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Medium-term outcomes of sacral neuromodulation in patients with refractory overactive bladder: A retrospective single-institution study.

ABSTRACT: BACKGROUND:Sacral neuromodulation (SNM) is a minimally invasive fully reversible therapy that was approved in 1997 for overactive bladder syndrome (OAB) refractory to behavior modification and pharmacotherapy. Despite being in use for over two decades, the data on medium to long-term safety and efficacy of SNM in OAB is limited. We investigated the medium-term efficacy and safety of SNM along with the predictive factors for its success in patients with refractory OAB. METHODS:A retrospective consecutive case series of 66 patients undergoing SNM for refractory OAB between July 2009 and July 2018. All patients underwent a test period followed by permanent implantation, if there was > = 50% improvement in any symptom. The primary outcome was "success" defined as > = 50% improvement in any clinical parameter based on the subjective assessment of patient's response. The secondary outcomes were number of pads used in 24 hours, post-operative complications and re-operation rates. RESULTS:66 females with an average age of 62.7 years were included. 55/66 patients (83.3%) had a successful test phase and underwent permanent implantation. After a median follow-up of 32 months, SNM was successful in 41/55 (74.5%) patients. Mean number of pads used in 24 hours decreased significantly from 3.5 preoperatively to 1.2 at last follow-up (p<0.001). 8/55 (14.5%) patients reported complications of pain, lead migration, wound dehiscence and device malfunction. 10/55 (18.2%) patients underwent revision surgeries after a median duration of 21.9 months. Device was explanted in 15/55 (27.3%) patients after a median duration of 24 months. No significant predictor for success was identified. CONCLUSIONS:The success rate of SNM is 75% with a complication rate of 14.5% after a median follow-up of ~3 years. This study suggests medium-term efficacy and safety but a high re-operation rate of SNM in patients with refractory OAB.

SUBMITTER: Kaaki B

PROVIDER: S-EPMC7347151 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Medium-term outcomes of sacral neuromodulation in patients with refractory overactive bladder: A retrospective single-institution study.

Kaaki Bilal B Gupta Digant D

PloS one 20200709 7

<h4>Background</h4>Sacral neuromodulation (SNM) is a minimally invasive fully reversible therapy that was approved in 1997 for overactive bladder syndrome (OAB) refractory to behavior modification and pharmacotherapy. Despite being in use for over two decades, the data on medium to long-term safety and efficacy of SNM in OAB is limited. We investigated the medium-term efficacy and safety of SNM along with the predictive factors for its success in patients with refractory OAB.<h4>Methods</h4>A re ...[more]

PMID: 32645082

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Project description:ImportanceWomen with refractory urgency urinary incontinence are treated with sacral neuromodulation and onabotulinumtoxinA with limited comparative information.ObjectiveTo assess whether onabotulinumtoxinA is superior to sacral neuromodulation in controlling refractory episodes of urgency urinary incontinence.Design, setting, and participantsMulticenter open-label randomized trial (February 2012-January 2015) at 9 US medical centers involving 381 women with refractory urgency urinary incontinence.InterventionsCystoscopic intradetrusor injection of 200 U of onabotulinumtoxinA (n = 192) or sacral neuromodulation (n = 189).Main outcomes and measuresPrimary outcome, change from baseline mean number of daily urgency urinary incontinence episodes over 6 months, was measured with monthly 3-day diaries. Secondary outcomes included change from baseline in urinary symptom scores in the Overactive Bladder Questionnaire Short Form (SF); range, 0-100, higher scores indicating worse symptoms; Overactive Bladder Satisfaction questionnaire; range, 0-100; includes 5 subscales, higher scores indicating better satisfaction; and adverse events.ResultsOf the 364 women (mean [SD] age, 63.0 [11.6] years) in the intention-to-treat population, 190 women in the onabotulinumtoxinA group had a greater reduction in 6-month mean number of episodes of urgency incontinence per day than did the 174 in the sacral neuromodulation group (-3.9 vs -3.3 episodes per day; mean difference, 0.63; 95% CI, 0.13 to 1.14; P = .01). Participants treated with onabotulinumtoxinA showed greater improvement in the Overactive Bladder Questionnaire SF for symptom bother (-46.7 vs -38.6; mean difference, 8.1; 95% CI, 3.0 to 13.3; P = .002); treatment satisfaction (67.7 vs 59.8; mean difference, 7.8; 95% CI, 1.6 to 14.1; P = .01) and treatment endorsement (78.1 vs 67.6; mean difference; 10.4, 95% CI, 4.3 to 16.5; P < .001) than treatment with sacral neuromodulation. There were no differences in convenience (67.6 vs 70.2; mean difference, -2.5; 95% CI, -8.1 to 3.0; P = .36), adverse effects (88.4 vs 85.1; mean difference, 3.3; 95% CI, -1.9 to 8.5; P = .22), and treatment preference (92.% vs 89%; risk difference, -3%; 95% CI, -16% to 10%; P = .49). Urinary tract infections were more frequent in the onabotulinumtoxinA group (35% vs 11%; risk difference, -23%; 95% CI, -33% to -13%; P < .001). The need for self-catheterization was 8% and 2% at 1 and 6 months in the onabotulinumtoxinA group. Neuromodulation device revisions and removals occurred in 3%.Conclusions and relevanceAmong women with refractory urgency urinary incontinence, treatment with onabotulinumtoxinA compared with sacral neuromodulation resulted in a small daily improvement in episodes that although statistically significant is of uncertain clinical importance. In addition, it resulted in a higher risk of urinary tract infections and need for transient self-catheterizations.

