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

Pain, Procedural Clinical Trial

— PMC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04198064
• Other study ID #: 19-5661
• Status: Completed
• Phase: N/A
• Start date: September 16, 2019
• Est. completion date: November 12, 2019

Study information

• Verified date: November 2019
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: November 12, 2019
• Est. primary completion date: November 12, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Procedural

Intervention

Procedure:
• Bag Squeeze
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
Participants will receive a standard cystocopy procedure as per standard of care.

Locations

Country	Name	City	State
Canada	Heidi Wagner	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Rating	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.	The outcome measure will be assessed for up to 4 hours after consent and completion of clinical procedure.