Clinical trial NCT05385822: Pelvic Floor Muscle Training in the Treatment of Erectile Dysfunction
Official title: Pelvic Floor Muscle Training in the Treatment of Erectile Dysfunction: A Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Erectile Dysfunction
Keywords: Pelvic Floor Muscle
Erectile Dysfunction
Sexual Dysfunction
Impotence
Kegel Exercise
Training
Lead sponsor: Herlev and Gentofte Hospital
Sponsor class: OTHER
First posted: 2022-05-23
Enrollment: 80
Sex: MALE
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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)
Primary purpose: TREATMENT

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


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)

Primary outcomes:
measure: Clinically significant improvements in erectile function
timeFrame: 1 month after first pelvic floor muscle training session
measure: Clinically significant improvements in erectile function
timeFrame: 4 months after first pelvic floor muscle training session
measure: Clinically significant improvements in erectile function
timeFrame: 6 months after first pelvic floor muscle training session
measure: Clinically significant improvements in erectile function
timeFrame: 12 months after first pelvic floor muscle training session
Secondary outcomes:
measure: Changes in the International Index of Erectile Function questionnaire category; orgasmic function. Items 9-10. Score range: 0-5. Maximum score: 10.
timeFrame: 1 month after first pelvic floor muscle training session
measure: Changes in the International Index of Erectile Function questionnaire category; orgasmic function. Items 9-10. Score range: 0-5. Maximum score: 10.
timeFrame: 4 months after first pelvic floor muscle training session
measure: Changes in the International Index of Erectile Function questionnaire category; orgasmic function. Items 9-10. Score range: 0-5. Maximum score: 10.
timeFrame: 6 months after first pelvic floor muscle training session
measure: Changes in the International Index of Erectile Function questionnaire category; orgasmic function. Items 9-10. Score range: 0-5. Maximum score: 10.
timeFrame: 12 months after first pelvic floor muscle training session
measure: Changes in the International Index of Erectile Function questionnaire category; sexual desire. Items 11-12. Score range: 1-5. Maximum score: 10.
timeFrame: 1 month after first pelvic floor muscle training session
measure: Changes in the International Index of Erectile Function questionnaire category; sexual desire. Items 11-12. Score range: 1-5. Maximum score: 10.
timeFrame: 4 months after first pelvic floor muscle training session
measure: Changes in the International Index of Erectile Function questionnaire category; sexual desire. Items 11-12. Score range: 1-5. Maximum score: 10.
timeFrame: 6 months after first pelvic floor muscle training session
measure: Changes in the International Index of Erectile Function questionnaire category; sexual desire. Items 11-12. Score range: 1-5. Maximum score: 10.
timeFrame: 12 months after first pelvic floor muscle training session
measure: Changes in the International Index of Erectile Function questionnaire category; intercourse satisfaction. Items 6-8. Score range: 0-5. Maximum score: 15.
timeFrame: 1 month after first pelvic floor muscle training session
measure: Changes in the International Index of Erectile Function questionnaire category; intercourse satisfaction. Items 6-8. Score range: 0-5. Maximum score: 15.
timeFrame: 4 months after first pelvic floor muscle training session
measure: Changes in the International Index of Erectile Function questionnaire category; intercourse satisfaction. Items 6-8. Score range: 0-5. Maximum score: 15.
timeFrame: 6 months after first pelvic floor muscle training session
measure: Changes in the International Index of Erectile Function questionnaire category; intercourse satisfaction. Items 6-8. Score range: 0-5. Maximum score: 15.
timeFrame: 12 months after first pelvic floor muscle training session
measure: Changes in the International Index of Erectile Function questionnaire category; overall satisfaction. Items 13-14. Score range: 1-5. Maximum score: 10.
timeFrame: 1 month after first pelvic floor muscle training session
measure: Changes in the International Index of Erectile Function questionnaire category; overall satisfaction. Items 13-14. Score range: 1-5. Maximum score: 10.
timeFrame: 4 months after first pelvic floor muscle training session
measure: Changes in the International Index of Erectile Function questionnaire category; overall satisfaction. Items 13-14. Score range: 1-5. Maximum score: 10.
timeFrame: 6 months after first pelvic floor muscle training session
measure: Changes in the International Index of Erectile Function questionnaire category; overall satisfaction. Items 13-14. Score range: 1-5. Maximum score: 10.
timeFrame: 12 months after first pelvic floor muscle training session
measure: Participant satisfaction
timeFrame: 4 months after first pelvic floor muscle training
measure: Changes in the International Prostate Symptom Score
timeFrame: 1 month after first pelvic floor muscle training session
measure: Changes in the International Prostate Symptom Score
timeFrame: 6 months after first pelvic floor muscle training session
measure: Changes in the International Prostate Symptom Score
timeFrame: 12 months after first pelvic floor muscle training session
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Urological Research Unit
state: Hovedstaden
Study officials:
References: