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Completed

NCT Number: NCT06537544

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Comprehensive Rehabilitation Program

Other

Pelvic Floor Muscle Strengthening Exercises Core Strengthening Exercises Breathing Exercises Patient education about bladder diary Postural education

Conventional Pelvic Floor Training

Other

Kegels exercises in different body positions

Primary outcomes

  1. 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

  1. Strength of pelvic floor muscle

    Time frame: 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

  2. Quality of life in women with 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 quality of life in women with stress urinary incontinence

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 5, 2024
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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