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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
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07171424
Enrollment
104
Registered
2025-09-12
Start date
2026-01-01
Completion date
2026-06-30
Last updated
2026-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overactive Bladder Syndrome

Keywords

overactive bladder, minimal clinically important difference, urinary incontinence, quality of life, ROC curve

Brief 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.

Interventions

OTHERBehavioral 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.

Sponsors

Artvin Coruh University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

In this prospective study, one treatment group was formed to receive behavioral therapy and transcutaneous posterior tibial nerve stimulation (TPTNS).

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Overactive Bladder Questionnaire-Version 8 (OAB-V8)BaselineOn this scale, which ranges from 0 to 40 points, higher scores are associated with greater symptom severity.

Secondary

MeasureTime frameDescription
International Consultation on Incontinence Questionnaire- Short Form (ICIQ-SF)BaselineThe 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.

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATORZeynep Yıldız Kızkın

Artvin Coruh University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 29, 2026