Interstitial Cystitis and Urinary pH
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03024619|
Recruitment Status : Active, not recruiting
First Posted : January 19, 2017
Last Update Posted : January 24, 2019
|Condition or disease||Intervention/treatment|
|Interstitial Cystitis||Other: Pain and Urinary pH|
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. )
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Official Title:||A Pilot Study of the Correlation Between Symptoms of Interstitial Cystitis and Urinary pH|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||June 2020|
- Other: Pain and Urinary pH
assess the correlation between urinary pH and Interstitial Cystitis (IC) pain, with emphasis placed on exploring the type and severity of pain
- Correlation between urinary pH and bladder pain. [ Time Frame: 3 days ]Measure urine pH and visual analog pain scale score and describe correlation between them.
- Correlation between urinary specific gravity and bladder pain. [ Time Frame: 3 days ]Measure urine specific gravity and visual analog pain scale score and describe correlation between them.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03024619
|Principal Investigator:||Eugen Campian, MD||St. Louis University|