Case Control Study to Investigate the Use of Urethral Pressure Profile Measurement in Children

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age7-16
SponsorKing's College London

About this trial

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.

Eligibility criteria

Qualifiers

Concurrent urological disease requiring surgery which includes cystoscopy

No significant urinary symptoms

No day-time urinary incontinence

Urinary frequency 4-7 per day

Disqualifiers

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

Conditions where gas may be trapped in a body cavity, eg middle ear occlusion, intestinal obstruction

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

36 Participants
are grouped into 3 trial groups

Sponsors and collaborators