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

NCT06537544 | Completed

• 1 other identifier: Shahzadi Safoora Shamail
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• Severity of stress urinary incontinence

  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 Outcomes (2)

• 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 Arms (2)

Conventional Pelvic Floor Training

ACTIVE COMPARATOR

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

Comprehensive Rehabilitation Program

EXPERIMENTAL

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

Other: Comprehensive Rehabilitation Program

Interventions

Comprehensive Rehabilitation Program OTHER

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

Comprehensive Rehabilitation Program

Conventional Pelvic Floor Training OTHER

Kegels exercises in different body positions

Conventional Pelvic Floor Training

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

King Abdullah Teaching Hospital

Mansehra, KPK, 21300, Pakistan

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Huma Riaz, PhD

  Riphah International University, Islamabad, Pakistan

  STUDY CHAIR

• Shahzadi Safoora Shamail, DPT

  Riphah International University, Islamabad, Pakistan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2024
• First Posted: August 5, 2024
• Study Start: August 1, 2024
• Primary Completion: January 10, 2025
• Study Completion: January 10, 2025
• Last Updated: March 5, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)