Penile Vibratory Stimulation in the Prevention of Sexual Dysfunction and Urinary Incontinence After Radical Prostatectomy
Launched by HERLEV AND GENTOFTE HOSPITAL · Dec 29, 2023
Trial Information
Current as of July 21, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying whether using a special vibrator, called "Ferticare 2.0," can help prevent sexual dysfunction and urinary incontinence in men after they have surgery for prostate cancer. The trial includes men who will have nerve-sparing surgery, which means the nerves related to erections are preserved. To be eligible, participants should have good erectile function before surgery and be continent, meaning they do not have issues with involuntary leakage of urine.
Participants in the trial will be divided into two groups: one group will use the vibrator for at least five minutes a day for nine months, while both groups will also engage in pelvic floor training and receive standard medication for erectile dysfunction if needed. Throughout the study, participants will fill out questionnaires to assess their sexual and urinary health at different times, including before the surgery and at three, six, and ten months after. The main goal is to determine if there is a significant improvement in sexual function in those using the vibrator compared to those who are not. If you're considering participating, the study offers a chance to contribute to understanding better ways to support men after prostate surgery.
Gender
MALE
Eligibility 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
About Herlev And Gentofte Hospital
Herlev and Gentofte Hospital, a leading healthcare institution in Denmark, is dedicated to advancing medical research and patient care through innovative clinical trials. As a prominent sponsor, the hospital focuses on a wide range of therapeutic areas, leveraging its multidisciplinary expertise and state-of-the-art facilities to facilitate rigorous scientific investigation. Committed to enhancing treatment outcomes and improving patient quality of life, Herlev and Gentofte Hospital collaborates with academic institutions and industry partners to foster groundbreaking discoveries and translate research findings into clinical practice.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Herlev, , Denmark
Patients applied
Trial Officials
Mikkel Fode, MD, PhD
Principal Investigator
Department of Urology, Herlev and Gentofte University Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported