Evaluation of Transperineal US in Stress Incontinence

NCT03397368 | Unknown DMC

• 1 other identifier: stress incontinence
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Stress Incontinence, Female

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Transperineal Ultrasound - DIAGNOSTIC_TEST

Every women with stress incontinence witll be subjected to urodynamics to confirm genuine stress incontinence then will be subjected Transperineal US

Also known as: Urodynamics

Eligibility Criteria

• Age: 20 Years - 75 Years
• Gender Eligibility Details: females who are complaining from stress incontinence
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• females between 20-75 years old
• Women diagnosed to have genuine stress urinary incontinence diagnosed by history taking, voiding diary and confirmed by urodynamic.

You may not qualify if:

• 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

Sponsors & Collaborators

• Aljazeera Hospital: lead
• Kasr El Aini Hospital: collaborator

Study Sites (2)

Kasralainy Hospital

Cairo, Egypt

RECRUITING

Algazeerah

Giza, Egypt

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

Urodynamics

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Urinary Tract Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Mahmoud Alalfy, M.s.c

  Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt

  STUDY CHAIR

Central Study Contacts

Mahmoud Alalfy, M.s.c

CONTACT

+201002611058; mahmoudalalfy@ymail.com

Ahmed Ellithy, M.D

CONTACT

+201120205000; ahmedellithy75@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 5 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Researcher , National Research centre and Specialist of Obstetrics and Gynecology in Aljazeerah hospital

Study Record Dates

• First Submitted: January 5, 2018
• First Posted: January 12, 2018
• Study Start: January 16, 2018
• Primary Completion: November 2, 2019
• Study Completion: December 8, 2019
• Last Updated: August 6, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)