Effect of Acupuncture Augmented With Pelvic Floor Exercises on Overactive Bladder
Effect of Pelvic Floor Exercises Versus Pelvic Floor Exercises and Acupuncture on Overactive Bladder
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Rana Ahmed, Master
- Phone Number: 0201094761174
- Email: ranaahmedmohamed35@gmail.com
Study Contact Backup
- Name: Rana Ahmed, master
- Phone Number: 01094761174
- Email: ranaahmedmohamed35@gmail.com
Study Locations
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Giza, Egypt, 12611
- Recruiting
- Faculty of Physical Therapy
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Contact:
- Rana Ahmed, master
- Phone Number: 01094761174
- Email: ranaahmedmohamed35@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: The patients will do pelvic floor exercises and acupuncture
The patients will perform pelvic floor exercises and acupuncture 3 times per week for 12 weeks
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Participants will be asked to assume supine lying position on the plinth and the following points will be located then needles will be inserted:
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
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Experimental: The patient will do 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. |
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Modified Oxford scale
Time Frame: 12 weeks
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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
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
patient perception of intensity and urgency scale (PPIUS)
Time Frame: 12 WEEKS
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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
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12 WEEKS
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
8 Items overative bladder questionnaire
Time Frame: 12 weeks
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: 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 .
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12 weeks
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3days bladder diary test
Time Frame: 12 weeks
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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.
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12 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: cairo U Egypt, Faculty of Physical Therapy
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/004593
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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