Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-03-01 @ 10:09 AM
Study NCT ID:
NCT06349694
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-05
First Post:
2024-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Efficacy of Transcutaneos Nerve Stimulations in Women With Idiopathic Overactive Bladder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}], 'ancestors': [{'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-04-22', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-01', 'studyFirstSubmitDate': '2024-04-01', 'studyFirstSubmitQcDate': '2024-04-01', 'lastUpdatePostDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in incontinence episodes (positive response rate)', 'timeFrame': 'Change from baseline positive response rate at the 6th week after the treatment', 'description': 'Reduction in incontinence episodes will be collected from the 3-day bladder diary. Woman with ≥50% reduction in incontinence episodes were considered positive responders'}], 'secondaryOutcomes': [{'measure': 'The severity of incontinence', 'timeFrame': 'Change from baseline the 24-hour pad test at the 6th week after the treatment', 'description': 'The 24-hour pad test will be carried out to evaluate the severity of incontinence'}, {'measure': 'Symptom severity', 'timeFrame': 'Change from baseline Overactive Bladder Questionnaire (OAB-V8) at the 6th week after the treatment', 'description': 'Overactive Bladder Questionnaire (OAB-V8) was used to evaluate symptom severity in women with OAB'}, {'measure': 'Frequency of voiding, nocturia, number of pads', 'timeFrame': 'Change from baseline voiding, nocturia, and the number of pads used will be collected from the 3-day bladder diary at the 6th week after the treatment', 'description': 'The frequency of voiding, nocturia, and the number of pads used will be collected from the 3-day bladder diary.'}, {'measure': 'Quality of life (IIQ7)', 'timeFrame': 'Change from baseline point of The Quality of Life-Incontinence Impact Questionnaire at the 6th week after the treatment', 'description': 'The Quality of Life-Incontinence Impact Questionnaire (IIQ7)'}, {'measure': 'The Hospital Anxiety and Depression Scale (HAD)', 'timeFrame': 'Change from baseline point of The Hospital Anxiety and Depression Scale (HAD) at the 6th week after the treatment', 'description': 'The Hospital Anxiety and Depression Scale (HAD), developed by Zigmond and Snaith in 1983, with its validity and reliability study conducted in Turkey by Aydemir et al. in 1987, assesses anxiety and depression levels. It consists of 14 questions, seven for anxiety and seven for depression, scored on a four-point Likert scale. Scores are summed for each subscale: 1, 3, 5, 7, 9, 11, and 13 for anxiety, and 2, 4, 6, 8, 10, 12, and 14 for depression. In Turkey, cutoff scores are 10/11 for anxiety and 7/8 for depression, indicating risk.'}, {'measure': 'FSFI', 'timeFrame': 'Change from baseline point of FSFI at the 6th week after the treatment', 'description': 'In the evaluation of sexual function, the FSFI questionnaire is used, consisting of 19 questions assessing six main factors: sexual desire, arousal, lubrication, orgasm, satisfaction, and pain/discomfort. The highest possible total raw score is 95, while the lowest is 4. After multiplying the coefficients, the highest score is 36, and the lowest is 2. Impact coefficients used for scoring are: 0.6 for sexual desire, 0.3 for arousal and lubrication, and 0.4 for orgasm, satisfaction, and pain/discomfort. An FSFI score below 26.55 is indicative of sexual dysfunction'}, {'measure': 'Cure-improvement rates', 'timeFrame': 'Change from baseline cure and improvements at the 6th week after the treatment', 'description': 'Cure and improvement rates will be recorded in all groups at the end-of-treatment assessments. Values under 1.3 g in the 24-hour pad test will be considered as "cure", while a 50% or greater reduction in wet weight compared to baseline measurements