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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07719400
Enrollment
120
Registered
2026-07-22
Start date
2026-09-01
Completion date
2027-12-01
Last updated
2026-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Dysfunction

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

OTHERBladder 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.

Bladder training includes strategies for suppressing urgency, gradually extending the intervals between voiding, managing fluid intake, and reducing caffeine consumption

Sponsors

Bingol University
Lead SponsorOTHER
Istanbul Rumeli University
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Outcome assessors will be blinded to group allocation

Eligibility

Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

MeasureTime frame
Pelvic floor muscle strength as assessed by ultrasoundFrom enrollment to the end of treatment at 12 weeks

Contacts

CONTACTHasan Bingöl, Assoc. Prof, PhD
hesenbingol@gmail.com+90 0(426) 216 0012

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 23, 2026