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Clinical Trials/CTRI/2024/03/064728
CTRI/2024/03/064728
Not yet recruiting
Not Applicable

Changes in strength and endurance of pelvic floor muscles post a Pelvic Floor Muscle Training program using EMG biofeedback in middle-aged women with urinary incontinence in a tertiary care hospital- Pilot study

M S Ramaiah University of Applied Sciences1 site in 1 country32 target enrollmentStarted: March 31, 2024Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
M S Ramaiah University of Applied Sciences
Enrollment
32
Locations
1
Primary Endpoint
1.Pelvic floor muscle strength 2.Pelvic floor muscle endurance

Overview

Brief Summary

The prevalence and causes of incontinence have been reported extensively in the literature. However, there is a dearth of literature on conservative management of incontinence using advanced technology in a tertiary care center from India. It is also important to report the feasibility and acceptability of this intervention as it requires an extended center based follow up period. Evidence suggests that women between the age group of 41-50 years are most likely to experience urinary incontinence and can be managed conservatively.

Thus, this pilot study will help in analyzing objectively the effect of a structured pelvic floor muscle training program (PFMT) using EMG biofeedback on improving pelvic floor muscle strength and endurance in middle aged women with incontinence and report their acceptance and adherence to the program in a tertiary care center.

Middle aged women with incontinence referred by urologist or gynecologist or direct walk in to physiotherapy will be screened for the program. 32participants who meet the inclusion criteria with consent will be recruited in the study. Participants will undergo a pre and post assessment for symptoms and pelvic floor strength and endurance using a Perineometer. They will undergo a 3 months routine structured PFMT program incorporating patient education, pelvic floor exercise using biofeedback and home exercises. Acceptability and adherence of the program will be recorded. Patient interviews will be conducted to analyze the acceptability of the program and understand any challenges.

Study Design

Study Type
Interventional
Allocation
Na
Masking
None

Eligibility Criteria

Ages
40.00 Year(s) to 60.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • Middle aged women in the age group of 40-60 years
  • Symptomatic with urinary incontinence.

Exclusion Criteria

  • Untreated Urinary Tract Infection
  • Haematuria
  • Grade 3 or 4 pelvic organ prolapse
  • Pelvic surgeries in the past 6 months
  • Uncontrolled diabetes.

Outcomes

Primary Outcomes

1.Pelvic floor muscle strength 2.Pelvic floor muscle endurance

Time Frame: 1st assessment-Baseline | 2nd assessment after 3 months

Secondary Outcomes

  •  Quantitative measures-(1. Attendance rate- Number of sessions attended)

Investigators

Sponsor
M S Ramaiah University of Applied Sciences
Sponsor Class
Other [State Private University]
Responsible Party
Principal Investigator
Principal Investigator

Ms Kirti Joshi

M S Ramaiah College of Physiotherapy, M S Ramaiah University of applied sciences

Study Sites (1)

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