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

March 4, 2025 updated by: Riphah International University

Comparison of Comprehensive Rehabilitation Program and Conventional 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • KPK
      • Mansehra, KPK, Pakistan, 21300
        • King Abdullah Teaching Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Other: Conventional Pelvic Floor Training
Kegels exercises in different body positions
Experimental: Comprehensive Rehabilitation Program
This group will receive Core Strengthening Exercises, Breathing Exercises and education along with Pelvic Floor Muscle Strengthening Exercises
Other: Comprehensive Rehabilitation Program
Pelvic Floor Muscle Strengthening Exercises Core Strengthening Exercises Breathing Exercises Patient education about bladder diary Postural education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Changes from Baseline to 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Changes from Baseline to 8 weeks
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
Changes from Baseline to 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Study Chair: Huma Riaz, PhD, Riphah International University, Islamabad, Pakistan
  • Principal Investigator: Shahzadi Safoora Shamail, DPT, Riphah International University, Islamabad, Pakistan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2024

Primary Completion (Actual)

January 10, 2025

Study Completion (Actual)

January 10, 2025

Study Registration Dates

First Submitted

July 27, 2024

First Submitted That Met QC Criteria

July 31, 2024

First Posted (Actual)

August 5, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 4, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Shahzadi Safoora Shamail

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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