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
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)|
|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|
Experimental: All patients
All patients in this study receive hydrodistension
Patients who are already scheduled to have a gynecologic, urologic or uro-gynecologic procedure involving cystoscopy if consented will have hydrodistension performed
- 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).
- 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
- 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
- The correlation between PUF score and cystoscopic findings [ Time Frame: up to 5 years ]Correlation between PUF score and cystoscopic findings
- 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
- 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
- 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
- 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
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
|United States, Missouri|
|St. Mary's Health Center|
|Saint Louis, Missouri, United States, 63117|
|Principal Investigator:||Eugen Campian, MD||St. Louis University|