3-Year Followup of a New Implantable Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome.

PURPOSE: We evaluated the 3-year safety and efficacy of the BlueWind Medical RENOVA™ iStim system for the treatment of overactive bladder syndrome. MATERIALS AND METHODS: All patients who previously underwent implantation with the RENOVA system were offered continued participation. The primary long-term study end point was to evaluate the safety profile based on incidence of serious adverse events (system and/or procedure related), which was measured by the impact and frequency of serious adverse events. The secondary end points included clinical improvement compared to baseline and quality of life improvement compared to baseline at 36 months, which was measured by 3-day voiding diary and quality of life questionnaires at certain time points. RESULTS: Of the 34 patients with overactive bladder syndrome who previously underwent implantation with the RENOVA system 20 consented to continuation in this 3-year followup study. Mean patient age was 56.1 years and 80% (16) of the study cohort was female. The overall treatment success rate was 75% at 36 months in the per protocol (16) and the intent to treat (20) analyses. In total, 73% of the patients reported improvement in health related quality of life scores above the minimal important difference of 10 points. CONCLUSIONS: This 3-year followup study using the BlueWind RENOVA iStim system for the treatment of overactive bladder syndrome symptoms confirms the long-term good safety profile with no technical failures reported. Lasting treatment efficacy is mirrored by a sustained positive impact on patient quality of life.

A New Implanted Posterior Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome: 3-Month Results of a Novel Therapy at a Single Center.

PURPOSE: This study was designed to investigate the safety and performance of a new implantable system for tibial nerve stimulation for overactive bladder symptoms. MATERIALS AND METHODS: A battery-free stimulation device for tibial nerve stimulation (BlueWind Medical, Herzliya, Israel) was implanted in 15 patients. Safety and efficacy assessments were done at 3 months after activation with a 3-day bladder diary, a 24-hour pad test and 2 quality of life questionnaires. RESULTS: Two males and 13 females were enrolled in the study. Mean age was 54 years (range 19 to 72). Five of 15 patients were previously treated with percutaneous tibial nerve stimulation and 12 experienced urgency urinary incontinence. Median operative time was 34 minutes. At 3 months of followup a significant change was seen in 24-hour frequency from a mean ± SD of 11.8 ± 3.5 to 8.1 ± 2.0 times per day (p = 0.002), the number of severe urinary urgency episodes from 6.5 ± 5.1 to 2.0 ± 2.1 times per day (p = 0.002), the number of severe incontinence episodes from 2.8 ± 5.2 to 0.3 ± 0.4 episodes per day (p = 0.017), urinary loss per day from 243 ± 388 to 39 ± 55 gm (p = 0.038) and improvement in quality of life. After implantation, 3 patients received prolonged antibiotic treatment and 3 received pain medication for 1 week. In 1 patient the device was explanted due to pain and swelling suspicious for infection, although tissue cultures did not reveal a bacterial infection. CONCLUSIONS: This novel posterior tibial nerve stimulator is safe and easy to implant with good clinical results.

Para-Urethral Injections with Urolastic® for Treatment of Female Stress Urinary Incontinence: Subjective Improvement and Safety.

INTRODUCTION: Female stress urinary incontinence (SUI) is often treated surgically. Urethral bulking agents are a minimally invasive alternative, especially in patients suffering from intrinsic sphincter deficiency, but often with limited long-term efficacy. Urolastic® is a non-deformable, non-resorbable silicone elastomer that is used as an injectable. Its properties might result in a more durable response after injection. If this durability factor can be combined with a low complication rate, this can become a useful treatment option. We therefore assessed the subjective improvement and safety after treatment with Urolastic®. MATERIALS AND METHODS: In 2 Dutch hospitals, 65 patients were treated with Urolastic®. The subjective improvement was assessed and the medical charts were reviewed for complications that appeared during the follow-up period. The complications were classified using the Clavien-Dindo classification. RESULTS: We found that 76-88% of the patients showed subjective improvement at 12-25 months follow-up. The rate of improvement experienced was 50-70%. The rate of complications classified as Clavien-Dindo >II was 24-33%. The 12 patients with 75-100% subjective improvement after 2 months, showed 85% improvement after a median of 25 months. CONCLUSIONS: With careful patient selection, Urolastic® seems to be a safe, durable and effective treatment option for female SUI.

Subject-Controlled, On-demand, Dorsal Genital Nerve Stimulation to Treat Urgency Urinary Incontinence; a Pilot.

