Erectile DysfunctionNCT06425211
Effectiveness of Pelvic Floor Therapy for the Management of Erectile Dysfunction and Premature Ejaculation.
A study testing Therapeutic exercises, Perineal electromyographic biofeedback and Electrical stimulation in people with Erectile Dysfunction and Premature (Early) Ejaculation, run by Boston Medical Group at 1 site in Colombia.
Trial summary
The objective of this clinical trial is to evaluate the effectiveness of pelvic floor therapy for the management of erectile dysfunction and premature ejaculation in patients with erectile dysfunction and premature ejaculation. Read more about this study
- Who is it for?
- Ages 18 to 100 years, men only
- Conditions the study is for
- Erectile Dysfunction, Premature (Early) Ejaculation, Premature Ejaculation
- What is being tested?
- Therapeutic exercises, Perineal electromyographic biofeedback and Electrical stimulation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteColombia
- Study dates
- 30 Oct 2021to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Overall:
- Men over 18 years of age
- Erectile dysfunction or premature ejaculation for at least 6 months
- Sexual activity with a heterosexual partner at least once a week
- Signing of informed consent before the start of the study
- For the premature ejaculation group:
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- Premature ejaculation according to the International Society of Sexual Medicine (ISSM) criteria
- Premature Ejaculation Diagnosis Tool (PEDT) questionnaire score greater than 11
- For the erectile dysfunction group:
- Clinical diagnosis of primary erectile dysfunction
- International Index Erectile Function - Erectile Function domain (IIEF-EF) score less than 26
Who cannot join
- Pharmacological treatment for erectile dysfunction or premature ejaculation in the last 3 months
- Erection Hardness Score (EHS) greater than 3 for patients with erectile dysfunction
- History of hypogonadism or suspected hypogonadism due to Aging Males Symptoms (AMS) score greater than 36 for patients with erectile dysfunction
- History of pelvic radiotherapy
- Pacemaker or cardiac arrhythmia, epilepsy
- History of spinal cord trauma or spinal surgeries.
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- Inability to attend therapies or controls
- Illiteracy or cognitive disability that prevents you from completing the questionnaires
- Psychiatric, psychological disorders, or cognitive deficiencies
- Injuries in the area of application of the therapy
- Active pelvic organ cancer
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Colombia1 site, 1 recruiting
- Recruiting
Boston Medical Group Colombia
Bogotá, Cundinamarca, 11022
Carolina Sandoval, Master, 57 3208899777, csandoval@bostonmedical.com.co
Héctor Corredor, MD, +57 3174317162, hcorredor@bostonmedical.com.co
About this study
The objective of this clinical trial is to evaluate the effectiveness of pelvic floor therapy for the management of erectile dysfunction and premature ejaculation in patients with erectile dysfunction and premature ejaculation. The main question to answer is:
What is the effectiveness of pelvic floor therapy (electrostimulation, biofeedback, and therapeutic exercise) for the treatment of patients with erectile dysfunction and or premature ejaculation?
Read more
Patients will:
- Have an initial consultation of pelvic floor rehabilitation before therapy.
- Be given pelvic floor therapy.
- Have a secondary consultation of pelvic floor rehabilitation after therapy.
Three intervention groups will be included: Group 1: Patients with premature ejaculation Group 2: Patients with erectile dysfunction Group 3: Patients with erectile dysfunction and premature ejaculation.
Read the detailed description
The objective of this clinical trial is to evaluate the effectiveness of pelvic floor therapy for the management of erectile dysfunction and premature ejaculation in patients with erectile dysfunction and premature ejaculation.
Methodology: Pre-post study. Erectile function or intravaginal latency time will be evaluated before and after pelvic floor therapy, in three groups of patients, independently:
- Group 1: Patients with premature ejaculation
- Group 2: Patients with erectile dysfunction
- Group 3: Patients with erectile dysfunction and premature ejaculation 66 patients will be included and will receive 24 sessions of pelvic floor therapy during 12 weeks. Outcomes will be evaluated at the end of therapy (12 weeks), 3 and 6 months follow-up.
