About this trial
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.
Research will compare biofeedback-assisted Pelvic Floor Muscle Training to non-biofeedback Pelvic Floor Muscle Training and control group to see if Pelvic Floor Muscle Training works to treat Erectile Disorders in males with functional hypogonadism.
Participants will:
1. Be measured using questionnaires and pelvic floor muscle electromyography 2. Do Pelvic Floor Muscle Training for 12 weeks 3. Provide a diary of their training routine 4. Have repeated measurements in 6 and 12 weeks
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
diagnosed functional hypogonadism
diagnosed erectile disorders
no diagnosed neurological disorders in pelvic floor area
no surgical interventions in pelvic floor area
Disqualifiers
severe cardiovascular diseases
cancer treatment in progress
scars and surgical interventions in the pelvic floor area
neurological disorders affecting to pelvic floor
Trial design
Parallel
Treatments tested in this trial
Training with handheld biofeedback device
DeviceParticipants will get handheld biofeedback device, and will do PFMT using those device.
Pelvic Floor Muscle Training (PFMT)
Other interventionParticipants will do PFMT as prescripted
Treatment groups
Trial outcomes
Primary outcomes
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.
Maximal Voluntary Contraction (MVC)
Measured by EMG device in micro volts.
Fatigue
Measured by EMG device as an increase in the amplitude and duration of the muscle action potential
Secondary outcomes
Sexual quality of life
Measured by SQOL-M (Sexual Quality of Life Male) questionnaire. Patient can get from 11 to 66 points (11 items rated from 1 to 6 each). The higher score means better quality of life.
Adherence to protocol
Measured by training diary
Sponsors and contacts
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Poznan University of Physical Education
Lead sponsor
Poznan University of Medical Sciences
Collaborator
This trial is not recruiting at the moment. You can still explore other options: