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

Recruiting now · Not applicable

Conditions studied: Erectile Dysfunction Following Radical Prostatectomy, Incontinence

In brief

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.

Key facts

Study ID

NCT06200987

Run by

Herlev and Gentofte Hospital

People needed

100

Starts

2024-02-01

Expected to finish

2026-10-01

Last updated by the study team

2024-03-12

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Urinary incontinent before surgery
• Comorbidity that prevents the patient from taking PDE5-inhibitors
• Disease in the penis or in the penile skin (Peyronies, phimosis)
• Problems using the vibrator ie impaired function of the hands

Where it is running

• Herlev and Gentofte Hospital — Herlev, Denmark (enrolling)

Full record on ClinicalTrials.gov

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