PainPhase 4NCT00883103
Double Blinded Randomized Trial Between Lidocaine And Plain Gel For Urethral Straight Catheterization And The Q-Tip Test
A Phase 4 study testing 2% Lidocaine jelly and Plain aqueous gel in people with Pain, run by Baystate Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to compare the pain perception between lidocaine and plain aqueous gel during assessment of postvoid residual volume and the Q-tip test. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- 2% Lidocaine jelly and Plain aqueous gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 137 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Sep 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All women who presented to a single urogynecologist's office for an initial consultation with a complaint of urinary incontinence and/or pelvic organ prolapse
Who cannot join
- Being a minor
- Pregnancy
- Allergy to Lidocaine or aqueous lubricant gel
- Any current use of analgesia
- Structural abnormalities of the urethra
- Active genital Herpes or other vulvovaginal infections or inability to cooperate with pain assessment due to mental disorders.
Trial locations and contacts
1 site in 1 country.
United States1 site
Baystate Medical Center
Springfield, Massachusetts, 01199
About this study
Official title: Double Blinded Randomized Trial Between Lidocaine Jelly And Plain Aqueous Gel For Urethral Straight Catheterization And The Q-Tip Test
The purpose of this study is to compare the pain perception between lidocaine and plain aqueous gel during assessment of postvoid residual volume and the Q-tip test.
Read the detailed description
This study was approved by the institutional review board at Baystate Medical Center. The study pool consists of all women who present to a single urogynecologist's office for an initial consultation with a complaint of urinary incontinence and/or pelvic organ prolapse. Those patients who consent for the research will be then randomized either to 2% Lidocaine Hydrochloride jelly (Akorn, Buffalo Grove, IL) or Surgilube (Fougera, Melville, NY) using computer generated blocks of 10. The latter is a commonly used, commercially available aqueous lubricant gel. Both the urogynecologist who perform the examinations and the patient will be blinded to the randomization. The appearances of the study gels are indistinguishable. Based on our power analysis targeting a power of 0.80, an α value of 0.05, and 20% difference in pain perception between the groups, we are aiming to recruit a sample of minimum132 subjects.
First, demographic information including the age, parity, previous vaginal births, body mass index (BMI), race, diabetes, vaginal atrophy, neurological impairment, current estrogen use, indication for visit and exam anxiety will be collected as a part of patient history. Immediately after voiding, each patient will be placed in a lithotomy position. An independent nurse who is not involved in patient's care will prepare the study gels according to the randomization. After cleansing external urethral meatus with povidone iodine solution, a lubricated a sterile 14-French polyvinyl chloride Mentor Self-Cath catheter (Coloplast, Minneapolis, MN) will be placed transurethrally into the bladder to measure the postvoid residual volume. Following removal of the catheter, a cotton swab, lubricated with the same allocated gel, will be advanced to the urethrovesical junction until resistance was felt. The angle of the Q-tip with the horizontal plane will be measured at rest and with Valsalva maneuver. All the examinations will be performed by the same urogynecologist in the same order. Immediately following the Q-tip test, patient's perception of pain level will be measured using a validated pain scoring system, the Wong-Baker FACES visual scale where 0 represented no pain and 5 represented worst imaginable pain. The rest of the physical examination will be completed after this pain assessment.
We will evaluate patient characteristics and pain score variables by exposure to either Lidocaine or Surgilube using SPSS Version 11.01 software (Chicago, Illinois). For continuous variables, we will calculate the mean and standard deviation and then evaluate significant differences using the Mann Whitney U test. For categorical variables, we will calculate the number and percent and then evaluate significant differences using Pearson's chi-square test. Significance for all results was set at an alpha of <0.05.
- Conditions
- Pain
- Being tested
- 2% Lidocaine jelly, Plain aqueous gel
- Keywords
- female urethral catheterization, Lidocaine, lubricant, Q-tip test, Q tip test, K-Y jelly, pain perception, straight catheterization
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2% Lidocaine jellyDrug
2% Lidocaine jelly will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test.
Plain aqueous gelDrug
Also called Surgilube
Plain aqueous gel will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test.
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine | Active comparator | 2% Lidocaine jelly will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test. Receives: Drug: 2% Lidocaine jelly |
| Aqueous gel | Placebo comparator | Plain aqueous gel as placebo will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test. Receives: Drug: Plain aqueous gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's Perception of Pain Using the Wong-Baker FACES Visual Scale: 0 - no Pain; 5 - Worst Imaginable Pain
A sterile catheter lubricated with the allocated gel was placed transurethrally into the bladder to measure the postvoid residual volume. After removal of the catheter, a cotton swab, coated with the same allocated gel, was advanced to the urethrovesical junction until resistance was felt. The angle of the swab with the horizontal plane was measured at rest and with a Valsalva maneuver. Immediately following the Q-tip test, the patient's perception of pain level was measured by Wong-Baker FACES Pain Scale, a visual scale where 0 represents no pain and 5 represents worst imaginable pain.
Measured: Immediately after the examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2009 (estimated)
- Study startNov 2007
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baystate Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Oz Harmanli, MD, Principal investigator, Baystate Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00883103
- Sponsor's protocol ID
- 07-091
- Status last verified
- Aug 2011
- First submitted
- 15 Apr 2009
- Last updated
- 13 Sep 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Harmanli OH, Okafor O, Ayaz R, Knee A. Lidocaine jelly and plain aqueous gel for urethral straight catheterization and the Q-tip test: a randomized controlled trial. Obstet Gynecol. 2009 Sep;114(3):547-550. doi: 10.1097/AOG.0b013e3181b43808.