- Conditions
- Erectile Dysfunction, Premature (Early) Ejaculation, Premature Ejaculation, Pelvic Floor; Weak
- Being tested
- Therapeutic exercises, Perineal electromyographic biofeedback, Electrical stimulation
- Medical subject headings
- Erectile Dysfunction, Premature Birth, Premature Ejaculation, Asthenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic exercisesBehavioural
Recognition of the pelvic area, respiratory management, lumbo-pelvic mobilization, discrimination of abdomino-pelvic contraction and myofascial release techniques.
Perineal electromyographic biofeedbackDevice
Free muscle work and gross motor coordination:
Electrical stimulationDevice
Muscular proprioceptive work: 50 Hz 300 µs
| Study group | Role | What they receive |
|---|---|---|
| Erectile Dysfunction | Experimental | The therapy depends if patient is classified within muscular hyperactivity or muscular hypoactivity.
For muscular hypoactivity:
Pelvic Floor Physiotherapy assessment: session 1 Proprioceptive and Coordination Work: sessions 2-7 Muscle workout: sessions 8-15 Functional training: sessions 16-23 Final evaluation: Session 24
For muscular hyperactivity they will be given:
Pelvic Floor Physiotherapy assessment: session 1 Proprioceptive and Coordination Work: sessions 2-7 Muscle workout: sessions 8-15 Functional training: sessions 16-23 Final evaluation: session 24
These interventions include: Therapeutic exercises, Perineal electromyographic biofeedback, and Electrical stimulation Receives: Behavioral: Therapeutic exercises; Device: Perineal electromyographic biofeedback; Device: Electrical stimulation |
| Premature Ejaculation | Experimental | Pelvic Floor Physiotherapy assessment: session 1 Proprioceptive and Coordination Work: sessions 2-15 Muscle workout: sessions 16-19 Functional training: sessions 20-23 Final evaluation: session 24
These interventions include: Therapeutic exercises, Perineal electromyographic biofeedback, and Electrical stimulation Receives: Behavioral: Therapeutic exercises; Device: Perineal electromyographic biofeedback; Device: Electrical stimulation |
| Premature Ejaculation + Erectile Dysfunction | Experimental | Pelvic Floor Physiotherapy assessment: session 1 Proprioceptive and Coordination Work: sessions 2-12 Muscle workout: sessions 13-20 Functional training: sessions 20-23 Final evaluation: session 24
These interventions include: Therapeutic exercises, Perineal electromyographic biofeedback, and Electrical stimulation Receives: Behavioral: Therapeutic exercises; Device: Perineal electromyographic biofeedback; Device: Electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in baseline intravaginal latency time (IVLT)
Change in baseline intravaginal latency time (IVLT) at the end of therapy. (Groups 1,3)
Measured: 12 weeks
Change in International Index of Erectile Dysfuntion - Erectile Dysfunction domain (IIEF-EF) score
International Index of Erectile Dysfuntion - Erectile Dysfunction domain (IIEF-EF) score change at the end of therapy. (Groups 2,3)
Measured: 12 weeks
Secondary outcomes (7)
Change in baseline intravaginal latency time (IVLT) at follow-up
Change in IVLT at 3 and 6 months of follow-up. (Groups 1,3)
Measured: 3 and 6 months of follow-up.
Change Premature Ejaculation Perfil (PEP) score
Change in baseline PEP score at the end of therapy, 3 and 6 months of follow-up. (Groups 1,3)
Measured: 12 weeks, 3 and 6 months follow-up.
Change in Premature Ejaculation Diagnosis Tool (PEDT) questionnnaire score
Change in baseline PEDT questionnaire score at the end of therapy, 3 and 6 months follow-up. (Groups 1,3)
Measured: 12 weeks, 3 and 6 months follow-up.
Change Intracavity Assessment
Change in the parameters of the baseline Intracavity Assessment at the end of therapy, 3 and 6 months follow-up.
