Clinical trial NCT03210038: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hematuria
Dysuria
Recurrent Uti
Keywords: Cystoscopy
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2017-07-06
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pain assessment 4 randomly assigned groups of women divided by type of cystoscope and type of local anesthesia.
Primary purpose: DIAGNOSTIC

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.


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.

Primary outcomes:
measure: Pain before procedure
timeFrame: Before cystoscopy
measure: Pain during meatus insertion of cystoscope
timeFrame: During the procedure, at the moment of cystoscopy insertion through the urethra
measure: Pain immediately after procedure
timeFrame: Immediately after withdrawal of the cystoscope from the urethra
measure: Pain 15 minutes after procedure
timeFrame: 15 minutes after end of procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Be'er Ya'aqov
country: Israel
facility: Assaf Harofe Medical Center
Study officials:
References:
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.
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.
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.
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.