Assessment of Effectiveness of Pelvic Floor Muscle Training With Biofeedback in Male With Hypogonadism and Erectile Dysfunction
1 other identifier
interventional
120
1 country
1
Brief Summary
The goal of this clinical trial is to learn if Pelvic Floor Muscle Training (PFMT) with biofeedback works to treat Erectile Disorders (ED) in males with Functional Hipogonadism. The main hypothesis is: 1\. Biofeedback-assisted Pelvic Floor Muscle Training will cause greater improvement in pelvic floor muscle strength and endurance and sexual life than in group without biofeedback and control group in males with Erectile Disorders caused by functional hypogonadism. The main questions it aims to answer are:
- 1.Does biofeedback-assisted pelvic floor muscle training cause greater improvement in pelvic floor muscle strength and endurance and sexual life than in group without biofeedback and control group.
- 2.Does using handheld biofeedback trainer device improves technique of Pelvic Floor Muscle Training performance compare to NO biofeedback.
- 3.Does 12-week intervention cause greater improvement in analyzed parameters than 6-week intervention.
- 4.Does participants using biofeedback will have greater adherence to training protocol than no biofeedback group.
- 5.Be measured using questionnaires and pelvic floor muscle electromyography
- 6.Do Pelvic Floor Muscle Training for 12 weeks
- 7.Provide a diary of their training routine
- 8.Have repeated measurements in 6 and 12 weeks
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 26, 2026
CompletedStudy Start
First participant enrolled
July 1, 2026
CompletedFirst Posted
Study publicly available on registry
July 7, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2029
July 7, 2026
April 1, 2026
2.9 years
June 26, 2026
July 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Erectile performance
Measured by International Index of Erectile Function (IIEF) questionnaire. Patient can get from 0 to 75 points (15 questions rated from 0 to 5 each). Lower score means more severe problem.
From enrollment to the end of treatment at 12 weeks
Maximal Voluntary Contraction (MVC)
Measured by EMG device in micro volts.
From enrollment to the end of treatment at 12 weeks
Fatigue
Measured by EMG device as an increase in the amplitude and duration of the muscle action potential
From enrollment to the end of treatment at 12 weeks
Secondary Outcomes (2)
Sexual quality of life
From enrollment to the end of treatment at 12 weeks
Adherence to protocol
From enrollment to the end of treatment at 12 weeks
Study Arms (3)
Intervention Grup 1: Exercise + Biofeedback
EXPERIMENTALParticipants in this group will be measured with EMG and questionnaires at the beginning of the intervention, after 6 and 12 weeks. Participants in this group will continue standard pharmacotherapy as before recruitment and will also do standardised PFMT as prescripted with handheld biofeedback trainer device. Participant will also provide a diary of their training.
Intervention grup 2: Exercise + NO biofeedback
EXPERIMENTALParticipnats in this grup will be measured with EMG and questionaires at the begining of the intervention, after 6 and 12 weeks. Participants in this grup will continue standard pharmacotherapy as before recrutation and will also do PFMT as prescripted WITHOUT handheld biofeedback trainer. Participant will also provide a diary of their training.
Control grup
NO INTERVENTIONParticipnats in this grup will be measured with EMG and questionaires at the begining of the intervention, and after 12 weeks. Participants in this grup will continue standard pharmacotherapy as before recrutation
Interventions
Participants will get handheld biofeedback device, and will do PFMT using those device.
Participants will do PFMT as prescripted
Eligibility Criteria
You may qualify if:
- diagnosed functional hypogonadism
- diagnosed erectile disorders
- no diagnosed neurological disorders in pelvic floor area
- no surgical interventions in pelvic floor area
- no cancer in its active phase
- ability to give individual consent
- consent of participation and following the protocol
You may not qualify if:
- severe cardiovascular diseases
- cancer treatment in progress
- scars and surgical interventions in the pelvic floor area
- neurological disorders affecting to pelvic floor
- scars that makes measurements impossible
- other treatment that affects sexual field similar to this protocol
- participation in other rehabilitation programme less than 6 months before this programme
- severe neurological disorders that makes cooperation impossible
- no technical possibilities to do the measures to the patient
- disagreement to participate in the programme
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Poznań University of Physical Education
Poznan, Wielkopolska, 61-871, Poland
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD Student
Study Record Dates
First Submitted
June 26, 2026
First Posted
July 7, 2026
Study Start
July 1, 2026
Primary Completion (Estimated)
June 1, 2029
Study Completion (Estimated)
June 1, 2029
Last Updated
July 7, 2026
Record last verified: 2026-04