Recruiting NCT07628322

Comparative Effects of Hypopressive Exercises and Paula Method in Postpartum Women.

No phase Interventional Urinary Incontinence (UI)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Hypopressive exercise, Paula exercise.
Who it may be relevant to: Registry conditions: Urinary Incontinence (UI). Basic parameters: 25 years — 40 years · Female.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Pakistan
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Comparative Effects of Hypopressive Exercises and Paula Method on Urinary Incontinence, Pelvic Floor Muscle Strength and Quality of Life in Postpartum Women

Overview

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.

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.

Interventions

Other Hypopressive exercise
(n=30) Each participant will receive treatment with hypopressive exercises for entire 08 weeks' intervention period.
Other Paula exercise
Each participant will receive treatment with the Paula method for entire 08 weeks' intervention period.

Primary outcome measures

International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF) [Time frame: 8 weeks]
Modified Oxford Grading Scale (Manual Muscle Testing of Pelvic Floor) [Time frame: 8 weeks]
Urinary Incontinence Impact Questionnaire - 7 (UIQ-7) [Time frame: 8 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Double blind
Primary purpose: Treatment

Study locations

Pakistan · 1 center

Bilal Medicare, Sargodha — Sargodha

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. PMID 39302396
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. PMID 33944979
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. PMID 38432833

Identifiers

NCT: NCT07628322 · REC/PCR & AHS/25/0513

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