Overactive Bladder Clinical Trial
Official title:
The Efficacy of Transcutaneous Tibial Nerve Stimulation on Symptoms of Overactive Bladder and Quality of Life in Women With Idiopathic Overactive Bladder
This study was designed to assess the efficacy of trans cutaneous tibial nerve stimulation on symptoms of overactive bladder in women with idiopathic overactive bladder
Status | Not yet recruiting |
Enrollment | 26 |
Est. completion date | August 30, 2026 |
Est. primary completion date | July 30, 2026 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - Overactive Bladder Questionnaire Validation Study questionnaire 8 scores higher than 11. - Post voiding residue levels less than 100 ml. - Women aged between 18-70 Exclusion Criteria: - Prior history of pelvic surgery - Pelvic organ prolapsus of grade 2 or more. - Current urinary tract infection |
Country | Name | City | State |
---|---|---|---|
Turkey | Ege University School of Medicine | Bornova | Izmir |
Lead Sponsor | Collaborator |
---|---|
Ege University |
Turkey,
Bo K, Frawley HC, Haylen BT, Abramov Y, Almeida FG, Berghmans B, Bortolini M, Dumoulin C, Gomes M, McClurg D, Meijlink J, Shelly E, Trabuco E, Walker C, Wells A. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for the conservative and nonpharmacological management of female pelvic floor dysfunction. Int Urogynecol J. 2017 Feb;28(2):191-213. doi: 10.1007/s00192-016-3123-4. Epub 2016 Dec 5. — View Citation
Gormley EA, Lightner DJ, Faraday M, Vasavada SP; American Urological Association; Society of Urodynamics, Female Pelvic Medicine. Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU guideline amendment. J Urol. 2015 May;193(5):1572-80. doi: 10.1016/j.juro.2015.01.087. Epub 2015 Jan 23. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Urination frequency | The frequency of urination will be recorded by using a bladder diary. Urination frequency will be questioned before and after the study period. | 1 day | |
Primary | Severity of overactive bladder symptoms. Overactive Bladder Questionnaire Validation Study questionnaire | This questionnaire assesses the severity of overactive bladder symptoms in 8 items. Each item is scored from 0 to 5. Higher scores denote worse symptom severity. Maximum score is 40. A score over 11 denotes presence of overactive bladder symptoms. Questionnaire will be answered before and after the treatment period. | 1 day | |
Secondary | Quality of life. King's quality of life questionnaire | This questionnaire includes a total of 19 questions assessing general quality of life and also questions related to urinary symptoms. Maximum score is 100 and higher scores denote lower levels of quality of life. Questionnaire will be answered before and after the treatment period. | 1 day | |
Secondary | Level of satisfaction with the treatment. Visual analog scale | After the completion of the study period, patients will be asked to assess their levels of satisfaction with the treatment they received on a visual analog scale. | 1 day | |
Secondary | Incontinence impact questionnaire-7. | This 7 item questionnaire assesses the impact of urinary incontinence on the patients' daily lives. Maximum score is 100. Higher scores denote worse outcomes. Questionnaire will be answered before and after the treatment period. | 1 day |
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