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

NCT07628322 | Recruiting

• 1 other identifier: REC/PCR & AHS/25/0513
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Urinary Incontinence (UI)

Keywords

Urinary Incontinence; pelvic floor; muscle strength; Quality of life; postpartum women

Outcome Measures

Primary Outcomes (3)

• International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF)

  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).

  8 weeks

• Modified Oxford Grading Scale (Manual Muscle Testing of Pelvic Floor)

  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.

  8 weeks

• Urinary Incontinence Impact Questionnaire - 7 (UIQ-7)

  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.

  8 weeks

Study Arms (2)

Hypopressive exercise

ACTIVE COMPARATOR

Group A will be given Hypopressive exercise

Other: Hypopressive exercise

Paula exercise

EXPERIMENTAL

Group B will be given Paula exercise protocol.

Other: Paula exercise

Interventions

Hypopressive exercise OTHER

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

Hypopressive exercise

Paula exercise OTHER

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

Paula exercise

Eligibility Criteria

• Age: 25 Years - 40 Years
• Gender Eligibility Details: Multipara women from 25-40 years, Six weeks postpartum with Vaginal delivery method and Reported ≥1 episodes of urine leakage per week and Diagnosed with SUI (ICIQ-UI SF ≥6)
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Bilal Medicare, Sargodha

Sargodha, Punjab Province, 40100, Pakistan

RECRUITING

Related Publications (5)

• 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 BACKGROUND

• 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).

  BACKGROUND

• 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.

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hafiza Iqra Rubab, MSWHPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Amjad, PhD

CONTACT

03324390125; imran.amjad@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 5, 2026
• Study Start: October 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)