Interstitial CystitisNCT02547298
Interstitial Cystitis (IC)-Like Findings With Hydrodistension
An observational study of Interstitial Cystitis, run by St. Louis University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Interstitial Cystitis
- How many people
- 734 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to 18 Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Between Urinary Symptoms and Interstitial Cystitis (IC)-Like Findings on Cystoscopy With Hydrodistension
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.
Read the detailed description
Patients who are already scheduled to have a gynecologic, urologic or uro-gynecologic procedure involving cystoscopy will be approached to participate in the study. They will be approached either at the time of an office visit or on the day of the scheduled procedure in the preoperative area.
Study-Related Once consented, they will be requested to fill out the study questionnaires. IC Problem Index/IC symptom Index, Pelvic Pain and Urgency/Frequency Patient Symptom Scale(PUF), IBS (Irritable Bowel Syndrome) questionnaire, Functional Esophageal Disorder Questionnaire, and Painful Bladder questionnaire. Completion of these questionnaires should take approximately 15 minutes.
All patients will undergo cystoscopy with hydrodistension as part of the study protocol. Cystoscopy with hydrodistension is used as a diagnostics/evaluative test.
Cystoscopy-Standard of care The bladder will be be emptied prior to cystoscopy. Cystoscopy will be performed with a 5 mm 30o or 70o cystoscope. The angle of view through the scope (or what the physician sees) is described as 30 degrees or 70 degrees. Sterile saline or water will be infused under direct visualization. Fluid bag will be held at 80 cm above the patient. After 200 cc's of filling the infusion will be stopped. This is the standard procedure for cystoscopy. A resurvey of the bladder will be performed. A minimum of two pictures will be taken - one of the back wall and one of the dome of the bladder. Any abnormal findings will be recorded as well.
Hydrodistension- standard of care or study related. The bladder will be filled by gravity (no pressure) the fluid bag is held 80-100cm above the bed level and the bladder is filled by gravity. Fluid will stop when the bladder reaches capacity or the physician will stop the flow when 700cc is reached. Once the bladder is filled, it is then partially emptied. This procedure should take no more than 60 seconds. The bladder is left partially filled so the physician can take a final look (resurvey) at the bladder before the procedure is completed and the scope withdrawn. This is the standard procedure for hydrodistension. At least five pictures will be taken: trigon, left and right bladder wall, posterior wall of the bladder, and dome of the bladder. A short video clip (approximately 10-15 seconds long) will be taken as well for documentation. Again, any abnormal findings will be documented.
Image review-study related Cystoscopic images will be de-identified and pooled. Batches of 25 sets of images will be evaluated by a panel of urogynecologists. Each reviewer will evaluate each set of images, ranking them as: positive, equivocal or negative for interstitial cystitis findings. A minimum of 10 glomerulations per quadrant in 3 out of 4 quadrants, or any Hunner ulcers will be required for positive diagnosis. Glomerulations will be graded by distribution and number. Additional findings will be recorded: trabeculations, metaplasia, masses, stones, etc. In cases of equivocal findings, the panel can review video clip that may contain additional visual information.
Study related Patients who have positive findings for interstitial cystitis during cystoscopy with hydrodistension, will be notified of the findings after the procedure. At their 4 week and 6 month followup visits these patients will be asked to fill out the IC Problem Index/IC symptom Index questionnaire, this will be compared to the same questionnaire the patient filled out pre op. If the patient is unable to come to the office they may receive a phone call to complete the questionnaire or if they have access to e-mail they may be able to complete the questionnaire on a secure web base site (Red Cap). The follow up questionnaire will not be completed by those who are not diagnosed with interstitial cystitis and their participation in this study will end after the procedure, and they will be referred back to their primary or referring physician for follow up.
Study related The patient's medical record will also be reviewed for history and demographics.
Standard of care Patients with IC will be treated by their primary providers as clinically indicated.
- Conditions
- Interstitial Cystitis
- Medical subject headings
- Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| All participants | All participants will be filling out questionnaires and undergoing cystoscopy with hydrodistension for evaluative reasons |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: up to 5 years
Secondary outcomes (7)
The association of GI symptoms with IC-like findings on cystoscopy with hydrodistension
Correlation between questionnaires responses and cystoscopic findings
Measured: up to 5 years
The correlation between O'Leary-Sant score and cystoscopic findings
correlation between O'Leary-Sant score and cystoscopic findings
Measured: up to 5 years
The correlation between PUF score and cystoscopic findings
Correlation between PUF score and cystoscopic findings
Measured: up to 5 years
The association between cystoscopic and previous urologic or gynecologic surgeries
Correlation between cystoscopic and previous urologic or gynecologic surgeries
Measured: up to 5 years
The number of patients with interstitial cystitis who's symptoms improve after cystoscopy with hydrodistension
To evaluate the number of patients with interstitial cystitis who's symptoms improve after cystoscopy with hydrodistension based on questionnaire responses
Measured: up to 5 years
Cystoscopic findings in this patient population
To evaluate other cystoscopic findings in this patient population based on review of reports and photos
Measured: up to 5 years
The safety and complications after cystoscopy with hydrodistension
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2015 (estimated)
- Study startJun 2015
- Primary completion18 Jan 2018
- Study completion18 Jan 2018
Why it stopped: Previous PI left, staffing changes especially in setting of COVID pandemic meant we no longer wanted to proceed with further recruitment. There were no adverse events or concerns leading to the termination of the study. Simply logistical concerns
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial CystitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 734 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Louis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ioana Marcu, MD, St. Louis University
- Investigators
- Ioana Marcu, MD, Principal investigator, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02547298
- Sponsor's protocol ID
- 25534
- Status last verified
- Jan 2022
- First submitted
- 26 Aug 2015
- Last updated
- 26 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Urinary Symptoms and Interstitial Cystitis (IC)-Like Findings on Cystoscopy With Hydrodistension
- ClinicalTrials.gov ID
- NCT02547298
- Acronym / sponsor ID
- 25534
- Conditions
- Interstitial Cystitis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Previous PI left, staffing changes especially in setting of COVID pandemic meant we no longer wanted to proceed with further recruitment. There were no adverse events or concerns leading to the termination of the study. Simply logistical concerns
- Enrolment
- 734 participants (actual)
- Lead sponsor
- St. Louis UniversityUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- 18 Jan 2018 (actual)
- Study completion
- 18 Jan 2018 (actual)
- First posted
- 11 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients who are already scheduled to have a gynecologic, urologic or uro-gynecologic procedure involving cystoscopy will be approached to participate in the study. They will be approached either at the time of an office visit or on the day of the scheduled procedure in the preoperative area.
