Recruiting

Bladder Stimulation

Sponsor:

Children's Hospital of Michigan

Code:

NCT03174834

Conditions

Urinary Tract Infections

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Bladder Stimulation technique

Study Details

Brief summary:

Urinary tract infection is the most common serious bacterial infection among infants. Bladder catheterization is considered the gold standard for diagnosis, yet is painful and invasive. In contrast, the bladder stimulation technique has been shown to be a quick and non-invasive approach to collecting urine in young infants with a contamination rate similar to bladder catheterization. Previous research, however, relied upon trained study personnel thereby limiting the generalizability of their findings. By training staff in the pediatric emergency department, this study aims to evaluate the feasibility of incorporating this technique into routine clinical practice while also assessing its impact on parent and provider satisfaction.

Conditions

Urinary Tract Infections

Study ID

NCT03174834

Start date

Sep 1, 2017

Status verified date

Jul, 2018

Completion date

Dec 31, 2018

Anticipated

Primary completion date

May 31, 2018

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Inclusion Criteria:

- Infants less than 6 months of age who require a urine sample for urinalysis and culture as part of their PED visit (as determined by the treating physician) are eligible for inclusion

Exclusion Criteria:

  • Parents / caregivers do not speak English
  • Parents / guardian unavailable to sign consent
  • Evidence of injury / infection to the abdomen / back precluding completion of the bladder stimulation technique
  • Known medical condition rendering it impossible to obtain a sample using the stimulation technique (e.g. urostomy)
  • Critical illness and/or hemodynamic instability
  • Current antibiotic therapy or antibiotics within 14 days of enrollment
  • Previous enrollment.

Study Design

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: Bladder Stimulation Technique

Single arm study, where urine collection will be done via bladder stimulation and subsequently catheterization if they meet the eligibility criteria.

Interventions

Bladder Stimulation technique

The bladder stimulation technique is performed following genital cleaning with a 2% castile soap towelette, which is part of the sterile clean catch urine collection cup kit. For the technique, infants will be held under their armpits by a parent over the bed, with legs dangling in males and hips flexed in females. The nurse or technician will then alternate between bladder stimulation maneuvers: gentle tapping in the suprapubic area at a frequency of 100 taps per minute for 30 seconds followed by lumbar paravertebral massage maneuvers for 30 seconds. These two stimulation maneuvers will be repeated until micturition begins, or for a maximum of 300 seconds.

Primary outcome measure

  • Proportion of patients for whom urine collection is successful using the bladder stimulation technique [ Time Frame: 6 Months ]
  • Proportion of bacterial contamination among samples collected using the bladder stimulation technique [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Yagnaram Ravichandran, MD

3137455205yaggudoc@gmail.com

Amy Delaroche, MD

3137455205ADelaroc@dmc.org

Locations

Children's Hospital of Michigan

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Deepak Kamat, MD

313-966-2810

More Information

Sponsor

Children's Hospital of Michigan

Last update posted

Jul 17, 2018

Last verified

Jul, 2018

Keywords

  • Bladder Stimulation Technique
  • Clean Catch Urine
  • UTI in infants less than 6 months

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospital of Michigan on 2018-07-17.