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

NCT06200987 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-03-12

No results posted yet for this study

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

Interventions

DEVICE

Penile vibrator

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

Sponsors & Collaborators

  • Herlev and Gentofte Hospital

    lead OTHER

Principal Investigators

  • Mikkel Fode, MD, PhD · Department of Urology, Herlev and Gentofte University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-01
Primary Completion
2026-03-31
Completion
2026-10-31
FDA Device
Yes

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06200987 on ClinicalTrials.gov