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Interstitial Cystitis (IC)-Like Findings With Hydrodistension

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ClinicalTrials.gov Identifier: NCT02547298
Recruitment Status : Active, not recruiting
First Posted : September 11, 2015
Last Update Posted : April 9, 2018
Sponsor:
Information provided by (Responsible Party):
Eugen C. Campian, MD, St. Louis University

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.


Condition or disease Intervention/treatment Phase
Interstitial Cystitis Procedure: Hydrodistension Device: Cystoscopy Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 734 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Correlation Between Urinary Symptoms and Interstitial Cystitis (IC)-Like Findings on Cystoscopy With Hydrodistension
Study Start Date : June 2015
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: All patients
All patients in this study receive hydrodistension
Procedure: Hydrodistension
Patients who are already scheduled to have a gynecologic, urologic or uro-gynecologic procedure involving cystoscopy if consented will have hydrodistension performed

Device: Cystoscopy



Primary Outcome Measures :
  1. Correlation between severity of urinary symptoms and IC-like findings on cystoscopy with hydrodistension. [ Time Frame: up to 5 years ]
    Change From Baseline in Pain on the 11 point Short Pain Scale (SPS-11).


Secondary Outcome Measures :
  1. The association of GI symptoms with IC-like findings on cystoscopy with hydrodistension [ Time Frame: up to 5 years ]
    Correlation between questionnaires responses and cystoscopic findings

  2. The correlation between O'Leary-Sant score and cystoscopic findings [ Time Frame: up to 5 years ]
    correlation between O'Leary-Sant score and cystoscopic findings

  3. The correlation between PUF score and cystoscopic findings [ Time Frame: up to 5 years ]
    Correlation between PUF score and cystoscopic findings

  4. The association between cystoscopic and previous urologic or gynecologic surgeries [ Time Frame: up to 5 years ]
    Correlation between cystoscopic and previous urologic or gynecologic surgeries

  5. The number of patients with interstitial cystitis who's symptoms improve after cystoscopy with hydrodistension [ Time Frame: up to 5 years ]
    To evaluate the number of patients with interstitial cystitis who's symptoms improve after cystoscopy with hydrodistension based on questionnaire responses

  6. Cystoscopic findings in this patient population [ Time Frame: up to 5 years ]
    To evaluate other cystoscopic findings in this patient population based on review of reports and photos

  7. The safety and complications after cystoscopy with hydrodistension [ Time Frame: up to 5 years ]
    Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0



Information from the National Library of Medicine

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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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. pregnancy
  2. planned cystotomy
  3. incidental cystotomy during surgery - patient not eligible for hydrodistention
  4. patient's age > 90
  5. history of pelvic radiation 6, Previous or newly diagnosed bladder tumor

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): NCT02547298


Locations
United States, Missouri
St. Mary's Health Center
Saint Louis, Missouri, United States, 63117
Sponsors and Collaborators
St. Louis University
Investigators
Principal Investigator: Eugen Campian, MD St. Louis University

Responsible Party: Eugen C. Campian, MD, MD, St. Louis University
ClinicalTrials.gov Identifier: NCT02547298     History of Changes
Other Study ID Numbers: 25534
First Posted: September 11, 2015    Key Record Dates
Last Update Posted: April 9, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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