at the end of treatment will be considered as "improvement"'}, {'measure': 'Treatment satisfaction', 'timeFrame': 'Change from baseline of their urinary incontinence on a 5-point Likert scale at the 6th week after the treatment', 'description': 'The change of their urinary incontinence on a 5-point Likert scale (5, very satisfied; 1, very unsatisfied)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Idiopatic overactive bladder', 'Transcutaneous medial plantar nerve stimulation', 'Transcutaneous tibial nerve stimulation'], 'conditions': ['Urinary Bladder, Overactive']}, 'referencesModule': {'references': [{'pmid': '27918122', 'type': 'BACKGROUND', 'citation': '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. Neurourol Urodyn. 2017 Feb;36(2):221-244. doi: 10.1002/nau.23107. Epub 2016 Dec 5.'}, {'type': 'BACKGROUND', 'citation': '2. C.K. Harding, M.C. Lapitan, S. Arlandis, K. Bø, H. Cobussen-Boekhorst, E. Costantini, et al. The European Association of Urology (EAU) Guidelines. EAU Guidelines on Management of Non-Neurogenic Female Lower Urinary Tract Symptoms. In: EAU Guidelines, 2023 (Internet). Available online at: https://uroweb.org/guidelines/non-neurogenic-female-luts'}, {'pmid': '25623739', 'type': 'BACKGROUND', '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.'}, {'pmid': '12100806', 'type': 'BACKGROUND', 'citation': 'Subak LL, Quesenberry CP, Posner SF, Cattolica E, Soghikian K. The effect of behavioral therapy on urinary incontinence: a randomized controlled trial. Obstet Gynecol. 2002 Jul;100(1):72-8. doi: 10.1016/s0029-7844(02)01993-2.'}, {'pmid': '12425706', 'type': 'BACKGROUND', 'citation': 'Burgio KL, Goode PS, Locher JL, Umlauf MG, Roth DL, Richter HE, Varner RE, Lloyd LK. Behavioral training with and without biofeedback in the treatment of urge incontinence in older women: a randomized controlled trial. JAMA. 2002 Nov 13;288(18):2293-9. doi: 10.1001/jama.288.18.2293.'}, {'pmid': '26003239', 'type': 'BACKGROUND', 'citation': 'de Groat WC, Yoshimura N. Anatomy and physiology of the lower urinary tract. Handb Clin Neurol. 2015;130:61-108. doi: 10.1016/B978-0-444-63247-0.00005-5.'}, {'pmid': '25589273', 'type': 'BACKGROUND', 'citation': 'de Groat WC, Griffiths D, Yoshimura N. Neural control of the lower urinary tract. Compr Physiol. 2015 Jan;5(1):327-96. doi: 10.1002/cphy.c130056.'}, {'pmid': '33429090', 'type': 'BACKGROUND', 'citation': 'Sonmez R, Yildiz N, Alkan H. Efficacy of percutaneous and transcutaneous tibial nerve stimulation in women with idiopathic overactive bladder: A prospective randomised controlled trial. Ann Phys Rehabil Med. 2022 Jan;65(1):101486. doi: 10.1016/j.rehab.2021.101486. Epub 2021 Nov 11.'}, {'pmid': '37417565', 'type': 'BACKGROUND', 'citation': 'Yildiz N, Sonmez R. Transcutaneous medial plantar nerve stimulation in women with idiopathic overactive bladder. Investig Clin Urol. 2023 Jul;64(4):395-403. doi: 10.4111/icu.20230009.'}, {'pmid': '23610706', 'type': 'BACKGROUND', 'citation': 'Lee HE, Cho SY, Lee S, Kim M, Oh SJ. Short-term Effects of a Systematized Bladder Training Program for Idiopathic Overactive Bladder: A Prospective Study. Int Neurourol J. 2013 Mar;17(1):11-7. doi: 10.5213/inj.2013.17.1.11. Epub 2013 Mar 31.'}, {'pmid': '20458465', 'type': 'BACKGROUND', 'citation': 'Schreiner L, dos Santos TG, Knorst MR, da Silva Filho IG. Randomized trial of transcutaneous tibial nerve stimulation to treat urge urinary incontinence in older women. Int Urogynecol J. 2010 Sep;21(9):1065-70. doi: 10.1007/s00192-010-1165-6. Epub 2010 May 11.'}, {'pmid': '23206722', 'type': 'BACKGROUND', 'citation': 'Booth J, Hagen S, McClurg D, Norton C, MacInnes C, Collins B, Donaldson C, Tolson D. A feasibility study of transcutaneous posterior tibial nerve stimulation for bladder and bowel dysfunction in elderly adults in residential care. J Am Med Dir Assoc. 2013 Apr;14(4):270-4. doi: 10.1016/j.jamda.2012.10.021. Epub 2012 Nov 30.'