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

Artvin Coruh University

Status: Not yet enrolling

Conditions: Overactive Bladder Syndrome

Treatments: Other: Behavioral therapy and transcutaneous posterior tibial nerve stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07171424

MCID-2

Details and patient eligibility

About

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).

Full 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.

Enrollment: 104 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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104 participants in 1 patient group

Experimental: Behavioral therapy and transcutaneous posterior tibial nerve stimulation

Experimental group

Description:

Patients with OAB will receive behavioral therapy and TPTNS one day a week for 12 weeks as previously recommended.

Treatment:

Other: Behavioral therapy and transcutaneous posterior tibial nerve stimulation