A Multicenter Study Evaluating the FREquency of Use and Efficacy of a Novel Closed-Loop Wearable Tibial Neuromodulation System for Overactive Bladder and Urgency Urinary Incontinence (FREEOAB).

OBJECTIVE: To evaluate the effectiveness and safety of a novel wearable neuromodulation system incorporating embedded electromyographic evaluation, representing the first closed-loop wearable therapy for bladder control. METHODS: This 12-week, multicenter, open-label, single-arm study of subjects with overactive bladder assessed response of bladder diary parameters and quality of life (QOL) metrics. Subjects used the transcutaneous tibial neuromodulation system, either once or three times weekly, with evaluations at weeks 1, 4, 8, and 12. Enrolled subjects (N = 96) were assessed for changes in urinary frequency, urgency, and urgency urinary incontinence episodes, and QOL changes using various questionnaires. RESULTS: In the intent-to-treat population (N = 96, mean age 60.8 ± 13.0years, 88.5% female), significant reductions in 3-day diary parameters were observed for daily voids, incontinence, and urgency episodes at 12weeks. QOL improvements exceeded the minimal clinically important difference for all QOL questionnaires. Long-term results remained robust at 12months. Device-related adverse events were mild and there were no device-related serious adverse events. Mean therapy compliance at 12weeks was 88.5%. High satisfaction rates were reported for the device overall. CONCLUSION: The Avation device demonstrates promising efficacy in treating adults with overactive bladder and urge urinary incontinence. At 12weeks, both diary parameters and QOL indicators showed significant improvement and remained robust at 12months. The device had a favorable safety profile with high compliance and patient satisfaction. This novel, closed-loop wearable tibial neuromodulation system represents a significant advancement in bladder control therapy, offering a noninvasive, patient-centered alternative with improved accessibility and ease of use.

Sensing in Sacral Neuromodulation: A Feasibility Study in Subjects With Urinary Incontinence and Retention.

OBJECTIVES: Sacral neuromodulation (SNM) therapy standard of care relies on visual-motor responses and patient-reported sensory responses in deciding optimized lead placement and programming. Automatic detection of stimulation responses could offer a simple, consistent indicator for optimizing SNM. The purpose of this study was to measure and characterize sacral evoked responses (SERs) resulting from sacral nerve stimulation using a commercial, tined SNM lead. MATERIALS AND METHODS: A custom external research system with stimulation and sensing hardware was connected to the percutaneous extension of an implanted lead during a staged (tined lead) evaluation for SNM. The system collected SER recordings across a range of prespecified stimulation settings (electrode configuration combinations for bipolar stimulation and bipolar sensing) during intraoperative and postoperative sessions in 21 subjects with overactive bladder (OAB) and nonobstructive urinary retention (NOUR). Motor and sensory thresholds were collected during the same sessions. RESULTS: SERs were detected in all 21 subjects. SER morphology (number of peaks, magnitude, and timing) varied across electrode configurations within and across subjects. Among subjects and electrode configurations tested, recordings contained SERs at motor threshold and/or sensory threshold in 75% to 80% of subjects. CONCLUSIONS: This study confirmed that implanted SNM leads can be used to directly record SERs elicited by stimulation in subjects with OAB and NOUR. SERs were readily detectable at typical SNM stimulation settings and procedural time points. Using these SERs as possible objective measures of SNM response has the capability to automate patient-specific SNM therapy, potentially providing consistent lead placement, programming, and/or closed-loop therapy.

A novel sacral neuromodulation protocol is associated with reduction in removal for device infection.

