Actively Recruiting
Penile Vibratory Stimulation in the Prevention of Sexual Dysfunction and Urinary Incontinence After Radical Prostatectomy
Led by Herlev and Gentofte Hospital · Updated on 2024-03-12
100
Participants Needed
1
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To investigate if post-operative penile vibration stimulation kan be used to reduce or prevent sexual dysfunction and urinary incontinence after radical prostatectomy. This will be done in a randomized, controlled, non-blinded study. Men that undergo nerve preserving surgery for prostate cancer is allocated into an intervention group and a control group. A total of 100 men will be included for a power of 80%. The intervention group will be instructed to use the "Ferticare 2.0" vibrator for at least five minutes a day with an amplitude of 1 mm and frequency of 90 Hz (these settings were found in a pilot study) for a total of 9 months. Both groups will do the standard pelvic floor training program and both groups will be offered regular phosphodiesterase-5-inhibitor treatment. Before surgery, 3, 6 and 10 months after the patients will have to fill out four different questionnaires regarding sexual and urinary function, including IIEF-EF, EHS, "neglected side effects" and ICIQ-SF. (10 months is due to a wash-out period of 1 month after the intervention). The collected data will be analysed and the primary goal is to see if there is a significant difference in average spontaneous IIEF-EF score in the two groups 10 months after the surgery.
CONDITIONS
Official 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 undergoing nerve-sparing radical prostatectomy
- Pre-operative erectile function with IIEF-EF score greater than 25
- Sexually active and continent before surgery, defined as a score of 0 on the ICIQ-SF questionnaire
You will not qualify if you...
- Urinary incontinence before surgery
- Comorbid conditions preventing use of PDE5-inhibitors
- Disease of 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
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Trial Site Locations
Total: 1 location
1
Herlev and Gentofte Hospital
Herlev, Denmark, 2730
Actively Recruiting
Research Team
H
Helene R Andersen, MD
CONTACT
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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