Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03210038
Recruitment Status : Completed
First Posted : July 6, 2017
Last Update Posted : December 4, 2019
Sponsor:
Information provided by (Responsible Party):
Prof. Kobi Stav, Assaf-Harofeh Medical Center

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 Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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.
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 : March 1, 2017
Actual Primary Completion Date : December 1, 2019
Actual Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Pain before procedure [ Time Frame: Before cystoscopy ]
    Pain measurement using a 0-10 visual analogue scale (VAS) and comparison of average pain score between the four study groups.

  2. Pain during meatus insertion of cystoscope [ Time Frame: 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.

  3. Pain immediately after procedure [ Time Frame: 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.

  4. Pain 15 minutes after procedure [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03210038


Locations
Layout table for location information
Israel
Assaf Harofe Medical Center
Be'er Ya'aqov, Israel, 70300
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Publications of Results:
Layout table for additonal information
Responsible Party: Prof. Kobi Stav, Senior Urologist, Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT03210038    
Other Study ID Numbers: 0290-16-ASF
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: December 4, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD data includes age, BMI, previous medical, urological information. Pain levels during different stages of cystoscopy will be recorded.

Layout table for additional information
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, Assaf-Harofeh Medical Center:
Cystoscopy
Additional relevant MeSH terms:
Layout table for MeSH terms
Hematuria
Dysuria
Urination Disorders
Urologic Diseases
Hemorrhage
Pathologic Processes
Lower Urinary Tract Symptoms
Urological Manifestations
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action