Back to resultsPain Management for Cystoscopy: A Prospective Randomized Study Focused on Understanding the Role of the "Bag Squeeze" to Manage Pain for Patients Undergoing Cystoscopy (PMC)
Primary Purpose
Pain, Procedural
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Bag Squeeze
No Bag Squeeze
Sponsored by
About this trial
This is an interventional other trial for Pain, Procedural
Eligibility Criteria
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.
Sites / Locations
- Heidi Wagner
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Group A- Bag Squeeze
Group B- No Bag Squeeze
Arm Description
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.
Participants will receive a standard cystoscopy procedure.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04198064
First Posted
October 1, 2019
Last Updated
December 12, 2019
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT04198064
Brief 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
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
September 16, 2019 (Actual)
Primary Completion Date
November 12, 2019 (Actual)
Study Completion Date
November 12, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Procedural
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
201 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A- Bag Squeeze
Arm Type
Experimental
Arm Description
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.
Arm Title
Group B- No Bag Squeeze
Arm Type
Other
Arm Description
Participants will receive a standard cystoscopy procedure.
Intervention Type
Procedure
Intervention Name(s)
Bag Squeeze
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
No Bag Squeeze
Intervention Description
Participants will receive a standard cystocopy procedure as per standard of care.
Primary Outcome Measure Information:
Title
Pain Rating
Description
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.
Time Frame
The outcome measure will be assessed for up to 4 hours after consent and completion of clinical procedure.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Heidi Wagner
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1Z5
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pain Management for Cystoscopy: A Prospective Randomized Study Focused on Understanding the Role of the "Bag Squeeze" to Manage Pain for Patients Undergoing Cystoscopy
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