Development And Evaluation Of Non – Invasive Biofeedback Device For The Pelvic Floor Muscle Training: An Exploratory Study
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Hitiksha Dedania
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- External observation method
Overview
Brief Summary
The pelvic floor muscles play a critical role in maintaining urinary continence, supporting pelvic viscera, and facilitating sexual function.
Dysfunction or weakness in these muscles can lead to a wide range of health issues, including urinary incontinence, pelvic organ prolapse, and sexual dysfunction. One promising approach to enhance the performance of the pelvic floor muscles is through the use of biofeedback devices. The electromyography (EMG) biofeedback device applied in clinical practice is not preferred by women with urinary incontinence because it is invasive, and involves the insertion of a probe into the vagina, causing pain. This research proposal aims at development of a non-invasive device that can provide feedback regarding the strength of pelvic floor muscles (PFM) contraction of the superficial layer of pelvic floor muscles.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- None
Eligibility Criteria
- Ages
- 45.00 Year(s) to 55.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Stress urinary incontinence symptoms Moderate symptom distress by the urogenital distress inventory (UDI 6).
- •Mild or moderately severe urinary incontinence as indicated by the (ICIQ-UI SF).
Exclusion Criteria
- •previous therapy or surgery for urinary incontinence urge incontinence, neurogenic urinary incontinence uncontrolled diabetes neurological abnormalities urinary tract infection previous therapy or surgery for urinary incontinence urge incontinence, neurogenic urinary incontinence uncontrolled diabetes neurological abnormalities urinary tract infection.
Outcomes
Primary Outcomes
External observation method
Time Frame: 0 day 30th day and 60th day
Secondary Outcomes
- Pelvic floor impact questionnaire (PFIQ – 7)(0 day 30th day and 60th day)
Investigators
Hitiksha Rasik Dedania
Parul University, (PhD - Marwadi University)