Project description:BACKGROUND:Women with refractory urgency urinary incontinence can be treated with onabotulinumtoxinA or sacral neuromodulation. Little data exists on the comparative effects of treatment of refractory urgency urinary incontinence on other pelvic floor complaints, such as bowel and sexual function. OBJECTIVE:The objective of this study was to compare the impact of these treatments on fecal incontinence and sexual symptoms. METHODS:This was a planned supplemental analysis of a randomized trial in women with refractory urgency urinary incontinence treated with onabotulinumtoxinA (n = 190) or sacral neuromodulation (n = 174). Fecal incontinence and sexual symptoms were assessed at baseline and at 6, 12, and 24 months. Fecal incontinence symptoms were measured using the St Mark's (Vaizey) Fecal Incontinence severity scale. Sexual symptoms were measured using the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-12 (PISQ-12) and the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR). The PISQ-IR allows measurement of sexual symptoms in both sexually active and non-sexually active adults. Primary outcomes were change in Vaizey and PISQ-12 scores between baseline and 6 months. Secondary outcomes were change in PISQ-IR total and subscores between baseline and 6 months and change in Vaizey, PISQ-12, and PISQ-IR scores between baseline and 12 and 24 months. Intent-to-treat analysis was performed using repeated measures mixed model to estimate change in all parameters from baseline while adjusting for the baseline score. A subgroup analysis of women with clinically significant bowel symptoms was conducted based on baseline Vaizey score of ?12. RESULTS:At baseline, mean Vaizey scores were indicative of mild fecal incontinence symptoms and were not different between onabotulinumtoxinA and sacral neuromodulation groups (7.6 ± 5.3 vs 6.6 ± 4.9, P = .07). The proportion of sexually active women (56% vs 63%, P = .25), mean PISQ-12 score (33.4 ± 7.5 vs 32.7 ± 6.7, P = .55), or PISQ-IR subscores were also not different between the onabotulinumtoxinA and sacral neuromodulation groups at baseline. There was no difference between women treated with onabotulinumtoxinA and those treated with sacral neuromodulation at 6 months in terms of improvement in fecal incontinence symptom score (Vaizey: -1.9, 95% confidence interval -2.6 to -1.2 vs -0.9, 95% confidence interval -1.7 to -0.2, P = .07) or sexual symptoms score (PISQ-12: 2.2, 95% confidence interval 0.7 to 3.7 vs 2.2, 95% confidence interval 0.7 to 3.7, P = .99). There was no difference in improvement between groups in the sexual symptom subscores in sexually active and non-sexually active women at 6 months. Similar findings were noted at 12 and 24 months. In a subgroup (onabotulinumtoxinA = 33 and sacral neuromodulation = 22) with clinically significant fecal incontinence at baseline (Vaizey score ?12), there was a clinically meaningful improvement in symptoms in both groups from baseline to 6 months, with no difference in improvement between the onabotulinumtoxinA and sacral neuromodulation groups (-5.1, 95% confidence interval -7.3 to -2.8 vs -5.6, 95% confidence interval -8.5 to -2.6, P = .8). CONCLUSION:There were no differences in improvement of fecal incontinence and sexual symptoms in women with urgency urinary incontinence treated with onabotulinumtoxinA or sacral neuromodulation. Women with significant fecal incontinence symptoms at baseline had clinically important improvement in symptoms, with no difference between the treatments. Our findings can help clinicians counseling women considering treatment for refractory urgency urinary incontinence.

Dataset Information

Medium-term outcomes of sacral neuromodulation in patients with refractory overactive bladder: A retrospective single-institution study.

Publications

Medium-term outcomes of sacral neuromodulation in patients with refractory overactive bladder: A retrospective single-institution study.

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