OBJECTIVES: To evaluate the effect of subject-controlled, on-demand, dorsal genital nerve (DGN) stimulation on non-neurogenic urgency urinary incontinence (UUI) in a domestic setting. MATERIALS AND METHODS: Non-neurogenic patients >18 years with overactive bladder symptoms and UUI were included. Exclusion criteria were mainly stress urinary incontinence. Patients underwent 1 week of subject-controlled, on-demand, DGN stimulation, delivered by a percutaneously placed electrode near the DGN connected to an external stimulator (pulse-rate 20 Hz, pulse-width 300 µs). Patients activated the stimulator when feeling the urge to void and stimulated for 30 s. The amplitude was set at the highest tolerable level. A bladder diary including a severity score of the UUI episodes/void (scores: 0 = none, 1 = drops, 2 = dashes, 3 = soaks) and a padtest was kept 3 days prior to, during, and 3 days after the test period. The subjective improvement was also scored. RESULTS: Seven patients (4 males/3 females) were enrolled, the mean age was 55 years (range 23-73). Six completed the test week. In the remaining patient the electrode migrated and was removed. 5/6 finalized the complete bladder diary, 1/6 recorded only the heavy incontinence episodes (score = 3). 4/6 completed the padtest. In all patients who finalized the bladder diary the number of UUI episodes decreased, in 3/5 with ≥60%. The heavy incontinence episodes (score = 3) were resolved in 2/6 patients, and improved ≥80% in the other 4. The severity score of the UUI episodes/void was improved with ≥ 60% in 3/5 patients. The mean subjective improvement was 73%. CONCLUSION: This feasibility study indicates that subject-controlled, on-demand DGN stimulation using a percutaneously placed electrode is possible over a longer time period, in a home setting, with a positive effect on non-neurogenic overactive bladder symptoms with UUI. Although the placement is an easy procedure, it is difficult to fixate the electrode to keep it in the correct position. Improvements in hardware, like a better fixated electrode and an easy to control stimulator, are necessary to make SODGNS a treatment possibility in the future.

Hidden prevalence of lower urinary tract symptoms in healthy nulligravid young women.

INTRODUCTION AND HYPOTHESIS: Lower urinary tract symptoms (LUTS) and urinary incontinence (UI) may have a major impact on quality of life. However, not all individuals with urological complaints seek medical advice. The aim of this study was to investigate the prevalence of LUTS in young otherwise healthy nulligravid women and the accompanying burden. METHODS: A total of 159 young presumably healthy female medical students aged 18-30 years were recruited at their university. All completed the International Consultation on Incontinence Modular Questionnaire for Female Lower Urinary Tract Symptoms. The prevalence of LUTS and the accompanying burden were measured. Correlations between symptoms and bother were analysed using Spearman's rho. RESULTS: LUTS was found in 94.3% of the women, urgency at least sometimes in 14.5%, and hesitancy in 14.5%. Nocturia once a night was reported by 18.2% of the women; none reported nocturia of more than twice a night. Involuntarily loss of urine was reported by 20.1% of the women but none reported this occurring more than twice a week. The median value of all bother scores was 0; the highest bother score was for urgency. For all questions a positive correlation was found between symptoms and bother; a strong correlation was found for bladder pain, urgency UI, stress UI and overall UI. CONCLUSIONS: In a presumably healthy population of young nulligravid women the prevalence of LUTS and UI was high, but with relatively low bother.

Botulinum Toxin A in Clinical Practice, the Technical Aspects and What Urologists Want to Know about It.

OBJECTIVES: To give an overview of the literature concerning the clinical practice of Botulinum toxin A (BTA) treatment to meet the needs and knowledge of urologists. METHODS: A literature search was performed to BTA treatment, together with a survey among Dutch urologist. RESULTS: The registration trials used strict inclusion and exclusion criteria, a standardized application technique and follow-up. The approval for BTA is based on these trials but differs from country to country. BTA was already used before these approvals, with different application techniques. Published manuscripts about application techniques (trigone sparing/suburothelial injections/intradetrusor injections) show different outcomes. In literature there is no positive or negative predictor found with a preoperatively urodynamic investigation. It is shown that retreatment does not cause inflammatory infiltration or fibrosis in the bladder wall. The survey showed that in 96% of the urology departments BTA is used. Urodynamic investigation is requested by 87% of urologists before the treatment. Although it is regarded as an easy-to-learn procedure 60% of urologists would like training in practical aspects. CONCLUSIONS: No firm data exist about the technique of application with consequently the most optimal results. BTA treatment is regarded as an easy-to-learn, but still there is a request for training in practical treatment aspects.