Management of female stress urinary incontinence with single-incision mini-sling (Altis®): 36 month multicenter outcomes.

PURPOSE: To assess noninferiority of the safety and effectiveness of the Altis® Single Incision Sling (SIS) with standard midurethral transobturator and/or retropubic slings through 36 months in a prospective, longitudinal, nonrandomized US Food and Drug Administration (FDA) 522 cohort study. MATERIALS AND METHODS: Adult females with confirmed predominant stress urinary incontinence (UI) through cough stress test (CST) or urodynamics and failed two noninvasive incontinence therapies. Effectiveness endpoints included objective dryness, negative CST, adverse events, and revision/resurgery through 36 months. The primary effectiveness endpoint was reduction from baseline in 24-h pad weight of ≥50% at 6 months, as requested by the FDA, and is included as a study point in this paper. Primary safety endpoint was rate of related serious adverse events (SAE) through 36 months. Noninferiority margins of 15% and 10% were prespecified for the effectiveness and safety endpoints. Due to the observational nature of the cohort study, a propensity methodology was conducted to assess the effect of potential confounding variables on the primary endpoints between groups. RESULTS: Three hundred fifty-five women underwent the sling procedure (n = 184 Altis; n = 171 Comparator). One hundred fourty (76%) Altis subjects and 101 (59%) Comparator subjects completed follow-up through 36 months. At 36 months, for the effectiveness endpoint, the difference in proportions of -0.005 for Altis versus Comparator (95% confidence interval [CI]: -0.102 to 0.092) was statistically significant (p = 0.002), supporting the hypothesis that Altis is noninferior to Comparator. Furthermore, both groups demonstrated high objective efficacy; in the Altis arm n = 99 (81.8%) subjects were a success, and in the Comparator arm, n = 79 (82.3%) subjects were a success. Additionally, regarding the CST, Altis was found to be noninferior to the Comparator at every study visit, and the rate of negative CST remained above 80% for both groups (p < 0.001). At 36 months, Altis (n = 2; 1.1%) and Comparator (n = 4; 2.3%) subjects experienced a device and/or procedure-related SAE. The difference in proportions of 0.013 for Altis versus Comparator (95% CI: -0.023 to 0.048) was statistically significant (p < 0.001), demonstrating that Altis is noninferior to Comparator with respect to the primary safety endpoint throughout the study. There were 62 (36.3%) retropubic midurethral slings (RMUS), 96 (56.1%) transobturator midurethral slings (TMUS), and 13 (7.6%) SIS slings in the Comparator group. For the 36 month effectiveness endpoint, assessing the noninferiority of Altis versus RMUS and Altis versus TMUS, 99 (81.8%) Altis and 37 (90.2%) RMUS were a success, trending toward statistical significance, however, it cannot be determined to be noninferior (p = 0.092). Ninty-nine (81.8%) Altis and 33 (71.7%) TMUS were a success; this was statistically significant (p < 0.001), demonstrating Altis was noninferior to TMUS. Rates of negative CST were 122 (87.1%) Altis, 40 (93.0%) RMUS (p < 0.001), and 44 (91.7%) TMUS (p < 0.001). CST demonstrated that Altis was noninferior to RMUS and Altis was noninferior to TMUS at 36 months. CONCLUSION: Altis single-incision sling was noninferior to standard midurethral sling for treatment of stress UI, throughout the study and at 36 months. Furthermore, adverse event rates were low.

Cost-effectiveness of urethral bulking polydimethylsiloxane-Urolastic® compared with mid-urethral sling surgery for stress urinary incontinence: A two-arm cohort study.

OBJECTIVE: To investigate the cost-effectiveness of urethral bulking polydimethylsiloxane-Urolastic® (PDMS-U) compared with mid-urethral sling (MUS) surgery for stress urinary incontinence (SUI) at 1-year follow-up. DESIGN: Prospective, two-arm cohort study with 2-year follow-up. SETTING: International multicentre. POPULATION: Women with moderate to severe SUI. MAIN OUTCOME MEASURES: Primary outcome was subjective cure (Patient Global Impression of Improvement). SECONDARY OUTCOMES: objective cure (negative cough stress test), Urogenital Distress Inventory (UDI-6), complications and re-interventions. Cost-effectiveness outcomes: total costs, quality-adjusted life year (QALY) using IIQ7-scores (Incontinence Impact Questionnaire) and EQ-5D-5L, incremental cost-effectiveness ratio (ICER) and monetary benefit (adjusted for baseline confounders). RESULTS: In all, 131 PDMS-U and 153 MUS surgery patients were treated. Subjective cure rates for MUS surgery and PDMS-U were, respectively: 101/112 (90%) versus 40/87 (46%), adjusted odds ratio (aOR; for age, body mass index [BMI], severity, type of urinary incontinence and previous SUI procedure) was 4.9. Objective cure rates for MUS surgery and PDMS-U were respectively: 98/109 (90%) versus 58/92 (63%), aOR 5.4. Average total costs for PDMS-U and MUS surgery were €3567 and €6688. ICER for MUS surgery cost €15 598 per IIQ QALY and €37 408 per EQ-5D-5L QALY. With a willingness to pay (WTP) of €25 000, MUS has a 84% chance of being cost-effective using IIQ, whereas PDMS-U has a 99% chance of being cost-effective using EQ-5D-5L. CONCLUSION: MUS surgery is more cost-effective in realising improved disease-specific quality of life (QoL), while PDMS-U is more cost-effective in realising improved generic QoL.

AbobotulinumtoxinA is effective in patients with urinary incontinence due to neurogenic detrusor overactivity regardless of spinal cord injury or multiple sclerosis etiology: Pooled analysis of two phase III randomized studies (CONTENT1 and CONTENT2).

BACKGROUND: Neurogenic detrusor overactivity incontinence (NDOI) is often inadequately managed with oral therapy. OBJECTIVE: To assess efficacy and safety of abobotulinumtoxinA (aboBoNT-A; Dysport®; Ipsen Ltd.) according to etiology of NDOI. DESIGN, SETTING, AND PARTICIPANTS: Two phase III, randomized, double-blind studies (CONTENT1 [NCT02660138] conducted in Asia, Europe and North America; CONTENT2 [NCT02660359] conducted in the Americas, Asia, Europe and Oceania) both included patients with spinal cord injury (SCI) or multiple sclerosis (MS), with inadequately managed NDOI, regularly performing clean intermittent catheterization (CIC). INTERVENTION: Patients in CONTENT1 and CONTENT2 received aboBoNT-A injections 600 U (n = 162)/800 U (n = 161), or placebo (n = 162) into the detrusor muscle. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Primary endpoint: mean change from baseline in number of NDOI episodes/week at Week 6. Secondary endpoints: proportion of patients with no NDOI episodes; incontinence-related quality of life (I-QoL); urodynamic parameters; and time-to-retreatment. Safety was also assessed. Statistical analyses were conducted for pooled populations by etiology (aboBoNT-A doses vs. placebo). RESULTS AND LIMITATIONS: Of 485 randomized patients, 341 (70%) and 144 (30%) had SCI and MS etiologies, respectively. A significant reduction was observed in mean NDOI episodes/week at Week 6 with both aboBoNT-A doses versus placebo in the SCI (all p < 0.001) and MS (all p < 0.01) groups, as well as significant improvements in I-QoL and urodynamic parameters. Median time-to-retreatment was longer in patients with MS (48-62 weeks across doses) than those with SCI (39-44 weeks). Safety data were similar between etiologies. Urinary tract infection was the most frequent adverse event; similar numbers were reported across treatment groups. CONCLUSIONS: AboBoNT-A was well tolerated and significantly improved continence and bladder function, and QoL, in patients with SCI or MS with NDOI performing regular CIC. PATIENT SUMMARY: AboBoNT-A injections improved QoL, symptoms, and bladder function in patients with SCI or MS with bladder muscle overactivity that causes incontinence.

