Voiding DisordersPhase 4NCT03390790
Lidocaine for Pain After Urodynamic Testing
A Phase 4 study testing Lidocaine gel 2% and Standard lubricant gel in people with Voiding Disorders and Overactive Bladder, run by Atlantic Health System at 1 site in United States.
Trial summary
Urodynamic testing can be associated with mild discomfort, particularly at the time of insertion, repositioning, and removal of the bladder catheter (a tube inserted into the bladder via the urethra). Few studies have investigated ways to improve patient comfort during this procedure. Read more about this study
- Who is it for?
- Ages 40 to 80 years, women only
- Conditions the study is for
- Voiding Disorders, Overactive Bladder, Urinary Incontinence
- What is being tested?
- Lidocaine gel 2% and Standard lubricant gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 134 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2018to 29 Mar 2019
- Phase
- Phase 4
- 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 40 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All female patients between the ages of 40-80 undergoing urodynamic testing.
Who cannot join
- Urinary tract infection or symptoms of infection at time of procedure or within past 2 weeks
- History of urinary retention
- Known or suggested history of urethral syndrome or painful bladder syndrome
- Prior anti-incontinence surgery
- Prior pelvic surgery with placement of transvaginal mesh
- Known urethral or bladder anomaly including urethral diverticulum or congenital anomalies of the bladder or urethra
Show all 13Show fewer
- History of genital herpes outbreak within the past 3 months
- Defects in mucosal surfaces including periurethral or vaginal abrasions, ulcerations, or lacerations
- Neurologic disease affecting urethral sensation
- Chronic pelvic pain
- Contraindication or allergy to topical anesthetic
- Pregnancy
- Syncopal episode during preparation for or execution of uroflowometry
Trial locations and contacts
1 site in 1 country.
United States1 site
Atlantic Health System
Morristown, New Jersey, 07960
About this study
Official title: The Impact of Pre-procedure Periurethral Topical Lidocaine Application on Pain Scores After Complex Urodynamic Testing in Women
Urodynamic testing can be associated with mild discomfort, particularly at the time of insertion, repositioning, and removal of the bladder catheter (a tube inserted into the bladder via the urethra). Few studies have investigated ways to improve patient comfort during this procedure. In this study, the investigators want to see if applying external lidocaine (a numbing gel) prior to the procedure can help to minimize patient discomfort.
Read the detailed description
Urodynamic testing can be associated with mild discomfort, particularly at the time of insertion, repositioning, and removal of the bladder catheter (a tube inserted into the bladder via the urethra). Few studies have investigated ways to improve patient comfort during this procedure. In this study, the investigators want to see if applying lidocaine (a numbing gel) prior to the procedure can help to minimize patient discomfort.
Participation in this study will involve only 1 clinic visit (for urodynamic testing), plus 2 phone calls to ask participants about pain (1 at 4-6 hours after testing; and 1 at 24 hours after testing). Additionally, the investigators will record any adverse effects (such as an allergic reaction to the gel or new irritation/pain) that happen within 2 weeks after testing.
Participants will be randomly assigned to receive either lidocaine gel or placebo gel for their urodynamic testing. The placebo gel will be a standard lubricant gel, meaning that it contains no active drug. The assigned study regimen will be chosen by chance, like flipping a coin. Participants will have an equal (50/50) chance of being given either study regimen. Neither the participant nor the study doctor or nurse practitioner will know which study regimen the participant is getting. Additionally, a member of the study team will ask participants about their pain level before and after the testing. The rest of the urodynamic testing procedure will take place exactly as it would if the participant was not in this research study.
- Conditions
- Voiding Disorders, Overactive Bladder, Urinary Incontinence
- Being tested
- Lidocaine gel 2%, Standard lubricant gel
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine gel 2%Drug
If assigned to this intervention via randomization, participants will receive lidocaine (numbing) gel prior to their urodynamics procedure.
