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

Official title

Effects of Pelvic Floor Muscle Training Combined With Bladder Training on Urinary Frequency, Pelvic Floor Function, and Post-Void Residual Volume in Men With Urinary Frequency: A Randomized Controlled Trial

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.

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

• Other Bladder training plus pelvic floor muscle training
  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.
• Other Bladder Training
  Bladder training includes strategies for suppressing urgency, gradually extending the intervals between voiding, managing fluid intake, and reducing caffeine consumption

Primary outcome measures

• Pelvic floor muscle strength as assessed by ultrasound [Time frame: From enrollment to the end of treatment at 12 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Carralero-Martinez A, Munoz Perez MA, Kauffmann S, Blanco-Ratto L, Ramirez-Garcia I. Efficacy of capacitive resistive monopolar radiofrequency in the physiotherapeutic treatment of chronic pelvic pain syndrome: A randomized controlled trial. Neurourol Urodyn. 2022 Apr;41(4):962-972. doi: 10.1002/nau.24903. Epub 2022 Mar 9. PMID 35266184
• Siegel AL. Pelvic floor muscle training in males: practical applications. Urology. 2014 Jul;84(1):1-7. doi: 10.1016/j.urology.2014.03.016. Epub 2014 May 10. PMID 24821468
• Clemens JQ, Nadler RB, Schaeffer AJ, Belani J, Albaugh J, Bushman W. Biofeedback, pelvic floor re-education, and bladder training for male chronic pelvic pain syndrome. Urology. 2000 Dec 20;56(6):951-5. doi: 10.1016/s0090-4295(00)00796-2. PMID 11113739

Identifiers

NCT: NCT07719400 · 2026/06-24.06.2026

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