.95, table 2). Table 2 also presents other patient reported outcomes such as patient satisfaction and ICIQ-SF. Sensitivity analysis was performed for PGI-I (primary outcome) with different assumptions for those lost to followup. Success rates ranged from 58% to 80% and the lack of significant differences between both groups pertained (table 3). Compared to the 1-year results there was no evidence of a significant difference in patient reported success rates on PGI-I (p >0.99, see supplementary table, Impact on QoL Compared to baseline scores there were statistically significant improvements in all domains of the KHQ, except general health, at 3-year followup (table 4). A clinically significant improvement (18 points or more in total KHQ from baseline) was seen in 86.7% (52 of 60) of women, with no significant difference between the groups (outside-in 87.5% vs inside-out 85.7%, OR 0.86, 95% CI 0.19e3.80, p >0.99). For comparison with the reported 1-year outcomes, 6 we repeated the KHQ analysis using a 10-point cutoff value in the total KHQ score. Of the women 88.3% (53 of 60) reported significant improvement in QoL at 3 years with no significant difference compared to the 1-year results (p >0.99). Impact on OAB Symptoms At 3 years 51.1% (34) of women reported cure/ significant improvement in urgency symptoms compared to 56.1% (37) at 1 year, while 24.2% (16) experienced persistence and 24.2% (16) experienced worsening of urgency, with no significant differences between the groups (table 5). The decrease in cure rate from 1 to 3 years was not statistically significant (p ¼ 0.25). Women reporting persistence or worsening of urgency were all (except 1) on various antimuscarinic treatments at 3 years, including 3 scheduled for BotoxÒ treatment and 1 on the waiting list for sacral neuromodulation. Compared to 1-year results there was an increase in the number of women taking antimuscarinic agents at 3 years (31 vs 25). Of these women 5 stopped antimuscarinic treatment due to improvement in OAB, while 8 restarted and a further 3 started treatment de novo. Table 2. Patient reported success rates at 3-year followup for whole cohort, and comparison between outside-in and inside-out techniques PGI-I Satisfaction ICIQ-SF* No./total No. total success/cured (%) 48/65 (73.8) 47/66 (71.2) 38/64 (59.4) No./total No. outside-in (%) 25/34 (73.5) 25/35 (71.4) 23/34 (67.6) No./total No. inside-out (%) 23/31 (74.2) 22/31 (71.0) 15/30 (50.0) OR (95% CI) 1.04 (0.34e3.13) 0.98 (0.34e2.84) 0.48 (0.17e1.32) p Value * Success defined as never leak/leak few drops once or less per week in response to, How much do you leak?.

4 TRANSOBTURATOR TAPES FOR MIXED URINARY INCONTINENCE 117 Table 3. Sensitivity analyses based on patient reported success on PGI-I All Missing Data as Failure All Missing Data as Success Last Observation Carried Forward No./total No. totals (%) 48/83 (58) 66/83 (79) 56/77 (73) No./total No. outside-in (%) 25/42 (59) 33/42 (79) 30/42 (71) No./total No. inside-out (%) 23/41 (56) 33/41 (81) 26/35 (74) OR (95% CI) 0.87 (0.36e2.08) 1.13 (0.39e3.27) 1.16 (0.42e3.18) p Value Impact on Sexual Function The PISQ-12 was completed by 30 sexually active women preoperatively and at the 3-year followup. Of these women 73.3% (22) showed an improvement in total PISQ-12 of 1 point or more, with no statistically significant difference between both groups (71.4% vs 75.0%, OR 1.2, 95% CI 0.24e6.07, p >0.99). There was a trend of decrease in PISQ-12 improvement compared to 1-year outcomes (81% showing improvement), but this did not reach statistical significance (p >0.99, table 4). DISCUSSION In a recent systematic review and meta-analysis Jain et al examined the effectiveness of MUS in women with mixed urinary incontinence. 7 The authors showed that MUS is associated with reasonable overall subjective cure rates (56.4%) in women with MUI at a mean SD followup of months. However, the cure rate for OAB (30% to 85%) was lower than that for SUI (85% to 97%) and decreased with time. Meta-analysis failed to detect a significant difference in the overall subjective cure rate between RP-TVT and TO-TVT. A main limitation in that review is the inclusion of observational studies with their inherited bias. Therefore, the authors called for RCTs with sound methodology and long-term followup on the use of MUS in women with MUI. In our RCT the response rate at 3 years for women with MUI was reasonable at 79.5% compared to 70% for the whole E-TOT cohort. 