Assessment of Effectiveness of Pelvic Floor Muscle Training With Biofeedback in Male With Hypogonadism and Erectile Dysfunction

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-60
SponsorPoznan University of Physical Education

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Training with handheld biofeedback device

    Device

    Participants will get handheld biofeedback device, and will do PFMT using those device.

  • Pelvic Floor Muscle Training (PFMT)

    Other intervention

    Participants will do PFMT as prescripted

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: Intervention Grup 1: Exercise + BiofeedbackExperimental treatment 2 interventions
Group B: Intervention grup 2: Exercise + NO biofeedbackExperimental treatment 1 intervention
Group C: Control grupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
From enrollment to the end of treatment at 12 weeks
2

Maximal Voluntary Contraction (MVC)

Measured by EMG device in micro volts.

Time frame
From enrollment to the end of treatment at 12 weeks
3

Fatigue

Measured by EMG device as an increase in the amplitude and duration of the muscle action potential

Time frame
From enrollment to the end of treatment at 12 weeks

Secondary outcomes

1

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.

Time frame
From enrollment to the end of treatment at 12 weeks
2

Adherence to protocol

Measured by training diary

Time frame
From enrollment to the end of treatment at 12 weeks

Other outcomes

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: