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

Primary Purpose

Hematuria, Dysuria, Recurrent Uti

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Lidocaine
Water
Sponsored by
Assaf-Harofeh Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hematuria focused on measuring Cystoscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Assaf Harofe Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Rigid cystoscopy, water based gel on introitus

Rigid cystoscopy, esracain gel based on introitus

Flexible cystoscopy, water based gel on introitus

Flexible cystoscopy, Esracain gel based on introitus

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Pain before procedure
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
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
Pain measurement using a 0-10 visual analogue scale (VAS) and comparison of average pain score between the four study groups.
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.

Secondary Outcome Measures

Full Information

First Posted
May 21, 2017
Last Updated
December 3, 2019
Sponsor
Assaf-Harofeh Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03210038
Brief Title
Cystoscopy in Females: Is There a Difference Between Rigid and Flex Cystoscopy, and Does it Require Local Anasthesia?
Official Title
Cystoscopy in Females: Is There a Difference Between Rigid and Flex Cystoscopy, and Does it Require Local Anasthesia?
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
December 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assaf-Harofeh Medical Center

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematuria, Dysuria, Recurrent Uti
Keywords
Cystoscopy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Pain assessment 4 randomly assigned groups of women divided by type of cystoscope and type of local anesthesia.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rigid cystoscopy, water based gel on introitus
Arm Type
Active Comparator
Arm Description
Rigid cystoscopy, Wolf 17FR. Pad soaked with water based gel put on introitus for 5 minutes prior to procedure.
Arm Title
Rigid cystoscopy, esracain gel based on introitus
Arm Type
Active Comparator
Arm Description
Rigid Cystoscopy, Wolf 17FR. Pad soaked with Esracain (Lidocaine) put on the introitus for 5 minutes prior to procedure.
Arm Title
Flexible cystoscopy, water based gel on introitus
Arm Type
Active Comparator
Arm Description
Flexible cystoscopy, Olympus 16FR. Pad soaked with water based gel put on introitus for 5 minutes prior to procedure.
Arm Title
Flexible cystoscopy, Esracain gel based on introitus
Arm Type
Active Comparator
Arm Description
Flexible cystoscopy, Olympus 16FR. Pad soaked with Esracain (Lidocaine) put on the introitus for 5 minutes prior to procedure.
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Description
Pad soaked with lidocaine gel (Esracaine) left on the introitus for 5 minutes
Intervention Type
Drug
Intervention Name(s)
Water
Intervention Description
Water based non-anesthetic lubricant gel left on the introitus for 5 minutes.
Primary Outcome Measure Information:
Title
Pain before procedure
Description
Pain measurement using a 0-10 visual analogue scale (VAS) and comparison of average pain score between the four study groups.
Time Frame
Before cystoscopy
Title
Pain during meatus insertion of cystoscope
Description
Pain measurement using a 0-10 visual analogue scale (VAS) and comparison of average pain score between the four study groups.
Time Frame
During the procedure, at the moment of cystoscopy insertion through the urethra
Title
Pain immediately after procedure
Description
Pain measurement using a 0-10 visual analogue scale (VAS) and comparison of average pain score between the four study groups.
Time Frame
Immediately after withdrawal of the cystoscope from the urethra
Title
Pain 15 minutes after procedure
Description
Pain measurement using a 0-10 visual analogue scale (VAS) and comparison of average pain score between the four study groups.
Time Frame
15 minutes after end of procedure

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Assaf Harofe Medical Center
City
Be'er Ya'aqov
ZIP/Postal Code
70300
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD data includes age, BMI, previous medical, urological information. Pain levels during different stages of cystoscopy will be recorded.
Citations:
PubMed Identifier
19239453
Citation
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.
Results Reference
result
PubMed Identifier
18206920
Citation
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.
Results Reference
result
PubMed Identifier
25817101
Citation
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.
Results Reference
result
PubMed Identifier
25818032
Citation
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.
Results Reference
result

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

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