HematuriaNCT03257293
A Trial of a Modified Cystoscopy Method to Reduce Pain Perception
A study testing Modified Cystoscopy and Routine Cystoscopy in people with Hematuria and Bladder Cancer, run by Western University, Canada at 1 site in Canada.
Trial summary
The goal of this project is to improve patient experience of cystoscopy using a non-pharmacologic modification of procedure. Cystoscopy is a common outpatient procedure for urology patients and is usually performed without sedation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematuria, Bladder Cancer, Bladder Disease
- What is being tested?
- Modified Cystoscopy and Routine Cystoscopy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2018to 1 Aug 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over the age of 18 undergoing cystoscopy for the first time for diagnostic investigation will be approached to participate in this study.
Who cannot join
- Cystoscopies involving other interventions concurrently (e.g. biopsy, urethral dilation, removal of ureteral stent, etc.) will be excluded.
- Patients currently taking medication for chronic pain (e.g. opioids, Tricyclic antidepressants (TCAs)) will be excluded from the study.
- Patients less than 18 years of age will be excluded.
- Patients who have received a cystoscopy previously will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Control Trial of a Modified Cystoscopy Method to Reduce Pain Perception
The goal of this project is to improve patient experience of cystoscopy using a non-pharmacologic modification of procedure. Cystoscopy is a common outpatient procedure for urology patients and is usually performed without sedation. However, there is limited research into reduction of patient discomfort throughout this procedure. The proposed modification technique was selected based on a well-documented psychological phenomenon in which only particular moments over the course of an aversive event determine the resultant perception of the experience. It is hypothesized that implementation of the technique will decrease the recalled pain intensity of the cystoscopy.
- Conditions
- Hematuria, Bladder Cancer, Bladder Disease
- Being tested
- Modified Cystoscopy, Routine Cystoscopy
- Medical subject headings
- Hematuria, Urinary Bladder Neoplasms, Urinary Bladder Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified CystoscopyBehavioural
The objective of this study is to examine whether a non-pharmacologic modification in procedure of cystoscopies improves patient perception of pain and discomfort.
Routine CystoscopyBehavioural
Routine cystoscopy as done as part of routine clinical practice
| Study group | Role | What they receive |
|---|---|---|
| Routine Cystoscopy | Active comparator | Not described Receives: Behavioral: Routine Cystoscopy |
| Modified Cystoscopy | Experimental | Not described Receives: Behavioral: Modified Cystoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Experience rated on the visual analogue scale
The primary outcome of the study will be pain experience, as rated on the visual analogue scale provided.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study start1 Apr 2018
- Primary completion1 Aug 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HematuriaStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicholas Power, MD, Principal investigator, London Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03257293
- Sponsor's protocol ID
- 10016740
- Status last verified
- Apr 2021
- First submitted
- 18 Aug 2017
- Last updated
- 27 Apr 2021
- 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 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial of a Modified Cystoscopy Method to Reduce Pain Perception
- ClinicalTrials.gov ID
- NCT03257293
- Acronym / sponsor ID
- 10016740
- Conditions
- Hematuria, Bladder Cancer, Bladder Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 22 Aug 2017 (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 goal of this project is to improve patient experience of cystoscopy using a non-pharmacologic modification of procedure. Cystoscopy is a common outpatient procedure for urology patients and is usually performed without sedation. However, there is limited research into reduction of patient discomfort throughout this procedure. The proposed modification technique was selected based on a well-documented psychological phenomenon in which only particular moments over the course of an aversive event determine the resultant perception of the experience. It is hypothesized that implementation of the technique will decrease the recalled pain intensity of the cystoscopy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine Cystoscopy | Active comparator | Behavioral: Routine Cystoscopy |
| Modified Cystoscopy | Experimental | Behavioral: Modified Cystoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients over the age of 18 undergoing cystoscopy for the first time for diagnostic investigation will be approached to participate in this study.
Key exclusion criteria (4 listed)
- Cystoscopies involving other interventions concurrently (e.g. biopsy, urethral dilation, removal of ureteral stent, etc.) will be excluded.
- Patients currently taking medication for chronic pain (e.g. opioids, Tricyclic antidepressants (TCAs)) will be excluded from the study.
- Patients less than 18 years of age will be excluded.
- Patients who have received a cystoscopy previously will be excluded.
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 |
|---|---|---|
| Modified CystoscopyThe objective of this study is to examine whether a non-pharmacologic modification in procedure of cystoscopies improves patient perception of pain and discomfort. | Behavioural | Modified Cystoscopy |
| Routine CystoscopyRoutine cystoscopy as done as part of routine clinical practice | Behavioural | Routine Cystoscopy |
Primary outcome
Pain Experience rated on the visual analogue scale
Time frame: 1 hour
The primary outcome of the study will be pain experience, as rated on the visual analogue scale provided.
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 27 Apr 2021.
- Individual participant dataSharing planned: No
Related trials for Hematuria
Active, not recruitingObservational study
Detection and Risk Stratification in Veterans Presenting With Microscopic Hematuria
Urothelial Carcinoma
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Screening for Urological Malignancies Using a Urine Exfoliated Cell Fluorescence Assay in a Hematuria Population
UTUC, UC (Urothelial Cancer)
Not yet recruitingPhase 3
Effectiveness of Medical and Environmental Interventions to Reduce Cystoscopy Discomfort (CystoDiscomfort)
Bladder (Urothelial, Transitional Cell) Cancer, Hematuria
Recruiting
Use of PuraStat Following Aquablation to Determine if There is Change in Hematuria & Probability of Same Day Discharge
BPH (Benign Prostatic Hyperplasia), BPH With Symptomatic Lower Urinary Tract Symptoms
Recruiting
Study to Assess the Impact of the Urine Test Cxbladder Triage Plus on the Number of Cystoscopies Performed on Patients With Invisible Blood in Their Urine.
Hematuria - Cause Not Known
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.
Nicholas Power, MD principal investigator
London Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Cystoscopy and Routine Cystoscopy in people with Hematuria and Bladder Cancer, run by Western University, Canada 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 1 inclusion and 4 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 27 Apr 2021. 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 Experience rated on the visual analogue scale (time frame: 1 hour). 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 27 Apr 2021.