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

Not Applicable

Completed

• Conditions: Hematuria; Dysuria; Recurrent Uti
• Interventions: Drug: Lidocaine; Drug: Water

• Registration Number: NCT03210038
• Lead Sponsor: Assaf-Harofeh Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-01
• Study First Submitted: 2017-05-21
• Study First Submitted QC: 2017-07-04
• Study First Posted: 2017-07-06
• Status Verified: 2019-12
• Primary Completion: 2019-12-01
• Study Completion: 2019-12-01
• Last Update Submitted: 2019-12-03
• Last Update Posted: 2019-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Flexible cystoscopy, Esracain gel based on introitus	Lidocaine	Flexible cystoscopy, Olympus 16FR. Pad soaked with Esracain (Lidocaine) put on the introitus for 5 minutes prior to procedure.
Rigid cystoscopy, esracain gel based on introitus	Lidocaine	Rigid Cystoscopy, Wolf 17FR. Pad soaked with Esracain (Lidocaine) put on the introitus for 5 minutes prior to procedure.
Flexible cystoscopy, water based gel on introitus	Water	Flexible cystoscopy, Olympus 16FR. Pad soaked with water based gel put on introitus for 5 minutes prior to procedure.
Rigid cystoscopy, water based gel on introitus	Water	Rigid cystoscopy, Wolf 17FR. Pad soaked with water based gel put on introitus for 5 minutes prior to procedure.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Assaf Harofe Medical Center; 🇮🇱 Be'er Ya'aqov, Israel