Evaluation of Transperineal US in Stress Incontinence

Stress Incontinence, Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03397368
• Other study ID #: stress incontinence
• Status: Recruiting
• Start date: January 16, 2018
• Est. completion date: December 8, 2019

Study information

• Verified date: August 2019
• Source: Aljazeera Hospital
• Contact: Mahmoud Alalfy, M.s.c
• Phone: +201002611058
• Email: mahmoudalalfy[@]ymail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 8, 2019
• Est. primary completion date: November 2, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Stress Incontinence, Female
• Urinary Incontinence, Stress

Intervention

Diagnostic Test:
• Transperineal Ultrasound -
Every women with stress incontinence witll be subjected to urodynamics to confirm genuine stress incontinence then will be subjected Transperineal US

Locations

Country	Name	City	State
Egypt	Kasralainy Hospital	Cairo
Egypt	Algazeerah	Giza

Sponsors (2)

Lead Sponsor	Collaborator
Aljazeera Hospital	Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	the outcome describes how much the transperineal us have a power to diagnose stress incontinence in comparison to urodynamic study	within a week