INTRODUCTION AND HYPOTHESIS: Sacral neuromodulation (SNM) has been established as an effective third-line therapy for non-obstructive urinary retention and urinary urgency-frequency syndrome. Device infection, ranging from 2-10%, is a severe complication usually necessitating device explanation. This study sought to demonstrate an infection protocol founded upon established device implantation risk factors and novel approaches to reduce the incidence of device infection, while maintaining good antibiotic stewardship following best practice statements. METHODS: A single-surgeon protocol was enacted from 2013 to 2022. Preoperatively, nasal swabs were cultured from each patient. If positive for methicillin-resistant Staphylococcus aureus or methicillin-sensitive Staphylococcus aureus, preoperative treatment with intranasal mupirocin was employed. Preoperative cefazolin was administered in patients with negative cultures or MSSA-positive. All protocol patients were given chlorhexidine wipes before surgery and prepped with a chlorhexidine scrub followed by alcohol/iodine paint. Post-procedural antibiotics were not given. Pre-protocol patients from 2011 to 2013 served as controls. RESULTS: Pre-protocol (n = 87) patients had a significantly higher rate of device infection compared to protocol patients (n = 444) in both the percentage of patients experiencing device infection (4.6% vs 0.9%, p = 0.01) and percentage of procedures associated with device infection (2.9% vs 0.5%, p < 0.05). A successful culture of the nares was achieved in 91.4% of protocol patients, with 11.6% MRSA-positive. Risk ratio for infection of pre-protocol/protocol patients was 0.19 (0.05-0.77) with odds ratio 5.1 (1.3-20.0). CONCLUSIONS: Utilization of a novel SNM infection protocol tailored to a patient's preoperative MRSA colonization is associated with a reduction in the overall incidence of explant for device infection while avoiding prolonged postoperative antibiotic regimens. CLINICAL TRIAL REGISTRATION: The study was initiated prior to January 18, 2017 and does not meet the definition of an applicable clinical trial (ACT) as defined in section 402 (J) of the US PHS Act.

Evaluation of clinical performance and safety for the rechargeable InterStim Micro device in overactive bladder subjects: 6-month results from the global postmarket ELITE study.

AIMS: Sacral neuromodulation (SNM) is an advanced therapy option for the treatment of overactive bladder (OAB), nonobstructive urinary retention, and fecal incontinence. The aim of this ongoing prospective, multicenter, global, postmarket study is to confirm safety and clinical performance of the InterStimTM Micro system for SNM in all indications. Reported here are the results for the OAB cohort through 6-month follow-up. METHODS: Eligible OAB subjects that had a successful therapy evaluation were enrolled after implant of an InterStim Micro implantable pulse generator (IPG). Subjects completed voiding diaries and the Overactive Bladder Quality of Life questionnaire (OAB-q) at baseline and follow-up visits occurring at 3 months and 6 months postimplant. Safety was evaluated as device-, procedure-, or therapy-related adverse events. The primary objective for the OAB cohort was to demonstrate an improvement in OAB-q Health Related Quality of Life (HRQL) total score at 3 months postimplant compared to baseline. RESULTS: Sixty-eight OAB subjects were enrolled and implanted with an InterStim Micro IPG. Of those, 67 and 66 subjects completed the 3- and 6-month follow-up visits, respectively. The OAB-q HRQL demonstrated a statistically significant improvement from baseline to 3-month follow-up with an average increase of 33 ± 24 points (n = 67, p < 0.001). The change was also observed at 6-months with an average increase of 31 ± 23 points (n = 65) compared to baseline. Eighty-two percent of subjects achieved the minimally important difference in HRQL score at 3- and 6-month, respectively, with a change of 10 points or greater. The majority of subjects reported that their bladder condition was better at 3-month (92.5%, 62/67) and 6-month (89%, 59/66) compared to before they were treated with SNM therapy delivered by the InterStim Micro system. For subjects with urgency urinary incontinence (UUI), the average change from baseline to follow-up in UUI episodes/day was -3.6 (95% CI: -4.7, -2.6; n = 62) at 3-month and -3.7 (95% CI: -4.7, -2.7; n = 61) at 6-month. Among subjects with urgency-frequency (UF), the average change from baseline to follow up in voids/day was -4.5 (95% CI: -6.3, -2.7; n = 52) at 3-months and -4.4 (95% CI: -6.0, -2.7; n = 52) at 6-month. The cumulative incidence of device-, procedure-, or therapy- related adverse events was 7.4% (5/68). Out of these five related adverse events, there was one serious adverse event (1.5%, implant site pain) at the time of database snapshot. CONCLUSIONS: These data confirm the safety and clinical performance of the InterStim Micro device for subjects with OAB by demonstrating a significant improvement in OAB-q HRQL score at 3-month. Similar improvements were observed at 6 months in addition to an incidence of adverse events that is comparable to previously reported rates for SNM.

