NCT03024619

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2016

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 19, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 4, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 4, 2019

Completed
Last Updated

September 13, 2021

Status Verified

September 1, 2021

Enrollment Period

3.3 years

First QC Date

January 11, 2017

Last Update Submit

September 3, 2021

Conditions

Interstitial Cystitis

Outcome Measures

Primary Outcomes (1)

  • Correlation between urinary pH and bladder pain.

    Measure urine pH and visual analog pain scale score and describe correlation between them.

    3 days

Secondary Outcomes (1)

  • Correlation between urinary specific gravity and bladder pain.

    3 days

Interventions

Pain and Urinary pHOTHER

assess the correlation between urinary pH and Interstitial Cystitis (IC) pain, with emphasis placed on exploring the type and severity of pain

Eligibility Criteria

Age18 Years - 90 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women with symptomatic diagnosed Interstitial Cystitis

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cystitis, Interstitial

Condition Hierarchy (Ancestors)

CystitisUrinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Ioana Marcu, MD

    St. Louis University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 11, 2017

First Posted

January 19, 2017

Study Start

February 1, 2016

Primary Completion

June 4, 2019

Study Completion

June 4, 2019

Last Updated

September 13, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share