NCT07719400

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

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
15mo left

Started Sep 2026

Status
not yet recruiting

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

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 22, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

July 22, 2026

Status Verified

July 1, 2026

Enrollment Period

1 year

First QC Date

July 18, 2026

Last Update Submit

July 18, 2026

Conditions

Keywords

Pelvic Floor Muscle TrainingUrinary FrequencyPelvic Floor FunctionBladder Training

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 COMPARATOR

Bladder Training + Pelvic Floor Muscle Training

Other: Bladder training plus pelvic floor muscle training

Group 2: Control group

ACTIVE COMPARATOR

Group 2: Bladder Training Alone

Other: Bladder Training

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.

Group 1: Intervention group

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

Group 2: Control group

Eligibility Criteria

Age18 Years - 60 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMen with urinary frequency will be enrolled in the study
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

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: 35266184BACKGROUND
  • 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: 24821468BACKGROUND
  • 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: 11113739BACKGROUND

Central Study Contacts

Hasan Bingöl, Assoc. Prof, PhD

CONTACT

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