Measured: 12 weeks, 3 and 6 months follow-up.
Side Effects
Incidente of side effects related to therapy.
Measured: 12 weeks, 3 and 6 months follow-up.
Change in International Index of Erectile Dysfuntion - Erectile Dysfunction domain (IIEF-EF) score at follow-up
International Index of Erectile Dysfuntion - Erectile Dysfunction domain (IIEF-EF) score change at the 3 and 6 months of follow-up. (Groups 2,3)
Measured: 3 and 6 months of follow-up.
Change in Erection Hardness Score (EHS)
Increase of 1 point in the baseline EHS at the end of therapy, 3 and 6 months of follow-up. (Groups 2,3)
Measured: 12 weeks, 3 and 6 months of follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start30 Oct 2021
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Medical Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cristina Amaya, Principal investigator, Boston Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06425211
- Sponsor's protocol ID
- BMGC-6
- Status last verified
- Jan 2026
- First submitted
- 17 May 2024
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Pelvic Floor Therapy for the Management of Erectile Dysfunction and Premature Ejaculation.
- ClinicalTrials.gov ID
- NCT06425211
- Acronym / sponsor ID
- BMGC-6
- Conditions
- Erectile Dysfunction, Premature (Early) Ejaculation, Premature Ejaculation, Pelvic Floor; Weak
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Boston Medical GroupIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2021 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 May 2024 (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.
The objective of this clinical trial is to evaluate the effectiveness of pelvic floor therapy for the management of erectile dysfunction and premature ejaculation in patients with erectile dysfunction and premature ejaculation. The main question to answer is:
What is the effectiveness of pelvic floor therapy (electrostimulation, biofeedback, and therapeutic exercise) for the treatment of patients with erectile dysfunction and or premature ejaculation?
Patients will:
- Have an initial consultation of pelvic floor rehabilitation before therapy.
- Be given pelvic floor therapy.
- Have a secondary consultation of pelvic floor rehabilitation after therapy.
Three intervention groups will be included: Group 1: Patients with premature ejaculation Group 2: Patients with erectile dysfunction Group 3: Patients with erectile dysfunction and premature ejaculation.
Detailed description
The objective of this clinical trial is to evaluate the effectiveness of pelvic floor therapy for the management of erectile dysfunction and premature ejaculation in patients with erectile dysfunction and premature ejaculation.
Methodology: Pre-post study. Erectile function or intravaginal latency time will be evaluated before and after pelvic floor therapy, in three groups of patients, independently:
- Group 1: Patients with premature ejaculation
- Group 2: Patients with erectile dysfunction
- Group 3: Patients with erectile dysfunction and premature ejaculation 66 patients will be included and will receive 24 sessions of pelvic floor therapy during 12 weeks. Outcomes will be evaluated at the end of therapy (12 weeks), 3 and 6 months follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Erectile Dysfunction | Experimental | Behavioral: Therapeutic exercises, Device: Perineal electromyographic biofeedback, Device: Electrical stimulationThe therapy depends if patient is classified within muscular hyperactivity or muscular hypoactivity. For muscular hypoactivity: Pelvic Floor Physiotherapy assessment: session 1 Proprioceptive and Coordination Work: sessions 2-7 Muscle workout: sessions 8-15 Functional training: sessions 16-23 Final evaluation: Session 24 For muscular hyperactivity they will be given: Pelvic Floor Physiotherapy assessment: session 1 Proprioceptive and Coordination Work: sessions 2-7 Muscle workout: sessions 8-15 Functional training: sessions 16-23 Final evaluation: session 24 These interventions include: Therapeutic exercises, Perineal electromyographic biofeedback, and Electrical stimulation |
