RecruitingNot ApplicableNCT06200987

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

Planned Penile Vibratory Stimulation in the Prevention of Sexual Dysfunction and Urinary Incontinence After Radical Prostatectomy: a Randomized Controlled Study


Sponsor

Herlev and Gentofte Hospital

Enrollment

100 participants

Start Date

Feb 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 Years

Inclusion Criteria3

  • 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 Criteria4

  • 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

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Interventions

DEVICEPenile vibrator

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


Locations(1)

Herlev and Gentofte Hospital

Herlev, Denmark

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NCT06200987


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