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

NCT ID: NCT04198064

Last Updated: 2019-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

201 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-16

Study Completion Date

2019-11-12

Brief Summary

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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

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Conditions

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Pain, Procedural

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Group A- 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 Type EXPERIMENTAL

Bag Squeeze

Intervention Type 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 B- No Bag Squeeze

Participants will receive a standard cystoscopy procedure.

Group Type OTHER

No Bag Squeeze

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type PROCEDURE

No Bag Squeeze

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Heidi Wagner

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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19-5661

Identifier Type: -

Identifier Source: org_study_id