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

Hematuria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03210038
• Other study ID #: 0290-16-ASF
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: December 1, 2019

Study information

• Verified date: December 2019
• Source: Assaf-Harofeh Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 1, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dysuria
• Hematuria
• Recurrent Uti

Intervention

Drug:
• Lidocaine
Pad soaked with lidocaine gel (Esracaine) left on the introitus for 5 minutes
• Water
Water based non-anesthetic lubricant gel left on the introitus for 5 minutes.

Locations

Country	Name	City	State
Israel	Assaf Harofe Medical Center	Be'er Ya'aqov

Sponsors (1)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (4)

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. — View 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. Ep — View Citation

Seklehner S, Remzi M, Fajkovic H, Saratlija-Novakovic Z, Skopek M, Resch I, Duvnjak M, Hruby S, Librenjak D, Hübner W, Breinl E, Riedl C, Engelhardt PF. Prospective multi-institutional study analyzing pain perception of flexible and rigid cystoscopy in me — View 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: 10.101 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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