Acupuncture for overactive bladder in adults: Study protocol for a randomized controlled trial

Background: Overactive bladder (OAB) is a prevalent condition that substantially degrades patient quality of life. Acupuncture is recognized as an effective therapeutic approach for various urological diseases. However, there is limited evidence validating the effectiveness and safety of acupuncture...

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Main Authors: Fengqin Cao, Diyuan Ma, Yueying Chen, Qiongqiong Liu, Ran Pang
Format: Article
Language:English
Published: Elsevier 2024-10-01
Series:Journal of Traditional Chinese Medical Sciences
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Online Access:http://www.sciencedirect.com/science/article/pii/S2095754824000681
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author Fengqin Cao
Diyuan Ma
Yueying Chen
Qiongqiong Liu
Ran Pang
author_facet Fengqin Cao
Diyuan Ma
Yueying Chen
Qiongqiong Liu
Ran Pang
author_sort Fengqin Cao
collection DOAJ
description Background: Overactive bladder (OAB) is a prevalent condition that substantially degrades patient quality of life. Acupuncture is recognized as an effective therapeutic approach for various urological diseases. However, there is limited evidence validating the effectiveness and safety of acupuncture for OABs. Objective: To assess the therapeutic efficacy of acupuncture for OAB and to investigate the potential mechanisms by analyzing its effects on relevant urinary biomarkers. Methods: This is a randomized, participants and outcome assessors blinded, sham acupuncture controlled trial. A total of 110 patients with OABs will be randomly divided in a 1:1 ratio between the acupuncture and sham acupuncture groups. Participants in the acupuncture group will undergo 30-min authentic acupuncture, while their counterparts in the sham acupuncture group will undergo sham acupuncture needling non-acupoints superficially three times weekly for a duration of 8 weeks. The two co-primary outcomes will be the change in the mean number of micturitions per 24 h from baseline to the end of the 8-week treatment and 20-week follow-up. The secondary outcomes will encompass the change in Overactive Bladder Symptom Score, Overactive Bladder Questionnaire Short Form, and average 24 h values of urgency, daytime micturition, nocturia, and mean volume voided per micturition from baseline to weeks 8 and 20. Urinary nerve growth factor, brain-derived neurotrophic factor, and monocyte chemoattractant protein-1 levels will be measured at baseline and week 8. Adverse events will also be documented. Discussion: The results of this trial will provide evidence for the effectiveness and safety of acupuncture in the management of OAB.
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spelling doaj-art-121ba02cbcd247c8b4b17e71f94705772025-08-20T01:54:15ZengElsevierJournal of Traditional Chinese Medical Sciences2095-75482024-10-0111442843410.1016/j.jtcms.2024.09.002Acupuncture for overactive bladder in adults: Study protocol for a randomized controlled trialFengqin Cao0Diyuan Ma1Yueying Chen2Qiongqiong Liu3Ran Pang4Graduate School, Beijing University of Chinese Medicine, Beijing, 100029, China; Department of Urology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, ChinaDepartment of Urology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, ChinaGraduate School, Beijing University of Chinese Medicine, Beijing, 100029, China; Department of Urology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, ChinaGraduate School, Beijing University of Chinese Medicine, Beijing, 100029, China; Department of Urology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, ChinaDepartment of Urology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China; Corresponding author.Background: Overactive bladder (OAB) is a prevalent condition that substantially degrades patient quality of life. Acupuncture is recognized as an effective therapeutic approach for various urological diseases. However, there is limited evidence validating the effectiveness and safety of acupuncture for OABs. Objective: To assess the therapeutic efficacy of acupuncture for OAB and to investigate the potential mechanisms by analyzing its effects on relevant urinary biomarkers. Methods: This is a randomized, participants and outcome assessors blinded, sham acupuncture controlled trial. A total of 110 patients with OABs will be randomly divided in a 1:1 ratio between the acupuncture and sham acupuncture groups. Participants in the acupuncture group will undergo 30-min authentic acupuncture, while their counterparts in the sham acupuncture group will undergo sham acupuncture needling non-acupoints superficially three times weekly for a duration of 8 weeks. The two co-primary outcomes will be the change in the mean number of micturitions per 24 h from baseline to the end of the 8-week treatment and 20-week follow-up. The secondary outcomes will encompass the change in Overactive Bladder Symptom Score, Overactive Bladder Questionnaire Short Form, and average 24 h values of urgency, daytime micturition, nocturia, and mean volume voided per micturition from baseline to weeks 8 and 20. Urinary nerve growth factor, brain-derived neurotrophic factor, and monocyte chemoattractant protein-1 levels will be measured at baseline and week 8. Adverse events will also be documented. Discussion: The results of this trial will provide evidence for the effectiveness and safety of acupuncture in the management of OAB.http://www.sciencedirect.com/science/article/pii/S2095754824000681Overactive bladderAcupunctureRandomized controlled trialNerve growth factorBrain-derived neurotrophic factorMonocyte chemoattractant protein-1
spellingShingle Fengqin Cao
Diyuan Ma
Yueying Chen
Qiongqiong Liu
Ran Pang
Acupuncture for overactive bladder in adults: Study protocol for a randomized controlled trial
Journal of Traditional Chinese Medical Sciences
Overactive bladder
Acupuncture
Randomized controlled trial
Nerve growth factor
Brain-derived neurotrophic factor
Monocyte chemoattractant protein-1
title Acupuncture for overactive bladder in adults: Study protocol for a randomized controlled trial
title_full Acupuncture for overactive bladder in adults: Study protocol for a randomized controlled trial
title_fullStr Acupuncture for overactive bladder in adults: Study protocol for a randomized controlled trial
title_full_unstemmed Acupuncture for overactive bladder in adults: Study protocol for a randomized controlled trial
title_short Acupuncture for overactive bladder in adults: Study protocol for a randomized controlled trial
title_sort acupuncture for overactive bladder in adults study protocol for a randomized controlled trial
topic Overactive bladder
Acupuncture
Randomized controlled trial
Nerve growth factor
Brain-derived neurotrophic factor
Monocyte chemoattractant protein-1
url http://www.sciencedirect.com/science/article/pii/S2095754824000681
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