NCT05845320

Brief Summary

Urinary incontinence (UI) is more common than any other chronic disease. Stress urinary incontinence (SUI), among the various forms of urinary incontinence, is the most prevalent (50%) type of this condition. Female urinary continence is maintained through an integrated function of pelvic floor muscles (PFMs), fascial structures, nerves, supporting ligaments, and the vagina. In women with SUI, the postural activity of the PFMs is delayed, and the balance ability is decreased. Many women, by learning the correct timing of a pelvic floor contraction during a cough, are able to eliminate consequent SUI. Timing is an important function of motor coordination and could be affected by proprioception. We aim to assess stress urinary incontinence in obese and non-obese Nulligravid females.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

April 26, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 6, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

May 14, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

May 30, 2023

Status Verified

May 1, 2023

Enrollment Period

7 months

First QC Date

April 26, 2023

Last Update Submit

May 26, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Prevalence of Stress Urinary Incontinence in Obese Versus Non-obese Nulligravid Women

    as detected by questionnaire score

    6 months

Study Arms (2)

Obese

BMI\>30

Other: ICIQ-UI SF questionnaire

Non-obesse

BMI\<25

Other: ICIQ-UI SF questionnaire

Interventions

validated arabic short form of ICIQ on urinary incontinence

Non-obesseObese

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

healthy nulligravid females

You may qualify if:

  • Women aged between18 and 45 years.
  • Non obese females with BMI \<25kg/m2.
  • Obese females with BMI ≥30kg/m2.
  • Nulligravid females.

You may not qualify if:

  • Multiparous Females
  • Patients with active urinary tract infection.
  • Patients with respiratory or neurological diseases.
  • Patients with communication problems, cognitive disorders \& mental disturbance.
  • Current treatment with drugs (benzodiazepines, diuretics)
  • Patients who underwent any previous abdominal or pelvic surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University maternity hospital

Cairo, Cairo/القاهرة, Egypt

RECRUITING

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

  • Maii Nawara, MD

    Associate professor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2023

First Posted

May 6, 2023

Study Start

May 14, 2023

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

May 30, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will share

all data will be available with principal investigator upon request

Locations