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Study of Penile Vibratory Therapy to Prevent Sexual Dysfunction and Urinary Incontinence After Nerve-Sparing Radical Prostatectomy

Led by Herlev and Gentofte Hospital · Updated on 2024-03-12

100

Participants Needed

1

Research Sites

30 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are investigating whether using a penile vibrator after nerve-sparing radical prostatectomy can reduce or prevent sexual dysfunction and urinary incontinence. This randomized, controlled, non-blinded study includes 100 men undergoing surgery for prostate cancer, comparing those who use the vibrator with those who receive standard treatment. The study aims to assess differences in erectile function 10 months after surgery using validated questionnaires. Participants are divided into two groups one uses the Ferticare 2.0 vibrator daily for at least five minutes at specific settings for nine months, starting just before surgery and continuing after. Both groups follow a standard pelvic floor training program and receive daily tadalafil treatment for erectile difficulties. After nine months, there is a four-week wash-out period without medication to evaluate spontaneous sexual function. Throughout the study, participants complete questionnaires on sexual and urinary function before surgery and at 3, 6, and 10 months afterward. Additional assessments include pad weighing tests for incontinence and monitoring of PSA levels and tumor status. The research team collects detailed clinical data to analyze outcomes, side effects, and any treatment impacts over the trial period ending in October 2026.

CONDITIONS

Brief Title

Penile Vibratory Stimulation in the Prevention of Sexual Dysfunction and Urinary Incontinence After Radical Prostatectomy

Research Team

H

Helene R Andersen, MD

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