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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2019-12-01

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.

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Detailed Description

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Conditions

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Hematuria Dysuria Recurrent Uti

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Pain assessment 4 randomly assigned groups of women divided by type of cystoscope and type of local anesthesia.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Rigid cystoscopy, water based gel on introitus

Rigid cystoscopy, Wolf 17FR. Pad soaked with water based gel put on introitus for 5 minutes prior to procedure.

Group Type ACTIVE_COMPARATOR

Water

Intervention Type DRUG

Water based non-anesthetic lubricant gel left on the introitus for 5 minutes.

Rigid cystoscopy, esracain gel based on introitus

Rigid Cystoscopy, Wolf 17FR. Pad soaked with Esracain (Lidocaine) put on the introitus for 5 minutes prior to procedure.

Group Type ACTIVE_COMPARATOR

Lidocaine

Intervention Type DRUG

Pad soaked with lidocaine gel (Esracaine) left on the introitus for 5 minutes

Flexible cystoscopy, water based gel on introitus

Flexible cystoscopy, Olympus 16FR. Pad soaked with water based gel put on introitus for 5 minutes prior to procedure.

Group Type ACTIVE_COMPARATOR

Water

Intervention Type DRUG

Water based non-anesthetic lubricant gel left on the introitus for 5 minutes.

Flexible cystoscopy, Esracain gel based on introitus

Flexible cystoscopy, Olympus 16FR. Pad soaked with Esracain (Lidocaine) put on the introitus for 5 minutes prior to procedure.

Group Type ACTIVE_COMPARATOR

Lidocaine

Intervention Type DRUG

Pad soaked with lidocaine gel (Esracaine) left on the introitus for 5 minutes

Interventions

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Lidocaine

Pad soaked with lidocaine gel (Esracaine) left on the introitus for 5 minutes

Intervention Type DRUG

Water

Water based non-anesthetic lubricant gel left on the introitus for 5 minutes.

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No