- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05385822
Pelvic Floor Muscle Training in the Treatment of Erectile Dysfunction
Pelvic Floor Muscle Training in the Treatment of Erectile Dysfunction: A Randomized, Controlled Trial
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Hovedstaden
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Herlev, Hovedstaden, Denmark, 2730
- Recruiting
- Urological Research Unit
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Contact:
- Urological Research Unit
- Phone Number: 004538680148
- Email: emil.durukan.01@regionh.dk
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Contact:
- Email: emil.durukan.01@regionh.dk
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Principal Investigator:
- Emil Durukan, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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NO_INTERVENTION: 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).
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EXPERIMENTAL: 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinically significant improvements in erectile function
Time Frame: 1 month after first pelvic floor muscle training session
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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)
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1 month after first pelvic floor muscle training session
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Clinically significant improvements in erectile function
Time Frame: 4 months after first pelvic floor muscle training session
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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)
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4 months after first pelvic floor muscle training session
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Clinically significant improvements in erectile function
Time Frame: 6 months after first pelvic floor muscle training session
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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)
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6 months after first pelvic floor muscle training session
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Clinically significant improvements in erectile function
Time Frame: 12 months after first pelvic floor muscle training session
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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)
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12 months after first pelvic floor muscle training session
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Changes in the International Index of Erectile Function questionnaire category; orgasmic function. Items 9-10. Score range: 0-5. Maximum score: 10.
Time Frame: 1 month after first pelvic floor muscle training session
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Low score points represent a reduced orgasmic function whereas high score points represent a better/improved orgasmic function.
The scores will be calculated and compared between groups as continuous variables.
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1 month after first pelvic floor muscle training session
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Changes in the International Index of Erectile Function questionnaire category; orgasmic function. Items 9-10. Score range: 0-5. Maximum score: 10.
Time Frame: 4 months after first pelvic floor muscle training session
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Low score points represent a reduced orgasmic function whereas high score points represent a better/improved orgasmic function.
The scores will be calculated and compared between groups as continuous variables.
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4 months after first pelvic floor muscle training session
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Changes in the International Index of Erectile Function questionnaire category; orgasmic function. Items 9-10. Score range: 0-5. Maximum score: 10.
Time Frame: 6 months after first pelvic floor muscle training session
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Low score points represent a reduced orgasmic function whereas high score points represent a better/improved orgasmic function.
The scores will be calculated and compared between groups as continuous variables.
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6 months after first pelvic floor muscle training session
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Changes in the International Index of Erectile Function questionnaire category; orgasmic function. Items 9-10. Score range: 0-5. Maximum score: 10.
Time Frame: 12 months after first pelvic floor muscle training session
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Low score points represent a reduced orgasmic function whereas high score points represent a better/improved orgasmic function.
The scores will be calculated and compared between groups as continuous variables.
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12 months after first pelvic floor muscle training session
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Changes in the International Index of Erectile Function questionnaire category; sexual desire. Items 11-12. Score range: 1-5. Maximum score: 10.
Time Frame: 1 month after first pelvic floor muscle training session
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Low score points represent a reduced sexual desire whereas high score points represent a high sexual desire.
The scores will be calculated and compared between groups as continuous variables.
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1 month after first pelvic floor muscle training session
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Changes in the International Index of Erectile Function questionnaire category; sexual desire. Items 11-12. Score range: 1-5. Maximum score: 10.
Time Frame: 4 months after first pelvic floor muscle training session
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Low score points represent a reduced sexual desire whereas high score points represent a high sexual desire.
The scores will be calculated and compared between groups as continuous variables.
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4 months after first pelvic floor muscle training session
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Changes in the International Index of Erectile Function questionnaire category; sexual desire. Items 11-12. Score range: 1-5. Maximum score: 10.
Time Frame: 6 months after first pelvic floor muscle training session
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Low score points represent a reduced sexual desire whereas high score points represent a high sexual desire.
The scores will be calculated and compared between groups as continuous variables.
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6 months after first pelvic floor muscle training session
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Changes in the International Index of Erectile Function questionnaire category; sexual desire. Items 11-12. Score range: 1-5. Maximum score: 10.
Time Frame: 12 months after first pelvic floor muscle training session
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Low score points represent a reduced sexual desire whereas high score points represent a high sexual desire.
The scores will be calculated and compared between groups as continuous variables.
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12 months after first pelvic floor muscle training session
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Changes in the International Index of Erectile Function questionnaire category; intercourse satisfaction. Items 6-8. Score range: 0-5. Maximum score: 15.
