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EMG Biofeedback Based Pelvic Floor Training in Post Partum Women

R

Riphah International University

Status

Completed

Conditions

Urinary Incontinence

Treatments

Device: Electromographic Biofeedback
Other: PFM exercises

Study type

Interventional

Funder types

Other

Identifiers

NCT04687748
Rec/00836 Asma Jamshed

Details and patient eligibility

About

This study intends to determine the effects of Electromyographic biofeedback on performance of pelvic floor muscles in urinary incontinence.

Full description

This is a single blinded randomized controlled trial ,will be conducted at Ripha Rehab Clinic,Rawalpindi. (EMG) biofeddback is a adjunct therapy to standard exercise regime for increasing muscle strength,this study is planned to determine the effects of electromyographic biofeedback on performance of pelvic floor muscles, strength,endurance ,rate of biofeedback and its impact on the qulatiy of life (QOL).The sample size was calculated to be n=28 through open-epitool version 3 ,with 95%confidence interval (CI),and power 80%.

After completion of therapeutic protocols, the participant will be assessed with the help EMG-biofeedback, Pelvic Floor distress inventory, King's Health Questionnaire.

Enrollment

30 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Post-partum females
  • Persistent urinary leakage at 3 months post-partum period
  • Urine leakage with coughing, sneezing or exercise

Exclusion criteria

  • Neurogenic bladder
  • History of pelvic surgeries, pelvic tumors, UTI, urge incontinence, uncontrolled diabetes, cerebral stroke, previous injuries within pelvic

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

30 participants in 2 patient groups

EMG BF Group
Experimental group
Description:
Pelvic floor muscle contraction will be performed via an S-EMGBF device; patients in the s-EMGBF group will receive visual and auditory feedback.
Treatment:
Device: Electromographic Biofeedback
Control Group
Active Comparator group
Description:
Patients would be advised to maximally contract the pelvic floor muscles as forcefully a possible for about 5 seconds.
Treatment:
Other: PFM exercises

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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