Standard lubricant gelOther
If assigned to this intervention via randomization, participants will receive standard lubricant gel prior to their urodynamics procedure.
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine gel | Experimental | If assigned to this arm, participants have lidocaine gel 2% applied to their external urethra and vagina one time prior to the urodynamics procedure. Receives: Drug: Lidocaine gel 2% |
| Lubricant gel | Placebo comparator | If assigned to this arm, participants will have a standard lubricant gel applied to their external urethra and vagina prior to the urodynamics procedure. Receives: Other: Standard lubricant gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in patient visual analog pain score (vaginal area only) from before procedure to 4-6 hours after urodynamic testing
Participants will rate their pain according to a visual analog pain scale from 0 (no pain) to 100 (worst pain imaginable).
Measured: Baseline and 4-6 hours post procedure.
Secondary outcomes (5)
Change in patient visual analog pain score (vaginal area only) from before procedure to 24 hours after urodynamic testing.
Participants will rate their pain according to a visual analog pain scale from 0 (no pain) to 100 (worst pain imaginable).
Measured: Baseline and 24 hours post procedure.
Patient visual analog pain score (vaginal area only) before procedure, at conclusion of all procedure-related activities, 4-6 hours after procedure, and 24 hours after procedure.
Participants will rate their pain according to a visual analog pain scale from 0 (no pain) to 100 (worst pain imaginable).
Measured: Baseline and 24 hours post procedure.
To assess voiding difficulties and other adverse events immediately after urodynamic testing, at 4-6 hours, 24 hours, and two weeks after urodynamic testing.
Participants will receive a phone call at 4-6 hours and 24 hours after urodynamic testing. Any study participant-initiated complaints of voiding difficulties within two weeks of the procedure will be documented and addressed.
Measured: Baseline and 2 weeks post-procedure.
Urodynamic findings
Standard urodynamics findings will be analyzed.
Measured: At time of procedure.
Procedure time
Procedure time will be recorded for all subjects.
Measured: At time of procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2018
- Study start25 Jan 2018
- Primary completion29 Mar 2019
- Study completion29 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Voiding DisordersStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atlantic Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, charbel salamon, Atlantic Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03390790
- Sponsor's protocol ID
- 1112951-1
- Status last verified
- Jul 2019
- First submitted
- 20 Oct 2017
- Last updated
- 19 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Avondstondt AM, Chiu S, Salamon C. Periurethral Lidocaine Does Not Decrease Pain After Urodynamic Testing in Women: A Double-Blinded Randomized Control Trial. Female Pelvic Med Reconstr Surg. 2021 May 1;27(5):e528-e532. doi: 10.1097/SPV.0000000000000983.
PubMed 33208652
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Pre-procedure Periurethral Topical Lidocaine Application on Pain Scores After Complex Urodynamic Testing in Women
- ClinicalTrials.gov ID
- NCT03390790
- Acronym / sponsor ID
- 1112951-1
- Conditions
- Voiding Disorders, Overactive Bladder, Urinary Incontinence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Atlantic Health SystemUniversity, hospital or other
- Study start
- 25 Jan 2018 (actual)
- Primary completion
- 29 Mar 2019 (actual)
- Study completion
- 29 Mar 2019 (actual)
- First posted
- 4 Jan 2018 (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.
Urodynamic testing can be associated with mild discomfort, particularly at the time of insertion, repositioning, and removal of the bladder catheter (a tube inserted into the bladder via the urethra). Few studies have investigated ways to improve patient comfort during this procedure. In this study, the investigators want to see if applying external lidocaine (a numbing gel) prior to the procedure can help to minimize patient discomfort.
Detailed description
Urodynamic testing can be associated with mild discomfort, particularly at the time of insertion, repositioning, and removal of the bladder catheter (a tube inserted into the bladder via the urethra). Few studies have investigated ways to improve patient comfort during this procedure. In this study, the investigators want to see if applying lidocaine (a numbing gel) prior to the procedure can help to minimize patient discomfort.
