Effect of Acupuncture Augmented With Pelvic Floor Exercises on Overactive Bladder

Not Applicable

Recruiting

• Conditions: Overactive Bladder Syndrome
• Interventions: Device: Acupuncture; Other: pelvic floor exercises

• Registration Number: NCT06088394
• Lead Sponsor: Cairo University

Brief Summary

The aim of this study is to investigate the effect of pelvic floor exercises augmented with acupuncture on overactive bladder

Detailed Description

Overactive bladder syndrome (OAB) is a common complaint affecting 11.8% of the population. OAB is defined by the International Continence Society as "urinary urgency, usually accompanied by frequency and nocturia, with or without urgency urinary incontinence, in the absence of urinary tract infection or other obvious pathology."Urinary frequency accompanies OAB in 20%-25% of cases, and nocturia is present in 70%-75% of cases. Around one in three people with OAB also experience urinary incontinence. . OAB can be further categorized into "OAB-dry" (urinary incontinence is absent) and "OAB-wet" (urinary incontinence is present). 2 OAB is a long-term condition that reduces quality of life, leading to anxiety and depression and a negative effect on self-esteem.

Pelvic floor exercises and acupuncture play an important role in overactive bladder.This trial has 2 groupes ,one will recieve pelvic floor exercises augmented with acupuncture ,the second will recive pelvic floor exercises only for 12weeks.

Study Timeline

• Status Verified: 2023-10
• Study First Submitted: 2023-10-12
• Study First Submitted QC: 2023-10-12
• Last Update Submitted: 2023-10-12
• Study Start: 2023-10-13
• Study First Posted: 2023-10-18
• Last Update Posted: 2023-10-18
• Primary Completion: 2024-01-15
• Study Completion: 2024-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

Patients with a clinical diagnosis of idiopathic OAB syndrome. Willingness to take part in the study protocol. Ability to complete outcome measures. Ability to give informed consent. Acupuncture not contra-indicated. Age:50-60 years. Vaginal delivery.

-Parity:2-3times. Body mass index <35kg/m2.

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Exclusion Criteria

• • Evidence of other pathology that may be contributing to OAB symptoms i.e., urinary tract infection or a neurological condition.
• Smoking.
• Taking sedative and hypnotic drugs.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The patients will do pelvic floor exercises and acupuncture	pelvic floor exercises	The patients will perform pelvic floor exercises and acupuncture 3 times per week for 12 weeks
The patient will do pelvic floor exercises	pelvic floor exercises	The patient will perform pelvic floor exercises 3 times per week for 12 weeks. pelvic floor muscles exercises involves repetitive contraction and relaxation of the pelvic floor muscles in an attempt to strengthen the muscles . Each training session involved three training rounds and each round lasted for five minutes. Women will be instructed to perform PFMC and rest with 10min break between each round. They will be instructed to perform two to three sets of PFE repetitions per day, with 8-10 PFMC lasting for 10 s each set. All women will be asked to document their practice of PFE in PFE diary to assess their compliance.
The patients will do pelvic floor exercises and acupuncture	Acupuncture	The patients will perform pelvic floor exercises and acupuncture 3 times per week for 12 weeks

Primary Outcome Measures

Name	Time	Method
Modified Oxford scale	12 weeks	The scale ranges from 0 to 5 ranging from "no contraction" to "maximal contraction which is assessed by digital palpation using 1 to 2 fingers inserted into the vagina or rectum . This method is reliable to assess improvements in overall function and voluntary control of the PFM necessary for proper voiding

Secondary Outcome Measures

Name	Time	Method
patient perception of intensity and urgency scale (PPIUS)	12 WEEKS	A 5-point scale designed for measurement of both urinary urgency and urge incontinence. It has been incorporated into a micturition diary and has been used in OAB clinical trials

Trial Locations

Locations (1)

Faculty of physical therapy; 🇪🇬 Giza, Egypt