Interstitial Cystitis (IC)-Like Findings With Hydrodistension

NCT02547298 | Terminated

• 1 other identifier: 25534
• Study Type: observational
• Target: 734
• Locations: 1 country
• Sites: 1

Brief Summary

Patients who are already scheduled to have a gynecologic, urologic or uro-gynecologic procedure involving cystoscopy (a lighted scope is used to look inside the bladder) under anesthesia will be approached to participate in the study. Once prospective study subjects are consented, they will be requested to complete the study questionnaires. At the time of the procedure, during the cystoscopy, patients will undergo hydrodistension (stretching the bladder with fluid). Photographic images of the bladder will be collected, to be later analyzed by examiners. Patients who have positive findings for interstitial cystitis during cystoscopy with hydrodistension, will be notified of the findings after the procedure. They will be asked to fill out an additional, previously completed questionnaire at the time of a follow-up visit, during a phone interview or responding to the questionnaire via a secure web site. These patients will be treated for interstitial cystitis by their primary providers as clinically indicated.

Conditions

Interstitial Cystitis

Outcome Measures

Primary Outcomes (1)

• Correlation between severity of urinary symptoms and IC-like findings on cystoscopy with hydrodistension.

  Change From Baseline in Pain on the 11 point Short Pain Scale (SPS-11).

  up to 5 years

Secondary Outcomes (7)

• The association of GI symptoms with IC-like findings on cystoscopy with hydrodistension

  up to 5 years

• The correlation between O'Leary-Sant score and cystoscopic findings

  up to 5 years

• The correlation between PUF score and cystoscopic findings

  up to 5 years

• The association between cystoscopic and previous urologic or gynecologic surgeries

  up to 5 years

• The number of patients with interstitial cystitis who's symptoms improve after cystoscopy with hydrodistension

  up to 5 years

Study Arms (1)

All participants

All participants will be filling out questionnaires and undergoing cystoscopy with hydrodistension for evaluative reasons

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All women scheduled to undergo cystoscopy or cystoscopy with hydrodistension in an academic institution, within the benign gynecologic division with eligibility criteria as above.

You may qualify if:

• Female
• Patients must be at least 18 years of age.
• Patients must have been previously scheduled for a surgical procedure that includes cystoscopy under anesthesia or cystoscopy with hydrodistension under anesthesia.
• Patients must be able to provide written informed consent.

You may not qualify if:

• pregnancy
• planned cystotomy
• incidental cystotomy during surgery - patient not eligible for hydrodistention
• patient's age \> 90
• history of pelvic radiation 6, Previous or newly diagnosed bladder tumor

Sponsors & Collaborators

• St. Louis University: lead

Study Sites (1)

St. Mary's Health Center

St Louis, Missouri, 63117, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine samples retained

MeSH Terms

Conditions

Cystitis, Interstitial

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Ioana Marcu, MD

  St. Louis University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 26, 2015
• First Posted: September 11, 2015
• Study Start: June 1, 2015
• Primary Completion: January 18, 2018
• Study Completion: January 18, 2018
• Last Updated: January 26, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)