Erectile DysfunctionNCT05385822
Pelvic Floor Muscle Training in the Treatment of Erectile Dysfunction
A study testing Pelvic Floor Muscle Training in people with Erectile Dysfunction, run by Herlev and Gentofte Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Pelvic Floor Muscle Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteDenmark
- Study dates
- 1 May 2022to Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Urological Research Unit
Herlev, Capital Region, 2730
Urological Research Unit, 004538680148, emil.durukan.01@regionh.dk
emil.durukan.01@regionh.dk
About this study
Official title: 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.
Read more
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
- Being tested
- Pelvic Floor Muscle Training
- Keywords
- Pelvic Floor Muscle, Erectile Dysfunction, Sexual Dysfunction, Impotence, Kegel Exercise, Training
- Medical subject headings
- Erectile Dysfunction, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic Floor Muscle TrainingBehavioural
- 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Pelvic Floor Muscle Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months after first pelvic floor muscle training session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start1 May 2022
- Primary completionMar 2024 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herlev and Gentofte Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emil Durukan, Herlev and Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05385822
- Sponsor's protocol ID
- PRE-Train Project
- Status last verified
- May 2022
- First submitted
- 4 May 2022
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pelvic Floor Muscle Training in the Treatment of Erectile Dysfunction: A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT05385822
- Acronym / sponsor ID
- PRE-Train Project
- Conditions
- Erectile Dysfunction
- Keywords
- Pelvic Floor Muscle, Erectile Dysfunction, Sexual Dysfunction, Impotence, Kegel Exercise, Training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Herlev and Gentofte HospitalUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 23 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Pelvic Floor Muscle TrainingParticipants who are randomized to pelvic floor training will then undergo instruction in the anatomy, function and training of the pelvic floor muscles. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | Pelvic Floor Muscle Training |
Primary outcome
Clinically significant improvements in erectile function
Time frame: 1 month after first pelvic floor muscle training session
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)
Clinically significant improvements in erectile function
Time frame: 4 months after first pelvic floor muscle training session
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)
Clinically significant improvements in erectile function
Time frame: 6 months after first pelvic floor muscle training session
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)
Clinically significant improvements in erectile function
Time frame: 12 months after first pelvic floor muscle training session
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)
20 secondary outcomes
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Participant satisfaction
Time frame: 4 months after first pelvic floor muscle training
Changes in the International Prostate Symptom Score
Time frame: 1 month after first pelvic floor muscle training session
Changes in the International Prostate Symptom Score
Time frame: 6 months after first pelvic floor muscle training session
Changes in the International Prostate Symptom Score
Time frame: 12 months after first pelvic floor muscle training session
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic Floor Muscle Training in people with Erectile Dysfunction, run by Herlev and Gentofte Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinically significant improvements in erectile function (time frame: 1 month after first pelvic floor muscle training session). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2022; AzTrials last refreshed its copy on 7 Nov 2026.