Participation in this study will involve only 1 clinic visit (for urodynamic testing), plus 2 phone calls to ask participants about pain (1 at 4-6 hours after testing; and 1 at 24 hours after testing). Additionally, the investigators will record any adverse effects (such as an allergic reaction to the gel or new irritation/pain) that happen within 2 weeks after testing.
Participants will be randomly assigned to receive either lidocaine gel or placebo gel for their urodynamic testing. The placebo gel will be a standard lubricant gel, meaning that it contains no active drug. The assigned study regimen will be chosen by chance, like flipping a coin. Participants will have an equal (50/50) chance of being given either study regimen. Neither the participant nor the study doctor or nurse practitioner will know which study regimen the participant is getting. Additionally, a member of the study team will ask participants about their pain level before and after the testing. The rest of the urodynamic testing procedure will take place exactly as it would if the participant was not in this research study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine gel | Experimental | Drug: Lidocaine gel 2%If assigned to this arm, participants have lidocaine gel 2% applied to their external urethra and vagina one time prior to the urodynamics procedure. |
| Lubricant gel | Placebo comparator | Other: Standard lubricant gelIf assigned to this arm, participants will have a standard lubricant gel applied to their external urethra and vagina prior to the urodynamics procedure. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All female patients between the ages of 40-80 undergoing urodynamic testing.
Key exclusion criteria (13 listed)
- Urinary tract infection or symptoms of infection at time of procedure or within past 2 weeks
- History of urinary retention
- Known or suggested history of urethral syndrome or painful bladder syndrome
- Prior anti-incontinence surgery
- Prior pelvic surgery with placement of transvaginal mesh
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 2%If assigned to this intervention via randomization, participants will receive lidocaine (numbing) gel prior to their urodynamics procedure. | Drug | Lidocaine gel |
| Standard lubricant gelIf assigned to this intervention via randomization, participants will receive standard lubricant gel prior to their urodynamics procedure. | Other | Lubricant gel |
Primary outcome
The change in patient visual analog pain score (vaginal area only) from before procedure to 4-6 hours after urodynamic testing
Time frame: Baseline and 4-6 hours post procedure.
Participants will rate their pain according to a visual analog pain scale from 0 (no pain) to 100 (worst pain imaginable).
5 secondary outcomes
Change in patient visual analog pain score (vaginal area only) from before procedure to 24 hours after urodynamic testing.
Time frame: Baseline and 24 hours post procedure.
Patient visual analog pain score (vaginal area only) before procedure, at conclusion of all procedure-related activities, 4-6 hours after procedure, and 24 hours after procedure.
Time frame: Baseline and 24 hours post procedure.
To assess voiding difficulties and other adverse events immediately after urodynamic testing, at 4-6 hours, 24 hours, and two weeks after urodynamic testing.
Time frame: Baseline and 2 weeks post-procedure.
Urodynamic findings
Time frame: At time of procedure.
Procedure time
Time frame: At time of procedure.
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 19 Jul 2019.
- Derived from this study: PubMed 33208652Avondstondt AM, Chiu S, Salamon C. Periurethral Lidocaine Does Not Decrease Pain After Urodynamic Testing in Women: A Double-Blinded Randomized Control Trial. Female Pelvic Med Reconstr Surg. 2021 May 1;27(5):e528-e532. doi: 10.1097/SPV.0000000000000983.
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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 Phase 4 study testing Lidocaine gel 2% and Standard lubricant gel in people with Voiding Disorders and Overactive Bladder, run by Atlantic Health System 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 13 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 19 Jul 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 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?
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?
The change in patient visual analog pain score (vaginal area only) from before procedure to 4-6 hours after urodynamic testing (time frame: Baseline and 4-6 hours post procedure.). 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 NCT03390790, 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 19 Jul 2019.