Evaluation of Transperineal US in Stress Incontinence

August 4, 2019 updated by: Mahmoud Alalfy, Aljazeera Hospital

Evaluation of Role of Transperineal US in Differentiating Degrees of Genuine Stress Incontinence in Females Diagnosed by Urodynamics

Stress urinary incontinence (SUI) has an observed prevalence of between 4%and 35%.Identified risk factors are aging, obesity and repeated pregnancies and deliveries.

Urodynamic remains the gold standard for diagnosis in the past years. Trans labial ultrasound appears to have a good role in diagnosing stress incontinence

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

A comparative observational cross sectional study will be conducted .

The symptom, or "subjective indicator of disease," of SUI is described as "the complaint of involuntary leakage on effort or exertion, or on sneezing or coughing." 1 Stress urinary incontinence (SUI) has an observed prevalence of between 4% and 35%.

It's a social problem that causes hygienic problem that s distressing for females.

Urodynamic study is the gold standard for diagnosis of most types of urinary incontinence with some limitations as it's not done routinely in all cases of urinary incontinence according to the NICE guidelines 2 Translabial ultrasound is a simple, noninvasive, available, and reproducible method for qualitative and quantitative evaluation of the lower urinary tract in females.

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
      • Giza, Egypt
        • Recruiting
        • Algazeerah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

females who are complaining from stress incontinence that did urodynamics study and proved to have a genuine stress incontinence and referred to do transperineal ultrasound

Description

Inclusion Criteria:

females between 20-75 years old

  • -Women diagnosed to have genuine stress urinary incontinence diagnosed by history taking, voiding diary and confirmed by urodynamic.

Exclusion Criteria:

  • -Known to be Diabetic
  • Urge incontinence or mixed type
  • Voiding dysfunction
  • Neurological problems
  • open suprapubic wound
  • Previous surgery for POP(pelvic organ prolapse) or incontinence
  • suspicion of pelvic malignancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of participants who will be properly diagnosed to have genuine stress incontinence To determine the role of transperineal ultrasound in diagnosing stress incontinence
Time Frame: within a week
the outcome describes how much the transperineal us have a power to diagnose stress incontinence in comparison to urodynamic study
within a week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aljazeera Hospital

Collaborators

Kasr El Aini Hospital

Investigators

  • Study Chair: Mahmoud Alalfy, M.s.c, Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 16, 2018

Primary Completion (Anticipated)

November 2, 2019

Study Completion (Anticipated)

December 8, 2019

Study Registration Dates

First Submitted

January 5, 2018

First Submitted That Met QC Criteria

January 10, 2018

First Posted (Actual)

January 12, 2018

Study Record Updates

Last Update Posted (Actual)

August 6, 2019

Last Update Submitted That Met QC Criteria

August 4, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • stress incontinence

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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