An interventional study of Pelvic Floor Muscle Training in Erectile Dysfunction, sponsored by Herlev and Gentofte Hospital. Status unknown at 1 site in Denmark. Open to male participants aged 30 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-23.
Sponsored by Herlev and Gentofte Hospital · Not applicable, Interventional, and Treatment
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
683 studies on the registry are indexed under Erectile Dysfunction; 117 are open to participants now.
This study's planned enrollment of 80 is above the median of 72 across 542 interventional studies indexed under Erectile Dysfunction.
Browse Erectile Dysfunction studies →Herlev and Gentofte Hospital is the lead sponsor of 73 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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).
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
* 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
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 12 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.
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.
Time frame: 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.
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.
Time frame: 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.
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.
Time frame: 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.
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.
Time frame: 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.
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.
Time frame: 1 month 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.
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.
Time frame: 4 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.
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.
Time frame: 6 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.
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.
Time frame: 12 months after first pelvic floor muscle training session
Changes in the International Index of Erectile Function questionnaire category; intercourse satisfaction. Items 6-8. Score range: 0-5. Maximum score: 15.
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.
Time frame: 1 month after first pelvic floor muscle training session
Changes in the International Index of Erectile Function questionnaire category; intercourse satisfaction. Items 6-8. Score range: 0-5. Maximum score: 15.
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.
Time frame: 4 months after first pelvic floor muscle training session
Changes in the International Index of Erectile Function questionnaire category; intercourse satisfaction. Items 6-8. Score range: 0-5. Maximum score: 15.
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.
Time frame: 6 months after first pelvic floor muscle training session
Changes in the International Index of Erectile Function questionnaire category; intercourse satisfaction. Items 6-8. Score range: 0-5. Maximum score: 15.
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.
Time frame: 12 months after first pelvic floor muscle training session
Changes in the International Index of Erectile Function questionnaire category; overall satisfaction. Items 13-14. Score range: 1-5. Maximum score: 10.
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.
Time frame: 1 month after first pelvic floor muscle training session
Changes in the International Index of Erectile Function questionnaire category; overall satisfaction. Items 13-14. Score range: 1-5. Maximum score: 10.
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.
Time frame: 4 months after first pelvic floor muscle training session
Changes in the International Index of Erectile Function questionnaire category; overall satisfaction. Items 13-14. Score range: 1-5. Maximum score: 10.
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.
Time frame: 6 months after first pelvic floor muscle training session
Changes in the International Index of Erectile Function questionnaire category; overall satisfaction. Items 13-14. Score range: 1-5. Maximum score: 10.
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.
Time frame: 12 months after first pelvic floor muscle training session
Participant satisfaction
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).
Time frame: 4 months after first pelvic floor muscle training
Changes in the International Prostate Symptom Score
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.
Time frame: 1 month after first pelvic floor muscle training session
Changes in the International Prostate Symptom Score
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.
Time frame: 6 months after first pelvic floor muscle training session
Changes in the International Prostate Symptom Score
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.
Time frame: 12 months after first pelvic floor muscle training session
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Herlev and Gentofte Hospital