Samuel Zylstra

Results of a Prospective, Randomized, Multicenter Study Evaluating Sacral Neuromodulation With InterStim Therapy Compared to Standard Medical Therapy at 6-Months in Subjects With Mild Symptoms of Overactive Bladder

This prospective, randomized, multicenter trial evaluated the 6‐month success rate of sacral neuromodulation (SNM) with InterStim® Therapy versus standard medical therapy (SMT) for overactive bladder (OAB).

Three-year Follow-up Results of a Prospective, Multicenter Study in Overactive Bladder Subjects Treated With Sacral Neuromodulation

OBJECTIVE To evaluate the therapeutic success rate, and changes in quality of life (QOL) and safety in subjects using sacral neuromodulation (InterStim System) at 36 months. Subjects with bothersome symptoms of overactive bladder (OAB) including urinary urge incontinence (UI) and/or urgency frequency (UF), who had failed at least 1 anticholinergic medication, and had at least 1 untried medication were included. METHODS Subjects with successful test stimulation received an InterStim implant. Therapeutic success and quality of life through 36 months was evaluated in implanted subjects with data at baseline and follow-up. Safety was evaluated using reported adverse events. RESULTS A total of 340 subjects received test stimulation resulting in 272 implanted subjects. Demographics include 91% female, mean age of 57 years, and baseline symptom severity of 3.1 ± 2.7 leaks/day (UI) and 12.6 ± 4.5 voids/day (UF). The analysis showed an OAB therapeutic success rate of 83% (95% confidence interval: 78%-88%). UI subjects had a mean reduction from baseline of 2.3 ± 2.3 leaks/day whereas UF subjects had a mean reduction of 5.3 ± 4.0 voids/day (both P < .0001). Statistically significant improvements were observed in all measures of the International Consultation on Incontinence Modular Questionnaire-OABqol (all P < .0001). Eighty percent of subjects reported improvements in their urinary symptom interference. Device-related adverse events occurred in 47% (127/272) of subjects post-implant; 91% were resolved at the time of this analysis. CONCLUSION The 36-month follow-up data from the multicenter study demonstrate sustained safety, effectiveness, and improved QOL in subjects implanted with InterStim, without requiring failure of all medications.

Results of a prospective, multicenter study evaluating quality of life, safety, and efficacy of sacral neuromodulation at twelve months in subjects with symptoms of overactive bladder

This prospective, multicenter post‐approval study evaluated the success rate of sacral neuromodulation (SNM) with the InterStim® System at 12‐months. Subjects with bothersome symptoms of overactive bladder (OAB) including urinary urge incontinence (UI) or urgency‐frequency (UF), who failed at least one anticholinergic medication and had at least one not tried were included.

Five-Year Followup Results of a Prospective, Multicenter Study of Patients with Overactive Bladder Treated with Sacral Neuromodulation

Purpose We evaluated the therapeutic success rate, changes in quality of life and safety of sacral neuromodulation 5 years after InterStim™ implantation. Included in study were subjects with bothersome symptoms of overactive bladder, including urinary urge incontinence and/or urgency‐frequency, in whom at least 1 anticholinergic medication failed and 1 medication had not been tried. Materials and Methods Therapeutic success was defined as a urinary urge incontinence or urgency‐frequency response of 50% or greater improvement in average leaks or voids per day, or return to normal voiding, defined as fewer than 8 voids per day. Quality of life was evaluated by ICIQ‐OABqol (International Consultation on Incontinence Modular Questionnaire). Safety was evaluated through adverse events. Results Of the 340 subjects who completed the test stimulation 272 had an implant, of whom 91% were female. Mean age was 57 years. At baseline 202 subjects with urinary urge incontinence had a mean ± SD of 3.1 ± 2.7 leaks per day and 189 with urgency‐frequency had a mean of 12.6 ± 4.5 voids per day. The 5‐year therapeutic success rate was 67% (95% CI 60–74) using modified completers analysis and 82% (95% CI 76–88) using completers analysis. Subjects with urinary urge incontinence had a mean reduction from baseline of 2.0 ± 2.2 leaks per day and subjects with urgency‐frequency had a mean reduction of 5.4 ± 4.3 voids per day (each completers analysis p <0.0001). Subjects showed improvement in all ICIQ‐OABqol measures (p <0.0001). The most common device related adverse events were an undesirable change in stimulation in 60 of the 272 subjects (22%), implant site pain in 40 (15%) and therapeutic product ineffectiveness in 36 (13%). Conclusions This multicenter study shows that sacral neuromodulation had sustained efficacy and quality of life improvements, and an acceptable safety profile through 5 years in subjects with overactive bladder.

