Using penile vibration to prevent sexual dysfunction and urinary incontinence after prostate surgery
Planned Penile Vibratory Stimulation in the Prevention of Sexual Dysfunction and Urinary Incontinence After Radical Prostatectomy: a Randomized Controlled Study
This study is testing if using a special vibrator can help men avoid sexual problems and urinary issues after prostate surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Herlev and Gentofte Hospital Academic / other |
| Locations | 1 site (Herlev) |
| Trial ID | NCT06200987 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of penile vibratory stimulation in reducing sexual dysfunction and urinary incontinence in men following nerve-sparing radical prostatectomy. A total of 100 men will be randomly assigned to either an intervention group, which will use the 'Ferticare 2.0' vibrator daily for nine months, or a control group receiving standard care. Both groups will participate in pelvic floor training and have access to phosphodiesterase-5-inhibitor treatment. Participants will complete questionnaires assessing their sexual and urinary function at multiple time points post-surgery.
Who should consider this trial
Good fit: Ideal candidates are sexually active men undergoing nerve-sparing radical prostatectomy with pre-operative erectile function scores above 25.
Not a fit: Patients who are already urinary incontinent before surgery or have comorbidities preventing the use of PDE5-inhibitors may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve sexual and urinary function in men after prostate surgery.
How similar studies have performed: While the specific use of penile vibratory stimulation is novel, similar approaches in managing post-operative sexual dysfunction have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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 this trial is running
Herlev
- Herlev and Gentofte Hospital — Herlev, Denmark (Recruiting)
Study contacts
- Principal investigator: Mikkel Fode, MD, PhD — Department of Urology, Herlev and Gentofte University Hospital
- Study coordinator: Helene R Andersen, MD
- Email: helene.reif.andersen@regionh.dk
- Phone: +4538681507
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.