Urethra IssuePhase 4LULUNCT04038099
Lessons on Urethral Lidocaine in Urodynamics
A Phase 4 study testing Water-Based Vaginal Lubricant and lidocaine topical in people with Urethra Issue and Pelvic Organ Prolapse, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
This trial will assess whether use of intraurethral 2% lidocaine jelly meaningfully impacts sensation during filling (i.e., a change of more than 25% of first sensation, first desire to void, strong desire to void, or maximum cystometric capacity) and determine whether the use of intraurethral 2% lidocaine jelly… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urethra Issue, Pelvic Organ Prolapse, Urinary Incontinence
- What is being tested?
- Water-Based Vaginal Lubricant and lidocaine topical
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2019to 18 Aug 2021
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients
- >18 years of age
- Already scheduled (or being scheduled) for UDS to assess urinary incontinence
- Able to speak and read in English
Who cannot join
- Diagnosis of pelvic pain, interstitial cystitis, or bladder pain syndrome
- Known neurogenic disease impacting voiding/ continence (e.g., Parkinson disease, multiple sclerosis, myasthenia gravis, recent stroke)
- Active UTI
- Pelvic organ prolapse that is unable to be easily reduced
- Pregnancy or breastfeeding
- Allergy or hypersensitivity to lidocaine or local anesthetics
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
About this study
Official title: Lessons on Urethral Lidocaine in Urodynamics (LULU): Impact of Intraurethral Lidocaine on Cystometric Parameters and Discomfort
This trial will assess whether use of intraurethral 2% lidocaine jelly meaningfully impacts sensation during filling (i.e., a change of more than 25% of first sensation, first desire to void, strong desire to void, or maximum cystometric capacity) and determine whether the use of intraurethral 2% lidocaine jelly meaningfully impacts pain/discomfort, filling metrics, and voiding metrics.
Read the detailed description
This trial is a randomized, double blind, controlled trial for patients undergoing complex cystometric evaluation. Patients will undergo routine complex cystometric evaluation for acquisition of baseline data using a small amount of intraurethral aqueous jelly for catheter lubrication. Then, they will be randomized to instillation of either placebo (additional intraurethral aqueous jelly, 5ml) or intraurethral 2% lidocaine jelly. Participants then undergo complex cystometry a second time. Normal variations in studies with placebo will be compared to variations within the 2% lidocaine jelly group to determine if cystometric parameters are altered in any clinically important ways. Patient discomfort will also be evaluated by both the patient and the urodynamics advanced practice nurse.
- Conditions
- Urethra Issue, Pelvic Organ Prolapse, Urinary Incontinence, Vaginal Vault Prolapse, Cystocele, Uterine Prolapse
- Being tested
- Water-Based Vaginal Lubricant, lidocaine topical
- Medical subject headings
- Pelvic Organ Prolapse, Urinary Incontinence, Cystocele, Uterine Prolapse, Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water-Based Vaginal LubricantDrug
5cc water based jelly applied intraurethral
lidocaine topicalDrug
5cc 2% lidocaine jelly applied intraurethral
| Study group | Role | What they receive |
|---|---|---|
| Water Based Lubricating Jelly | Placebo comparator | 5ml of Water Based Lubricating Jelly Receives: Drug: Water-Based Vaginal Lubricant |
| Lidocaine 2% Jelly | Active comparator | 5ml of Lidocaine 2% Jelly Receives: Drug: lidocaine topical |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensation as Indicated by the Volume of Water Filled (ml) at the Time of Patient Perception of First Sensation, First Urge to Void, Strong Urge to Void, and Full Bladder Capacity During Bladder Filling.
Assess whether use of intraurethral 2% lidocaine jelly meaningfully impacts sensation during filling (especially, strong desire to void).
Measured: Within same visit, approximately 90-120 minutes.
Secondary outcomes (10)
Patient Perception of Pain/Discomfort as Indicated by Visual Analog Scale (Scale of 0-100 With 0 Being no Pain and 100 Being the Worst the Pain Imaginable).
Determine whether the use of intraurethral lidocaine 2% jelly meaningfully impacts pain/discomfort measured by a visual analog scale during cystometry (catheter insertion and at maximum cystometric capacity), during pressure flow study (PFS), and post-procedure.
Measured: Change from cystometrogram 1 to cystometrogram 2 within same visit, approximately 90-120 minutes.
Provider Perception of Patient Pain/Discomfort as Indicated by Visual Analog Scale (Scale of 0-100 With 0 Being no Pain and 100 Being the Worst Pain Imaginable).
Determine whether the use of intraurethral 2% lidocaine jelly meaningfully impacts provider perception of patient discomfort.
Measured: Change from cystometrogram 1 to cystometrogram 2 within same visit, approximately 90-120 minutes.