High-Intensity Laser Therapy (HILT) as an Emerging Treatment for Vulvodynia and Chronic Musculoskeletal Pain Disorders: A Systematic Review of Treatment Efficacy.

High-intensity laser therapy (HILT) has been gaining popularity in the treatment of chronic musculoskeletal pain, including vulvodynia. The objective of this study was to critically appraise and synthesize the available evidence on the efficacy of HILT for reducing pain and improving function in vulvodynia and other chronic primary musculoskeletal pain conditions. Electronic databases and the grey literature were searched. Effects on pain intensity, function, and adverse events were assessed. One study investigating HILT in the treatment of vulvodynia and 13 studies on the treatment of chronic musculoskeletal pain were selected. The study assessing vulvodynia showed favorable results for reducing pain. Regarding chronic musculoskeletal pain, 12 out of the 13 studies selected consistently showed that HILT was more effective than the placebo/active comparator for reducing pain and improving function. The available effect sizes for pain showed large to huge effects. Similar effects were observed for function except for two studies showing moderate effects. The GRADE score was moderate. Conclusions: There are insufficient data to support the use of HILT in vulvodynia, but the promising results encourage further research. HILT appears to be effective in musculoskeletal pain conditions. More high-quality studies are needed to identify effective laser protocols.

A pilot study on oral cyclosporine A in association with fulguration for the treatment of interstitial cystitis with Hunner's lesions.

AIMS: To evaluate the efficacy and safety of lesion fulguration in combination with cyclosporine A (CyA) as a maintenance therapy in patients with interstitial cystitis/bladder pain syndrome (IC/BPS) with Hunner's lesion (HL). METHODS: Retrospective observational study of refractory patients with HL treated with daily 1.5 mg/kg or less of oral CyA following lesion fulguration. Pain severity, subjective improvement, urinary symptoms, and adverse events were used to assess long-term treatment efficiency and safety. RESULTS: Among the 22 patients, median follow-up under CyA was 27 months. Patients reported sustained significant reduction compared to pretreatment in pain (0/10 vs. 8/10; p < 0.001), urinary frequency per 24 h (9.5 vs. 20.8; p < 0.001), and nocturia (2.3 vs. 7.6; p < 0.001). Subjective improvement rate (SIR) and patient global impression of improvement were of 90% and 1 ("very much better"), respectively, including four patients who considered themselves cured (SIR: 100%). Three patients needed an additional procedure due to pain relapse. Minor increase in creatinine was observed and three patients developed or worsened their arterial hypertension. CyA dosage was decreased to 1.2 mg/kg or less for long-term relief (n = 8), creatinine increase (n = 5), and neutropenia (n = 1) with subsequent improvement in renal function without symptom deterioration. CONCLUSIONS: Oral CyA seems to allow a sustained long-term relief following HL fulguration by alleviating pain, decreasing urinary symptoms, and procuring great subjective improvement. The daily low dose of 1.5 mg/kg or less appears to have limited adverse events while preventing repeated procedures. Larger trials are warranted.

Does urinary urgency drive urinary frequency in overactive bladder?

OBJECTIVES: To determine if reduction in urgency in patients with refractory overactive bladder syndrome (rOAB) is correlated with a reduction in voiding frequency and symptom bother. METHODS: Data from a prospective series of women with rOAB undergoing radiofrequency ablation of the subtrigonal tissue, termed selective bladder denervation (SBD), was analyzed. Main outcome measures included urgency voids, nonurgency voids, and urgency urinary incontinence (UUI) epidsodes from a 3-day voiding diary and quality of life (QoL) measures (Overactive Bladder Questionnaire Short Form [OAB-q SF]). RESULTS: The dataset comprised 62 completer subjects at 6 months. Compared to baseline, UUI and urgency voids were lower (P < .001), but nonurgency voids were increased (P < .001) and QoL measures were improved (P < .001), but functional bladder capacity did not increase. At baseline and 6 months post treatment, symptom bother was correlated with urgency voids (P < .05) but inversely correlated with nonurgency voids (P < .001). Urgency and nonurgency voids were inversely related at baseline and at 6 months (P < .0001). Following treatment, urgency voids decreased by 41% and nonurgency voids increased by 33%. CONCLUSIONS: As with other interventions for OAB, SBD resulted in a reduction in OAB symptoms and an improvement in QoL measures. However, the decrease in urgency voids was offset by an increase in nonurgency voids, suggesting that habit or defensive voiding is a significant driver of urinary frequency. It is not certain if this is a unique finding of the SBD effect, but these data do suggest that analyses of outcomes of other OAB interventions are warranted to gain a better understanding of the genesis of OAB symptoms.

