Effect of Acupuncture Augmented With Pelvic Floor Exercises on Overactive Bladder

NCT ID: NCT06088394

Last Updated: 2023-10-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-13
• Study Completion Date: 2024-02-01

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.

Conditions

Overactive Bladder Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Acupuncture

Intervention Type: 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.

pelvic floor exercises

Intervention Type: 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 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.

Group Type: EXPERIMENTAL

pelvic floor exercises

Intervention Type: 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

Interventions

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.

Intervention Type: DEVICE

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Rana Ahmed Elsayed

principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

cairo U Egypt

Role: STUDY_CHAIR

faculty of physical therapy

Locations

Faculty of physical therapy

Giza, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Rana Ahmed, Master

Role: CONTACT

ranaahmedmohamed35@gmail.com

0201094761174

Rana Ahmed, Master

Role: CONTACT

ranaahmedmohamed35@gmail.com

01094761174

Facility Contacts

Rana Ahmed, master

Role: primary

ranaahmedmohamed35@gmail.com

01094761174

Other Identifiers

P.T.REC/012/004593

Identifier Type: -

Identifier Source: org_study_id