NCT07322328

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
0mo left

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress91%
Dec 2025May 2026

First Submitted

Initial submission to the registry

December 22, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

December 22, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 7, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 22, 2026

Last Updated

February 4, 2026

Status Verified

February 1, 2026

Enrollment Period

5 months

First QC Date

December 22, 2025

Last Update Submit

February 2, 2026

Conditions

Keywords

Post-partum stress urinary incontinenceHypopressive exercisesPelvic floor muscle trainingQuality of life

Outcome Measures

Primary Outcomes (1)

  • Symptoms severity

    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

    6 weeks

Secondary Outcomes (1)

  • Incontinence Quality of life

    6 weeks

Study Arms (2)

Hypopressive Exercises

EXPERIMENTAL

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.

Other: hypo-pressive exercise

Pelvic Floor Muscle Training

ACTIVE COMPARATOR

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.

Other: pelvic floor muscle training

Interventions

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).

Hypopressive Exercises

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.

Pelvic Floor Muscle Training

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspostpartum women
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Neurological disorder
  • Metabolic issue
  • Abdominal and pelvic surgery in previous years
  • Mentally retarded
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lahore University of Biological and Applied Sciences

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 22, 2025

First Posted

January 7, 2026

Study Start

December 22, 2025

Primary Completion (Estimated)

May 22, 2026

Study Completion (Estimated)

May 22, 2026

Last Updated

February 4, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

After the publication of the research

Shared Documents
STUDY PROTOCOL
Time Frame
July 2026- till any update

Locations