Evaluation of Benefits and Harms of Surgical Treatments for Post-radical Prostatectomy Urinary Incontinence: A Systematic Review and Meta-analysis.

CONTEXT: No meta-analysis has comprehensively addressed both benefits and harms, or the certainty of evidence of the implantable continence devices used in men to treat postprostatectomy urinary incontinence (PPI). OBJECTIVE: To evaluate the benefits and harms of surgical treatments for patients suffering from PPI and assess the certainty of evidence. The primary benefit was cure (one or fewer pad per day), and the primary harm was reoperations defined by surgical procedures following implantation. EVIDENCE ACQUISITION: We perform a search of Medline, PubMed, Embase, Cochrane Library, and gray literature. We included observational studies addressing PPI surgical interventions if they involved cohorts of ≥50 participants. The Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach provided the framework for certainty of evidence assessment informed by value and preference judgments provided by patients, and an advocacy group member (Canadian Cancer Society). EVIDENCE SYNTHESIS: Of 85 observational studies involving 13 100 patients, three addressed bulking agents, 35 male synthetic slings, ten adjustable continence therapies (ACTs), and 37 artificial urinary sphincters (AUSs). Cure was 26.1% (95% confidence interval [CI]: 10.6-51.4, I2 = 92.8%, very-low-quality evidence) for bulking agents, 58.6% (95% CI: 51.3-65.5, I2 = 89.1%, low-quality evidence) for slings, 63.2% (95% CI: 57.6-68.5, I2 = 22.5%, very-low-quality evidence) for ACT, and 74.0% (95% CI:61.2-83.7, I2 = 92.1%, very-low-quality evidence) for AUS. Estimated rates of reoperation were 5.8% (95% CI: 1.9-11.6, I2 = 94.1%, moderate-quality evidence) for slings, 23.8% (95% CI: 5.9-61.0, I2 = 95.5%, low-quality evidence) for ACT, and 22.2% (95% CI: 15.2-31.3, I2 = 92.3%, high-quality evidence) for AUS. CONCLUSIONS: Available evidence regarding the benefits of surgical interventions for PPI remains mainly uncertain while suggesting important harms. These results should guide consent procedures for PPI surgery in the context of shared decision-making, with disclosure of the uncertainty of evidence. PATIENT SUMMARY: Despite being used worldwide, available evidence regarding the benefits of surgeries to treat postprostatectomy urinary incontinence remains mainly uncertain while suggesting important harms. This highlights the need for a more rigorous evaluation process for commercially available surgical devices.

A Multicenter Prospective Study Evaluating Efficacy and Safety of a Single-incision Sling Procedure for Stress Urinary Incontinence.

