- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07322328
Effect of Hypo-pressive Exercises and Pelvic Floor Muscle Training in Postpartum Stress Urinary Incontinence Women (SUI PFMT HE)
Effects of Hypo-pressive Exercises and Pelvic Floor Muscle Training on the Severity of Stress Urinary Incontinence and Quality of Life in Postpartum Women
Postpartum stress urinary incontinence is a widespread condition characterized by involuntary loss of urine during physical exertion, such as sneezing, coughing, or lifting heavy weights. Most frequently occur in multiparous women with vaginal delivery, who are obese, constipated, or with low maternal education. Damage to the levator ani muscle complex and adjacent fascia during childbirth affects urethral mobility and consequently results in sphincter insufficiency.
Hypopressive exercises involve breathing techniques that regulate the intra-abdominal pressure. HE has been recently recognized for benefits such as pelvic floor muscle (PFM) strength, endurance, postural control, core muscle activation, and respiratory capacity, which efficiently improve symptom severity and quality of life in postpartum women.
Pelvic floor muscle training (PFMT) is a set of frequent voluntary contractions designed to improve strength, coordination, and control. PFMT is considered as standard treatment protocol for urinary incontinence and other postpartum complications.
The International Consultation on Incontinence Questionnaire-Short Form (ICIQ-UI-SF) and the Incontinence Quality of Life (IQOL) are used to assess symptom severity and quality of life, respectively. This study seeks to bridge that gap by evaluating and comparing the outcomes of HE and PFMT in postpartum women experiencing SUI. This research aims to support postpartum recovery, improve women's daily functioning, and enhance their overall well-being.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab Province
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Lahore, Punjab Province, Pakistan, 54000
- Lahore University of Biological and Applied Sciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Women aged between 20 and 40 years old
- Multiparous women
- Postpartum women ≤ 6 months.
- Vaginal deliveries.
- Women diagnosed with stress urinary incontinence within 6 weeks to six months
Exclusion Criteria:
- Neurological disorder
- Metabolic issue
- Abdominal and pelvic surgery in previous years
- Mentally retarded
- Pregnant women
Study Plan
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 |
|---|---|
|
Experimental: Hypopressive Exercises
Hypo-pressive Exercise (HE) training involves ribcage expansion and apnea to generate negative pressure, which in turn activates the deep core and pelvic floor muscles instinctively.
Activating type I muscle fibers improves postural control, endurance, and coordination.
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Exercise is performed 3 times per week for 6 weeks with moderate intensity for 20 min/session which includes diaphragmatic breathing, apnea, postural alignment (standing, seated, kneeling), and pelvic floor co-activation).
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Active Comparator: Pelvic Floor Muscle Training
Pelvic Floor Muscle Training (PFMT) through voluntary contraction and resistance training strengthens pelvic floor musculature.
In addition, these exercises have the potential to improve control over urine and fecal incontinence.
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Exercise is performed 3 times per week for 6 weeks with submaximal voluntary contraction (include both slow holds and quick flicks) for 20 min/session (each session includes multiple sets of 8 repetitions, hold for 5 seconds, with rest intervals).
These Kegel exercises are performed in different positions.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Symptoms severity
Time Frame: 6 weeks
|
Symptom severity due to SUI will assessed by International Consultation on Incontinence Questionnaire Urinary Incontinence short form (ICIQUI-SF) is a standardized, validated, self-administered questionnaire used to assess the severity of urinary incontinence (UI), influence quality of life, and situational triggers of leakage.
It consists of four items: frequency of urine leakage, amount of urine leakage, overall impact of UI on daily life (rated on a 0-10 scale), and a self-diagnostic item asking when urine leaks (non-scored).
The ICIQ-UI-SF showed a Cronbach's alpha value from 0.7 to 0.8, representing good internal consistency
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6 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Incontinence Quality of life
Time Frame: 6 weeks
|
Incontinence Quality of life (I-QOL) is a self-assessment tool that is repeatedly utilized in people with UI.
The 22-item I-QOL has three subscales: social embarrassment (SE), psychosocial impact (PSI), and avoidance and limiting behaviors (ALB).
It based on Likert scale which comprises of five point, i.e. 1=always, 2=often, 3=sometimes, 4=rarely and 5=never.
The IQOL showed a Cronbach's alpha value was 0.96, representing good internal consistency.
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6 weeks
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Male Urogenital Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urination Disorders
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Urinary Incontinence
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Urinary Incontinence, Stress
Other Study ID Numbers
- DPT/ERB/29
- U1111-1332-3272 (Registry Identifier: Isma Habib)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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