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

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.

Study Overview

• Status: Completed
• Conditions: Hematuria; Recurrent Uti; Dysuria
• Intervention / Treatment: Drug: Water; Drug: Lidocaine

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Be'er Ya'aqov, Israel, 70300
    • Assaf Harofe Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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.	Drug: Water; Water based non-anesthetic lubricant gel left on the introitus for 5 minutes.
ACTIVE_COMPARATOR: 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.	Drug: Lidocaine; Pad soaked with lidocaine gel (Esracaine) left on the introitus for 5 minutes
ACTIVE_COMPARATOR: 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.	Drug: Water; Water based non-anesthetic lubricant gel left on the introitus for 5 minutes.
ACTIVE_COMPARATOR: 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.	Drug: Lidocaine; Pad soaked with lidocaine gel (Esracaine) left on the introitus for 5 minutes

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Assaf-Harofeh Medical Center

Publications and helpful links

General Publications

• Aaronson DS, Walsh TJ, Smith JF, Davies BJ, Hsieh MH, Konety BR. Meta-analysis: does lidocaine gel before flexible cystoscopy provide pain relief? BJU Int. 2009 Aug;104(4):506-9; discussion 509-10. doi: 10.1111/j.1464-410X.2009.08417.x. Epub 2009 Feb 23.
• Patel AR, Jones JS, Babineau D. Lidocaine 2% gel versus plain lubricating gel for pain reduction during flexible cystoscopy: a meta-analysis of prospective, randomized, controlled trials. J Urol. 2008 Mar;179(3):986-90. doi: 10.1016/j.juro.2007.10.065. Epub 2008 Jan 18.
• Seklehner S, Remzi M, Fajkovic H, Saratlija-Novakovic Z, Skopek M, Resch I, Duvnjak M, Hruby S, Librenjak D, Hubner W, Breinl E, Riedl C, Engelhardt PF. Prospective multi-institutional study analyzing pain perception of flexible and rigid cystoscopy in men. Urology. 2015 Apr;85(4):737-41. doi: 10.1016/j.urology.2015.01.007.
• Stav K, Ohlgisser R, Siegel YI, Beberashvili I, Padoa A, Zisman A. Pain during Female Urethral Catheterization: Intraurethral Lubricant Injection versus Catheter Tip Lubrication--A Prospective Randomized Trial. J Urol. 2015 Oct;194(4):1018-21. doi: 10.1016/j.juro.2015.03.097. Epub 2015 Mar 25.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2017
• Primary Completion (ACTUAL): December 1, 2019
• Study Completion (ACTUAL): December 1, 2019

Study Registration Dates

• First Submitted: May 21, 2017
• First Submitted That Met QC Criteria: July 4, 2017
• First Posted (ACTUAL): July 6, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 4, 2019
• Last Update Submitted That Met QC Criteria: December 3, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Cystoscopy
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Hemorrhage; Urination Disorders; Hematuria; Dysuria; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 0290-16-ASF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD data includes age, BMI, previous medical, urological information. Pain levels during different stages of cystoscopy will be recorded.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No