Pelvic Floor Muscle Training in the Treatment of Erectile Dysfunction

NCT ID: NCT05385822

Last Updated: 2022-05-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2025-03-31

Brief 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

Conditions

Erectile Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Pelvic Floor Muscle Training

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

Group Type: EXPERIMENTAL

Pelvic Floor Muscle Training

Intervention Type: BEHAVIORAL

• Isolated, quite light tension in the pelvic floor 10 times, where the tension is released immediately
• Constant tension for 30 seconds twice, with a 30-second pause
• Total relaxation for 1 minute They must perform these exercises once a day during the trial period of 3 months

Interventions

Pelvic Floor Muscle Training

• Isolated, quite light tension in the pelvic floor 10 times, where the tension is released immediately
• Constant tension for 30 seconds twice, with a 30-second pause
• Total relaxation for 1 minute They must perform these exercises once a day during the trial period of 3 months

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Herlev and Gentofte Hospital

OTHER

Sponsor Role: lead

Responsible Party

Emil Durukan

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Urological Research Unit

Herlev, Capital Region, Denmark

Site Status: RECRUITING

Countries

Denmark

Facility Contacts

Urological Research Unit

Role: primary

emil.durukan.01@regionh.dk

004538680148

Role: backup

emil.durukan.01@regionh.dk

Other Identifiers

PRE-Train Project

Identifier Type: -

Identifier Source: org_study_id