Planned Penile Vibratory Stimulation in the Prevention of Sexual Dysfunction and Urinary Incontinence After Radical Prostatectomy: a Randomized Controlled Study

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• Men who are undergoing nerve-sparing radical prostatectomy

• Pre operative erectile function of IIEF-EF \> 25

• Sexually active . Continent before surgery defined as a score of 0 on the ICIQ-SF questionnaire

Locations
Other Locations
Denmark
Herlev and Gentofte Hospital
RECRUITING
Herlev
Contact Information
Primary
Helene R Andersen, MD
helene.reif.andersen@regionh.dk
+4538681507
Time Frame
Start Date: 2024-02-01
Estimated Completion Date: 2026-10
Participants
Target number of participants: 100
Treatments
Experimental: Intervention
The group randomized to use the vibrator for 9 months
No_intervention: Controls
Usual standard treatment
Sponsors
Leads: Herlev and Gentofte Hospital

This content was sourced from clinicaltrials.gov