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

NCT ID: NCT06537544

Last Updated: 2025-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2025-01-10

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.

Conditions

Stress Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Conventional Pelvic Floor Training

Intervention Type: OTHER

Kegels exercises in different body positions

Comprehensive Rehabilitation Program

This group will receive Core Strengthening Exercises, Breathing Exercises and education along with Pelvic Floor Muscle Strengthening Exercises

Group Type: EXPERIMENTAL

Comprehensive Rehabilitation Program

Intervention Type: OTHER

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

Interventions

Comprehensive Rehabilitation Program

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

Intervention Type: OTHER

Conventional Pelvic Floor Training

Kegels exercises in different body positions

Intervention Type: OTHER

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Huma Riaz, PhD

Role: STUDY_CHAIR

Riphah International University, Islamabad, Pakistan

Shahzadi Safoora Shamail, DPT

Role: PRINCIPAL_INVESTIGATOR

Riphah International University, Islamabad, Pakistan

Locations

King Abdullah Teaching Hospital

Mansehra, KPK, Pakistan

Countries

Pakistan

Other Identifiers

Shahzadi Safoora Shamail

Identifier Type: -

Identifier Source: org_study_id