NCT06576791

Brief Summary

Stress urinary incontinence (SUI) occur secondary to increased intra abdominal pressure, that directed the researchers to study the mechanical changes in urethra and bladder that associated with it. However, these urethral mechanical changes may be related to other mechanical changes in the body.

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 all trials

Timeline
Completed

Started Sep 2021

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 4, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2022

Completed
1.9 years until next milestone

First Posted

Study publicly available on registry

August 29, 2024

Completed
Last Updated

December 19, 2024

Status Verified

June 1, 2024

Enrollment Period

3 months

First QC Date

September 19, 2022

Last Update Submit

December 16, 2024

Conditions

Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (2)

  • 1- Measuring urethral rotation angles by transperineally ultrasound TPUS

    TPUS was performed using a Toshiba US machine with a 3.5 MHz electronic micro convex array probe. The bladder was comfortably partially filled with urine (about 150 mL).

    3 months

  • 2- foot pronation

    drop test

    3 months

Secondary Outcomes (1)

  • weight

    3 months

Eligibility Criteria

Age40 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

ll participants were assessed for their eligibility to participate in the study if they multiparous vaginal delivery women experienced more than one delivery with average three deliveries.

You may qualify if:

  • multiparous vaginal delivery women
  • experienced more than one delivery.

You may not qualify if:

  • urinary tract infection
  • any previous genitourinary surgery
  • congenital bone deformities, pelvic organ prolapse
  • taking any drugs for treating SUI
  • any hormonal replacement therapy
  • residual urine more than 150cc
  • history of lung diseases associated with chronic coughs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rovan Elbesh

Giza, 12651, 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 Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

September 19, 2022

First Posted

August 29, 2024

Study Start

September 4, 2021

Primary Completion

December 1, 2021

Study Completion

January 1, 2022

Last Updated

December 19, 2024

Record last verified: 2024-06

Locations

EG(1)