| Premature Ejaculation | Experimental | Behavioral: Therapeutic exercises, Device: Perineal electromyographic biofeedback, Device: Electrical stimulationPelvic Floor Physiotherapy assessment: session 1 Proprioceptive and Coordination Work: sessions 2-15 Muscle workout: sessions 16-19 Functional training: sessions 20-23 Final evaluation: session 24 These interventions include: Therapeutic exercises, Perineal electromyographic biofeedback, and Electrical stimulation |
| Premature Ejaculation + Erectile Dysfunction | Experimental | Behavioral: Therapeutic exercises, Device: Perineal electromyographic biofeedback, Device: Electrical stimulationPelvic Floor Physiotherapy assessment: session 1 Proprioceptive and Coordination Work: sessions 2-12 Muscle workout: sessions 13-20 Functional training: sessions 20-23 Final evaluation: session 24 These interventions include: Therapeutic exercises, Perineal electromyographic biofeedback, and Electrical stimulation |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Men over 18 years of age
- Erectile dysfunction or premature ejaculation for at least 6 months
- Sexual activity with a heterosexual partner at least once a week
- Signing of informed consent before the start of the study
- Premature ejaculation according to the International Society of Sexual Medicine (ISSM) criteria
Key exclusion criteria (11 listed)
- Pharmacological treatment for erectile dysfunction or premature ejaculation in the last 3 months
- Erection Hardness Score (EHS) greater than 3 for patients with erectile dysfunction
- History of hypogonadism or suspected hypogonadism due to Aging Males Symptoms (AMS) score greater than 36 for patients with erectile dysfunction
- History of pelvic radiotherapy
- Pacemaker or cardiac arrhythmia, epilepsy
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 |
|---|---|---|
| Therapeutic exercisesRecognition of the pelvic area, respiratory management, lumbo-pelvic mobilization, discrimination of abdomino-pelvic contraction and myofascial release techniques. | Behavioural | Erectile Dysfunction, Premature Ejaculation, Premature Ejaculation + Erectile Dysfunction |
| Perineal electromyographic biofeedbackFree muscle work and gross motor coordination: | Device | Erectile Dysfunction, Premature Ejaculation, Premature Ejaculation + Erectile Dysfunction |
| Electrical stimulationMuscular proprioceptive work: 50 Hz 300 µs | Device | Erectile Dysfunction, Premature Ejaculation, Premature Ejaculation + Erectile Dysfunction |
Primary outcome
Change in baseline intravaginal latency time (IVLT)
Time frame: 12 weeks
Change in baseline intravaginal latency time (IVLT) at the end of therapy. (Groups 1,3)
Change in International Index of Erectile Dysfuntion - Erectile Dysfunction domain (IIEF-EF) score
Time frame: 12 weeks
International Index of Erectile Dysfuntion - Erectile Dysfunction domain (IIEF-EF) score change at the end of therapy. (Groups 2,3)
7 secondary outcomes
Change in baseline intravaginal latency time (IVLT) at follow-up
Time frame: 3 and 6 months of follow-up.
Change Premature Ejaculation Perfil (PEP) score
Time frame: 12 weeks, 3 and 6 months follow-up.
Change in Premature Ejaculation Diagnosis Tool (PEDT) questionnnaire score
Time frame: 12 weeks, 3 and 6 months follow-up.
Change Intracavity Assessment
Time frame: 12 weeks, 3 and 6 months follow-up.
Side Effects
Time frame: 12 weeks, 3 and 6 months follow-up.
Change in International Index of Erectile Dysfuntion - Erectile Dysfunction domain (IIEF-EF) score at follow-up
Time frame: 3 and 6 months of follow-up.
Change in Erection Hardness Score (EHS)
Time frame: 12 weeks, 3 and 6 months of follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Cristina Amaya principal investigator
Boston Medical Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic exercises, Perineal electromyographic biofeedback and Electrical stimulation in people with Erectile Dysfunction and Premature (Early) Ejaculation, run by Boston Medical Group at 1 site in Colombia.
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 11 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 23 Jan 2026. 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 Colombia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carolina Sandoval, Master (+573133920816, csandoval@bostonmedical.com.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in baseline intravaginal latency time (IVLT) (time frame: 12 weeks). The study lists 2 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 Jan 2026.