Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of Transperineal US in Stress Incontinence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03397368
Recruitment Status : Recruiting
First Posted : January 12, 2018
Last Update Posted : August 6, 2019
Sponsor:
Collaborator:
Kasr El Aini Hospital
Information provided by (Responsible Party):
Mahmoud Alalfy, Aljazeera Hospital

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


Condition or disease Intervention/treatment
Stress Incontinence, Female Diagnostic Test: Transperineal Ultrasound -

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.


Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 50 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 5 Months
Official Title: Evaluation of Role of Transperineal US in Differentiating Degrees of Genuine Stress Incontinence in Females Diagnosed by Urodynamics
Actual Study Start Date : January 16, 2018
Estimated Primary Completion Date : November 2, 2019
Estimated Study Completion Date : December 8, 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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
    Other Name: Urodynamics


Primary Outcome Measures :
  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 [ 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   females who are complaining from stress incontinence
Accepts Healthy Volunteers:   Yes
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03397368


Contacts
Layout table for location contacts
Contact: Mahmoud Alalfy, M.s.c +201002611058 mahmoudalalfy@ymail.com
Contact: Ahmed Ellithy, M.D +201120205000 ahmedellithy75@gmail.com

Locations
Layout table for location information
Egypt
Kasralainy Hospital Recruiting
Cairo, Egypt
Contact: Ahmed el lithy, M.D    01120205000    ahmedellithy75@gmail.com   
Algazeerah Recruiting
Giza, Egypt
Contact: Mahmoud Alalfy, master    +201002611058    mahmoudalalfy@ymail.com   
Contact: Ahmed Elgazzar, M.D    +201014005959      
Principal Investigator: Mahmoud Alalfy, master         
Sponsors and Collaborators
Aljazeera Hospital
Kasr El Aini Hospital
Investigators
Layout table for investigator information
Study Chair: Mahmoud Alalfy, M.s.c Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt

Additional Information:

Layout table for additonal information
Responsible Party: Mahmoud Alalfy, Assistant Researcher , National Research centre and Specialist of Obstetrics and Gynecology in Aljazeerah hospital, Aljazeera Hospital
ClinicalTrials.gov Identifier: NCT03397368     History of Changes
Other Study ID Numbers: stress incontinence
First Posted: January 12, 2018    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Urinary Incontinence, Stress
Urinary Incontinence
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms