Status:
RECRUITING
Penile Vibratory Stimulation in the Prevention of Sexual Dysfunction and Urinary Incontinence After Radical Prostatectomy
Lead Sponsor:
Herlev and Gentofte Hospital
Conditions:
Erectile Dysfunction Following Radical Prostatectomy
Incontinence
Eligibility:
MALE
18+ years
Phase:
NA
Brief 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 randomize...
Detailed Description
Hypothesis The study's hypothesis is that vibration therapy, using the stimulation parameters found in the pilot study, will have a beneficial effect on erectile function, orgasm disturbances, penile ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06200987
Start Date
February 1 2024
End Date
October 1 2026
Last Update
March 12 2024
Active Locations (1)
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1
Herlev and Gentofte Hospital
Herlev, Denmark, 2730