}, {'pmid': '35593007', 'type': 'BACKGROUND', 'citation': 'Tezer T, Yildiz N, Sarsan A, Alkan H. Short-term effect of magnetic stimulation added to bladder training in women with idiopathic overactive bladder: A prospective randomized controlled trial. Neurourol Urodyn. 2022 Aug;41(6):1380-1389. doi: 10.1002/nau.24957. Epub 2022 May 20.'}, {'pmid': '24118165', 'type': 'BACKGROUND', 'citation': 'Yamanishi T, Homma Y, Nishizawa O, Yasuda K, Yokoyama O; SMN-X Study Group. Multicenter, randomized, sham-controlled study on the efficacy of magnetic stimulation for women with urgency urinary incontinence. Int J Urol. 2014 Apr;21(4):395-400. doi: 10.1111/iju.12289. Epub 2013 Oct 14.'}, {'pmid': '32960999', 'type': 'BACKGROUND', 'citation': 'Firinci S, Yildiz N, Alkan H, Aybek Z. Which combination is most effective in women with idiopathic overactive bladder, including bladder training, biofeedback, and electrical stimulation? A prospective randomized controlled trial. Neurourol Urodyn. 2020 Nov;39(8):2498-2508. doi: 10.1002/nau.24522. Epub 2020 Sep 22.'}, {'pmid': '15270937', 'type': 'BACKGROUND', 'citation': "O'Sullivan R, Karantanis E, Stevermuer TL, Allen W, Moore KH. Definition of mild, moderate and severe incontinence on the 24-hour pad test. BJOG. 2004 Aug;111(8):859-62. doi: 10.1111/j.1471-0528.2004.00211.x."}, {'type': 'BACKGROUND', 'citation': '19. Tarcan T, Mangır N, Özgür MÖ, Akbal C. OAB-V8 Overactive Bladder Questionnaire Validation Study. (Turkish) Üroloji Bülteni 2012;21:113-116. http://www.kontinansdernegi.org/userfiles/media/kontinans.galenos.com.tr/oab-v8-asiri-aktif-mesane-sorgulama-formu.pdf'}, {'pmid': '16527574', 'type': 'BACKGROUND', 'citation': 'Acquadro C, Kopp Z, Coyne KS, Corcos J, Tubaro A, Choo MS, Oh SJ. Translating overactive bladder questionnaires in 14 languages. Urology. 2006 Mar;67(3):536-40. doi: 10.1016/j.urology.2005.09.035.'}, {'pmid': '17083117', 'type': 'BACKGROUND', 'citation': 'Cam C, Sakalli M, Ay P, Cam M, Karateke A. Validation of the short forms of the incontinence impact questionnaire (IIQ-7) and the urogenital distress inventory (UDI-6) in a Turkish population. Neurourol Urodyn. 2007;26(1):129-33. doi: 10.1002/nau.20292.'}]}, 'descriptionModule': {'briefSummary': 'Our study is the first prospective randomized controlled trial that compares the effectiveness of transcutaneous medial plantar nerve stimulation (T-MPNS) and transcutaneous tibial nerve stimulation (TTNS) added to bladder training (BT) in women with idiopathic overactive bladder (OAB). İn this study, we aimed to assess the efficacy of T-MPNS and TTNS added to BT on quality of life (QoL) and clinical parameters asssociated with idiopathic OAB. In addition, preparation time for stimulation, treatment satisfaction and discomfort levels of the patients were evaluated.\n\nThe main questions we aim to answer are:\n\nIs T-MPNS as effective as TTNS in the treatment of idiopathic OAB? For this purpose, we planned to compare transcutaneous applications of the tibial and plantar medial nerve in women with idiopathic OAB. 60 women with OAB will be randomized to 3 groups by using random number generator: BT program alone to Group 1 (n=20), BT plus T-MPNS to Group 2 (n=20), BT plus TTNS to Group 3 (n=20) will be applied.', 'detailedDescription': 'The main questions we aim to answer are:\n\nIs T-MPNS as effective as TTNS in the treatment of idiopathic OAB? For this purpose, we planned to compare transcutaneous applications of the tibial and plantar medial nerve in women with idiopathic OAB. 60 women with OAB will be randomized to 3 groups by using random number generator: BT program alone to Group 1 (n=20), BT plus T-MPNS to Group 2 (n=20), BT plus TTNS to Group 3 (n=20) will be applied.