Clinical trial NCT06537544: Comparison of Comprehensive Rehab Program and Pelvic Floor Training in Women With Stress Urinary Incontinence
Official title: Comparison of Comprehensive Rehabilitation Program and Conventional Pelvic Floor Training in Women With Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-08-05
Enrollment: 62
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Severity of stress urinary incontinence
timeFrame: Changes from Baseline to 8 weeks
Secondary outcomes:
measure: Strength of pelvic floor muscle
timeFrame: Changes from Baseline to 8 weeks
measure: Quality of life in women with stress urinary incontinence
timeFrame: Changes from Baseline to 8 weeks
Other outcomes:
Locations:
city: Mansehra
country: Pakistan
facility: King Abdullah Teaching Hospital
state: KPK
Study officials:
affiliation: Riphah International University, Islamabad, Pakistan
name: Huma Riaz, PhD
role: STUDY_CHAIR
affiliation: Riphah International University, Islamabad, Pakistan
name: Shahzadi Safoora Shamail, DPT
role: PRINCIPAL_INVESTIGATOR
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