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

NCT04147793 | Not Yet Recruiting

• 1 other identifier: 269193
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Dysfunctional Voiding; Stress Incontinence, Urinary

Keywords

child; Adolescent; urinary incontinence

Outcome Measures

Primary Outcomes (1)

• maximum urethral closure pressure (MUCP).

  Urodynamics finding

  approximately 3 months

Secondary Outcomes (1)

• Urethral pressure profile pattern

  approximately 3 months

Study Arms (3)

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

Eligibility Criteria

• Age: 7 Years - 16 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patients attending paediatric urology or bladder clinic

You may qualify if:

• 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:

You may not qualify if:

• Unaccompanied by adult with parental responsibility who can give consent
• Previous bladder outlet or urethral surgery
• 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

Sponsors & Collaborators

• King's College London: lead

Study Sites (1)

Evelina London Children's Hosital

London, SE1 7EH, United Kingdom

Location

Related Publications (16)

• Afshar K, Mirbagheri A, Scott H, MacNeily AE. Development of a symptom score for dysfunctional elimination syndrome. J Urol. 2009 Oct;182(4 Suppl):1939-43. doi: 10.1016/j.juro.2009.03.009. Epub 2009 Aug 20.

  PMID: 19695637 BACKGROUND

• Austin PF, Bauer SB, Bower W, Chase J, Franco I, Hoebeke P, Rittig S, Vande Walle J, von Gontard A, Wright A, Yang SS, Neveus T. The standardization of terminology of lower urinary tract function in children and adolescents: update report from the Standardization Committee of the International Children's Continence Society. J Urol. 2014 Jun;191(6):1863-1865.e13. doi: 10.1016/j.juro.2014.01.110. Epub 2014 Feb 4.

  PMID: 24508614 BACKGROUND

• Bauer SB, Nijman RJ, Drzewiecki BA, Sillen U, Hoebeke P; International Children's Continence Society Standardization Subcommittee. International Children's Continence Society standardization report on urodynamic studies of the lower urinary tract in children. Neurourol Urodyn. 2015 Sep;34(7):640-7. doi: 10.1002/nau.22783. Epub 2015 May 21.

  PMID: 25998310 BACKGROUND

• Comiter CV, Sullivan MP, Yalla SV. Correlation among maximal urethral closure pressure, retrograde leak point pressure, and abdominal leak point pressure in men with postprostatectomy stress incontinence. Urology. 2003 Jul;62(1):75-8. doi: 10.1016/s0090-4295(03)00123-7.

  PMID: 12837426 BACKGROUND

• Dave S, Salle JL. Current status of bladder neck reconstruction. Curr Opin Urol. 2008 Jul;18(4):419-24. doi: 10.1097/MOU.0b013e328302edd5.

  PMID: 18520766 BACKGROUND

• DeLancey JO, Trowbridge ER, Miller JM, Morgan DM, Guire K, Fenner DE, Weadock WJ, Ashton-Miller JA. Stress urinary incontinence: relative importance of urethral support and urethral closure pressure. J Urol. 2008 Jun;179(6):2286-90; discussion 2290. doi: 10.1016/j.juro.2008.01.098. Epub 2008 Apr 18.

  PMID: 18423707 BACKGROUND

• Edwards L, Malvern J. The urethral pressure profile: theoretical considerations and clinical application. Br J Urol. 1974 Jun;46(3):325-35. doi: 10.1111/j.1464-410x.1974.tb03834.x. No abstract available.

  PMID: 4858680 BACKGROUND

• Farhat W, Bagli DJ, Capolicchio G, O'Reilly S, Merguerian PA, Khoury A, McLorie GA. The dysfunctional voiding scoring system: quantitative standardization of dysfunctional voiding symptoms in children. J Urol. 2000 Sep;164(3 Pt 2):1011-5. doi: 10.1097/00005392-200009020-00023.

  PMID: 10958730 BACKGROUND

• Fowler CJ, Kirby RS, Harrison MJ. Decelerating burst and complex repetitive discharges in the striated muscle of the urethral sphincter, associated with urinary retention in women. J Neurol Neurosurg Psychiatry. 1985 Oct;48(10):1004-9. doi: 10.1136/jnnp.48.10.1004.

  PMID: 4056803 BACKGROUND

• Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A, Petri E, Rizk DE, Sand PK, Schaer GN. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Int Urogynecol J. 2010 Jan;21(1):5-26. doi: 10.1007/s00192-009-0976-9. Epub 2009 Nov 25.

  PMID: 19937315 BACKGROUND

• Heron J, Grzeda MT, von Gontard A, Wright A, Joinson C. Trajectories of urinary incontinence in childhood and bladder and bowel symptoms in adolescence: prospective cohort study. BMJ Open. 2017 Mar 14;7(3):e014238. doi: 10.1136/bmjopen-2016-014238.

  PMID: 28292756 BACKGROUND

• Jiang R, Kelly MS, Routh JC. Assessment of pediatric bowel and bladder dysfunction: a critical appraisal of the literature. J Pediatr Urol. 2018 Dec;14(6):494-501. doi: 10.1016/j.jpurol.2018.08.010. Epub 2018 Aug 28.

  PMID: 30297226 BACKGROUND

• Meunier P, Mollard P. Urethral pressure profile in children: a comparison between perfused catheters and micro-transducers, and a study of the usefulness of urethral pressure profile measurements in children. J Urol. 1978 Aug;120(2):207-10. doi: 10.1016/s0022-5347(17)57110-4.

  PMID: 671637 BACKGROUND

• Sihra N, Malde S, Panicker J, Kightley R, Solomon E, Hamid R, Ockrim J, Greenwell TJ, Pakzad M. Does the appearance of the urethral pressure profile trace correlate with the sphincter EMG findings in women with voiding dysfunction? Neurourol Urodyn. 2018 Feb;37(2):751-757. doi: 10.1002/nau.23341. Epub 2017 Jul 5.

  PMID: 28678412 BACKGROUND

• Tran K, Kuo B, Zibaitis A, Bhattacharya S, Cote C, Belkind-Gerson J. Effect of propofol on anal sphincter pressure during anorectal manometry. J Pediatr Gastroenterol Nutr. 2014 Apr;58(4):495-7. doi: 10.1097/MPG.0000000000000190.

  PMID: 24121151 BACKGROUND

• Wiseman OJ, Swinn MJ, Brady CM, Fowler CJ. Maximum urethral closure pressure and sphincter volume in women with urinary retention. J Urol. 2002 Mar;167(3):1348-51; discussion 1351-2. doi: 10.1016/s0022-5347(05)65297-4.

  PMID: 11832729 BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence, Stress; Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• arash taghizadeh, mbbs

  Evelina London Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

arash taghizadeh, MBBS

CONTACT

+44 2071884610; arash.taghizadeh@gstt.nhs.uk

anne wright, mbbs

CONTACT

+44 2071884610; anne.wright@gstt.nhs.uk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2019
• First Posted: November 1, 2019
• Study Start: March 1, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: February 2, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)