An interventional study of Bladder training plus pelvic floor muscle training and Bladder Training in Urinary Dysfunction, sponsored by Bingol University. Not yet recruiting. Open to male participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by Bingol University · Not applicable, Interventional, and Treatment
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.
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
Bingol University is the lead sponsor of 8 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Bladder Training + Pelvic Floor Muscle Training
Other: Bladder training plus pelvic floor muscle training
Group 2: Bladder Training Alone
Other: Bladder 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
Pelvic floor muscle strength as assessed by ultrasound
Time frame: From enrollment to the end of treatment at 12 weeks
No study locations are listed for this record.
Plan to share: Undecided
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Bingol University