NCT04959084

Brief Summary

This study will be directed to determine the effectiveness of laser acupuncture(LA) and pelvic floor training (PFT) on stress urinary incontinence (SUI) in obese postmenopausal women. Forty obese postmenopausal women will be selected , suffering from mild to moderate stress urinary incontinence from mild to moderate stress urinary incontinence, their age ranges from 50-65 years old and the body mass index (BMI) ≥ 30 ≤ 40 Kg/m2. then separate randomly into two equivalent gatherings. The study group (A) will receive laser acupuncture therapy and pelvic floor training for 30 min every other day for 12 sessions (3 times per week). While the control group (B) maintaining their ordinary medical treatment. All participants will be assessed the pelvic floor muscles strength by using Modified oxford grading scale and perineometer before starting intervention and at the end of the 12th session.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 13, 2021

Completed
19 days until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

July 13, 2021

Status Verified

July 1, 2021

Enrollment Period

4 months

First QC Date

June 28, 2021

Last Update Submit

July 1, 2021

Conditions

StressUrinaryIncontinence

Keywords

laser acupuncturepelvic floor trainingUrinary incontinencepostmenopausal

Outcome Measures

Primary Outcomes (1)

  • Change in the pelvic floor muscles strength

    Modified oxford grading scale (MOS) Via vaginal palpation, it was used to measure pelvic floor muscle strength. The strength of PFMS is graded on a scale of 0-5. subjective assessment

    4 weeks following the end of sessions

Study Arms (2)

Acupuncture

EXPERIMENTAL

Acupuncture group A , consisting of 20 women will be received laser acupuncture therapy and pelvic floor training every other day for 30 min , 3 times per week for 12 sessions

Other: Laser acupuncture therapy and pelvic floor training

Medical

NO INTERVENTION

Medical group B, consisting of 20 women will be maintained their ordinary medical treatment

Interventions

Laser acupuncture therapy and pelvic floor trainingOTHER

The laser will be applied directly to the skin over acupuncture points and each point receive a shoot of 65 seconds followed by Pelvic floor exercises for 15 min.

Acupuncture

Eligibility Criteria

Age50 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPostmenopausal women with mild to moderate stress urinary incontinence will be included in the study
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Forty obese postmenopausal women suffer from mild to moderate stress urinary incontinence
  • Their age ranges from 50-65 years old
  • The body mass index (BMI) ≥ 30 ≤ 40 Kg/m2.

You may not qualify if:

  • neuromuscular disorders
  • Lumbar disc prolapse
  • Gynaecological disorders
  • Pacemakers
  • Tumors
  • Dermatological conditions
  • Patient who take anticoagulant agents.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of physical therapy

Cairo, Egypt

Location

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Heba Embaby, Ph.D.

    Cairo University CU

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Heba Embaby, Ph.D.

CONTACT

00201003191889dr.hebaembaby@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor for physical therapy

Study Record Dates

First Submitted

June 28, 2021

First Posted

July 13, 2021

Study Start

August 1, 2021

Primary Completion

December 1, 2021

Study Completion

April 1, 2022

Last Updated

July 13, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)