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

Not Applicable

Recruiting

• Conditions: Stress Urinary Incontinence
• Interventions: Other: Conventional Pelvic Floor Training; Other: Comprehensive Rehabilitation Program

• Registration Number: NCT06537544
• Lead Sponsor: Riphah International University

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.

Study Timeline

• Study First Submitted: 2024-07-27
• Study First Submitted QC: 2024-07-31
• Status Verified: 2024-08
• Study Start: 2024-08-01
• Study First Posted: 2024-08-05
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-14
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 62

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Pelvic Floor Training	Conventional Pelvic Floor Training	This group will receive pelvic floor muscle training exercises in supine, sitting , kneeling and standing position with gradual increase in frequency, dosage and duration of exercises.
Comprehensive Rehabilitation Program	Comprehensive Rehabilitation Program	This group will receive Core Strengthening Exercises, Breathing Exercises and education along with Pelvic Floor Muscle Strengthening Exercises

Primary Outcome Measures

Name	Time	Method
Severity of stress urinary incontinence	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 Outcome Measures

Name	Time	Method
Strength of pelvic floor muscle	Changes from Baseline to 8 weeks	To compare the effects of comprehensive rehabilitation program and conventional pelvic floor training on the strength of pelvic floor muscle
Quality of life in women with stress urinary incontinence	Changes from Baseline to 8 weeks	To compare the effects of comprehensive rehabilitation program and conventional pelvic floor training on quality of life in women with stress urinary incontinence

Trial Locations

Locations (1)

King Abdullah Teaching Hospital; 🇵🇰 Mansehra, KPK, Pakistan