Effects of Pelvic Floor Muscle Training Combined With Bladder Training on Some Parametrs of Men With Urinary Frequency

Overview

This prospective, single-center, parallel-group, assessor-blinded randomized controlled trial will include 120 voluntary male participants who have had complaints of urinary frequency for at least 3 months and meet the inclusion criteria. Participants will be randomly allocated into two groups (Group 1: Bladder Training + Pelvic Floor Muscle Training; Group 2: Bladder Training Alone). Assessments will be repeated at baseline, at week 4, and at week 8. The primary outcome measure will be 3-day bladder diary data (24-hour voiding frequency); secondary outcomes will include the OAB-V8, ICIQ-OAB, and PGI-I scales, as well as transabdominal ultrasonographic measurements of bladder neck elevation (strength and endurance) and PVR.

Study Design: Prospective Single-center Parallel-group 1:1 randomized Assessor-blinded RCT CONSORT-compliant Inclusion Criteria: Male Age 18-65 years Complaint of urinary frequency persisting for at least 3 months On a 3-day bladder diary: ≥8 voids/24 hours Provision of written informed consent Sufficient cognitive capacity to learn pelvic floor muscle contraction Exclusion Criteria: Active urinary tract infection Prostate cancer Prostate surgery within the last 12 months Neurological diseases: Parkinson's disease Multiple sclerosis (MS) Stroke Spinal cord injury Neurogenic bladder due to diabetes mellitus Bladder stones Bladder tumor Urethral stricture Within the last 3 months: PFMT (pelvic floor muscle training) Biofeedback PTNS (percutaneous tibial nerve stimulation) Tibial nerve stimulation Recent dose change in antimuscarinic or β3-agonist therapy Randomization Computer-generated block randomization Block size of 4 or 6 Allocation concealment Sealed opaque envelopes Assessment Time Points T0 = Baseline T1 = Week 6 T2 = Week 12 T3 = 6-month follow-up Primary Outcome 3-day bladder diary 24-hour voiding frequency Secondary Outcomes OAB-V8 Symptom severity ICIQ-OAB Quality of life and symptom impact PGI-I Patient global impression of improvement Ultrasound Measurements A) Pelvic Floor Muscle Strength Transabdominal ultrasound During maximum voluntary contraction: Bladder neck elevation (mm) 3 repetitions Average will be calculated B) Pelvic Floor Muscle Endurance Following maximum contraction 10-second hold Duration of bladder neck elevation maintenance or Percentage of elevation maintained over 10 seconds C) Post-Void Residual Volume (PVR) Via ultrasound Within the first 5 minutes after voiding Recorded in mL Interventions Group 1 Bladder Training Urge suppression strategies Extending voiding intervals Fluid management Caffeine education ● (placeholder/bullet) Pelvic Floor Muscle Training 8 weeks 1 face-to-face session per week Home exercise program Fast contractions: 10 reps × 3 sets Maximal (sustained) contractions: 10 reps × 10 seconds each Functional contractions: To be performed when urgency is felt Group 2 Bladder training only Same follow-up frequency Same training duration