Urinary Dysfunction
Conditions
Keywords
Pelvic Floor Muscle Training, Urinary Frequency, Pelvic Floor Function, Bladder Training
Brief summary
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.
Detailed description
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
Interventions
Bladder training includes strategies for suppressing urgency, gradually extending the intervals between voiding, managing fluid intake, and reducing caffeine consumption. The pelvic floor muscle training component involves three types of contractions: fast contractions (10 repetitions, 3 sets), maximal sustained contractions (10 repetitions, held for 10 seconds each), and functional contractions integrated into daily activities to improve real-life muscle control.
Bladder training includes strategies for suppressing urgency, gradually extending the intervals between voiding, managing fluid intake, and reducing caffeine consumption
Sponsors
Study design
Masking description
Outcome assessors will be blinded to group allocation
Eligibility
Inclusion criteria
* Male sex * Age 18-65 years * Complaint of urinary frequency persisting for at least 3 months * On a 3-day bladder diary: ≥8 voids per 24 hours * Provision of written informed consent Sufficient cognitive capacity to learn pelvic floor muscle contraction (assessed by clinical judgment)
Exclusion criteria
* Active urinary tract infection * Prostate cancer * Prostate surgery within the last 12 months * Parkinson's disease, Multiple sclerosis (MS), Stroke, Spinal cord injury * Neurogenic bladder due to diabetes mellitus * Bladder stones, Bladder tumor, Urethral stricture
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pelvic floor muscle strength as assessed by ultrasound | From enrollment to the end of treatment at 12 weeks |