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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| International Consultation on Incontinence Questionnaire- Short Form (ICIQ-SF) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Global Rating Change (GRC) | 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 |
Inclusion Criteria:
Exclusion Criteria:
Only women with an overactive bladder will be included.
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| Name | Affiliation | Role |
|---|---|---|
| Zeynep Yıldız Kızkın | Artvin Coruh University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prof. Dr. Cemil Taşçıoğlu City Hospital | Istanbul | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36854167 | Background | 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. | |
| 27057265 | 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. |
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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In this prospective study, one treatment group was formed to receive behavioral therapy and transcutaneous posterior tibial nerve stimulation (TPTNS).
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|
| International Consultation on Incontinence Questionnaire- Short Form (ICIQ-SF) | 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 |
| 31039103 | 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. |
| 34011072 | 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. |
| 24958472 | 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. |
| 16418145 | 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. |
| 15227649 | 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. |
| 10812317 | 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. |
| 33844342 | 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. |
| 31524367 | Background | Hu JS, Pierre EF. Urinary Incontinence in Women: Evaluation and Management. Am Fam Physician. 2019 Sep 15;100(6):339-348. |
| 30311692 | 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. |
| 20044494 | 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. |
| 20638823 | 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. |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014555 | Urination Disorders |