Case Control Study to Investigate the Use of Urethral Pressure Profile Measurement in Children
|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: NCT04147793|
Recruitment Status : Not yet recruiting
First Posted : November 1, 2019
Last Update Posted : January 6, 2021
The bladder has a muscle that acts like a tap called the sphincter. Just like a tap, when pee is stored the sphincter muscle is closed and during peeing the sphincter opens. Sometimes the sphincter tap does not work properly and can cause problems. If the sphincter is weak there can be urine leak (incontinence). If the sphincter is too strong bladder might not empty properly.
Children who require investigation of their urinary problems are usually assessed with non-invasive tests. Sometimes investigation is with a more invasive test videourodynamics or video cystometrogram (VCMG; this test requires the insertion of catheters into the bladder and rectum. This test provides only indirect information about sphincter function.
It would be helpful to have a more direct test of the sphincter. It will allow better targeted treatments of sphincter problems which are often therapeutically challenging. Urethral pressure profile is a test used in adults to assess the sphincter. Although it has been described in children normal values have not been described.
The research project is to define urethral pressure profile values in children and young people with normal, weak and overactive sphincters.
Urethral pressure profile measurement is invasive as it requires the insertion of a special catheter. It will therefore be performed at the time of other invasive procedures eg VCMG or urology surgery under general anaesthetic.
The study will be conducted at single site, which is a children's hospital. The study will be an observational case controlled study with three arms: controls, those with overactive sphincters and those with underactive sphincters. The study is intended to run over three years.
|Condition or disease|
|Dysfunctional Voiding Stress Incontinence, Urinary|
|Study Type :||Observational|
|Estimated Enrollment :||36 participants|
|Official Title:||Case Control Study to Investigate the Use of Urethral Pressure Profile Measurement in Children|
|Estimated Study Start Date :||June 1, 2021|
|Estimated Primary Completion Date :||January 1, 2023|
|Estimated Study Completion Date :||January 1, 2023|
patients attneding for surgery with no known bladder disease
those with evidence of dysfunctional voiding
those with genuine stress incontinence
- maximum urethral closure pressure (MUCP). [ Time Frame: approximately 3 months ]Urodynamics finding
- Urethral pressure profile pattern [ Time Frame: approximately 3 months ]Urodynamics finding
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): NCT04147793
|Contact: arash taghizadeh, MBBS||+44 firstname.lastname@example.org|
|Contact: anne wright, mbbs||+44 email@example.com|
|Evelina London Children's Hosital|
|London, United Kingdom, SE1 7EH|
|Contact: Arash Taghizadeh|
|Sub-Investigator: Anne Wright|
|Sub-Investigator: Eskinder Solomon|
|Sub-Investigator: Jo Clothier|
|Principal Investigator:||arash taghizadeh, mbbs||Evelina London Children's Hospital|