Karen Noblett

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.

Randomized prospective crossover study of interstim lead wire placement with curved versus straight stylet

To assess whether InterStim lead wire placement with the curved stylet achieves motor response at lower amplitudes compared to straight stylet use.

Does pelvic organ prolapse quantification exam predict urethral mobility in stages 0 and I prolapse

Objective: To determine if women with anterior support stages 0 or I by pelvic organ prolapse quantification (POP-Q) system require Q-tip testing to assess urethral mobility. Methods: A prospective study of 134 women presenting for urogynecologic evaluation were examined and assigned stages of anterior wall support according to the POP-Q system. A Q-tip test was performed and urethral hypermobility was defined as a straining angle ≥30°. The Spearman correlation coefficient was used to assess degree of correlation between POP-Q point Aa position and Q-tip values. Results: The correlation coefficient between point Aa position and Q-tip angle was r=0.787 (P<0.001). Urethral hypermobility was noted in 91% of stage I and 100% of stage II–IV patients. The positive predictive value of Q-tip angle ≥30° in stage I–IV prolapse was 99%. Conclusion: The POP-Q system is highly predictive of straining urethral angle in all stages of prolapse.

Detailed analysis of adverse events and surgical interventions in a large prospective trial of sacral neuromodulation therapy for overactive bladder patients

The InSite trial is a prospective, multicenter study of sacral neuromodulation (SNM) therapy with the InterStim® System in subjects with overactive bladder (OAB). One of the primary aims of the study is to report on long‐term safety of the tined lead. This analysis provides detailed descriptions of device‐related adverse events (AEs) and surgical interventions to 12 months.

Patient characteristics associated with a successful pessary fitting.

Objective: The objective of the study was to assess if patient characteristics, including Pelvic Organ Prolapse Quantification measurements, are predictive of successful pessary fitting in women with pelvic organ prolapse (POP) and/or incontinence. Methods: This was a retrospective chart review of patients who underwent a pessary fitting for POP and/or incontinence. Multiple demographic parameters, pessary fitting data, and Pelvic Organ Prolapse Quantification measurements were examined. Results: Complete data were available on 158 patients, and 59% were successfully fit. Shorter total vaginal length (TVL), less than 8 cm, was associated with an unsuccessful pessary fitting (odds ratio [OR], 0.1; 95% confidence interval [CI], 0.02-0.46). A genital hiatus (GH)/TVL ratio of less than 0.9 was predictive of successful fitting (OR, 12.5; 95% CI, 1.5-102). Patients with a prior hysterectomy were more likely to have an unsuccessful pessary fitting (OR, 0.41; 95% CI, 0.22-0.8). The GH/TVL ratio and TVL were predictors only in patients with a previous hysterectomy. Conclusions: Patients with a previous hysterectomy and a TVL of less than 8 cm or a GH/TVL ratio of 0.9 or greater can be counseled that successful pessary fitting is unlikely.

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.

Comparison of the cough stress test and 24-h pad test in the assessment of stress urinary incontinence

Introduction and hypothesisThe 24-h pad test and cough stress test are commonly used to assess stress urinary incontinence; however, no comparative data are available. The cough stress test is superior to the 24-h pad test.MethodsWomen with predominant stress urinary incontinence symptoms underwent a cough stress test, a 24-h pad test, and urodynamic testing.ResultsComplete data were available on 55 women. Agreement between the urodynamic results and the stress test occurred in 89% of women (k = 0.51). Sensitivity, specificity, and positive and negative predictive values were 90%, 80%, 98%, and 44%. Agreement between the urodynamic results and the pad test occurred in 60% of women (k = 0.08). Sensitivity, specificity, and positive and negative predictive values were 60%, 60%, 94%, and 13%. Agreement between the cough stress test and the pad test occurred in 67% (k = 0.26).ConclusionsThe cough stress test is more reliable than the pad test for documentation of stress urinary incontinence.

In vivo recovery of the injured anal sphincter after repair and injection of myogenic stem cells: an experimental model.

OBJECTIVE: This study aims to evaluate in vivo function of the external anal sphincter after transection and repair augmented with myogenic stem cells, and to establish normative electromyography parameters of the rodent external anal sphincter. DESIGN AND SETTING: Thirty-three Sprague-Dawley rodents underwent baseline needle electromyography of the external anal sphincter. Motor unit action potentials were obtained and normative parameters established. Animals were randomly assigned to a myogenic stem cell group (n = 24) or control group (n = 9). All underwent proctoepisiotomy. The control group underwent layered repair with phosphate-buffered saline injection to the external anal sphincter. The treatment group underwent identical repair with injection of myogenic stem cells 5.0 × 106. Baseline anal pressure recordings were collected and repeated 2 weeks postintervention, and electromyography was repeated at 2 and 4 weeks. Groups were compared across 3 time points with the use of repeated measures ANOVA. MAIN OUTCOME MEASURES: The primary outcomes measured were the functional recovery of rat anal sphincters after stem cell transplantation as assessed by objective electromyography and anal pressure measures. RESULTS: A mean of 17 motor unit action potentials were sampled per animal. At 2 weeks postrepair, there was a significant difference between control and transplant groups with respect to amplitude, duration, turns, and phases (p < 0.01 for each). No significant electromyography differences were seen at 4 weeks. Resting and peak anal pressures declined significantly at 2 weeks postinjury in the control but not in the stem cell group. LIMITATIONS: Use of a murine animal population limited the subjective feedback and wider applicability. CONCLUSIONS: In vivo functional studies show recovery of anal sphincter pressures and electromyography to preinjury levels by day 14 in the myogenic stem cell group but not controls. At 4 weeks, all electromyography parameters returned to baseline irrespective of group. Restoration of function may be accelerated by the transplantation of myogenic stem cells and associated trophic factors.