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women over the age of 18 with clinical diagnosis of idiopathic OAB\n* Not tolerated or unresponsive to antimuscarinics and discontinued at least 4 weeks\n* Able to understand the procedures, advantages and possible side effects\n* Willing and able to complate the voiding diary and QoL questionnaire\n* The strength of PFM 3/5 and more\n\nExclusion Criteria:\n\n* Women with stress urinary incontinence\n* History of conservative therapy (BT, T-MPNS and TTNS/PTNS) within 6 months\n* Pregnancy or intention to become pregnant during the study\n* Current vulvovaginitis or urinary tract infections or malignancy\n* Anatomic or posttraumatic malformations/skin disorders of medial plantar/tibial nerve region on inner foot/ankle that cannot allow to apply the electrodes\n* More than stage 2 according to the pelvic organ prolapse quantification (POP-Q)\n* Cardiac pacemaker, implanted defibrillator\n* Previous urogyneceological surgery within 3 months\n* Neurogenic bladder, signs of neurologic abnormalities at objective examination; history of the peripheral or central neurologic pathology\n* Ultrasonographic evidence of PVR volume more than 100 ml'}, 'identificationModule': {'nctId': 'NCT06349694', 'briefTitle': 'Comparison of the Efficacy of Transcutaneos Nerve Stimulations in Women With Idiopathic Overactive Bladder', 'organization': {'class': 'OTHER', 'fullName': 'Pamukkale University'}, 'officialTitle': 'Comparison of the Efficacy of Transcutaneos Medial Plantar Nerve and Tibial Nerve Stimulation in Women With Idiopathic Overactive Bladder: A Prospective Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'PamukkaleU.ftr-NYıldız-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BT plus T-MPNS', 'description': 'T-MPNS sessions will be performed twice a week for 6 weeks. Each session will be lasted 30 minutes. The intervention will be included a 12-session BT plus T-MPNS treatment program', 'interventionNames': ['Other: Transcutaneous MPN stimulation (T-MPNS)']}, {'type': 'EXPERIMENTAL', 'label': 'BT plus TTNS', 'description': 'TTNS sessions will be performed twice a week for 6 weeks. Each session will be lasted 30 minutes. The intervention will be included a 12-session BT plus TTNS treatment program', 'interventionNames': ['Other: Transcutaneous tibial nerve stimulation (TTNS)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BT (Control group)', 'description': 'Information about BT will be explained to patients for 30 min. Then written form about BT will be given to be implemented as a home program.', 'interventionNames': ['Other: BT (Control group)']}], 'interventions': [{'name': 'Transcutaneous MPN stimulation (T-MPNS)', 'type': 'OTHER', 'description': 'Transcutaneous MPN stimulation (T-MPNS) is the electrostimulation of the lumbosacral roots that produce an activation of the lumbosacral plexus that controls the visceral organs and the pelvic floor muscles, thereby improving bladder control.', 'armGroupLabels': ['BT plus T-MPNS']}, {'name': 'Transcutaneous tibial nerve stimulation (TTNS)', 'type': 'OTHER', 'description': 'Transcutaneous tibial nerve stimulation (TTNS) is the electrostimulation of the lumbosacral roots that produce an activation of the lumbosacral plexus that controls the visceral organs and the pelvic floor muscles, thereby improving bladder control.', 'armGroupLabels': ['BT plus TTNS']}, {'name': 'BT (Control group)', 'type': 'OTHER', 'description': 'Conventional bladder training', 'armGroupLabels': ['BT (Control group)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Denizli', 'country': 'Turkey (Türkiye)', 'facility': 'Pamukkale University', 'geoPoint': {'lat': 37.77417, 'lon': 29.0875}}], 'centralContacts': [{'name': 'Rabia Melis Gündoğan, M.d', 'role': 'CONTACT', 'email': 'r.gundogan@gmail.com', 'phone': '+905544730153'}], 'overallOfficials': [{'name': 'Necmettin Yıldız, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pamukkale University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pamukkale University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Doctor', 'investigatorFullName': 'Necmettin Yildiz', 'investigatorAffiliation': 'Pamukkale University'}}}}