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โ† Trials
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Penile Vibratory Stimulation in the Prevention of Sexual Dysfunction and Urinary Incontinence After Radical Prostatectomy

RecruitingNAAges 18 Years - anyMaleHerlev and Gentofte Hospital
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In plain words

What the trial is, and whether it could suit you

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 regardi

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Penile vibrator
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Where

1 site
Herlev and Gentofte Hospital
Herlev, Denmark
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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