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Trial record 11 of 158 for:    interstitial cystitis

Interstitial Cystitis and Urinary pH

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ClinicalTrials.gov Identifier: NCT03024619
Recruitment Status : Active, not recruiting
First Posted : January 19, 2017
Last Update Posted : January 24, 2019
Sponsor:
Information provided by (Responsible Party):
Eugen C. Campian, MD, St. Louis University

Brief 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.

Condition or disease Intervention/treatment
Interstitial Cystitis Other: Pain and Urinary pH

Detailed 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. )


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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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


Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women with symptomatic diagnosed Interstitial Cystitis
Criteria

Inclusion Criteria:

  • Women aged 18-70, with diagnosed Interstitial Cystitis (IC) and bladder pain present during week preceding enrollment.

Exclusion Criteria:

  • Subjects who are pregnant. Subjects with current UTI or are unwilling/unable to provide consent.

Information from the National Library of Medicine

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


Sponsors and Collaborators
St. Louis University
Investigators
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Principal Investigator: Eugen Campian, MD St. Louis University

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Responsible Party: Eugen C. Campian, MD, Principal Investigator, St. Louis University
ClinicalTrials.gov Identifier: NCT03024619     History of Changes
Other Study ID Numbers: 26300
First Posted: January 19, 2017    Key Record Dates
Last Update Posted: January 24, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Cystitis
Cystitis, Interstitial
Urinary Bladder Diseases
Urologic Diseases