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.
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
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
Parallel
Penile vibrator
DeviceIn addition to standard treatment with PDE5-inhibitors the intervention is daily stimulation for five minutes with the vibrator for 9 months
Erectile function
The erectile function compared to controls measured by IIEF-EF
ICIQ-UI-SF: The International Consultation on Incontinence Questionnaire - Urinary Incontinence - short form
Difference in ICIQ-SF score between the two groups after 3, 6 and 10 months. The score is from 0-21. The higher the score the more incontinent. A score of 0 is no urinary incontinence.
IIEF-EF score (The International Index of Erectile Function - Erectile Function)
Difference in IIEF-EF score between the two groups after 3, 6 and 10 months. The minimum score is 0 and the maximum score is 30. The higher the score the better erectile function.
Diaper weighing test
Difference in 24 hour diaper weighing test between the two groups after 3, 6 and 10 months
IIEF-EF (The International Index of Erectile Function - Erectile Function) over 25
The percentage of patients who gain a post-operative spontaneous IIEF-EF score of at least 25. The minimum score is 0 and the maximum score is 30. The higher the score the better erectile function.
Click on the lead sponsor to view all of their trials.
