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

Not Applicable

Completed

• Conditions: Pain, Procedural
• Interventions: Procedure: Bag Squeeze; Procedure: No Bag Squeeze

• Registration Number: NCT04198064
• Lead Sponsor: University Health Network, Toronto

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-16
• Study First Submitted: 2019-10-01
• Status Verified: 2019-11
• Primary Completion: 2019-11-12
• Study Completion: 2019-11-12
• Study First Submitted QC: 2019-12-12
• Last Update Submitted: 2019-12-12
• Study First Posted: 2019-12-13
• Last Update Posted: 2019-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 201

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

Read More

Exclusion Criteria

• Patients that do not meet the inclusion criteria.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A- Bag Squeeze	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 cystoscopy.
Group B- No Bag Squeeze	No Bag Squeeze	Participants will receive a standard cystoscopy procedure.

Primary Outcome Measures

Name	Time	Method
Pain Rating	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.

Trial Locations

Locations (1)

Heidi Wagner; 🇨🇦 Toronto, Ontario, Canada