Study-Related Once consented, they will be requested to fill out the study questionnaires. IC Problem Index/IC symptom Index, Pelvic Pain and Urgency/Frequency Patient Symptom Scale(PUF), IBS (Irritable Bowel Syndrome) questionnaire, Functional Esophageal Disorder Questionnaire, and Painful Bladder questionnaire. Completion of these questionnaires should take approximately 15 minutes.
All patients will undergo cystoscopy with hydrodistension as part of the study protocol. Cystoscopy with hydrodistension is used as a diagnostics/evaluative test.
Cystoscopy-Standard of care The bladder will be be emptied prior to cystoscopy. Cystoscopy will be performed with a 5 mm 30o or 70o cystoscope. The angle of view through the scope (or what the physician sees) is described as 30 degrees or 70 degrees. Sterile saline or water will be infused under direct visualization. Fluid bag will be held at 80 cm above the patient. After 200 cc's of filling the infusion will be stopped. This is the standard procedure for cystoscopy. A resurvey of the bladder will be performed. A minimum of two pictures will be taken - one of the back wall and one of the dome of the bladder. Any abnormal findings will be recorded as well.
Hydrodistension- standard of care or study related. The bladder will be filled by gravity (no pressure) the fluid bag is held 80-100cm above the bed level and the bladder is filled by gravity. Fluid will stop when the bladder reaches capacity or the physician will stop the flow when 700cc is reached. Once the bladder is filled, it is then partially emptied. This procedure should take no more than 60 seconds. The bladder is left partially filled so the physician can take a final look (resurvey) at the bladder before the procedure is completed and the scope withdrawn. This is the standard procedure for hydrodistension. At least five pictures will be taken: trigon, left and right bladder wall, posterior wall of the bladder, and dome of the bladder. A short video clip (approximately 10-15 seconds long) will be taken as well for documentation. Again, any abnormal findings will be documented.
Image review-study related Cystoscopic images will be de-identified and pooled. Batches of 25 sets of images will be evaluated by a panel of urogynecologists. Each reviewer will evaluate each set of images, ranking them as: positive, equivocal or negative for interstitial cystitis findings. A minimum of 10 glomerulations per quadrant in 3 out of 4 quadrants, or any Hunner ulcers will be required for positive diagnosis. Glomerulations will be graded by distribution and number. Additional findings will be recorded: trabeculations, metaplasia, masses, stones, etc. In cases of equivocal findings, the panel can review video clip that may contain additional visual information.
Study related Patients who have positive findings for interstitial cystitis during cystoscopy with hydrodistension, will be notified of the findings after the procedure. At their 4 week and 6 month followup visits these patients will be asked to fill out the IC Problem Index/IC symptom Index questionnaire, this will be compared to the same questionnaire the patient filled out pre op. If the patient is unable to come to the office they may receive a phone call to complete the questionnaire or if they have access to e-mail they may be able to complete the questionnaire on a secure web base site (Red Cap). The follow up questionnaire will not be completed by those who are not diagnosed with interstitial cystitis and their participation in this study will end after the procedure, and they will be referred back to their primary or referring physician for follow up.
Study related The patient's medical record will also be reviewed for history and demographics.
Standard of care Patients with IC will be treated by their primary providers as clinically indicated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | – | –All participants will be filling out questionnaires and undergoing cystoscopy with hydrodistension for evaluative reasons |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
7 secondary outcomes
The association of GI symptoms with IC-like findings on cystoscopy with hydrodistension
Time frame: up to 5 years
The correlation between O'Leary-Sant score and cystoscopic findings
Time frame: up to 5 years
The correlation between PUF score and cystoscopic findings
Time frame: up to 5 years
The association between cystoscopic and previous urologic or gynecologic surgeries
Time frame: up to 5 years
The number of patients with interstitial cystitis who's symptoms improve after cystoscopy with hydrodistension
Time frame: up to 5 years
Cystoscopic findings in this patient population
Time frame: up to 5 years
The safety and complications after cystoscopy with hydrodistension
Time frame: up to 5 years
Results and safety
The study was stopped early (reason given: Previous PI left, staffing changes especially in setting of COVID pandemic meant we no longer wanted to proceed with further recruitment. There were no adverse events or concerns leading to the termination of the study. Simply logistical concerns). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ioana Marcu, MD principal investigator
St. Louis University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Interstitial Cystitis, run by St. Louis University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Previous PI left, staffing changes especially in setting of COVID pandemic meant we no longer wanted to proceed with further recruitment. There were no adverse events or concerns leading to the termination of the study. Simply logistical concerns). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between severity of urinary symptoms and IC-like findings on cystoscopy with hydrodistension. (time frame: up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2022.