[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100373849":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":18,"centralContacts":23,"locations":32,"responsibleParty":55,"collaborators":10,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":61,"acronym":10,"eligibilityCriteria":62,"healthyVolunteers":59,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":10,"studyType":69,"phases":10,"briefSummary":70,"conditions":71,"keywords":74,"overallStatus":78,"whyStopped":10,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"King's College London","OTHER",[8,12,15],{"label":9,"type":10,"description":11,"interventionNames":10},"Controls",null,"patients attneding for surgery with no known bladder disease",{"label":13,"type":10,"description":14,"interventionNames":10},"Overactice sphincter","those with evidence of dysfunctional voiding",{"label":16,"type":10,"description":17,"interventionNames":10},"Underactive sphincter","those with genuine stress incontinence",[19],{"name":20,"affiliation":21,"role":22},"arash taghizadeh, mbbs","Evelina London Children's Hospital","PRINCIPAL_INVESTIGATOR",[24,29],{"name":25,"role":26,"phone":27,"phoneExt":10,"email":28},"arash taghizadeh, MBBS","CONTACT","+44 2071884610","arash.taghizadeh@gstt.nhs.uk",{"name":30,"role":26,"phone":27,"phoneExt":10,"email":31},"anne wright, mbbs","anne.wright@gstt.nhs.uk",[33],{"facility":34,"status":10,"city":35,"state":10,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Evelina London Children's Hosital","London","SE1 7EH","United Kingdom","UK",{"type":40,"coordinates":41},"Point",[42,43],-0.12574,51.50853,{"lat":43,"lon":42},[46,48,51,53],{"name":47,"role":26,"phone":10,"phoneExt":10,"email":10},"Arash Taghizadeh",{"name":49,"role":50,"phone":10,"phoneExt":10,"email":10},"Anne Wright","SUB_INVESTIGATOR",{"name":52,"role":50,"phone":10,"phoneExt":10,"email":10},"Eskinder Solomon",{"name":54,"role":50,"phone":10,"phoneExt":10,"email":10},"Jo Clothier",{"type":56,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100373849","case-control-study-to-investigate-the-use-of-urethral-pressure-profile-measurement-in-children-100373849",false,"NCT04147793","Case Control Study to Investigate the Use of Urethral Pressure Profile Measurement in Children","Inclusion Criteria All subjects • Age 7-16 years inclusive\n\nControls\n\n* Concurrent urological disease requiring surgery which includes cystoscopy\n* No significant urinary symptoms\n* No day-time urinary incontinence\n* Urinary frequency 4-7 per day\n* No history of recurrent urinary infections (more than two infections in previous year)\n* Has not passed a renal tract stone\n\nOveractive sphincter\n\n* Require VCMG as part of their clinical care\n* 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):\n\n  * Intermittent and\u002For fluctuating flow rate\n  * Pelvic EMG activity during voiding\n* either perform intermittent catheterisation or have no contraindication to Entonox sedation (see below)\n\nUnderactive sphincter\n\n* Have either:\n\n  * Symptoms of stress urinary incontinence\n  * Or urinary incontinence with a neuropathic bladder\n* Require VCMG as part of their clinical care.\n* either perform intermittent catheterisation or have no contraindication to Entonox sedation (see below)\n* 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)\n\nExclusion Criteria:\n\n* Unaccompanied by adult with parental responsibility who can give consent\n* Previous bladder outlet or urethral surgery\n* Other urological disease not mentioned specifically in the treatment group inclusion criteria; including posterior urethral valves, cerebral palsy, inherited metabolic disease\n* Contraindication to Entonox if sedation required for catheter insertion:\n\n  * Conditions where gas may be trapped in a body cavity, eg middle ear occlusion, intestinal obstruction\n  * Unable to understand instruction for use of Entonox\n* Evidence urinary tract infection on day UPP measurement\n\n  * Symptoms of dysuria\n  * Abnormally cloudy or offensive urine\n  * Temperature of 38oc or more\n* Urine dipstick positive nitrates or leucocytes on the day of the study, in the absence of a renal tract stone or indwelling catheter","ALL","7 Years","16 Years",{"count":67,"type":68},36,"ESTIMATED","OBSERVATIONAL","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.\n\nChildren 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.\n\nIt 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.\n\nThe research project is to define urethral pressure profile values in children and young people with normal, weak and overactive sphincters.\n\nUrethral 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.\n\nThe 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.",[72,73],"Dysfunctional Voiding","Stress Incontinence, Urinary",[75,76,77],"child","Adolescent","urinary incontinence","NOT_YET_RECRUITING","2024-02-01",{"date":81,"type":82},"2024-02-02","ACTUAL",{"date":84,"type":68},"2024-03-01",{"date":86,"type":68},"2028-03-01",{"name":5,"class":6},1]