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Clinical Trials/NCT06537544
NCT06537544
Completed
N/A

Comparison of Comprehensive Rehabilitation Program and Conventional Pelvic Floor Training in Women With Stress Urinary Incontinence

Riphah International University1 site in 1 country62 target enrollmentAugust 1, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stress Urinary Incontinence
Sponsor
Riphah International University
Enrollment
62
Locations
1
Primary Endpoint
Severity of stress urinary incontinence
Status
Completed
Last Updated
last year

Overview

Brief Summary

The goal of this clinical trial is to compare a comprehensive rehabilitation program and a conventional pelvic floor training program in women with stress urinary incontinence,to compare the effects of comprehensive rehabilitation program and conventional pelvic floor training on the severity of SUI, on the strength of pelvic floor muscle and on quality of life in women with SUI. Following the randomization into either the conventional pelvic floor training or comprehensive rehabilitation program group, participants will receive their assigned interventions of three weekly sessions for eight weeks.

Detailed Description

The proposed study comparing the effects of conventional pelvic floor training versus a comprehensive rehabilitation program on stress urinary incontinence (SUI) among perimenopausal women holds significant rationale and importance. Given the prevalence and impact of SUI on the quality of life of perimenopausal women, investigating the comparative efficacy of these interventions is crucial for informing evidence-based clinical practice. The study aims to provide insights into the most effective management strategies for SUI in this population, potentially leading to improved treatment outcomes, enhanced quality of life, and reduced healthcare burden associated with this common condition. By addressing this research gap, the study has the potential to significantly benefit both individual patients and the broader healthcare system. This will be a randomized controlled trial. Non probability sampling technique will be used.The data collection procedure begins with the recruitment phase, potential participants meeting the study's criteria will be identified and provided with detailed information about the research aims and procedures. Once recruited, participants will undergo a screening process to confirm their eligibility, including assessments such as medical history reviews and diagnostic tests. After obtaining informed consent, baseline assessments will be conducted to establish the participants' initial status regarding urinary symptoms and quality of life. Following randomization into either the conventional pelvic floor training or comprehensive rehabilitation program group, participants will receive their assigned interventions of three weekly sessions for eight weeks.

Registry
clinicaltrials.gov
Start Date
August 1, 2024
End Date
January 10, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Perimenopausal and post-menopausal women
  • Age 40-60 years
  • Medically diagnosed patients of stress urinary incontinence

Exclusion Criteria

  • History of pelvic surgery within the past six months.
  • Current urinary tract infections or other active urinary tract disorders.
  • Neurological conditions affecting bladder control.
  • Inability to participate in the prescribed intervention due to physical or cognitive limitations.
  • Participation in other pelvic floor rehabilitation programs concurrently or previously within the last 6 months.

Outcomes

Primary Outcomes

Severity of stress urinary incontinence

Time Frame: Changes from Baseline to 8 weeks

To compare the effects of comprehensive rehabilitation program and conventional pelvic floor training on the severity of stress urinary incontinence

Secondary Outcomes

  • Strength of pelvic floor muscle(Changes from Baseline to 8 weeks)
  • Quality of life in women with stress urinary incontinence(Changes from Baseline to 8 weeks)

Study Sites (1)

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