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Clinical Trials/CTRI/2024/11/076341
CTRI/2024/11/076341
Not yet recruiting
Phase 2

Effects of education, electrical stimulation and pelvic floor muscle exercise on strength,Quality of Life, Severity in female stress urinary incontinence

M L Ramya Krishna1 site in 1 country82 target enrollmentStarted: December 26, 2024Last updated:

Overview

Phase
Phase 2
Status
Not yet recruiting
Sponsor
M L Ramya Krishna
Enrollment
82
Locations
1
Primary Endpoint
Perineometer

Overview

Brief Summary

Urinary incontinence (UI) is a common condition that affects the quality of life (QoL) of women at different stages of life. To date, about 50% of UI cases are due to stress urinary incontinence (SUI)**.**The  overall  prevalence  of  UI  ranges  from  8-45% in  women  in different studies in india15,16.the prevalence of SUI  in  Indian females with age group of 18-32 was (25.8%)and age group of 33-48was (33.7%)17.Socioeconomic report demonstrates that across all EU countries, the estimated economic burden of UI was €69.1 billion in 202318. Adding Education, Electrical stimulation to PFMT makes any difference in terms of severity, strength, quality of life inconclusive and shows very low quality evidences and there is scarcity of the studies using individual electrical stimulation and Russian currents, and in other studies Russian current prompted to show positive results on muscle strength. Our hypothesis is to find out the effects of Education, Electrical stimulations, Exercises may improve the urinary leakage and pelvic floor muscle strength and QOL.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant Blinded

Eligibility Criteria

Ages
30.00 Year(s) to 50.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • SUI greater than 1 times per week, SUI symptoms, women were asked whether they leaked urine when they coughed, sneezed, laughed, or exercised or with physical exertion, such as lifting something heavy or moving furniture.

Exclusion Criteria

  • Pregnancy Post menopausal women Previous UI surgery, medications Known malignancy in lower abdomen Impaired bladder or sphincter function Macroscopic haematuria Inter menstrual bleedings Severe psychiatric disorders &Neurological diseases with affection on sensibility in legs or lower limb.

Outcomes

Primary Outcomes

Perineometer

Time Frame: 8th week

Kings health questionnaire

Time Frame: 8th week

1 hour pad test

Time Frame: 8th week

Secondary Outcomes

  • BMI(Age)

Investigators

Sponsor
M L Ramya Krishna
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

M L Ramya Krishna

Apollo Institute of Medical Science and Research

Study Sites (1)

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