Pelvic Floor Muscle Training in the Treatment of Erectile Dysfunction

NCT05385822 | Unknown DMC

• 1 other identifier: PRE-Train Project
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

Pelvic Floor Muscle; Erectile Dysfunction; Sexual Dysfunction; Impotence; Kegel Exercise; Training

Outcome Measures

Primary Outcomes (4)

• Clinically significant improvements in erectile function

  The proportion of patients who achieve clinically significant improvements in the erectile function (EF) domain of the International Index of Erectile Function (IIEF) after 3 months of pelvic floor training or observation in an intention-to-treat analysis (assessed 1 month after the last training session). This is defined according to Rosen et al. (mild ED: 2 points; moderate ED: 5 points; severe ED: 7 points)

  1 month after first pelvic floor muscle training session

• Clinically significant improvements in erectile function

  The proportion of patients who achieve clinically significant improvements in the erectile function (EF) domain of the International Index of Erectile Function (IIEF) after 3 months of pelvic floor training or observation in an intention-to-treat analysis (assessed 1 month after the last training session). This is defined according to Rosen et al. (mild ED: 2 points; moderate ED: 5 points; severe ED: 7 points)

  4 months after first pelvic floor muscle training session

• Clinically significant improvements in erectile function

  The proportion of patients who achieve clinically significant improvements in the erectile function (EF) domain of the International Index of Erectile Function (IIEF) after 3 months of pelvic floor training or observation in an intention-to-treat analysis (assessed 1 month after the last training session). This is defined according to Rosen et al. (mild ED: 2 points; moderate ED: 5 points; severe ED: 7 points)

  6 months after first pelvic floor muscle training session

• Clinically significant improvements in erectile function

  The proportion of patients who achieve clinically significant improvements in the erectile function (EF) domain of the International Index of Erectile Function (IIEF) after 3 months of pelvic floor training or observation in an intention-to-treat analysis (assessed 1 month after the last training session). This is defined according to Rosen et al. (mild ED: 2 points; moderate ED: 5 points; severe ED: 7 points)

  12 months after first pelvic floor muscle training session

Secondary Outcomes (20)

• Changes in the International Index of Erectile Function questionnaire category; orgasmic function. Items 9-10. Score range: 0-5. Maximum score: 10.

  1 month after first pelvic floor muscle training session

• Changes in the International Index of Erectile Function questionnaire category; orgasmic function. Items 9-10. Score range: 0-5. Maximum score: 10.

  4 months after first pelvic floor muscle training session

• Changes in the International Index of Erectile Function questionnaire category; orgasmic function. Items 9-10. Score range: 0-5. Maximum score: 10.

  6 months after first pelvic floor muscle training session

• Changes in the International Index of Erectile Function questionnaire category; orgasmic function. Items 9-10. Score range: 0-5. Maximum score: 10.

  12 months after first pelvic floor muscle training session

• Changes in the International Index of Erectile Function questionnaire category; sexual desire. Items 11-12. Score range: 1-5. Maximum score: 10.

  1 month after first pelvic floor muscle training session

Study Arms (2)

Control

NO INTERVENTION

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

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

Behavioral: Pelvic Floor Muscle Training

Interventions

Pelvic Floor Muscle Training 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

Pelvic Floor Muscle Training

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Herlev and Gentofte Hospital: lead

Study Sites (1)

Urological Research Unit

Herlev, Capital Region, 2730, Denmark

RECRUITING

MeSH Terms

Conditions

Erectile Dysfunction; Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: Men who meet all inclusion criteria will be randomized 1:1 for either pelvic floor training or control. Stratified randomization with correction for IIEF-EF category is used (mild 17-25, moderate 11-16, severe 0-10)

Study Record Dates

• First Submitted: May 4, 2022
• First Posted: May 23, 2022
• Study Start: May 1, 2022
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2025
• Last Updated: May 23, 2022

Record last verified: 2022-05

Locations

DK (1)