A prospective, multicenter, international study to explore the effect of three different amplitude settings in female subjects with urinary urge incontinence receiving interstim therapy.

AIMS: The aim of this study is to evaluate the effect of sub-sensory amplitude settings of sacral neuromodulation therapy on overactive bladder symptoms in subjects with urinary urge incontinence. METHODS: Subjects who qualified for a neurostimulator device implant were randomized to one of three amplitude settings (50% of sensory threshold [ST], 80% of ST, and ST). Subjects completed urinary voiding diaries (3-day), International consultation on incontinence modular questionnaire-overactive bladder symptoms quality of life questionnaire, and patient global impression of improvement (PGI-I) to assess change in voiding symptoms and quality of life (QoL) from baseline through 12 weeks. RESULTS: Forty-eight subjects had a successful test stimulation, 46 were implanted with a neurostimulator device and 43 completed the 12-week follow-up visit. The change from baseline to 12 weeks is -3.0 urinary incontinence (UI) episodes/day (95% confidence interval [CI]: -4.4 to -1.7) for the 50% of sensory threshold group, -2.9 UI episodes/day (95% CI: -4.7 to -1.2) for 80% of sensory threshold group, and -3.6 UI episodes/day (95% CI: -5.2 to -1.9) for the sensory threshold group. In each randomized group, improvements were observed in health-related QoL, its subscales, and symptom interference. Subjects across all three randomization groups reported on the PGI-I that their bladder condition was better at 12 weeks compared to before they were treated with InterStim therapy. CONCLUSION: These findings provide insights into possible advancements in the postimplantation phase of therapy with potential for improved patient comfort and increased device longevity.

Reproduction of Female Lower Urinary Tract Symptoms on Urodynamics.

OBJECTIVES: Urodynamic testing (UDS) can be a valuable tool in the assessment of urinary incontinence and voiding dysfunction. The success of UDS in reproducing patients' symptoms has not been well defined. We sought to determine the ability of UDS to reliably reproduce various lower urinary tract symptoms and secondarily the ability of UDS to produce disparate findings not associated with patients presenting symptoms. METHODS: Following Institutional Review Board approval, patient data was accumulated prospectively over 10 months. Notation was made of primary and secondary symptoms as well as if these stated symptoms were reproduced during the urodynamic procedure. Presenting lower urinary tract symptoms included for analysis were stress, mixed and urge incontinence, urgency, and obstructive symptoms. We also reviewed the number of disparate urodynamic observations that did not correlate with patient history. RESULTS: Over a 10-month period, 127 women had interpretable data with respect to whether their presenting symptoms were reproduced during UDS. Presenting symptoms were successfully reproduced on 83% of UDS studies. Disparate urodynamic observations were noted in 60% of patients. CONCLUSIONS: Reproduction of patient symptoms during UDS occurred in the majority of cases if the patient was queried regarding this association. Additional disparate urodynamic observations were also noted in a majority of patients undergoing UDS. It remains unclear whether reproduction of symptoms during UDS in females ultimately results in improved interventional outcomes. The implications of new or unexpected UDS findings during UDS are unknown.

Transvaginal bladder neck closure with posterior urethral flap for devastated urethra.

