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NCT07687173
Assessment of Effectiveness of Pelvic Floor Muscle Training With Biofeedback in Male With Hypogonadism and Erectile Dysfunction
Conditions: Erectile Disfunction, Hypogonadal Males, Functional Hypogonadism, Pelvic Floor Muscle Exercise, Biofeedback Training, EMG
Sex: Male
Ages: 18 Years – 60 Years
Healthy volunteers: No
Phase: NA
Enrollment: 120
Sponsor: Poznan University of Physical Education
Location: Poznań University of Physical Education Poznan Wielkopolska
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.
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
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Source: ClinicalTrials.gov (NCT07687173). StuddyBuddy aggregates publicly available trial information.