Interstitial Cystitis and Urinary pH

September 3, 2021 updated by: Iona Marcu, MD, St. Louis University

A Pilot Study of the Correlation Between Symptoms of Interstitial Cystitis and Urinary pH

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.

Study Overview

Status

Completed

Intervention / Treatment

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. )

Study Type

Observational

Enrollment (Actual)

20

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women with symptomatic diagnosed Interstitial Cystitis

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ioana Marcu, MD, St. Louis University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Actual)

June 4, 2019

Study Completion (Actual)

June 4, 2019

Study Registration Dates

First Submitted

January 11, 2017

First Submitted That Met QC Criteria

January 16, 2017

First Posted (Estimate)

January 19, 2017

Study Record Updates

Last Update Posted (Actual)

September 13, 2021

Last Update Submitted That Met QC Criteria

September 3, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 26300

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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