Flexible CystoscopyNCT03874364
The Effect of Intraurethral Lidocaine Gel on Pain Perception During Flexible Cystoscopy
A study testing Lidocaine gel, Counselling and Monitor in people with Flexible Cystoscopy, run by Ajet Hyseni at 1 site in Switzerland.
Trial summary
Flexible cystoscopy is routinely performed by urologists. Many patients have concerns to undergo this procedure and expect it to be unpleasant or even painful. Thus, reduction of pain and discomfort during cystoscopy is of great interest, but there is not sufficient evidence regarding the most appropriate conduct of… Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Flexible Cystoscopy
- What is being tested?
- Lidocaine gel, Counselling and Monitor
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 280 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Feb 2019to Jan 2021
- 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
- Men 18 - 80 years
- Given indication for flexible cystoscopy
- Written informed consent
Who cannot join
- Allergy to amid anesthetics
- Urinary tract infection
- Use of analgesics in the previous 24 hours and chronic intake of analgesics
- Dementia
- Presence of a sensory disorder such as or spinal cord injury
- Indwelling catheter carrier
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Klinik für Urologie, Kantonsspital Luzern
Lucerne, 6000
Carlo Di Bona, +41 41 205 6308, carlo.dibona@luks.ch
About this study
Official title: The Effect of Intraurethral Lidocaine Gel in Comparison With Plain Lubricating Gel on Pain Perception During Flexible Cystoscopy: A Prospective Randomized Study
Flexible cystoscopy is routinely performed by urologists. Many patients have concerns to undergo this procedure and expect it to be unpleasant or even painful. Thus, reduction of pain and discomfort during cystoscopy is of great interest, but there is not sufficient evidence regarding the most appropriate conduct of cystoscopy.
In this study the impact of lidocaine gel, patient counseling and monitoring regarding pain perception during flexible cystoscopy are investigated.
- Conditions
- Flexible Cystoscopy
- Being tested
- Lidocaine gel, Counselling, Monitor, Lubricating gel, No counselling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine gelDevice
10 ml 2% lidocaine gel is instilled with a syringe through the length of the urethra and kept in site at least 5 minutes prior the introduction of the cystoscope.
CounsellingOther
Patients receive a brochure in the waiting room explaining the procedure in details.
MonitorOther
Patients are allowed to view and follow the procedure on a monitor connected to the cystoscope's camera.
Lubricating gelDevice
10 ml plain lubrificant gel is instilled with a syringe through the length of the urethra and kept in site at least 5 minutes prior the introduction of the cystoscope.
No counsellingOther
Patients won't receive a brochure in the waiting room explaining the procedure in details.
No monitorOther
Patients are not allowed to view and follow the procedure on a monitor connected to the cystoscope's camera.
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine gel, counselling, monitor | Active comparator | Not described Receives: Device: Lidocaine gel; Other: Counselling; Other: Monitor |
| Lidocaine gel, counselling, no monitor | Active comparator | Not described Receives: Device: Lidocaine gel; Other: Counselling; Other: No monitor |
| Lidocaine gel, no counselling, monitor | Active comparator | Not described Receives: Device: Lidocaine gel; Other: Monitor; Other: No counselling |
| Lidocaine gel, no counselling, no monitor | Active comparator | Not described Receives: Device: Lidocaine gel; Other: No counselling; Other: No monitor |
| Lubricating gel, counselling, monitor | Placebo comparator | Not described Receives: Other: Counselling; Other: Monitor; Device: Lubricating gel |
| Lubricating gel, counselling, no monitor | Placebo comparator | Not described Receives: Other: Counselling; Device: Lubricating gel; Other: No monitor |
| Lubricating gel, no counselling, monitor | Placebo comparator | Not described Receives: Other: Monitor; Device: Lubricating gel; Other: No counselling |
| Lubricating gel, no counselling, no monitor | Placebo comparator | Not described Receives: Device: Lubricating gel; Other: No counselling; Other: No monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain based on a numeric rating scale
The pain scale ranging from 0 ("no pain") to 10 ("worst possible pain").
Measured: During flexible cystoscopy
Secondary outcomes (4)
Pain based on a numeric rating scale
The pain scale ranging from 0 ("no pain") to 10 ("worst possible pain").
Measured: Immediately before flexible cystoscopy
Pain based on a numeric rating scale
The pain scale ranging from 0 ("no pain") to 10 ("worst possible pain").
Measured: 10 min after flexible cystoscopy
Pain based on a numeric rating scale
The pain scale ranging from 0 ("no pain") to 10 ("worst possible pain").
Measured: 3 days after flexible cystoscopy
Pain based on a verbal rating scale
The pain scale ranging from 0 ("it was not unpleasant") to 5 ("the investigation was almost unbearable").
