UCLA The Men's Clinic
Santa Monica, California, 90403, United States
NCT Number: NCT07534696
Urinary incontinence is a common complication following prostatectomy and affects a substantial proportion of patients. Despite advances in surgical technique, many patients experience persistent symptoms that negatively impact quality of life. Current management strategies include pelvic floor muscle training, biofeedback and physical therapy, and surgical options. However, these approaches may be limited by adherence, access, and invasiveness, leaving a subset of patients with ongoing symptoms despite standard care.
Non-invasive pelvic floor neuromuscular stimulation has emerged as a potential adjunct for pelvic floor rehabilitation by inducing supramaximal muscle contractions and enhancing neuromuscular activation without requiring active patient effort. Preliminary studies suggest that high-intensity electromagnetic stimulation may improve patient-reported continence outcomes and pad usage in women as well as men following radical prostatectomy, though existing data are limited by small sample sizes and short follow-up durations. Additionally, no clinical studies exist evaluating outcomes in men following prostatectomy prior to established stress incontinence.
Given these limitations, further evaluation is needed to assess the feasibility, tolerability, and short-term effectiveness of this intervention in a post-prostatectomy population.
Interested in participating?
Request Info18 year and older
Male
Interventional
Not applicable
Santa Monica, California, 90403, United States
This prospective study aims to evaluate feasibility, safety, and patient-reported continence outcomes associated with non-invasive pelvic floor neuromuscular stimulation in men with urinary incontinence following prostatectomy. Findings may inform future clinical implementation and guide the design of larger, controlled trials.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will complete an 8-week intervention (12 sessions total), with outcomes assessed at baseline, end of treatment, and follow-up within three months of starting the intervention.
Time frame: From enrollment to 3 months after initiation of treatment
The Expanded Prostate Cancer Index Composite (EPIC) is a validated questionnaire assessing urinary, bowel, sexual, and hormonal outcomes.
Time frame: From enrollment to 3 months after initiation of treatment
The International Consultation on Incontinence Questionnaire Urinary Incontinence (ICIQ-UI) short form is a validated questionnaire assessing urinary incontinence.
Time frame: From enrollment to 3 months after initiation of treatment
Continence is measured by number of pads used per 24 hours, with continence defined as less than one pad used per day.
Time frame: From enrollment to 3 months after initiation of treatment
Treatment failure is defined as requiring procedural or surgical intervention for urinary incontinence following prostatectomy.
University of California, Los Angeles
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06669468
Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications
Denizli, Turkey (Türkiye)
View Trial DetailsNCT03721029
Erectile Dysfunction, Female Urogenital Diseases
Herlev, Central Region, Denmark
View Trial DetailsNCT05700487
Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications
Kayseri, Turkey (Türkiye)
View Trial DetailsNCT07639580
Feeding and Eating Disorders, Female Urogenital Diseases
Siena, Italy
View Trial Details