Effects of Pelvic Floor Muscle Training Combined With Bladder Training on Some Parametrs of Men With Urinary Frequency
1 other identifier
interventional
120
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2026
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 18, 2026
CompletedFirst Posted
Study publicly available on registry
July 22, 2026
CompletedStudy Start
First participant enrolled
September 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2027
Study Completion
Last participant's last visit for all outcomes
December 1, 2027
July 22, 2026
July 1, 2026
1 year
July 18, 2026
July 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pelvic floor muscle strength as assessed by ultrasound
From enrollment to the end of treatment at 12 weeks
Study Arms (2)
Group 1: Intervention group
ACTIVE COMPARATORBladder Training + Pelvic Floor Muscle Training
Group 2: Control group
ACTIVE COMPARATORGroup 2: Bladder Training Alone
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
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bingol Universitylead
- Istanbul Rumeli Universitycollaborator
Related Publications (3)
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: 35266184BACKGROUNDSiegel 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: 24821468BACKGROUNDClemens 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: 11113739BACKGROUND
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Outcome assessors will be blinded to group allocation
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assoc. Prof.
Study Record Dates
First Submitted
July 18, 2026
First Posted
July 22, 2026
Study Start (Estimated)
September 1, 2026
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
July 22, 2026
Record last verified: 2026-07