Skip to main content
OpenTrials
Completed

NCT Number: NCT04198064

Pain Management for Cystoscopy: A Prospective Randomized Study Focused on Understanding the Role of the "Bag Squeeze" to Manage Pain for Patients Undergoing Cystoscopy

The purpose of this study is to determine whether utilization of the "bag squeeze" technique during flexible cystoscopy changes pain scores using a study questionnaire designed by the team which comprises a validated Lingard pain rating scale.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pain, Procedural Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Heidi Wagner

Toronto, Ontario, M5G 1Z5, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male
  • Undergoing flexible cystocopy at University Health Network that have undergone a flexible cystocopy and did not demonstrate difficulty during exploration (meatal stenosis or urethral stricture), simultaneous removal or ureteral stents or bladder biopsies or have a chronic history of pelvic pain

Exclusion criteria

  • Patients that do not meet the inclusion criteria.

Treatment and study plan

Bag Squeeze

Procedure

Participants will receive a "bag squeeze" of irrigation fluid (500 ml/~2 cups of % 0.9 saline solution) during the insertion of the cystocopy tube during their cystocopy.

No Bag Squeeze

Procedure

Participants will receive a standard cystocopy procedure as per standard of care.

Primary outcomes

  1. Pain Rating

    Time frame: The outcome measure will be assessed for up to 4 hours after consent and completion of clinical procedure.

    Participants will be asked to rate their pain on the study-specific Lingard pain scale post-cystocopy.

    The Lingard pain scale is an outcome measure scaled from 0 (no pain) to 10 (pain as bad it could be). The higher the reported rating out of 10, the more pain the participant has experienced.

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Acronym: PMC

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 13, 2019
Registry last updated
Dec 13, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.