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Interstitial Cystitis: Examination of the Central Autonomic Network

NCT03008382 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2025-02-17

Study results available
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Summary

This proposal aims to move the science of chronic pelvic pain (CPP) from simple associations towards an investigation of cause and effect relationships. The investigators will determine whether the striking changes in autonomic nervous system responsiveness (ANS-R) contribute meaningfully to the pathogenesis of CPP.

Conditions

  • Interstitial Cystitis/Painful Bladder Syndrome
  • Myofascial Pelvic Pain

Interventions

DRUG

Metoprolol Tartrate Oral Tablet

Metoprolol is a beta-blocker commonly used for mild blood pressure control, and also commonly used for migraine. Subjects with IC/BPS or MPP will start metoprolol at 25 mg once daily and increase to the goal dose of 25 mg 2/day after one week and continue for 8 weeks total.

DRUG

Placebo Oral Tablet

Subjects with IC/BPS or MPP will start placebo distributed in a double-blind manner. Subjects will take placebo once daily and increase to the goal dose of 25 mg 2/day after one week and continue for 8 weeks total.

OTHER

No intervention- observational sub-study

Participants did not receive placebo or metoprolol during the entire duration of the study.

Sponsors & Collaborators

  • Endeavor Health

    collaborator OTHER

  • Case Western Reserve University

    collaborator OTHER

  • Virginia Commonwealth University

    lead OTHER

Principal Investigators

  • Thomas Chelimsky, MD · Virginia Commonwealth University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-01
Primary Completion
2022-03-16
Completion
2022-03-16
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03008382 on ClinicalTrials.gov