Pelvic Floor Muscle Training in the Treatment of Erectile Dysfunction

Last updated: May 17, 2022
Sponsor: Herlev and Gentofte Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Infertility

Impotence

Male Hormonal Deficiencies/abnormalities

Treatment

N/A

Clinical Study ID

NCT05385822
PRE-Train Project
  • Ages 30-70
  • Male
  • Accepts Healthy Volunteers

Study Summary

Erectile dysfunction affects about 40% of all men above the age of 40 and the prevalence increases with increasing age. It is not possible to cure the condition as current forms of treatment are aimed solely at improving symptoms. Treatment options today include medications, injection therapy, and vacuum pumps, among others. However, pelvic floor muscle training is a natural, inexpensive, and non-invasive form of treatment that is used to a limited extent.

Theoretically, a strengthening of the pelvic floor muscles can help increase the intracavernous pressure and thereby the hardness of the erection. Furthermore, tense pelvic floor muscles can help compress pelvic veins and reduce blood flow away from the penis which prolongs the erection. Finally, it is possible that pelvic floor muscle training can contribute to an increased blood supply to the pelvic floor and the penis which will have positive effects in relation to both the integrity of the penile tissue and the physiological erection mechanism itself.

This study aims to investigate the effect of pelvic floor muscle training in men with erectile dysfunction.

The study hypothesis is that pelvic floor training can provide a clinically significant improvement in the erection function at individual patient level

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Erectile Dysfunction for more than 6 months
  • IIEF-EF score < 25
  • In a stable heterosexual relationship in minimum of 3 months (since all questionnairesare only validated for heterosexuals)

Exclusion

Exclusion Criteria:

  • Known psychiatric, neurological, and/or endocrine disorders (including hypogonadismwith total testosterone <12 nmol / l)
  • Traumatic nerve damage
  • Diabetes
  • Previous surgery or radiotherapy in the pelvic region
  • Nerve disorders that prevent nerve connection to the pelvic floor muscles
  • Severe heart disease in the form of unstable angina, NYHA class > II heart failure,uncontrolled arrhythmia or severe symptomatic and/or severe valvular disease
  • Use of anti-androgen drugs Peyronie's disease and/or previous cases of priapism
  • Alcohol overconsumption (more than 21 items per week)

Study Design

Total Participants: 80
Study Start date:
May 01, 2022
Estimated Completion Date:
March 31, 2025

Connect with a study center

  • Urological Research Unit

    Herlev, Hovedstaden 2730
    Denmark

    Active - Recruiting

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