Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : November 7, 2019
Sponsor:
Information provided by (Responsible Party):
King's College London

Brief Summary:

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 when we do a wee 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

Show Show detailed description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 36 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Case Control Study to Investigate the Use of Urethral Pressure Profile Measurement in Children
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : January 1, 2023

Resource links provided by the National Library of Medicine


Group/Cohort
Controls
patients attneding for surgery with no known bladder disease
Overactice sphincter
those with evidence of dysfunctional voiding
Underactive sphincter
those with genuine stress incontinence



Primary Outcome Measures :
  1. maximum urethral closure pressure (MUCP). [ Time Frame: approximately 3 months ]
    Urodynamics finding


Secondary Outcome Measures :
  1. Urethral pressure profile pattern [ Time Frame: approximately 3 months ]
    Urodynamics finding



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:   7 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients attending paediatric urology or bladder clinic
Criteria

Inclusion Criteria All subjects • Age 7-16 years inclusive

Controls

  • Concurrent urological disease requiring surgery which includes cystoscopy
  • No significant urinary symptoms
  • No day-time urinary incontinence
  • Urinary frequency 4-7 per day
  • No history of recurrent urinary infections (more than two infections in previous year)
  • Has not passed a renal tract stone

Overactive sphincter

  • Require VCMG as part of their clinical care
  • A prior diagnosis of dysfunctional voiding. This will have been made in a neurologically intact child following previous non-invasive bladder investigation including two representative urine flows that demonstrate the following (Austin et al., 2014):

    • Intermittent and/or fluctuating flow rate
    • Pelvic EMG activity during voiding
  • either perform intermittent catheterisation or have no contraindication to Entonox sedation (see below)

Underactive sphincter

  • Have either:

    • Symptoms of stress urinary incontinence
    • Or urinary incontinence with a neuropathic bladder
  • Require VCMG as part of their clinical care.
  • either perform intermittent catheterisation or have no contraindication to Entonox sedation (see below)
  • For the UPP data to be included for analysis their videocystometry should demonstrate o Stress urinary incontinence: defined as involuntary leakage of urine during increased abdominal pressure, in the absence of a detrusor contraction (Austin et al., 2014)

Exclusion Criteria:

  • Unaccompanied by adult with parental responsibility who can give consent
  • Previous bladder outlet or urethral surgery
  • Other urological disease not mentioned specifically in the treatment group inclusion criteria; including posterior urethral valves, cerebral palsy, inherited metabolic disease
  • Contraindication to Entonox if sedation required for catheter insertion:

    • Conditions where gas may be trapped in a body cavity, eg middle ear occlusion, intestinal obstruction
    • Unable to understand instruction for use of Entonox
  • Evidence urinary tract infection on day UPP measurement

    • Symptoms of dysuria
    • Abnormally cloudy or offensive urine
    • Temperature of 38oc or more
  • Urine dipstick positive nitrates or leucocytes on the day of the study, in the absence of a renal tract stone or indwelling catheter

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): NCT04147793


Contacts
Layout table for location contacts
Contact: arash taghizadeh, MBBS +44 2071884610 arash.taghizadeh@gstt.nhs.uk
Contact: anne wright, mbbs +44 2071884610 anne.wright@gstt.nhs.uk

Locations
Layout table for location information
United Kingdom
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         
Sponsors and Collaborators
King's College London
Investigators
Layout table for investigator information
Principal Investigator: arash taghizadeh, mbbs Evelina London Children's Hospital
Publications:

Layout table for additonal information
Responsible Party: King's College London
ClinicalTrials.gov Identifier: NCT04147793    
Other Study ID Numbers: 269193
First Posted: November 1, 2019    Key Record Dates
Last Update Posted: November 7, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: there is no plan to share IPD

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by King's College London:
child
Adolescent
urinary incontinence
Additional relevant MeSH terms:
Layout table for MeSH terms
Urinary Incontinence, Stress
Urinary Incontinence
Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Behavioral Symptoms
Elimination Disorders
Mental Disorders