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

Shamir Medical Center (Assaf-Harofeh)

Status: Completed

Conditions: Recurrent Uti; Hematuria; Dysuria

Treatments: Drug: Lidocaine; Drug: Water

Study type: Interventional

Funder types: Other

Identifiers

NCT03210038

0290-16-ASF

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 4 patient groups

Rigid cystoscopy, water based gel on introitus

Active Comparator group

Description:

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

Treatment:

Drug: Water

Rigid cystoscopy, esracain gel based on introitus

Active Comparator group

Description:

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

Treatment:

Drug: Lidocaine

Flexible cystoscopy, water based gel on introitus

Active Comparator group

Description:

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

Treatment:

Drug: Water

Flexible cystoscopy, Esracain gel based on introitus

Active Comparator group

Description:

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

Treatment:

Drug: Lidocaine