Actively Recruiting
Planned Penile Vibratory Stimulation to Prevent Sexual Dysfunction and Urinary Incontinence After Radical Prostatectomy in a Randomized Controlled Study
Led by Herlev and Gentofte Hospital · Updated on 2024-03-12
100
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men who are undergoing nerve-sparing radical prostatectomy
- Pre-operative erectile function with an IIEF-EF score greater than 25
- Sexually active men who are continent before surgery, defined as a score of 0 on the ICIQ-SF questionnaire
You will not qualify if you...
- Urinary incontinence before surgery
- Medical conditions preventing use of PDE5-inhibitors
- Diseases affecting the penis or penile skin such as Peyronie's disease or phimosis
- Difficulty using the vibrator due to impaired hand function
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 to 4 weeks before surgery
Participants in the vibration group get used to the penile vibrator before surgery.
1 visit before surgery
Duration - 9 months
Participants undergo nerve-sparing radical prostatectomy and receive standard treatment with daily PDE5-inhibitors. Those in the vibration group perform daily penile vibratory stimulation at home for 9 months alongside pelvic floor training.
Follow-up visits at 3 months, 6 months, and 10 months after surgery
Duration - 4 weeks
Participants stop PDE5-inhibitor treatment during a 4-week wash-out period to evaluate spontaneous sexual function and continue with assessments of erectile function, urinary incontinence, and other sexual health outcomes.
Assessment visit at 10 months after surgery
Trial Site Locations
Total: 1 location
1
Herlev and Gentofte Hospital
Herlev, Denmark, 2730
Actively Recruiting
Research Team
H
Helene R Andersen, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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