STUDY OBJECTIVE: The aim of the Altis 522 study was to compare the safety and efficacy of the Altis Single-Incision Sling System (SIS) (Coloplast, Minneapolis, MN) with standard midurethral transobturator and/or retropubic slings through 36 months. In this report, we present data through 12 months of follow-up. DESIGN: Postmarket, prospective, multicenter, nonrandomized cohort design. SETTING: The study was performed at 23 hospitals in the United States and Canada. PATIENTS: Adult female patients with stress urinary incontinence (SUI) clinically indicated for an incontinence sling were treated (n = 355). INTERVENTIONS: Altis SIS was compared with any Food and Drug Administration-cleared transobturator or retropubic sling. MEASUREMENTS AND MAIN RESULTS: Collected measures included device- and/or procedure-related serious adverse events, relevant nonserious and all adverse events, and revision surgery. Objective efficacy measures included 24-hour pad weight, dryness (defined as pad weight ≤4.0 g), and cough stress test. Subjective outcome measures included patient global impression of improvement, urogenital distress inventory, Incontinence Impact Questionnaire-Short Form, Surgical Satisfaction Questionnaire, and visual analog scale for pain. At 12 months, 24-hour pad weight success (≥50% reduction), negative cough stress test, patient global impression of improvement, urogenital distress inventory, and Incontinence Impact Questionnaire-Short Form appeared similar between groups. Through 12 months, 2 subjects in the Altis group and 3 subjects in the comparator group experienced a serious device- and/or procedure-related adverse event. In the Altis group, 1 subject (0.5%) experienced a device revision, and 1 subject (0.5%) had the device explanted. In the comparator group, 7 subjects (4.1%) experienced a device revision, and 1 device (0.6%) was explanted before the 12-month visit. The occurrence of relevant nonserious procedure and/or device-related adverse events was similar between groups. CONCLUSION: At 12-months follow-up, safety and efficacy appeared similar between Altis SIS and standard transobturator and retropubic midurethral slings.

Multicentered Assessment of Clinical Outcomes and Factors Associated With Failure of the Adjustable TransObturator Male System (ATOMS).

OBJECTIVE: To assess postoperative outcomes from the Adjustable TransObturator Male System (ATOMS) and identify factors influencing failure to achieve continence. PATIENTS AND METHODS: A multicentered analysis was performed on all patients treated for postprostatectomy incontinence using the third-generation ATOMS at 9 Canadian tertiary referral centers. The primary outcome was continence (defined as requiring ≤1 pad postoperatively for patients requiring ≥2 pads preoperatively and 0 pads for those requiring 1 pad preoperatively). Secondary outcomes included improvement (>50% change in pad use), patient satisfaction, explantation, and postoperative complications. RESULTS: Two hundred and eighty nine patients with a mean age of 68.9 years were analyzed. Pre-operatively mean pad per day use was 4.2 (1-12), 31.5% of patients reported severe incontinence (≥5 pads/day), 33.9% had concurrent radiotherapy and 19.4% had failed previous incontinence surgery. Overall continence rate was 73.3% (n = 212) at a mean follow-up of 19.6 months. More than eighty nine percent (89.3%) (n = 258) of patients experienced >50% improvement, 84.4% (n = 244) of patients were satisfied with the results of surgery. More than seven percent (7.9%) (n = 23) required device explantation. On multivariate Cox regression analysis, concurrent radiotherapy (hazard ratio [H.R.] 2.3, P < .001), diabetes (H.R. 2.2, P = .007) and increased pre-operative pad usage (H.R. 1.1, P = .02) were each associated with failure to achieve continence, while patient age (P = .60), obesity (P = .08), prior urethral stenosis (P = .56), and prior incontinence surgery (P = .13) were not. Radiation therapy was also associated with device explantation (H.R. 2.7, P = .02). CONCLUSION: ATOMS is a safe and efficacious for treatment of postprostatectomy incontinence. However, patients with prior radiation, increased pre-operative pad use, or diabetes are less likely to achieve continence.

The iTind Temporarily Implanted Nitinol Device for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: A Multicenter, Randomized, Controlled Trial.

OBJECTIVE: To report the results of a multicenter, randomized, controlled trial with a temporarily implanted nitinol device (iTind; Medi-Tate Ltd, Hadera, Israel) compared to sham for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. MATERIALS AND METHODS: Men 50 years or older were randomized 2:1 between iTind and sham procedure arms. A self-expanding, temporary nitinol device was placed for 5-7 days and an 18F Foley catheter was inserted and removed for the iTind and sham group, respectively. Patients were assessed at baseline, 1.5, 3, and 12 months postoperatively using the IPSS, peak urinary flow rate, residual urine, quality of life, and the International Index of Erectile Function. Unblinding occurred at 3 months. RESULTS: A total of 175 men (mean age 61.1 ± 6.5) participated (118 iTind vs 57 sham). A total of 78.6% of patients in the iTind arm showed a reduction of ≥3 points in IPSS, vs 60% of patients in the control arm at 3 months. At 12 months, the iTind group reported a 9.25 decrease in IPSS (P< .0001), a 3.52ml/s increase in peak urinary flow rate (P < .0001) and a 1.9-point reduction in quality of life (P < .0001). Adverse events were typically mild and transient, most Clavien-Dindo grade I or II, in 38.1% of patients in the iTind arm and 17.5% in the control arm. No de novo ejaculatory or erectile dysfunction occurred. CONCLUSION: Treatment with the second-generation iTind provided rapid and sustained improvement in lower urinary tract symptoms for the study period while preserving sexual function.

