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Enrolling by Invitation

NCT Number: NCT07171424

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

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).

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Key information

Conditions

Overactive Bladder Syndrome Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Prof. Dr. Cemil Taşçıoğlu City Hospital

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Behavioral therapy and transcutaneous posterior tibial nerve stimulation

Other

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Artvin Coruh University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 12, 2025
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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