Miguel Martin-Garcia1, Jennifer Crampton2. 1. Physiotherapy Department, Liverpool Women's NHS Trust, Crown Street, Liverpool, L8 7SS, UK. Electronic address: miguel.martin-garcia@lwh.nhs.uk. 2. Department of Health Professions, Manchester Metropolitan University, Brooks Building, 53 Bonsall Street, Manchester, M15 6GX, UK. Electronic address: j.crampton@mmu.ac.uk.
Abstract
OBJECTIVES: To evaluate the effectiveness of transcutaneous tibial nerve stimulation (TTNS) compared to percutaneous tibial nerve stimulation (PTNS) in sustaining symptom improvement over a 6-month period in women with idiopathic Overactive Bladder (OAB) who had responded to an initial 12-week course of PTNS. DESIGN: Randomized, active-controlled trial. PARTICIPANTS: Twenty-four women diagnosed with idiopathic OAB successfully treated withPTNS were included in this study. INTERVENTIONS:Twelve subjects were allocated to receive monthly sessions of PTNS for six months, and twelve subjects followed a flexible home-based TTNS regime after instruction on the use of a TENS device for the same follow-up time. OUTCOMES: Participants were assessed at six weeks, three months and six months after completing the initial course of PTNS. Primary outcomes were changes from baseline in urinary frequency, number of episodes of urgency and number of episodes of urge urinary incontinence (UUI). Subjectively reported severity of symptoms and quality of life (QoL) were assessed using the validated OAB questionnaire (OAB-q). RESULTS:Urinary frequency, episodes of urinary urgency and episodes of UUI did not change significantly between baseline and six months in either group. Similarly, OAB-q scores for severity of symptoms and QoL were maintained within both arms for the duration of the study. There were no statistically significant differences between the groups in any of the outcome measures at any of the study points. CONCLUSION:TTNS is effective in the maintenance of symptom improvement in women with OAB who had positively responded to a course of 12 weekly PTNS sessions. The trial was registered in the Clinicaltrials.gov PRS database (Identifier: NCT02377765).
RCT Entities:
OBJECTIVES: To evaluate the effectiveness of transcutaneous tibial nerve stimulation (TTNS) compared to percutaneous tibial nerve stimulation (PTNS) in sustaining symptom improvement over a 6-month period in women with idiopathic Overactive Bladder (OAB) who had responded to an initial 12-week course of PTNS. DESIGN: Randomized, active-controlled trial. PARTICIPANTS: Twenty-four women diagnosed with idiopathic OAB successfully treated with PTNS were included in this study. INTERVENTIONS: Twelve subjects were allocated to receive monthly sessions of PTNS for six months, and twelve subjects followed a flexible home-based TTNS regime after instruction on the use of a TENS device for the same follow-up time. OUTCOMES: Participants were assessed at six weeks, three months and six months after completing the initial course of PTNS. Primary outcomes were changes from baseline in urinary frequency, number of episodes of urgency and number of episodes of urge urinary incontinence (UUI). Subjectively reported severity of symptoms and quality of life (QoL) were assessed using the validated OAB questionnaire (OAB-q). RESULTS: Urinary frequency, episodes of urinary urgency and episodes of UUI did not change significantly between baseline and six months in either group. Similarly, OAB-q scores for severity of symptoms and QoL were maintained within both arms for the duration of the study. There were no statistically significant differences between the groups in any of the outcome measures at any of the study points. CONCLUSION:TTNS is effective in the maintenance of symptom improvement in women with OAB who had positively responded to a course of 12 weekly PTNS sessions. The trial was registered in the Clinicaltrials.gov PRS database (Identifier: NCT02377765).
Authors: Ciara M E Daly; Lynette Loi; Jo Booth; Dalia Saidan; Karen Guerrero; Veenu Tyagi Journal: BMC Womens Health Date: 2021-10-27 Impact factor: 2.809