PainNCT01837628
Reducing Urethral Pain During Urodynamic Test - Comparison Between Lidocaine Gel and Paraffin Oil
A study testing Lidocaine Gel and Paraffin Oil in people with Pain, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
Our purpose is to compare between intraurethral lidocaine gel and paraffin oil in reducing urethral pain during urodynamic test. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Pain
- What is being tested?
- Lidocaine Gel and Paraffin Oil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2013to Jan 2014
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All men who will be referred for urodynamic test
Who cannot join
- Active infection
- Permanent Catheter
Trial locations and contacts
1 site in 1 country.
Kobi Stav, MD contact
Israel1 site, 1 recruiting
- Recruiting
Assaf Harofe Medical Center
Tsrifin, 70300
Kobi Stav, MD, stavkobi@gmail.com
Kobi Stav, MD
About this study
Our purpose is to compare between intraurethral lidocaine gel and paraffin oil in reducing urethral pain during urodynamic test.
Read the detailed description
Patients will be randomized into two groups: 1) Lidocaine Gel 2) Paraffin Oil. They will fill out 1 visual analogue scale (0-10) for urethral pain during the test.
- Conditions
- Pain
- Being tested
- Lidocaine Gel, Paraffin Oil
- Keywords
- Urodynamic, Paraffin oil, Lidocaine gel, Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine GelDrug
Paraffin OilDrug
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine gel | Active comparator | Intraurethral Lidocaine gel 2% Receives: Drug: Lidocaine Gel |
| Paraffin Oil | Experimental | Intraurethral injection Receives: Drug: Paraffin Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue scale (0-10) for pain
patients will fill ou the scale before, during and immediately after the test
Measured: up to 1 hour after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2013 (estimated)
- Study startFeb 2013
- Primary completionJan 2014 (estimated)
- Study completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Kobi Stav, MD, Principal investigator, Assaf Harofe MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01837628
- Sponsor's protocol ID
- 7/13
- Status last verified
- Apr 2013
- First submitted
- 18 Apr 2013
- Last updated
- 23 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Urethral Pain During Urodynamic Test - Comparison Between Lidocaine Gel and Paraffin Oil
- ClinicalTrials.gov ID
- NCT01837628
- Acronym / sponsor ID
- 7/13
- Conditions
- Pain
- Keywords
- Urodynamic, Paraffin oil, Lidocaine gel, Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Feb 2013
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 23 Apr 2013 (estimated)
- 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.
Our purpose is to compare between intraurethral lidocaine gel and paraffin oil in reducing urethral pain during urodynamic test.
Detailed description
Patients will be randomized into two groups: 1) Lidocaine Gel 2) Paraffin Oil. They will fill out 1 visual analogue scale (0-10) for urethral pain during the test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine gel | Active comparator | Drug: Lidocaine GelIntraurethral Lidocaine gel 2% |
| Paraffin Oil | Experimental | Drug: Paraffin OilIntraurethral injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All men who will be referred for urodynamic test
Key exclusion criteria (2 listed)
- Active infection
- Permanent Catheter
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 Gel | Drug | Lidocaine gel |
| Paraffin Oil | Drug | Paraffin Oil |
Primary outcome
Visual Analogue scale (0-10) for pain
Time frame: up to 1 hour after the procedure
patients will fill ou the scale before, during and immediately after the test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2013.
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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.
Kobi Stav, MD contact
Kobi Stav, MD principal investigator
Assaf Harofe MC
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 and Paraffin Oil in people with Pain, run by Assaf-Harofeh Medical Center at 1 site in Israel.
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 2 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 23 Apr 2013. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kobi Stav, MD (stavkobi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue scale (0-10) for pain (time frame: up to 1 hour after the 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 23 Apr 2013.