Measured: Immediately after flexible cystoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2019
- Study start1 Feb 2019
- Primary completionJan 2021 (estimated)
- Study completionJan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flexible CystoscopyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ajet Hyseni
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ajet Hyseni, Luzerner Kantonsspital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03874364
- Sponsor's protocol ID
- Lidocaine-study
- Status last verified
- Mar 2019
- First submitted
- 12 Mar 2019
- Last updated
- 14 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intraurethral Lidocaine Gel in Comparison With Plain Lubricating Gel on Pain Perception During Flexible Cystoscopy: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT03874364
- Acronym / sponsor ID
- Lidocaine-study
- Conditions
- Flexible Cystoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Ajet HyseniUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 14 Mar 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.
Flexible cystoscopy is routinely performed by urologists. Many patients have concerns to undergo this procedure and expect it to be unpleasant or even painful. Thus, reduction of pain and discomfort during cystoscopy is of great interest, but there is not sufficient evidence regarding the most appropriate conduct of cystoscopy.
In this study the impact of lidocaine gel, patient counseling and monitoring regarding pain perception during flexible cystoscopy are investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Lidocaine gel, counselling, monitor | Active comparator | Device: Lidocaine gel, Other: Counselling, Other: Monitor |
| Lidocaine gel, counselling, no monitor | Active comparator | Device: Lidocaine gel, Other: Counselling, Other: No monitor |
| Lidocaine gel, no counselling, monitor | Active comparator | Device: Lidocaine gel, Other: Monitor, Other: No counselling |
| Lidocaine gel, no counselling, no monitor | Active comparator | Device: Lidocaine gel, Other: No counselling, Other: No monitor |
| Lubricating gel, counselling, monitor | Placebo comparator | Other: Counselling, Other: Monitor, Device: Lubricating gel |
| Lubricating gel, counselling, no monitor | Placebo comparator | Other: Counselling, Device: Lubricating gel, Other: No monitor |
| Lubricating gel, no counselling, monitor | Placebo comparator | Other: Monitor, Device: Lubricating gel, Other: No counselling |
| Lubricating gel, no counselling, no monitor | Placebo comparator | Device: Lubricating gel, Other: No counselling, Other: No monitor |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men 18 - 80 years
- Given indication for flexible cystoscopy
- Written informed consent
Key exclusion criteria (6 listed)
- Allergy to amid anesthetics
- Urinary tract infection
- Use of analgesics in the previous 24 hours and chronic intake of analgesics
- Dementia
- Presence of a sensory disorder such as or spinal cord injury
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 |
|---|---|---|
| Lidocaine gel10 ml 2% lidocaine gel is instilled with a syringe through the length of the urethra and kept in site at least 5 minutes prior the introduction of the cystoscope. | Device | Lidocaine gel, counselling, monitor, Lidocaine gel, counselling, no monitor, Lidocaine gel, no counselling, monitor, Lidocaine gel, no counselling, no monitor |
| CounsellingPatients receive a brochure in the waiting room explaining the procedure in details. | Other | Lidocaine gel, counselling, monitor, Lidocaine gel, counselling, no monitor, Lubricating gel, counselling, monitor, Lubricating gel, counselling, no monitor |
| MonitorPatients are allowed to view and follow the procedure on a monitor connected to the cystoscope's camera. | Other | Lidocaine gel, counselling, monitor, Lidocaine gel, no counselling, monitor, Lubricating gel, counselling, monitor, Lubricating gel, no counselling, monitor |
| Lubricating gel10 ml plain lubrificant gel is instilled with a syringe through the length of the urethra and kept in site at least 5 minutes prior the introduction of the cystoscope. | Device | Lubricating gel, counselling, monitor, Lubricating gel, counselling, no monitor, Lubricating gel, no counselling, monitor, Lubricating gel, no counselling, no monitor |
| No counsellingPatients won't receive a brochure in the waiting room explaining the procedure in details. | Other | Lidocaine gel, no counselling, monitor, Lidocaine gel, no counselling, no monitor, Lubricating gel, no counselling, monitor, Lubricating gel, no counselling, no monitor |
| No monitorPatients are not allowed to view and follow the procedure on a monitor connected to the cystoscope's camera. | Other | Lidocaine gel, counselling, no monitor, Lidocaine gel, no counselling, no monitor, Lubricating gel, counselling, no monitor, Lubricating gel, no counselling, no monitor |
Primary outcome
Pain based on a numeric rating scale
Time frame: During flexible cystoscopy
The pain scale ranging from 0 ("no pain") to 10 ("worst possible pain").
4 secondary outcomes
Pain based on a numeric rating scale
Time frame: Immediately before flexible cystoscopy
Pain based on a numeric rating scale
Time frame: 10 min after flexible cystoscopy
Pain based on a numeric rating scale
Time frame: 3 days after flexible cystoscopy
Pain based on a verbal rating scale
Time frame: Immediately after flexible cystoscopy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine gel, Counselling and Monitor in people with Flexible Cystoscopy, run by Ajet Hyseni at 1 site in Switzerland.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 14 Mar 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 Switzerland. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ajet Hyseni, Dr.med.univ.RKS (0+41 41 205 6959, ajet.hyseni@luks.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain based on a numeric rating scale (time frame: During flexible cystoscopy). 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 14 Mar 2019.