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

NCT04198064 | Completed

• 1 other identifier: 19-5661
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Procedural

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Group A- Bag Squeeze

EXPERIMENTAL

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.

Procedure: Bag Squeeze

Group B- No Bag Squeeze

OTHER

Participants will receive a standard cystoscopy procedure.

Procedure: No Bag Squeeze

Interventions

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.

Group A- Bag Squeeze

No Bag Squeeze PROCEDURE

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

Group B- No Bag Squeeze

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Heidi Wagner

Toronto, Ontario, M5G 1Z5, Canada

Location

MeSH Terms

Conditions

Pain, Procedural

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2019
• First Posted: December 13, 2019
• Study Start: September 16, 2019
• Primary Completion: November 12, 2019
• Study Completion: November 12, 2019
• Last Updated: December 13, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)