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

NCT06200987 | Recruiting FDA Device

• 1 other identifier: ProVibrate
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Erectile Dysfunction Following Radical Prostatectomy; Incontinence

Outcome Measures

Primary Outcomes (1)

• Erectile function

  The erectile function compared to controls measured by IIEF-EF

  10 months

Secondary Outcomes (6)

• ICIQ-UI-SF: The International Consultation on Incontinence Questionnaire - Urinary Incontinence - short form

  10 months

• IIEF-EF score (The International Index of Erectile Function - Erectile Function)

  10 months

• Diaper weighing test

  10 months

• IIEF-EF (The International Index of Erectile Function - Erectile Function) over 25

  10 months

• EHS (Erection Hardness Scale)

  10 months

Study Arms (2)

Intervention

EXPERIMENTAL

The group randomized to use the vibrator for 9 months

Device: Penile vibrator

Controls

NO INTERVENTION

Usual standard treatment

Interventions

Penile vibrator DEVICE

In addition to standard treatment with PDE5-inhibitors the intervention is daily stimulation for five minutes with the vibrator for 9 months

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Herlev and Gentofte Hospital: lead

Study Sites (1)

Herlev and Gentofte Hospital

Herlev, 2730, Denmark

RECRUITING

Study Officials

• Mikkel Fode, MD, PhD

  Department of Urology, Herlev and Gentofte University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Helene R Andersen, MD

CONTACT

+4538681507; helene.reif.andersen@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD fellow

Study Record Dates

• First Submitted: December 29, 2023
• First Posted: January 11, 2024
• Study Start: February 1, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

DK (1)