Time Frame: 1 month after first pelvic floor muscle training session
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Low score points represent a reduced intercourse satisfaction whereas high score points represent high intercourse satisfaction.
The scores will be calculated and compared between groups as continuous variables.
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1 month after first pelvic floor muscle training session
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Changes in the International Index of Erectile Function questionnaire category; intercourse satisfaction. Items 6-8. Score range: 0-5. Maximum score: 15.
Time Frame: 4 months after first pelvic floor muscle training session
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Low score points represent a reduced intercourse satisfaction whereas high score points represent high intercourse satisfaction.
The scores will be calculated and compared between groups as continuous variables.
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4 months after first pelvic floor muscle training session
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Changes in the International Index of Erectile Function questionnaire category; intercourse satisfaction. Items 6-8. Score range: 0-5. Maximum score: 15.
Time Frame: 6 months after first pelvic floor muscle training session
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Low score points represent a reduced intercourse satisfaction whereas high score points represent high intercourse satisfaction.
The scores will be calculated and compared between groups as continuous variables.
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6 months after first pelvic floor muscle training session
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Changes in the International Index of Erectile Function questionnaire category; intercourse satisfaction. Items 6-8. Score range: 0-5. Maximum score: 15.
Time Frame: 12 months after first pelvic floor muscle training session
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Low score points represent a reduced intercourse satisfaction whereas high score points represent high intercourse satisfaction.
The scores will be calculated and compared between groups as continuous variables.
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12 months after first pelvic floor muscle training session
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Changes in the International Index of Erectile Function questionnaire category; overall satisfaction. Items 13-14. Score range: 1-5. Maximum score: 10.
Time Frame: 1 month after first pelvic floor muscle training session
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Low score points represent a reduced overall satisfaction whereas high score points represent high overall satisfaction.
The scores will be calculated and compared between groups as continuous variables.
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1 month after first pelvic floor muscle training session
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Changes in the International Index of Erectile Function questionnaire category; overall satisfaction. Items 13-14. Score range: 1-5. Maximum score: 10.
Time Frame: 4 months after first pelvic floor muscle training session
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Low score points represent a reduced overall satisfaction whereas high score points represent high overall satisfaction.
The scores will be calculated and compared between groups as continuous variables.
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4 months after first pelvic floor muscle training session
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Changes in the International Index of Erectile Function questionnaire category; overall satisfaction. Items 13-14. Score range: 1-5. Maximum score: 10.
Time Frame: 6 months after first pelvic floor muscle training session
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Low score points represent a reduced overall satisfaction whereas high score points represent high overall satisfaction.
The scores will be calculated and compared between groups as continuous variables.
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6 months after first pelvic floor muscle training session
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Changes in the International Index of Erectile Function questionnaire category; overall satisfaction. Items 13-14. Score range: 1-5. Maximum score: 10.
Time Frame: 12 months after first pelvic floor muscle training session
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Low score points represent a reduced overall satisfaction whereas high score points represent high overall satisfaction.
The scores will be calculated and compared between groups as continuous variables.
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12 months after first pelvic floor muscle training session
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Participant satisfaction
Time Frame: 4 months after first pelvic floor muscle training
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Subjective participant satisfaction assessed using a modified version of the patient version of the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire after treatment.
This analysis will be performed as an intention-to-treat analysis without correction for missing data.
Each EDITS item is scored from 0 to 4, with higher scores indicating greater treatment satisfaction.
The mean EDITS questionnaire score is multiplied by 25, yielding a standardized EDITS index of treatment satisfaction score, ranging from 0 (low satisfaction) to 100 (extremely high satisfaction).
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4 months after first pelvic floor muscle training
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Changes in the International Prostate Symptom Score
Time Frame: 1 month after first pelvic floor muscle training session
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Changes in the International Prostate Symptom Score will be assessed from all the participants.
The IPSS is made up of 7 questions related to voiding symptoms.
A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.
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1 month after first pelvic floor muscle training session
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Changes in the International Prostate Symptom Score
Time Frame: 6 months after first pelvic floor muscle training session
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Changes in the International Prostate Symptom Score will be assessed from all the participants.
The IPSS is made up of 7 questions related to voiding symptoms.
A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.
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6 months after first pelvic floor muscle training session
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Changes in the International Prostate Symptom Score
Time Frame: 12 months after first pelvic floor muscle training session
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Changes in the International Prostate Symptom Score will be assessed from all the participants.
The IPSS is made up of 7 questions related to voiding symptoms.
A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.
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12 months after first pelvic floor muscle training session
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRE-Train Project
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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