Pelvic Floor Muscle Training in the Treatment of Erectile Dysfunction

Herlev and Gentofte Hospital

Status: Enrolling

Conditions: Erectile Dysfunction

Treatments: Behavioral: Pelvic Floor Muscle Training

Study type: Interventional

Funder types: Other

Identifiers

NCT05385822

PRE-Train Project

Details and patient eligibility

About

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

Enrollment: 80 estimated patients

Sex: Male

Ages: 30 to 70 years old

Volunteers: Accepts Healthy Volunteers

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 questionnaires are only validated for heterosexuals)

Exclusion criteria

• Known psychiatric, neurological, and/or endocrine disorders (including hypogonadism with 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

80 participants in 2 patient groups

Control

No Intervention group

Description:

The control group will not recieve any training in the trial period but will have to answer the same questionnaires on erectile function (IIEF-EF) and international prostate symptom score (IPSS).

Pelvic Floor Muscle Training

Experimental group

Description:

Participants who are randomized to pelvic floor training will then undergo instruction in the anatomy, function and training of the pelvic floor muscles.

Treatment:

Behavioral: Pelvic Floor Muscle Training