Pain, ProceduralPMCNCT04198064
Pain Management for Cystoscopy: A Prospective Randomized Study Focused on Understanding the Role of the "Bag Squeeze" to Manage Pain for Patients Undergoing Cystoscopy
A study testing Bag Squeeze and No Bag Squeeze in people with Pain, Procedural, run by University Health Network, Toronto at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Pain, Procedural
- What is being tested?
- Bag Squeeze and No Bag Squeeze
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 1 siteCanada
- Study dates
- 16 Sep 2019to 12 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients that do not meet the inclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Bag Squeeze, No Bag Squeeze
- Medical subject headings
- Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bag SqueezeProcedure or surgery
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 SqueezeProcedure or surgery
Participants will receive a standard cystocopy procedure as per standard of care.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Bag Squeeze |
| Group B- No Bag Squeeze | Other | Participants will receive a standard cystoscopy procedure. Receives: Procedure: No Bag Squeeze |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The outcome measure will be assessed for up to 4 hours after consent and completion of clinical procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start16 Sep 2019
- Primary completion12 Nov 2019
- Study completion12 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, ProceduralStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04198064
- Sponsor's protocol ID
- 19-5661
- Acronym
- PMC
- Status last verified
- Nov 2019
- First submitted
- 1 Oct 2019
- Last updated
- 13 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04198064
- Acronym / sponsor ID
- PMC / 19-5661
- Conditions
- Pain, Procedural
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 16 Sep 2019 (actual)
- Primary completion
- 12 Nov 2019 (actual)
- Study completion
- 12 Nov 2019 (actual)
- First posted
- 13 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A- Bag Squeeze | Experimental | Procedure: Bag SqueezeParticipants 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 | Other | Procedure: No Bag SqueezeParticipants will receive a standard cystoscopy procedure. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Patients that do not meet the inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bag SqueezeParticipants 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. | Procedure or surgery | Group A- Bag Squeeze |
| No Bag SqueezeParticipants will receive a standard cystocopy procedure as per standard of care. | Procedure or surgery | Group B- No Bag Squeeze |
Primary outcome
Pain Rating
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bag Squeeze and No Bag Squeeze in people with Pain, Procedural, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Rating (time frame: The outcome measure will be assessed for up to 4 hours after consent and completion of clinical procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2019.