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OpenTrials
Completed

NCT Number: NCT03210038

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Assaf Harofe Medical Center

Be’er Ya‘aqov, 70300, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lidocaine

Drug

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

Water

Drug

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

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Assaf-Harofeh Medical Center

Other Gov

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 6, 2017
Registry last updated
Dec 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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