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

NCT03210038 | Completed DMC

• 1 other identifier: 0290-16-ASF
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematuria; Dysuria; Recurrent Uti

Keywords

Cystoscopy

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (4)

Rigid cystoscopy, water based gel on introitus

ACTIVE COMPARATOR

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

Drug: Water

Rigid cystoscopy, esracain gel based on introitus

ACTIVE COMPARATOR

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

Drug: Lidocaine

Flexible cystoscopy, water based gel on introitus

ACTIVE COMPARATOR

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

Drug: Water

Flexible cystoscopy, Esracain gel based on introitus

ACTIVE COMPARATOR

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

Drug: Lidocaine

Interventions

Lidocaine DRUG

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

Flexible cystoscopy, Esracain gel based on introitus; Rigid cystoscopy, esracain gel based on introitus

Water DRUG

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

Flexible cystoscopy, water based gel on introitus; Rigid cystoscopy, water based gel on introitus

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All women referred to elective outpatient cystoscopy.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

Study Sites (1)

Assaf Harofe Medical Center

Be’er Ya‘aqov, 70300, Israel

Location

Related 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.

  PMID: 19239453 RESULT

• 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.

  PMID: 18206920 RESULT

• 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.

  PMID: 25817101 RESULT

• 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.

  PMID: 25818032 RESULT

MeSH Terms

Conditions

Hematuria; Dysuria; Urinary Tract Infections

Interventions

Lidocaine; Water

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Infections

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Urologist

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

Study Record Dates

• First Submitted: May 21, 2017
• First Posted: July 6, 2017
• Study Start: March 1, 2017
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: December 4, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share

Locations

IL (1)