search
Back to results

Effect of Acupuncture Augmented With Pelvic Floor Exercises on Overactive Bladder

Primary Purpose

Overactive Bladder Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Acupuncture
pelvic floor exercises
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder Syndrome focused on measuring pelvic floor exercises and acupuncture

Eligibility Criteria

50 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of physical therapyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

The patients will do pelvic floor exercises and acupuncture

The patient will do pelvic floor exercises

Arm Description

The patients will perform pelvic floor exercises and acupuncture 3 times per week for 12 weeks

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 12, 2023
Last Updated
October 12, 2023
Sponsor
Cairo University
search

1. Study Identification

Unique Protocol Identification Number
NCT06088394
Brief Title
Effect of Acupuncture Augmented With Pelvic Floor Exercises on Overactive Bladder
Official Title
Effect of Pelvic Floor Exercises Versus Pelvic Floor Exercises and Acupuncture on Overactive Bladder
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 13, 2023 (Anticipated)
Primary Completion Date
January 15, 2024 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder Syndrome
Keywords
pelvic floor exercises and acupuncture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
pelvic floor exercises and acupuncture
Masking
Participant
Masking Description
random generator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
The patients will do pelvic floor exercises and acupuncture
Arm Type
Experimental
Arm Description
The patients will perform pelvic floor exercises and acupuncture 3 times per week for 12 weeks
Arm Title
The patient will do pelvic floor exercises
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Acupuncture
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
pelvic floor exercises
Intervention Description
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
Primary Outcome Measure Information:
Title
Modified Oxford scale
Description
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
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
patient perception of intensity and urgency scale (PPIUS)
Description
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
Time Frame
12 WEEKS
Other Pre-specified Outcome Measures:
Title
8 Items overative bladder questionnaire
Description
: 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 .
Time Frame
12 weeks
Title
3days bladder diary test
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rana Ahmed, Master
Phone
0201094761174
Email
ranaahmedmohamed35@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Rana Ahmed, Master
Phone
01094761174
Email
ranaahmedmohamed35@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
cairo U Egypt
Organizational Affiliation
faculty of physical therapy
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of physical therapy
City
Giza
ZIP/Postal Code
12611
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rana Ahmed, master
Phone
01094761174
Email
ranaahmedmohamed35@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Effect of Acupuncture Augmented With Pelvic Floor Exercises on Overactive Bladder

We'll reach out to this number within 24 hrs