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

Sponsor

Assaf-Harofeh Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT03210038

Collaborator

(none)

120

Enrollment

1

Location

4

Arms

33

Actual Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hematuria Dysuria Recurrent Uti	Drug: Lidocaine Drug: Water	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Mar 1, 2017

Actual Primary Completion Date :

Dec 1, 2019

Actual Study Completion Date :

Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Rigid cystoscopy, water based gel on introitus Rigid cystoscopy, Wolf 17FR. Pad soaked with water based gel put on introitus for 5 minutes prior to procedure.	Drug: Water Water based non-anesthetic lubricant gel left on the introitus for 5 minutes.
Active Comparator: Rigid cystoscopy, esracain gel based on introitus Rigid Cystoscopy, Wolf 17FR. Pad soaked with Esracain (Lidocaine) put on the introitus for 5 minutes prior to procedure.	Drug: Lidocaine Pad soaked with lidocaine gel (Esracaine) left on the introitus for 5 minutes
Active Comparator: Flexible cystoscopy, water based gel on introitus Flexible cystoscopy, Olympus 16FR. Pad soaked with water based gel put on introitus for 5 minutes prior to procedure.	Drug: Water Water based non-anesthetic lubricant gel left on the introitus for 5 minutes.
Active Comparator: Flexible cystoscopy, Esracain gel based on introitus Flexible cystoscopy, Olympus 16FR. Pad soaked with Esracain (Lidocaine) put on the introitus for 5 minutes prior to procedure.	Drug: Lidocaine Pad soaked with lidocaine gel (Esracaine) left on the introitus for 5 minutes

Outcome Measures

Primary Outcome Measures

Pain before procedure [Before cystoscopy]
Pain 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 cystoscope [During the procedure, at the moment of cystoscopy insertion through the urethra]
Pain measurement using a 0-10 visual analogue scale (VAS) and comparison of average pain score between the four study groups.
Pain immediately after procedure [Immediately after withdrawal of the cystoscope from the urethra]
Pain measurement using a 0-10 visual analogue scale (VAS) and comparison of average pain score between the four study groups.
Pain 15 minutes after procedure [15 minutes after end of procedure]
Pain measurement using a 0-10 visual analogue scale (VAS) and comparison of average pain score between the four study groups.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assaf Harofe Medical Center	Be'er Ya'aqov		Israel	70300

Sponsors and Collaborators

Assaf-Harofeh Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Prof. Kobi Stav, Senior Urologist, Assaf-Harofeh Medical Center

ClinicalTrials.gov Identifier:

NCT03210038

Other Study ID Numbers:

0290-16-ASF

First Posted:

Jul 6, 2017

Last Update Posted:

Dec 4, 2019

Last Verified:

Dec 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

No

Studies a U.S. FDA-regulated Device Product:

No

Product Manufactured in and Exported from the U.S.:

No

Keywords provided by Prof. Kobi Stav, Senior Urologist, Assaf-Harofeh Medical Center

Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 4, 2019