The history of sacral neuromodulation in Canada.

Sacral neuromodulation (SNM) has been used for the past 30 years, with significant improvements in the implantation technique and technology over the last several years. Canadian centers were involved with this technique from the very beginning by participating in several multicenter clinical trials and engaging in basic and clinical research. Presently, six Canadian centers continue to have SNM implantation programs.

Assessment of the effects of autologous muscle-derived cell injections on urethral sphincter morphometry using 3D/4D ultrasound.

PURPOSE: The primary objective was to evaluate the effect of autologous muscle-derived cell (AMDC) injections on the urethral sphincter morphometry compared to placebo injections. Secondary aims were to explore the reduction of stress incontinence episode frequency (IEF) and factors associated with the efficacy of AMDC. METHODS: This prospective randomized-controlled study compared the urethral sphincter volumes of participants who had received either an intra-sphincteric injection of 4 cc AMDC in injection media or 4 cc placebo solution, using a transperineal 3D/4D ultrasound at baseline and at 12 months. The reduction of stress IEF on 3-day bladder diary and potential predictors at baseline for response to AMDC were assessed. RESULTS: Fifty-eight participants were included in the study. Compared to baseline, the mean total and external sphincter volumes increased significantly in both groups (respectively, p = 0.001 and p < 0.001 in the AMDC group, p < 0.001 and p = 0.005 in the placebo group) at 12 months. Both groups showed a significant reduction of stress IEF compared to baseline (p = 0.03 and p ≤ 0.001 for AMDC and placebo groups, respectively). There were no between-group differences regarding total and external sphincter volumes and reduction of stress IEF. A longer urethral length (p ≤ 0.001) and a larger external sphincter volume (p ≤ 0.05) were significantly associated with lower stress IEF. CONCLUSION: Significant increases of sphincter volumes as well as reduction of stress IEF occurred among the AMDC and placebo injection groups with no between-group differences at 12 months. A longer urethral length and a larger external sphincter volume at baseline were identified as potential predictors of AMDC injection response.

A Preliminary Study on the Impact of Detrusor Overactivity on the Efficacy of Selective Bladder Denervation for the Treatment of Female Refractory Overactive Bladder.

OBJECTIVE: To determine whether the presence of detrusor overactivity (DO) is associated with the 12-week and 12-month clinical outcomes of selective bladder denervation (SBD) in women with refractory overactive bladder (OAB). METHODS: Prospective single institutional study of refractory OAB females who underwent a urodynamic study and were categorized according to DO status (DO- vs DO+) prior to receiving SBD. RESULTS: Among the 23 patients, 10 were DO- and 13 were DO+. Both groups reported improvement at 12 weeks on the 24-hour pad weight test, in urgency urinary incontinence (UUI) and urgency. At 12 months, both groups still reported improvement in urgency, but only the DO- group reported reduction on the pad weight test and only the DO+ group maintained improvement in the UUI rate. Clinical success (≥50% reduction in UUI) was achieved by all DO- and by 69% of DO+ patients at 12 weeks, and by 60% of DO- and 92% of DO+ patients at 12 months. Treatment benefit (Treatment Benefit Scale ≤2) was reported in 90% of DO- and 85% of DO+ patients at 12 weeks, and in 60% of DO- and 85% of DO+ patients at 12 months. When directly comparing both group outcomes, the only significant difference was the greater reduction of UUI in the DO- group at 12 weeks (-9.0 vs -6.5; P = .045). CONCLUSION: Refractory OAB females appear to be effectively treated by SBD regardless of baseline DO status. DO status does not seem to be associated with the 12-week and 12-month outcomes of SBD.