PubMed 19701033
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blinded Randomized Trial Between Lidocaine Jelly And Plain Aqueous Gel For Urethral Straight Catheterization And The Q-Tip Test
- ClinicalTrials.gov ID
- NCT00883103
- Acronym / sponsor ID
- 07-091
- Conditions
- Pain
- Keywords
- female urethral catheterization, Lidocaine, lubricant, Q-tip test, Q tip test, K-Y jelly, pain perception, straight catheterization
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Baystate Medical CenterUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 17 Apr 2009 (estimated)
- Results
- Posted 13 Sep 2011
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 compare the pain perception between lidocaine and plain aqueous gel during assessment of postvoid residual volume and the Q-tip test.
Detailed description
This study was approved by the institutional review board at Baystate Medical Center. The study pool consists of all women who present to a single urogynecologist's office for an initial consultation with a complaint of urinary incontinence and/or pelvic organ prolapse. Those patients who consent for the research will be then randomized either to 2% Lidocaine Hydrochloride jelly (Akorn, Buffalo Grove, IL) or Surgilube (Fougera, Melville, NY) using computer generated blocks of 10. The latter is a commonly used, commercially available aqueous lubricant gel. Both the urogynecologist who perform the examinations and the patient will be blinded to the randomization. The appearances of the study gels are indistinguishable. Based on our power analysis targeting a power of 0.80, an α value of 0.05, and 20% difference in pain perception between the groups, we are aiming to recruit a sample of minimum132 subjects.
First, demographic information including the age, parity, previous vaginal births, body mass index (BMI), race, diabetes, vaginal atrophy, neurological impairment, current estrogen use, indication for visit and exam anxiety will be collected as a part of patient history. Immediately after voiding, each patient will be placed in a lithotomy position. An independent nurse who is not involved in patient's care will prepare the study gels according to the randomization. After cleansing external urethral meatus with povidone iodine solution, a lubricated a sterile 14-French polyvinyl chloride Mentor Self-Cath catheter (Coloplast, Minneapolis, MN) will be placed transurethrally into the bladder to measure the postvoid residual volume. Following removal of the catheter, a cotton swab, lubricated with the same allocated gel, will be advanced to the urethrovesical junction until resistance was felt. The angle of the Q-tip with the horizontal plane will be measured at rest and with Valsalva maneuver. All the examinations will be performed by the same urogynecologist in the same order. Immediately following the Q-tip test, patient's perception of pain level will be measured using a validated pain scoring system, the Wong-Baker FACES visual scale where 0 represented no pain and 5 represented worst imaginable pain. The rest of the physical examination will be completed after this pain assessment.
We will evaluate patient characteristics and pain score variables by exposure to either Lidocaine or Surgilube using SPSS Version 11.01 software (Chicago, Illinois). For continuous variables, we will calculate the mean and standard deviation and then evaluate significant differences using the Mann Whitney U test. For categorical variables, we will calculate the number and percent and then evaluate significant differences using Pearson's chi-square test. Significance for all results was set at an alpha of <0.05.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine | Active comparator | Drug: 2% Lidocaine jelly2% Lidocaine jelly will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test. |
| Aqueous gel | Placebo comparator | Drug: Plain aqueous gelPlain aqueous gel as placebo will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All women who presented to a single urogynecologist's office for an initial consultation with a complaint of urinary incontinence and/or pelvic organ prolapse
Key exclusion criteria (6 listed)
- Being a minor
- Pregnancy
- Allergy to Lidocaine or aqueous lubricant gel
- Any current use of analgesia
- Structural abnormalities of the urethra
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 |
|---|---|---|
| 2% Lidocaine jelly2% Lidocaine jelly will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test. | Drug | Lidocaine |
| Plain aqueous gelAlso: SurgilubePlain aqueous gel will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test. | Drug | Aqueous gel |
Primary outcome
Patient's Perception of Pain Using the Wong-Baker FACES Visual Scale: 0 - no Pain; 5 - Worst Imaginable Pain
Time frame: Immediately after the examination
A sterile catheter lubricated with the allocated gel was placed transurethrally into the bladder to measure the postvoid residual volume. After removal of the catheter, a cotton swab, coated with the same allocated gel, was advanced to the urethrovesical junction until resistance was felt. The angle of the swab with the horizontal plane was measured at rest and with a Valsalva maneuver. Immediately following the Q-tip test, the patient's perception of pain level was measured by Wong-Baker FACES Pain Scale, a visual scale where 0 represents no pain and 5 represents worst imaginable pain.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19701033Harmanli OH, Okafor O, Ayaz R, Knee A. Lidocaine jelly and plain aqueous gel for urethral straight catheterization and the Q-tip test: a randomized controlled trial. Obstet Gynecol. 2009 Sep;114(3):547-550. doi: 10.1097/AOG.0b013e3181b43808.
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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.
Oz Harmanli, MD principal investigator
Baystate Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 2% Lidocaine jelly and Plain aqueous gel in people with Pain, run by Baystate Medical Center at 1 site in United States.
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 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: finished, as of the sponsor's last update on 13 Sep 2011. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Sep 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Patient's Perception of Pain Using the Wong-Baker FACES Visual Scale: 0 - no Pain; 5 - Worst Imaginable Pain (time frame: Immediately after the examination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00883103, which also lists 1 linked publication.
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 Sep 2011.