OBJECTIVES: To present a modified transvaginal bladder neck closure (TV BNC) technique using a posterior urethral flap to minimize the potential risk of ureteral injury and fistula formation. Urethral and bladder neck destruction owing to chronic indwelling urethral catheters in female neurogenic patients is a devastating complication. METHODS: A retrospective review was performed of all patients undergoing TV BNC at a single institution during a 3-year period. All patients had had a nonfunctional or destroyed urethra because of a long-term indwelling urethral catheter. In brief, the devastated outlet was closed using the dorsally bivalved urethra as a flap that was rotated cephalad onto the incised anterior bladder wall for closure, thereby rotating the suture line high into the retropubic space. A postoperative cystogram was obtained at 2-3 weeks. RESULTS: A total of 11 consecutive female patients with a devastated outlet underwent TV BNC, as described, with placement of a suprapubic tube. One patient experienced failure at 6 weeks postoperatively. The mean follow-up for the entire cohort was 9.6 months (range 1-36). Serial upper tract imaging at the last follow-up visit revealed no new hydroureteronephrosis. CONCLUSIONS: The results of our study have shown that TV BNC with a posterior urethral flap provides satisfactory early results. This technique creates a suture line far removed from the ureteral orifices, minimizing the risk of upper tract injury during closure. Also, the rotation of the posterior urethra onto the anterior bladder wall secures the suture line high into the retropubic space, minimizing the risk of failure and postoperative fistula formation.

An update on surgery for pelvic organ prolapse.

PURPOSE OF REVIEW: The surgical management of pelvic organ prolapse continues to evolve. Recent advancements in techniques and materials have increased the available treatments for pelvic organ prolapse. A current understanding of the benefits and limitations offered by recently introduced materials and techniques is essential to their proper application. RECENT FINDINGS: Current surgical therapies for prolapse now include augmentation with synthetic mesh, which may also be utilized as part of a 'kit'. In addition, both laparoscopic and robot-assisted techniques have been developed to address apical vaginal prolapse. Both the use of synthetic mesh and laparoscopic and robotic techniques should continue to be subjected to appropriate scrutiny to assess their long-term success and complications. SUMMARY: While the introduction of novel approaches to pelvic organ prolapse provide further options when considering appropriate therapy, the application of these materials and techniques should be examined with scientific rigor and should demonstrate both a significant benefit and low morbidity prior to widespread adoption. With continued research, we hopefully will be able to identify the ideal approaches and repairs to achieve optimal patient outcomes.

Urodynamics in the evaluation of overactive bladder.

Overactive bladder (OAB) is a clinical syndrome characterized by urinary urgency, frequency, and nocturia with or without accompanying urinary incontinence. Thus, using this operational definition based on symptoms at presentation, urodynamic testing is not required for an initial diagnosis of OAB. An increasing body of evidence suggests that, although there is a relationship between the urodynamic finding of detrusor overactivity and OAB, these are quite separate findings, and successful response to nonsurgical and surgical interventions for OAB does not depend on finding detrusor overactivity on urodynamic testing. The role of urodynamics in the setting of OAB is not well defined at present, but there are several clinical scenarios where such testing may be useful. However, at this time, the evidence to support their routine use in patients with OAB is limited.

Which injectable to use in the treatment of intrinsic sphincter deficiency?

PURPOSE OF REVIEW: Injectable agents are frequently used in the treatment of stress urinary incontinence in a variety of patients. Materials and techniques used in this therapy have evolved over time, with the relatively recent introduction of several novel therapies. The publication of recent evidence regarding these newer agents as well as older materials has provided fuel for the debate over which therapy is best. RECENT FINDINGS: Each of the agents discussed in this paper has variable biophysical properties that affect its efficacy and safety. Despite increasing evidence evaluating the various injectable materials for the treatment of stress incontinence, there is no clear data to establish any agent as superior or inferior in the various subgroups in which they are used. SUMMARY: The ideal periurethral injectable agent has not yet been identified though many of the currently used agents have acceptable efficacy in selected populations. There is active research into novel therapies that may prove effective.