Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07628322

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

25 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Bilal Medicare, Sargodha

Sargodha, Punjab Province, 40100, Pakistan

Location status: Recruiting

Location contact

Khadeeja Cheema, MSWHPT

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hypopressive exercise

Other

(n=30) Each participant will receive treatment with hypopressive exercises for entire 08 weeks' intervention period.

Paula exercise

Other

Each participant will receive treatment with the Paula method for entire 08 weeks' intervention period.

Primary outcomes

  1. 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).

  2. 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.

  3. Urinary Incontinence Impact Questionnaire - 7 (UIQ-7)

    Time frame: 8 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Imran Amjad, PhD

CONTACT

[email protected]

03324390125

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 5, 2026
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.