- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07628322
Comparative Effects of Hypopressive Exercises and Paula Method in Postpartum Women.
Comparative Effects of Hypopressive Exercises and Paula Method on Urinary Incontinence, Pelvic Floor Muscle Strength and Quality of Life in Postpartum Women
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Stress urinary incontinence (SUI) is a prevalent pelvic floor disorder among postpartum women specially with multi-parity, significantly affecting their physical, psychological, and social well-being. Repeated vaginal deliveries can lead to pelvic floor muscle weakness, reduced support to pelvic organs, and impaired urinary control. Many non-invasive physical therapy strategies have gained popularity, particularly among women unable to effectively contract their pelvic floor muscles voluntarily. Two such techniques are Hypopressive Exercises and the Paula Method. Hypopressive exercises involve specific breathing patterns combined with postural adjustments that activate the pelvic floor through reflex mechanisms. In contrast, the Paula Method is based on the concept of muscular synergy among circular muscles. It utilizes rhythmic contractions of peripheral circular muscles (such as the eyes, lips, and sphincters) to stimulate the pelvic floor, making it especially beneficial for individuals with coordination issues or discomfort performing direct pelvic contractions.
This study will be a randomized clinical trial with a sample size of 60 postpartum females. The setting of the study will be Bilal Medicare, Sargodha. 60 postpartum women will be included based on age, parity, mode of delivery and type of urinary incontinence. Women with primary gravida, cesarean section and urge and mixed urinary incontinence will be excluded. This study aims to compare the effectiveness of Hypopressive Exercises and the Paula Method in improving urinary incontinence severity, pelvic floor muscle strength and quality of life in postpartum women. Patients of both groups receive two treatment sessions per week over an 8-week period. Group A will be given Hypopressive exercise and Group B will be given Paula exercise protocol. Both groups will perform a standardized kegel exercises for pelvic floor muscle activation and strengthening as baseline treatment followed by their assigned interventions. Outcome measures will include the International Consultation on Incontinence Questionnaire (ICIQ-UI SF), Modified Oxford Scale for muscle strength, and Incontinence Impact Questionnaire (IIQ-7) for QoL assessment. Data will be statistically analyzed using SPSS version 25.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Imran Amjad, PhD
- Phone Number: 03324390125
- Email: Imran.amjad@riphah.edu.pk
Study Locations
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Punjab Province
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Sargodha, Punjab Province, Pakistan, 40100
- Recruiting
- Bilal Medicare, Sargodha
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Principal Investigator:
- Khadeeja Cheema, MSWHPT
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
• Multipara women from 25-40 years
- Six weeks postpartum
- Vaginal delivery method
- Reported ≥1 episodes of urine leakage per week
- Diagnosed with SUI (ICIQ-UI SF ≥6)
Exclusion Criteria:
• No pelvic floor physiotherapy in last 6 months
- Patients with any medical and gynaecological risk factors and /or conditions
- Patients with any neurological problems, urinary tract infection, diabetes mellitus, hepatitis and ascites
- Pelvic surgery in last 6 months
- Mental or cognitive impairment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Hypopressive exercise
Group A will be given Hypopressive exercise
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(n=30) Each participant will receive treatment with hypopressive exercises for entire 08 weeks' intervention period.
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Experimental: Paula exercise
Group B will be given Paula exercise protocol.
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Each participant will receive treatment with the Paula method for entire 08 weeks' intervention period.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF)
Time Frame: 8 weeks
|
The ICIQ-UI SF is a standardized and internationally recognized tool for assessing the severity of urinary incontinence and its impact on quality of life.
It consists of 4 questions; frequency of leakage, amount of urine lost, overall impact on daily life and self-diagnostic items (non-scored).
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8 weeks
|
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Modified Oxford Grading Scale (Manual Muscle Testing of Pelvic Floor)
Time Frame: 8 weeks
|
This clinical scale is used to assess pelvic floor muscle strength through vaginal palpation, grading the strength from 0 (no contraction) to 5 (strong contraction).
It helps determine the baseline function and progress of pelvic floor rehabilitation.
The scale uses a single-item score ranging from 0 to 5, based on the therapist's tactile evaluation of the pelvic floor contraction.
Though subjective, its validity is supported through clinical correlation with manometric and EMG readings.
It is especially useful in low-resource settings where instrumentation is unavailable.
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8 weeks
|
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Urinary Incontinence Impact Questionnaire - 7 (UIQ-7)
Time Frame: 8 weeks
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The UIQ-7 is a subscale of the PFIQ-7 and is used to evaluate the impact of urinary incontinence on daily activities and social functioning.
It is especially useful for measuring the subjective burden of incontinence on the patient's life.
The UIQ-7 consists of 7 questions, each scored on a scale of 0 (not at all) to 3 (quite a bit), with a total score ranging from 0 to 21.
Higher scores indicate greater impact on quality of life.
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8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hafiza Iqra Rubab, MSWHPT, Riphah International University
Publications and helpful links
General Publications
- Li C, Li K. Effect of pelvic floor muscle exercise combined with infrared physiotherapy on postpartum urinary incontinence. Technol Health Care. 2025;33(1):225-234. doi: 10.3233/THC-240831.
- Sherif Mohamed MM, Hanafy HM, Awad MA, Samir SH. Effect of Hip Strengthening Exercises and Pelvic Floor Exercises on Stress Urinary Incontinence in Postnatal Women. Frontiers in Health Informatics. 2024;13(3).
- Mahmoud NSA. Effect of hypopressive exercises versus pelvic floor muscle exercises on stress urinary incontinence among multiparous women. Assiut Scientific Nursing Journal. 2023;11(40):162-74.
- Zhong R, Zeng L, Wang X, Wang Y. A retrospective study of risk factors for stress urinary incontinence 1 year after delivery in multiparous women. Int Urogynecol J. 2022 Aug;33(8):2275-2281. doi: 10.1007/s00192-021-04802-1. Epub 2021 May 4.
- Katz CMS, Barbosa CP. Effects of hypopressive exercises on pelvic floor and abdominal muscles in adult women: A systematic review of randomized clinical trials. J Bodyw Mov Ther. 2024 Jan;37:38-45. doi: 10.1016/j.jbmt.2023.03.003. Epub 2023 Aug 24.
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
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
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Urinary Incontinence
Other Study ID Numbers
- REC/PCR & AHS/25/0513
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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