Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03024619 |
| Other study ID # |
26300 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 2016 |
| Est. completion date |
June 4, 2019 |
Study information
| Verified date |
September 2021 |
| Source |
St. Louis University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
This is a pilot study to assess the correlation between urinary pH and Interstitial Cystitis
(IC) pain, with emphasis placed on exploring the type and severity of pain.
Description:
Subjects who agree to participate in the study will meet with a research team member who will
review the study with them, obtain informed consent sign the HIPPA form, and provide study
materials (void diary for urine quantification and recording of IC symptoms, pH strips to dip
urine, "hat" to measure urine). Medical charts will be reviewed to determined how
Interstitial Cystitis was diagnosed, medications, medical/surgical history, and demographics
such as weight, height, BMI, race, age, marital status, education, insurance, tobacco or
alcohol use. Subjects will need to dip pH paper into the urine and specific gravity reagent
strip, and, by color comparison between the strips and the corresponding scales, determine
and record urine pH and specific gravity. They will need to fill out the corresponding
section in the voiding diary that is a survey to type and severity or pain as well as other
symptoms of IC. The research team member will teach the subject how to measure the volume of
their urine and how to measure and record specific gravity and pH. When not practical to
record the volume of the urine (when patients are at work or away from home) they will still
be asked to record pH, specific gravity and experienced symptoms. Subjects will be asked to
perform the above described protocol with each episode of micturition for 3 days.
After enrollment, subjects will complete the O'Leary-Sant pain (symptom and problem index)
questionnaire, if subjects have a combined score greater than or equal to 12 they are
considered to have problematic or symptomatic IC. The voiding diary that include pH and
specific gravity measurement measurements, times, volume, and survey of symptoms will be
returned 1-2 weeks following completion of 3 day void diary for a face-to-face meeting with a
research team member. Attempts will be made to have those meetings coincide with a clinical
visit to minimize study burden to the subject(e.g. - at the time of cystoscopy or follow-up
visit. )