Canadian Experience with the Adjustable Transobturator Male System for Post-Prostatectomy Incontinence: A Multicenter Study.

PURPOSE: We assessed the efficacy and safety profile of the ATOMS® (Adjustable Transobturator Male System) for post-prostatectomy incontinence in a multicenter North American setting. MATERIALS AND METHODS: We reviewed outcomes from 8 centers in men who underwent treatment of post-prostatectomy incontinence with an ATOMS. Primary study outcomes were pad changes and continence, defined as requiring 1.0 or 0 pad postoperatively in patients who required 2.0 or more pads preoperatively and 0 pad in those who required more than 1.0 or 2.0 pads preoperatively. Secondary outcomes included improvement, 90-day complications and patient satisfaction. RESULTS: A total of 160 patients were enrolled in study with a median followup of 9.0 months. Preoperative median pad use was 4 per day (IQR 3-5). Of the patients 36.3% reported severe preoperative incontinence, 31.3% received prior radiotherapy and 16.3% underwent previous incontinence surgery. Median postoperative pad use after adjustments was 0.5 per day (IQR 0-1, p <0.001). The overall continence rate was 80.0% with improvement in 87.8% of cases. Of the patients 70.1% underwent a mean ± SD of 2.4 ± 2.7 adjustments (IQR 0-16). The patient satisfaction rate was 86.3%, 22.3% experienced 90-day complications of any grade and 7 (4.4%) experienced Clavien III complications primarily related to the injection port. Patients with a history of radiotherapy were less likely to be continent (62.5% vs 87.9%, p=0.002), improved (77.1% vs 92.6%, p=0.02) or satisfied (69.8% vs 93.2%, p=0.001). Similarly patients with previous incontinence surgery had lower rates of continence, improvement and satisfaction (57.7%, 73.1% and 69.6%, respectively). CONCLUSIONS: In the short term the ATOMS is a safe and efficacious device to treat post-prostatectomy incontinence. Patients with concurrent radiotherapy and previous incontinence surgery respond to treatment but are less likely to be continent, improved or satisfied.

Initial clinical experience with selective bladder denervation for refractory overactive bladder.

AIMS: To report the initial clinical experience with selective bladder denervation (SBD) of the trigone in women with refractory overactive bladder (OAB). METHODS: Females with refractory OAB underwent SBD of the bladder sub-trigone region. Patients were treated using a 10-s voltage-controlled radiofrequency (RF) algorithm (RF10) at study onset. The protocol was modified during the study after which point remaining patients received 60-s temperature-controlled RF (RF60). Patients were followed for 12 weeks and evaluated for adverse events and changes in OAB symptoms. Exploratory analyses on the influence of RF duration were performed. RESULTS: Among 63 patients, SBD resulted in statistically significant and clinically important improvements for most outcomes. Comparing RF10 (n = 34) to RF60 (n = 29), treatment benefit was greater with RF60 including mean reduction in urgency urinary incontinence (-2.5 vs -0.9; P < 0.01), urinary incontinence (-2.6 vs -0.8; P < 0.001), and total urgency and frequency score (-13 vs -7; P = 0.02); and improvements in symptom bother (-33 vs -18; P < 0.01) and quality of life (28 vs 16; P = 0.02) on the OAB questionnaire. The proportion of urgency urinary incontinence treatment responders (≥50% reduction in episodes) was 79% with RF60 and 31% with RF10. The frequency of device- or procedure-related adverse events was comparable in RF10 versus RF60 groups (14.7% vs 17.2%). CONCLUSIONS: This study demonstrated the feasibility of SBD in alleviating symptoms of refractory OAB. A 60-s RF algorithm using deeper ablations of the sub-trigonal tissues was more effective and comparably safe to a 10-s RF algorithm using more superficial ablations.