Effect of Acupuncture Augmented With Pelvic Floor Exercises on Overactive Bladder

NCT06088394 | Unknown

• 1 other identifier: P.T.REC/012/004593
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Overactive Bladder Syndrome

Keywords

pelvic floor exercises and acupuncture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• patient perception of intensity and urgency scale (PPIUS)

  12 WEEKS

Other Outcomes (2)

• 8 Items overative bladder questionnaire

  12 weeks

• 3days bladder diary test

  12 weeks

Study Arms (2)

The patients will do pelvic floor exercises and acupuncture

EXPERIMENTAL

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

Device: Acupuncture; Other: pelvic floor exercises

The patient will do pelvic floor exercises

EXPERIMENTAL

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.

Other: pelvic floor exercises

Interventions

Acupuncture DEVICE

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.

The patients will do pelvic floor exercises and acupuncture

pelvic floor exercises OTHER

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

The patient will do pelvic floor exercises; The patients will do pelvic floor exercises and acupuncture

Eligibility Criteria

• Age: 50 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of physical therapy

Giza, 12611, Egypt

RECRUITING

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• cairo U Egypt

  faculty of physical therapy

  STUDY CHAIR

Central Study Contacts

Rana Ahmed, Master

CONTACT

0201094761174; ranaahmedmohamed35@gmail.com

Rana Ahmed, Master

CONTACT

01094761174; ranaahmedmohamed35@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: random generator
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Model Details: pelvic floor exercises and acupuncture

Study Record Dates

• First Submitted: October 12, 2023
• First Posted: October 18, 2023
• Study Start: October 13, 2023
• Primary Completion: January 15, 2024
• Study Completion: February 1, 2024
• Last Updated: October 18, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)