8 However, this rate was lower than that of Porena et al, who reported a response rate of 98% (145 of 148) at a median followup of 35 months for a RCT of MUS in women with stress and mixed urinary incontinence. 9 Interestingly, repeat analysis of their published figures showed that only 76% of their patients had a followup of 24 months or more. This RCT provides the first reported mediumterm evidence to our knowledge of the outcomes of TO-TVT in women with MUI. It showed a 73.8% patient reported success rate at a minimum of 3 years postoperatively. We analyzed and presented the patient reported success rate using alternative validated tools. Our results were lower than those reported by Jain et al, perhaps because they included observational results and studies with short-term outcomes. 7 In our study there were no significant differences between outside-in and inside-out TO-TVT, and the results pertained on sensitivity analysis using all possible assumptions for those lost to followup. However, it is important to acknowledge that the relatively small cohort in each group could lead to the study being underpowered to show such differences. In a similar RCT by But and Faganelj patients with MUI reported a significantly lower overall satisfaction rate compared to those with SUI (87.3% vs 96.6%, p ¼ ). 10 However, the authors only reported 4-month outcomes. In our RCT, with longer (3-year) followup, a lower patient reported success rate was seen in women with MUI at 73.8% compared to 81.2% in women with urodynamic SUI. However, the difference from our RCT did not reach statistical significance (p ¼ 0.233). Our results showed that 51.5% of women reported cure of urgency at 3 years postoperatively with no statistically significant difference between the outside-in and inside-out groups. This finding is Table 4. KHQ and PISQ-12 scores for whole cohort, and comparison of outside-in and inside-out techniques Median Score (IQR) Median Difference (IQR) Preop 3 yrs Postop p Value Outside-In Inside-Out p Value General health (25.00e25.00) (0e43.75) (e25.0e25.0) 0.00 (0.00e25.0) 0.74 Incontinence impact 100 (66.67e100.0) 0.00 (0.00e33.33) < (66.67e100.0) (66.67e100.0) 0.50 Role limitations (50.00e100.0) 0.00 (0.00e33.33) < (0.00e16.67) 0.00 (e25e16.67) 0.43 Physical limitations (50.00e83.33) 0.00 (0.00e33.33) < (20.83e83.33) 50.0 (37.5e66.67) 0.60 Social limitations (22.22e77.78) 0.00 (0.00e0.00) < (11.11e77.78) (11.11e77.78) 0.87 Personal limitations (0.00e79.17) 0.00 (0.00e8.33) (0.00e47.75) (0.00e83.37) 0.39 Emotions 6.67 (44.44e88.89) 0.00 (0.00e22.22) < (33.33e66.67) (33.33e66.67) 0.57 Sleep/energy (33.33e83.33) (0.00e33.33) < (16.67e66.67) (0.00e50.0) 0.14 Severity measure (66.67e91.67) (0.00e58.33) < (33.33e83.33) (33.33e83.33) 0.58 Total KHQ (44.75e77.77) (4.63e27.75) < (23.84e56.94) (22.51e55.2) 0.75 Total PISQ (22.00e35.00) (28.0e40.25) (e4.00e15.75) 8.00 (1.50e11.00) 0.28

5 118 TRANSOBTURATOR TAPES FOR MIXED URINARY INCONTINENCE Table 5. Outcomes for urgency and urgency incontinence symptoms at 3-year followup Total Outside-In Inside-Out OR (95%CI) p Value No./total No. preop urgency (%): Cure of urgency 34/66 (51) 19/35 (54) 15/31 (48) 1.27 (0.48e3.34) 0.63 Persistent urgency 16/66 (24) 9/35 (26) 7/31 (23) 1.19 (0.38e3.69) 0.77 Worsening urgency 16/66 (24) 7/35 (20) 9/31 (29) 1.27 (0.48e3.34) 0.63 No./total No. preop UI (%): Cure of UI 26/46 (57) 15/25 (60) 11/21 (52) 1.36 (0.50e3.69) 0.54 Persistent UI 11/46 (24) 5/25 (20) 6/21 (29) 0.69 (0.19e2.55) 0.58 Worsening UI 9/46 (20) 5/25 (20) 4/21 (19) 1.13 (0.27e4.63) >0.99 In the BBUQ-22 there is only 1 question to assess each symptom such as urgency and urgency urinary incontinence with 4 choices of answers including never, sometimes, most of the time and all the time. Cure defined as improvement in at least 2 points on the relevant BBUQ-22, eg from all of the time to occasionally. Persistence defined as no change on BBUQ-22. Worsening defined as deterioration of at least 1 point on BBUQ. comparable to the results of Jain et al 7 and the recent findings of Lee et al. 11 The latter group reported that 59.7% of women with MUI and predominant stress symptoms were cured of urgency after insertion of MUS with up to 50 months of followup. On multivariate analysis Lee et al found that the presence of detrusor overactivity on preoperative urodynamics increased the risk of persistent postoperative urgency, whereas the insertion of a TO-TVT compared to other types of MUS decreased the risk of urgency. 