Filling Metrics: Number of Participants With Detrusor Overactivity
Determine whether the use of intraurethral 2% lidocaine jelly meaningfully impacts the presence/absence of detrusor overactivity (bladder spasm) during urodynamic bladder testing. Detrusor overactivity was noted and compared between placebo and lidocaine jelly on UDS #2.
Measured: Cystometrogram 2 within same visit, approximately 90-120 minutes.
Filling Metrics: Number of Participants With Normal Bladder Compliance
Determine whether the use of intraurethral 2% lidocaine jelly meaningfully impacts bladder compliance (change in volume/ change in detrusor pressure (Pdet)). Compliance in UDS #2 was noted and compared in both groups: water-based lubricant and intraurethral 2% lidocaine jelly. Results indicate how many participants in which normal compliance was observed. *There were 3 missing data values in our data.
Measured: Within same visit, approximately 90-120 minutes.
Voiding Metrics: Maximum Flow Rate
Determine whether the use of intraurethral 2% lidocaine jelly meaningfully impacts maximum flow rate (mL/sec).
Measured: Within same visit, approximately 90-120 minutes.
Voiding Metrics: Voiding Pattern (Normal vs. Intermittent/Interrupted vs Prolonged) as Perceived by Provider Interpretation of Pressure Flow Study During Voiding Based on Seconds to Void and Whether Urine Stream is Constant or Intermittent/Interrupted.
Determine whether the use of intraurethral 2% lidocaine jelly meaningfully impacts voiding pattern. Voiding pattern was assessed in UDS #2 and identified as either "normal", "prolonged", "intermittent", "interrupted" or a combination of those identifiers and compared between the two groups.
Measured: within same visit, approximately 90-120 minutes.
Voiding Metrics: Voided Volume and Post-void Residual
Determine whether the use of intraurethral 2% lidocaine jelly meaningfully impacts voided volume and post-void residual (mL) as recorded during UDS #2.
Measured: Within same visit, approximately 90-120 minutes.
Voiding Metrics: Percentage of Voiding Efficiency
Determine whether the use of intraurethral 2% lidocaine jelly meaningfully impacts voiding efficiency, which is calculated as the voided volume (mL) divided by the sum of the voided volume (mL) and the post-void residual volume (mL). Voiding efficiency was compared by treatment arm in UDS #2.
Measured: Cystometrogram 2 within same visit, approximately 90-120 minutes.
Voiding Metrics: Pdet Max
Determine whether the use of intraurethral 2% lidocaine jelly meaningfully impacts Pdet Max (cm/H2O) on UDS #2.
Measured: Within same visit, approximately 90-120 minutes.
Voiding Metrics: Pdet Peak Flow
Determine whether the use of intraurethral 2\& lidocaine jelly meaningfully impacts Pdet Peak Flow (cm/H2O) on UDS #2.
Measured: Within same visit, approximately 90-120 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start14 Aug 2019
- Primary completion18 Aug 2021
- Study completion18 Aug 2021
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 Urethra IssueStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina Hegan, University of Texas Southwestern Medical Center
- Investigators
- Christina M Hegan, APRN WHNP-BC, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04038099
- Sponsor's protocol ID
- STU-2019-0540
- Acronym
- LULU
- Status last verified
- Jul 2023
- First submitted
- 24 Jul 2019
- Last updated
- 1 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Hicks, C., Schaffer, J., Pruzynski, J., & Rahn, D. (2022). Impact of Intraurethral Lidocaine on Cystometric Parameters and Patient Discomfort: A Randomized Controlled Trial. Urologic Nursing, 42(5), 237-257. https://doi.org/10.7257/2168-4626.2022.42.5.237
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lessons on Urethral Lidocaine in Urodynamics (LULU): Impact of Intraurethral Lidocaine on Cystometric Parameters and Discomfort
- ClinicalTrials.gov ID
- NCT04038099
- Acronym / sponsor ID
- LULU / STU-2019-0540
- Conditions
- Urethra Issue, Pelvic Organ Prolapse, Urinary Incontinence, Vaginal Vault Prolapse, Cystocele, Uterine Prolapse
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 14 Aug 2019 (actual)
- Primary completion
- 18 Aug 2021 (actual)
- Study completion
- 18 Aug 2021 (actual)
- First posted
- 30 Jul 2019 (actual)
- Results
- Posted 1 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial will assess whether use of intraurethral 2% lidocaine jelly meaningfully impacts sensation during filling (i.e., a change of more than 25% of first sensation, first desire to void, strong desire to void, or maximum cystometric capacity) and determine whether the use of intraurethral 2% lidocaine jelly meaningfully impacts pain/discomfort, filling metrics, and voiding metrics.