PD26-02 THE EFFECT OF SACRAL NEUROMODULATION ON COMPLETE CONTINENCE AT 5 YEARS FOR SUBJECTS WITH URINARY INCONTINENCE

compression. The buckling experiment showed different patterns of deformity (Figure 2). CONCLUSIONS: Data suggests that these prostheses exhibit significant physical differences. The clinical impact of these differences is poorly elucidated. These variations in the prostheses behaviors could be considered by the physician and the patient while objectively assessing the choice of the prosthesis. These findings could aid in objective patient counseling.

MP31-16 CONCOMITANT OVERACTIVE BLADDER MEDICATION USAGE AFTER SACRAL NEUROMODULATION IMPLANT

INTRODUCTION AND OBJECTIVES: This analysis aims to describe the use of concomitant overactive bladder (OAB) medications following implant of the sacral neuromodulation (SNM) InterStim system. Subjects with bothersome symptoms of OAB including urinary urge incontinence (UI) or urgency-frequency (UF), who had not exhausted all medication options (failed at least 1 anticholinergic medication and had at least 1 medication not tried) were included in the InSite study. METHODS: Subjects were restricted from taking OAB medications for the first 6 months post-implant. Concomitant use of OAB medications was allowed after 6 months. At each visit, data were collected on OAB medications used since previous visit. The number of implanted subjects who used any concomitant OAB medication postimplant is summarized by medication type. Baseline characteristics were compared between implanted subjects with and without concomitant OAB medication use during any time between implant and 5-years follow-up. Logistic regression was used to assess the effect of concomitant OAB medication use on 5-year therapeutic success in UI and UF subjects respectively. RESULTS: Of 272 subjects that were implanted, 91% were female and the mean age was 57 years. A total of 73 subjects used any concomitant OAB medications between 6 months and 5 years post implant; the most commonly used medications were mirabegron, oxybutynin, and solifenacin. At baseline, subjects qualified more frequently as both UI and UF in the group with concomitant OAB medication use vs. the group with no concomitant OAB medication (54% vs. 44%, p1⁄40.0479), and subjects with concomitant OAB medication use were older (mean age of 60.5 vs 55.6, p1⁄40.0163). When assessing the effect of concomitant OAB medications use on therapeutic response with baseline characteristics and test stimulation response adjusted, UI subjects were less likely to have 5-year therapeutic success if they had concomitant OAB medication use compared to those who didn’t (Odds Ratio1⁄40.28, 95% Confidence Interval 0.10-0.80, p1⁄40.0171). No relationship between concomitant OAB medication use and UF therapeutic response was observed. CONCLUSIONS: This result shows that a small portion of subjects implanted with InterStim use concomitant OAB medications post implant. However, the presence of OAB medications after implant does not improve long term therapeutic success. In UI subjects, the association between concomitant OAB medication use and poorer long term therapeutic success might indicate that a subset of subjects with symptoms remain refractory even with addition of OAB medications.

Does pelvic mesh treated with phosphorylcholine improve outcomes? An early experience

OBJECTIVES Implantable devices treated with phosphorylcholine (PC) have been successfully used in cardiac, ophthalmic, and other applications. This surface modification has resulted in a reduction in the host inflammatory responses. This pilot study tested the safety and efficacy of PC treated polypropylene mesh grafts implanted for the treatment of pelvic organ prolapse. STUDY DESIGN Surgeons from five U.S. sites collected data on subjects implanted with Perigee IntePro Lite+PC. Pre-procedure data collected included demographics and prolapse severity. At follow-up, subjects were assessed for anatomical outcomes (success≤stage I POPQ or Baden Walker), symptomatic improvement, and complications, particularly mesh exposure. RESULTS A total of 40 subjects were enrolled with 80% (32/40) of them completing at least 5-7 months of follow-up. Mean patient age was 60 years (range 36-78 years) and the mean BMI was 28 (range 20-40). There were no cases of mesh exposure/extrusion or granuloma formation. The anatomical success rate was 100% at 5-7 months (32/32). CONCLUSIONS This is the first publication on pelvic mesh treated with PC. There were no adverse events attributed to this surface modification. However, as the numbers are small, the results are not statistically significant. PC surface modification of pelvic mesh shows promise in its application for the reduction of mesh related complications.