11 Jain et al described a trend of decreasing cure of urgency symptoms over time, with 81% to 100% cure of the urge component at 12 months compared to 35% to 43% at 38-month followup. 7 Our findings reflected a less sharp decline, with a decrease in the cure rate of urgency from 56.2% to 51.5% at 1 and 3-year followup, respectively, with a nearly 10% increase in the number of women using antimuscarinic agents. The long-term impact of continence procedures on QoL and sexual function in women is complicated to assess because a number of outside factors may contribute to positive or negative changes. To overcome this difficulty we assessed QoL using a disease specific questionnaire. We recently demonstrated that the 18-point improvement is the minimum requirement to show significant clinical improvement in QoL in women. 12 We found that 87% of women reported significant improvement in QoL with no significant difference compared to 1-year outcomes. Unfortunately the reporting of QoL in clinical trials investigating TO-TVT is sporadic and different questionnaires are often used, which makes comparisons difficult. We identified only one RCT that evaluated the impact of TO-TVT on quality of life in women with MUI, but with only 4 months of followup. 10 Similarly they demonstrated significant improvement in QoL in women after TO-TVT with no difference between the outside-in and inside-out groups. Our findings also show an improvement in sexual function in 73.3% of women at 3-year followup compared to baseline. The change in sexual function in women with MUI after TO-TVT was not reported previously in the literature except in the results of the E-TOT RCT at 1 year. 6 A number of studies previously evaluated the impact of MUS (RP-TVT and TO-TVT) in the treatment of SUI on sexual function in women, and the majority reported a statistically significant improvement. 8,13,14 However, there is evidence to suggest that insertion of RP- TVT can have a detrimental 15,16 or equivocal 17,18 effect on sexual function in women with SUI. This study addresses a current gap in the literature and is the first to our knowledge to report the 3-year outcomes of TO-TVT in women with MUI. The study has several strengths, including adequate randomization and allocation concealment, as well as inclusion and exclusion criteria to ensure the results are generalizable. In addition, the outcomes were assessed using validated questionnaires with an emphasis on patient reported outcomes, as they are increasingly seen as more clinically relevant and were recently deemed the most important form of assessment in gynecology. 19 There was a good response rate at 3 years and sensitivity analysis was performed to address differences in losses to followup in the 2 arms. However, there are also several limitations to the study. The objective cure rate was not reported due to the postal nature of the followup and the pad test could have been performed at the patient s home, but there is evidence to suggest that this would have resulted in poorer patient compliance. 20 Finally, the relatively small sample size could have introduced a type II error for between group analyses. CONCLUSIONS Transobturator tape provides a good overall patient reported success rate of 73.8% in women with MUI with a minimum 3-year followup, with no evidence of significant differences between the outside-in and inside-out approaches. The majority of women continue to show a clinically significant improvement in QoL and OAB symptoms. However, improvement in OAB symptoms showed a nonsignificant trend of decreasing compared to 1-year outcomes.

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