Detailed description
This trial is a randomized, double blind, controlled trial for patients undergoing complex cystometric evaluation. Patients will undergo routine complex cystometric evaluation for acquisition of baseline data using a small amount of intraurethral aqueous jelly for catheter lubrication. Then, they will be randomized to instillation of either placebo (additional intraurethral aqueous jelly, 5ml) or intraurethral 2% lidocaine jelly. Participants then undergo complex cystometry a second time. Normal variations in studies with placebo will be compared to variations within the 2% lidocaine jelly group to determine if cystometric parameters are altered in any clinically important ways. Patient discomfort will also be evaluated by both the patient and the urodynamics advanced practice nurse.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Water Based Lubricating Jelly | Placebo comparator | Drug: Water-Based Vaginal Lubricant5ml of Water Based Lubricating Jelly |
| Lidocaine 2% Jelly | Active comparator | Drug: lidocaine topical5ml of Lidocaine 2% Jelly |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female patients
- >18 years of age
- Already scheduled (or being scheduled) for UDS to assess urinary incontinence
- Able to speak and read in English
Key exclusion criteria (6 listed)
- Diagnosis of pelvic pain, interstitial cystitis, or bladder pain syndrome
- Known neurogenic disease impacting voiding/ continence (e.g., Parkinson disease, multiple sclerosis, myasthenia gravis, recent stroke)
- Active UTI
- Pelvic organ prolapse that is unable to be easily reduced
- Pregnancy or breastfeeding
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 |
|---|---|---|
| Water-Based Vaginal Lubricant5cc water based jelly applied intraurethral | Drug | Water Based Lubricating Jelly |
| lidocaine topical5cc 2% lidocaine jelly applied intraurethral | Drug | Lidocaine 2% Jelly |
Primary outcome
Sensation as Indicated by the Volume of Water Filled (ml) at the Time of Patient Perception of First Sensation, First Urge to Void, Strong Urge to Void, and Full Bladder Capacity During Bladder Filling.
Time frame: Within same visit, approximately 90-120 minutes.
Assess whether use of intraurethral 2% lidocaine jelly meaningfully impacts sensation during filling (especially, strong desire to void).
10 secondary outcomes
Patient Perception of Pain/Discomfort as Indicated by Visual Analog Scale (Scale of 0-100 With 0 Being no Pain and 100 Being the Worst the Pain Imaginable).
Time frame: Change from cystometrogram 1 to cystometrogram 2 within same visit, approximately 90-120 minutes.
Provider Perception of Patient Pain/Discomfort as Indicated by Visual Analog Scale (Scale of 0-100 With 0 Being no Pain and 100 Being the Worst Pain Imaginable).
Time frame: Change from cystometrogram 1 to cystometrogram 2 within same visit, approximately 90-120 minutes.
Filling Metrics: Number of Participants With Detrusor Overactivity
Time frame: Cystometrogram 2 within same visit, approximately 90-120 minutes.
Filling Metrics: Number of Participants With Normal Bladder Compliance
Time frame: Within same visit, approximately 90-120 minutes.
Voiding Metrics: Maximum Flow Rate
Time frame: Within same visit, approximately 90-120 minutes.
Voiding Metrics: Voiding Pattern (Normal vs. Intermittent/Interrupted vs Prolonged) as Perceived by Provider Interpretation of Pressure Flow Study During Voiding Based on Seconds to Void and Whether Urine Stream is Constant or Intermittent/Interrupted.
Time frame: within same visit, approximately 90-120 minutes.
Voiding Metrics: Voided Volume and Post-void Residual
Time frame: Within same visit, approximately 90-120 minutes.
Voiding Metrics: Percentage of Voiding Efficiency
Time frame: Cystometrogram 2 within same visit, approximately 90-120 minutes.
Voiding Metrics: Pdet Max
Time frame: Within same visit, approximately 90-120 minutes.
Voiding Metrics: Pdet Peak Flow
Time frame: Within same visit, approximately 90-120 minutes.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationHicks, C., Schaffer, J., Pruzynski, J., & Rahn, D. (2022). Impact of Intraurethral Lidocaine on Cystometric Parameters and Patient Discomfort: A Randomized Controlled Trial. Urologic Nursing, 42(5), 237-257. https://doi.org/10.7257/2168-4626.2022.42.5.237
- Research VideoLink provided by the sponsor.
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.
Christina M Hegan, APRN WHNP-BC principal investigator
University of Texas Southwestern 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 Water-Based Vaginal Lubricant and lidocaine topical in people with Urethra Issue and Pelvic Organ Prolapse, run by University of Texas Southwestern 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 4 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 1 Aug 2023. 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 1 Aug 2023). 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?
Sensation as Indicated by the Volume of Water Filled (ml) at the Time of Patient Perception of First Sensation, First Urge to Void, Strong Urge to Void, and Full Bladder Capacity During Bladder Filling. (time frame: Within same visit, approximately 90-120 minutes.). 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 NCT04038099, 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 1 Aug 2023; AzTrials last refreshed its copy on 26 Oct 2026.