Cystoscopy in Females: Is There a Difference Between Rigid and Flex Cystoscopy, and Does it Requi… (NCT03210038) | Clinical Trial Compass
CompletedNot Applicable
Cystoscopy in Females: Is There a Difference Between Rigid and Flex Cystoscopy, and Does it Require Local Anasthesia?
Israel120 participantsStarted 2017-03-01
Plain-language summary
Women arriving to the Urology department outpatient clinic at Assaf-Harofeh Medical Center in order to undergo a cystoscopy examination will be recruited.
Patients will be randomly assigned to one of four groups by method of cystoscopy (flexible and rigid) and by use of anesthesia to the introitus.
Pain levels will be recorded prior to the examination, during entrance of the cystoscope in the urethral meatus, immediately after the examination and 15 minutes after conclusion.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* All women referred to elective outpatient cystoscopy.
Exclusion Criteria:
* Known urethral stricture.
* Known allergy to lubricant/anesthesia gel.
* Patients under the age of 18 (minors).
* Patients with current Urinary Tract Infections.
* Chronic pelvic pain (e.g Interstitial Cystitis/Bladder Pain Syndrome.
* Known neurlogical or other chronic pain syndrome requiring chronic analgesia medication.
* Mentally incapable for consensual agreement of participation.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain before procedure
Timeframe: Before cystoscopy
2
Pain during meatus insertion of cystoscope
Timeframe: During the procedure, at the moment of cystoscopy insertion through the urethra
3
Pain immediately after procedure
Timeframe: Immediately after withdrawal of the cystoscope from the urethra