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

March 14, 2026 updated by: Zeynep Yıldız Kızkın, Artvin Coruh University

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

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).

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye)
        • Prof. Dr. Cemil Taşcıoğlu City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • individuals diagnosed with urge and mixed urinary incontinence symptoms or with OAB symptoms only (no history of urinary incontinence),
  • women over 18 years of age.

Exclusion Criteria:

  • patients who did not give consent to participate in the study,
  • not understanding the instructions given by the researcher,
  • pregnancy or planning a pregnancy in the near future,
  • urinary tract infection or kidney stones,
  • pelvic organ prolapse of grade II or higher,
  • stress-type urinary incontinence,
  • neurogenic bladder,
  • use of a pacemaker,
  • epilepsy,
  • peripheral neuropathy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: Behavioral therapy and transcutaneous posterior tibial nerve stimulation
Patients with OAB will receive behavioral therapy and TPTNS one day a week for 12 weeks as previously recommended.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overactive Bladder Questionnaire-Version 8 (OAB-V8)
Time Frame: Baseline
On this scale, which ranges from 0 to 40 points, higher scores are associated with greater symptom severity.
Baseline
Overactive Bladder Questionnaire-Version 8 (OAB-V8)
Time Frame: After the 12-week intervention
On this scale, which ranges from 0 to 40 points, higher scores are associated with greater symptom severity.
After the 12-week intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
International Consultation on Incontinence Questionnaire- Short Form (ICIQ-SF)
Time Frame: Baseline
The total score of the scale ranges from 0 to 21, with higher scores indicating more severe symptoms. It measures the frequency, severity, and impact of OAB through three main questions. An additional open-ended question allows patients to describe their symptoms.
Baseline
International Consultation on Incontinence Questionnaire- Short Form (ICIQ-SF)
Time Frame: After the 12-week intervention
The total score of the scale ranges from 0 to 21, with higher scores indicating more severe symptoms. It measures the frequency, severity, and impact of OAB through three main questions. An additional open-ended question allows patients to describe their symptoms.
After the 12-week intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global Rating Change (GRC)
Time Frame: After the 12-week intervention
The GRC comprised seven responses, ranging from 1 to 5, indicating "very much better," "slightly better," "no change," "slightly worse," and "very much worse," respectively.
After the 12-week intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Artvin Coruh University

Investigators

  • Principal Investigator: Zeynep Yıldız Kızkın, Artvin Çoruh University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2026

Primary Completion (Estimated)

May 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

September 6, 2025

First Submitted That Met QC Criteria

September 6, 2025

First Posted (Actual)

September 12, 2025

Study Record Updates

Last Update Posted (Actual)

March 17, 2026

Last Update Submitted That Met QC Criteria

March 14, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCID-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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