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

Background and study aims:

The study aims to evaluate whether pelvic floor muscle training (PFMT), supported by biofeedback improves the treatment outcomes in male with erectile dysfunction (ED) and functional hypogonadism, compared to PFMT alone and standard pharmacological therapy. ED is a common condition affecting approximately 30-60% of men, with prevalence increasing with age. The aetiology of ED is multifactorial and includes vascular, hormonal, neurological, and psychological factors. Despite its prevalence only 25% of them seek treatment.

Current ED treatment relies primarily on pharmacotherapy, including testosterone replacement therapy (in confirmed deficiency) and PDE5 inhibitors, which are effective in many patients (60-80%) but less so in specific populations, such as those with diabetes. There is increasing interest in physiotherapy interventions, particularly PFMT, as a supportive treatment for ED. However, evidence regarding its effectiveness in hormonally driven ED remains limited.

The primary hypothesis is that PFMT supported by biofeedback will lead to greater improvements in pelvic floor muscle function, erectile performance, and sexual quality of life compared with PFMT without biofeedback and pharmacological treatment alone. Additional hypotheses suggest that biofeedback enhances exercise technique, increases patient adherence to training, and that longer intervention (12 weeks vs. 6 weeks) leads to superior outcomes.

Study design and material:

This study is designed as a prospective, randomized controlled trial (RCT) with a mixed design (repeated measures over time) and three parallel groups. Approximately 100 men aged 18-60 with diagnosed functional hypogonadism (serum testosterone \<12 nmol/L; free testosterone \<225 pmol/L) and erectile dysfunction will be recruited. All participants will have been prescribed pharmacological treatment (e.g. testosterone therapy, GLP-1 analogues, or dual GLP-1/GIP receptor agonists) prior to enrolment, according to medical indications.

Participants will be randomised into one of three groups: a control group receiving only pharmacotherapy, a group performing PFM training, and a group performing PFM training with biofeedback. Various measurements will be taken, including physical parameters, sexual function questionnaires, muscle activity (EMG), and psychological assessments.

All participants will continue previously prescribed and stable pharmacological treatment according to medical indications. The study intervention consists of adding PFMT, with or without biofeedback, to standard pharmacological care.

Methods:

Participants will be randomly allocated into three groups:

Control group will receive standard pharmacological treatment only Exercise group will continue pharmacotherapy while performing pelvic floor muscle (PFM) training without biofeedback Exercise + Biofeedback group will combine pharmacotherapy with PFM training supported by portable biofeedback devices.

Baseline and final assessment

All participants will undergo a detailed clinical interview aimed at identifying contraindications and collecting information on comorbidities and current medications. A comprehensive set of baseline measurements will be collected, including:

anthropometric data (height, body mass, waist and hip circumference), physical activity levels assessed by the short version of the International Physical Activity Questionnaire (IPAQ), sexual function evaluated using the standardized International Index of Erectile Function (IIEF), sexual quality of life evaluated using the standardized Sexual Quality of Life - Male (SQOL-M) pelvic floor muscle function will be assessed by palpation based on the PERFECT scheme and the Oxford scale, electromyographic (EMG) evaluation of pelvic floor muscles and synergistic muscle groups using surface electrodes, psychological status, including levels of depression and perceived stress, will be measured using validated tools such as the BDI-II and PSS-10 questionnaires.

Intervention Both intervention groups will follow an PFMT programme based on the 'Graduated Strength Training: Pelvic Floor Muscle Training' protocol. Participants will also receive education on healthy lifestyle practices and pelvic floor health. The biofeedback group will additionally use a handheld biofeedback device connected to a mobile application, providing real-time feedback on muscle activity and training performance. Those in the biofeedback group will receive additional instruction on the proper use of the device.

Duration: 12 weeks. Frequency: ≥5 sessions per week. Session duration: 5-10 minutes Mode: home-based training in a seated position Participants will maintain training diaries to monitor adherence. On-line follow-up consultations will be conducted at weeks 2, 4 and 9 to evaluate progress and adjust training if necessary.

Follow-up and measurements:

baseline (week 0): full assessment (all groups) week 6: repeated assessment (intervention groups only) week 12: final assessment (all groups)

Potential outcomes:

The study is expected to provide evidence on the effectiveness of PFM training-particularly when supported by biofeedback-in improving erectile function and pelvic floor muscle performance in male with functional hypogonadism. The findings may contribute to the development of clinical guidelines, optimization of treatment strategies, and improved patient quality of life and health awareness.

• Sexual quality of life [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• Adherence to protocol [Срок оценки: From enrollment to the end of treatment at 12 weeks]