Effect of Acupuncture Augmented With Pelvic Floor Exercises on Overactive Bladder

Overactive Bladder Syndrome Clinical Trial

Official title:

Effect of Pelvic Floor Exercises Versus Pelvic Floor Exercises and Acupuncture on Overactive Bladder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06088394
• Other study ID #: P.T.REC/012/004593
• Status: Recruiting
• Phase: N/A
• Start date: October 13, 2023
• Est. completion date: February 1, 2024

Study information

• Verified date: October 2023
• Source: Cairo University
• Contact: Rana Ahmed, Master
• Phone: 0201094761174
• Email: ranaahmedmohamed35[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 1, 2024
• Est. primary completion date: January 15, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 60 Years

Eligibility

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.

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.

Related Conditions & MeSH terms

• Overactive Bladder Syndrome
• Urinary Bladder, Overactive

Intervention

Device:
• Acupuncture
Participants will be asked to assume supine lying position on the plinth and the following points will be located then needles will be inserted: CV3,4 &5-40 mm needles at a depth of 1 cun perpendicular insertion. ST 25 bilaterally-40 mm needles at a depth of 1 cun oblique insertion. SP6 & 9, K13&7 bilaterally-25 mm needles at a depth of 0.5 cun perpendicular insertion. A total of 13 needles will be inserted at each session.

Other:
• pelvic floor exercises
pelvic floor muscle exercises can help strengthen pelvic floor muscle, which provides better control of urinary urgency by interfering with urethral-detrusor reflexes and inhibiting detrusor contractions

Locations

Country	Name	City	State
Egypt	Faculty of physical therapy	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	8 Items overative bladder questionnaire	: The OAB-V8 asks how bothered one is by the 4 hallmark symptoms of OAB: urinary frequency, urgency, nocturia, and urge incontinence Patients respond on a 6-point Likert scale ranging from 0 (not at all) to 5 (a very great deal), with a maximum possible score of 40. After completing the awareness tool, patients were asked to calculate their scores by adding their responses .	12 weeks
Other	3days bladder diary test	It consists of three sheets to be completed by the patient (one for each day) and one evaluation sheet to be completed by the clinician based on the interpretation of the three patient-completed sheets. The patient should record, on the daily sheet, the time they wake up and go to bed and the time and volume of every micturition.	12 weeks
Primary	Modified Oxford scale	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	12 weeks
Secondary	patient perception of intensity and urgency scale (PPIUS)	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	12 WEEKS