NCT06653582

Brief Summary

The purpose of the study is to evaluate the effects of postural reeducation compared to pelvic floor muscle training on urinary incontinence (UI) symptoms, the impact of UI, and quality of life (QoL) in women experiencing stress urinary incontinence (SUI)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

October 19, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 22, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

October 25, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2025

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

February 21, 2025

Status Verified

February 1, 2025

Enrollment Period

3 months

First QC Date

October 19, 2024

Last Update Submit

February 20, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Urinary incontinence (UI) symptoms

    UI symptoms will be measured using a 48-hour Pad Test \[14\]. This is a standardized test for assessing urine leakage that can be performed at home\[15\]. Women replace pads as needed over the course of 48 hours. The results are calculated by subtracting the net weight of used pads from the total weight of non-used pads. The Pad Test results can be classified as mild (4-20 g), moderate (21-74 g), or severe UI (\> 75 g).

    12 weeks

  • Urinary incontinence (UI) impact

    It will be assessed using the International Consultation Incontinence Short-Form (ICIQ-UI-SF). UI impact will be derived from the values of the third question assessing overall impact ("How much does leaking urine interfere with everyday life?", ranging from 0 to 10), with a higher score indicating a greater UI impact.

    12 weeks

Secondary Outcomes (1)

  • Urinary incontinence-Quality of life (UI-QoL)

    12 weeks

Study Arms (2)

Postural reeducation

EXPERIMENTAL

They will receive a program of postural reeducation with a home program for 12 weeks.

Other: Postural reeducation

Pelvic floor exercises

EXPERIMENTAL

They will receive a program of pelvic floor exercises with a home program for 12 weeks.

Other: Pelvic floor exercises

Interventions

The program will include postural awareness, stretching, McKenzie's method, and manual therapy for 12 weeks.

Postural reeducation

The program will include pelvic floor exercises for 12 weeks. Three sets of 10 long contractions will be performed, each sustained for 6-8 seconds, three times a day. After each contraction, participants will be asked to rest for the same period. Two series of 10 fast contractions will be recommended, consisting of short, quick exercises of 1- to 2-second contractions, followed by long, sustained exercises lasting 5-10 seconds.

Pelvic floor exercises

Eligibility Criteria

Age30 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Fifty females with stress urinary incontinence.
  • Age of 30-40 years.
  • Body mass index (BMI) \> 30 kg/m2

You may not qualify if:

  • Genital prolapse grade 3 or 4 based on Pelvic Organ Prolapse Quantification Classification (POP-Q).
  • Overactive bladder (OAB)
  • Functional impairment (Barthel scale \<85 points).
  • Neurological or cognitive impairment (mini mental examination \<24 points).
  • Any other type of urinary incontinence.
  • Pregnancy.
  • History of spinal, hip, knee or foot surgery, pelvic and abdominal surgery (including cesarean section)
  • Smoking, chronic cough, history of respiratory diseases, osteoporosis (self-reported).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of physical therapy, MUST University

Giza, Egypt

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 Officials

  • Sally Mohamed Saeed, PhD

    Lecturer, MUST university

    PRINCIPAL INVESTIGATOR
  • Malak Adel Elmahdy, PhD

    Lecturer, Al Hayah university

    PRINCIPAL INVESTIGATOR

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
Principal Investigator

Study Record Dates

First Submitted

October 19, 2024

First Posted

October 22, 2024

Study Start

October 25, 2024

Primary Completion

January 25, 2025

Study Completion

February 1, 2025

Last Updated

February 21, 2025

Record last verified: 2025-02

Locations