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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03210038
Enrollment
120
Registered
2017-07-06
Start date
2017-03-01
Completion date
2019-12-01
Last updated
2019-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysuria, Hematuria, Recurrent Uti

Keywords

Cystoscopy

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.

Interventions

DRUGLidocaine

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

DRUGWater

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

Sponsors

Assaf-Harofeh Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Pain before procedureBefore cystoscopyPain 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 cystoscopeDuring the procedure, at the moment of cystoscopy insertion through the urethraPain measurement using a 0-10 visual analogue scale (VAS) and comparison of average pain score between the four study groups.
Pain immediately after procedureImmediately after withdrawal of the cystoscope from the urethraPain measurement using a 0-10 visual analogue scale (VAS) and comparison of average pain score between the four study groups.
Pain 15 minutes after procedure15 minutes after end of procedurePain measurement using a 0-10 visual analogue scale (VAS) and comparison of average pain score between the four study groups.

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026