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

NCT07171424 | Enrolling By Invitation

• 1 other identifier: MCID-2
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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).

Conditions

Overactive Bladder Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Overactive Bladder Questionnaire-Version 8 (OAB-V8)

  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)

  On this scale, which ranges from 0 to 40 points, higher scores are associated with greater symptom severity.

  After the 12-week intervention

Secondary Outcomes (2)

• International Consultation on Incontinence Questionnaire- Short Form (ICIQ-SF)

  Baseline

• International Consultation on Incontinence Questionnaire- Short Form (ICIQ-SF)

  After the 12-week intervention

Other Outcomes (1)

• Global Rating Change (GRC)

  After the 12-week intervention

Study Arms (1)

Experimental: Behavioral therapy and transcutaneous posterior tibial nerve stimulation

EXPERIMENTAL

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

Interventions

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.

Experimental: Behavioral therapy and transcutaneous posterior tibial nerve stimulation

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only women with an overactive bladder will be included.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Artvin Coruh University: lead

Study Sites (1)

Prof. Dr. Cemil Taşçıoğlu City Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (13)

• Chiengthong K, Bunyavejchevin S. Efficacy of Erbium YAG laser treatment in overactive bladder syndrome: a randomized controlled trial. Menopause. 2023 Apr 1;30(4):414-420. doi: 10.1097/GME.0000000000002159. Epub 2023 Feb 27.

  PMID: 36854167 BACKGROUND

• Reynolds WS, Fowke J, Dmochowski R. The Burden of Overactive Bladder on US Public Health. Curr Bladder Dysfunct Rep. 2016 Mar;11(1):8-13. doi: 10.1007/s11884-016-0344-9. Epub 2016 Jan 23.

  PMID: 27057265 BACKGROUND

• Lightner DJ, Gomelsky A, Souter L, Vasavada SP. Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic) in Adults: AUA/SUFU Guideline Amendment 2019. J Urol. 2019 Sep;202(3):558-563. doi: 10.1097/JU.0000000000000309. Epub 2019 Aug 8.

  PMID: 31039103 BACKGROUND

• Yang DY, Zhao LN, Qiu MX. Treatment for overactive bladder: A meta-analysis of transcutaneous tibial nerve stimulation versus percutaneous tibial nerve stimulation. Medicine (Baltimore). 2021 May 21;100(20):e25941. doi: 10.1097/MD.0000000000025941.

  PMID: 34011072 BACKGROUND

• Abrams P, Smith AP, Cotterill N. The impact of urinary incontinence on health-related quality of life (HRQoL) in a real-world population of women aged 45-60 years: results from a survey in France, Germany, the UK and the USA. BJU Int. 2015 Jan;115(1):143-52. doi: 10.1111/bju.12852. Epub 2014 Aug 16.

  PMID: 24958472 BACKGROUND

• Coyne KS, Zyczynski T, Margolis MK, Elinoff V, Roberts RG. Validation of an overactive bladder awareness tool for use in primary care settings. Adv Ther. 2005 Jul-Aug;22(4):381-94. doi: 10.1007/BF02850085.

  PMID: 16418145 BACKGROUND

• Avery K, Donovan J, Peters TJ, Shaw C, Gotoh M, Abrams P. ICIQ: a brief and robust measure for evaluating the symptoms and impact of urinary incontinence. Neurourol Urodyn. 2004;23(4):322-30. doi: 10.1002/nau.20041.

  PMID: 15227649 BACKGROUND

• Husted JA, Cook RJ, Farewell VT, Gladman DD. Methods for assessing responsiveness: a critical review and recommendations. J Clin Epidemiol. 2000 May;53(5):459-68. doi: 10.1016/s0895-4356(99)00206-1.

  PMID: 10812317 BACKGROUND

• Frawley H, Shelly B, Morin M, Bernard S, Bo K, Digesu GA, Dickinson T, Goonewardene S, McClurg D, Rahnama'i MS, Schizas A, Slieker-Ten Hove M, Takahashi S, Voelkl Guevara J. An International Continence Society (ICS) report on the terminology for pelvic floor muscle assessment. Neurourol Urodyn. 2021 Jun;40(5):1217-1260. doi: 10.1002/nau.24658. Epub 2021 Apr 12.

  PMID: 33844342 BACKGROUND

• Hu JS, Pierre EF. Urinary Incontinence in Women: Evaluation and Management. Am Fam Physician. 2019 Sep 15;100(6):339-348.

  PMID: 31524367 BACKGROUND

• Ramirez-Garcia I, Blanco-Ratto L, Kauffmann S, Carralero-Martinez A, Sanchez E. Efficacy of transcutaneous stimulation of the posterior tibial nerve compared to percutaneous stimulation in idiopathic overactive bladder syndrome: Randomized control trial. Neurourol Urodyn. 2019 Jan;38(1):261-268. doi: 10.1002/nau.23843. Epub 2018 Oct 12.

  PMID: 30311692 BACKGROUND

• Greco NJ, Anderson AF, Mann BJ, Cole BJ, Farr J, Nissen CW, Irrgang JJ. Responsiveness of the International Knee Documentation Committee Subjective Knee Form in comparison to the Western Ontario and McMaster Universities Osteoarthritis Index, modified Cincinnati Knee Rating System, and Short Form 36 in patients with focal articular cartilage defects. Am J Sports Med. 2010 May;38(5):891-902. doi: 10.1177/0363546509354163. Epub 2009 Dec 31.

  PMID: 20044494 BACKGROUND

• Lehman LA, Velozo CA. Ability to detect change in patient function: responsiveness designs and methods of calculation. J Hand Ther. 2010 Oct-Dec;23(4):361-70; quiz 371. doi: 10.1016/j.jht.2010.05.003. Epub 2010 Jul 17.

  PMID: 20638823 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Zeynep Yıldız Kızkın

  Artvin Coruh University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

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

Study Record Dates

• First Submitted: September 6, 2025
• First Posted: September 12, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)