NCT07171424

Moving Beyond p-Values: MCID for OAB-V8 8 and ICIQ-SF in Patients With OAB

Moving Beyond p-Values: Minimal Clinically Important Difference for Overactive Bladder Questionnaire - Version 8 and International Consultation on Incontinence Questionnaire - Short Form in Patients With Overactive Bladder Syndrome

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 104 (estimated)
• Sponsor: Artvin Coruh University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study was to determine the Minimal Clinically Important Difference (MCID) for the Overactive Bladder Questionnaire-Version 8 (OAB-V8) and the International Consultation on Incontinence Questionnaire- Short Form (ICIQ-SF) in people with Overactive Bladder Syndrome (OAB).

Detailed description

104 patients with OAB will receive common behavioral therapy and transcutaneous posterior tibial nerve stimulation (TPTNS) for 12 weeks. OAB-related symptoms and quality of life (QoL) will be assessed with the OAB-V8 and ICIQ-SF baseline and post-intervention. The receiver operating characteristic (ROC) analysis and the Gamma coefficient will be employed to determine sensitivity.

Conditions

• Overactive Bladder Syndrome

Interventions

Type	Name	Description
OTHER	Behavioral therapy and transcutaneous posterior tibial nerve stimulation	Behavioral therapy included appropriate fluid intake, bladder training, habit training, pelvic floor muscle exercises (Kegel exercises), prompted voiding, and scheduled voiding. TPTNS will be applied in a biphasic square waveform with a frequency of 20 Hz and 200 cycles/sec in 30-minute sessions. The current intensity will be varied between 0.5-20 mA according to the patient's pain threshold.

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-05-30
• Completion: 2026-06-30
• First posted: 2025-09-12
• Last updated: 2026-03-17

Locations

1 site across 1 country: Turkey (Türkiye)