Cystoscopy in Females: Is There a Difference Between Rigid and Flex Cystoscopy, and Does it Require Local Anasthesia?

Study Overview
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Brief Summary
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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.

Official Title
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Cystoscopy in Females: Is There a Difference Between Rigid and Flex Cystoscopy, and Does it Require Local Anasthesia?

Conditions
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Hematuria, Dysuria, Recurrent Uti

Intervention / Treatment
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* Drug: Lidocaine
* Drug: Water


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pain assessment 4 randomly assigned groups of women divided by type of cystoscope and type of local anesthesia.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rigid cystoscopy, water based gel on introitus<br>Rigid cystoscopy, Wolf 17FR. Pad soaked with water based gel put on introitus for 5 minutes prior to procedure. | Drug: Water<br>* Water based non-anesthetic lubricant gel left on the introitus for 5 minutes.<br>|
| Active Comparator: Rigid cystoscopy, esracain gel based on introitus<br>Rigid Cystoscopy, Wolf 17FR. Pad soaked with Esracain (Lidocaine) put on the introitus for 5 minutes prior to procedure. | Drug: Lidocaine<br>* Pad soaked with lidocaine gel (Esracaine) left on the introitus for 5 minutes<br>|
| Active Comparator: Flexible cystoscopy, water based gel on introitus<br>Flexible cystoscopy, Olympus 16FR. Pad soaked with water based gel put on introitus for 5 minutes prior to procedure. | Drug: Water<br>* Water based non-anesthetic lubricant gel left on the introitus for 5 minutes.<br>|
| Active Comparator: Flexible cystoscopy, Esracain gel based on introitus<br>Flexible cystoscopy, Olympus 16FR. Pad soaked with Esracain (Lidocaine) put on the introitus for 5 minutes prior to procedure. | Drug: Lidocaine<br>* Pad soaked with lidocaine gel (Esracaine) left on the introitus for 5 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain before procedure | Pain measurement using a 0-10 visual analogue scale (VAS) and comparison of average pain score between the four study groups. | Before cystoscopy | 
| Pain during meatus insertion of cystoscope | Pain measurement using a 0-10 visual analogue scale (VAS) and comparison of average pain score between the four study groups. | During the procedure, at the moment of cystoscopy insertion through the urethra | 
| Pain immediately after procedure | Pain measurement using a 0-10 visual analogue scale (VAS) and comparison of average pain score between the four study groups. | Immediately after withdrawal of the cystoscope from the urethra | 
| Pain 15 minutes after procedure | Pain measurement using a 0-10 visual analogue scale (VAS) and comparison of average pain score between the four study groups. | 15 minutes after end of procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cystoscopy