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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Water Based Lubricating Jelly | Placebo Comparator | 5ml of Water Based Lubricating Jelly |
|
| Lidocaine 2% Jelly | Active Comparator | 5ml of Lidocaine 2% Jelly |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Water-Based Vaginal Lubricant | Drug | 5cc water based jelly applied intraurethral |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Within same visit, approximately 90-120 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christina M Hegan, APRN WHNP-BC | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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 |
| Label | URL |
|---|---|
| Research Video | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Water Based Lubricating Jelly | 5ml of Water Based Lubricating Jelly Water-Based Vaginal Lubricant: 5cc water based jelly applied intraurethral |
| FG001 | Lidocaine 2% Jelly | 5ml of Lidocaine 2% Jelly lidocaine topical: 5cc 2% lidocaine jelly applied intraurethral |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Water Based Lubricating Jelly | 5ml of Water Based Lubricating Jelly Water-Based Vaginal Lubricant: 5cc water based jelly applied intraurethral |
| BG001 | Lidocaine 2% Jelly | 5ml of Lidocaine 2% Jelly lidocaine topical: 5cc 2% lidocaine jelly applied intraurethral |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Median | Inter-Quartile Range | mL | Within same visit, approximately 90-120 minutes. |
|
Patients undergoing urodynamics were found to have positive urine cultures from sample sent immediately prior to the procedure. Patients were treated only if symptomatic. Treatment included antibiotic medication for 1 week.
There were no deaths, all-cause mortality or serious adverse events. Other adverse events exceeding 5% frequency include asymptomatic bacteuria- presence of bacteria in urine without any urinary tract infection symptoms present.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Water Based Lubricating Jelly | 5ml of Water Based Lubricating Jelly Water-Based Vaginal Lubricant: 5cc water based jelly applied intraurethral |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| asymptomatic bacteuria | Renal and urinary disorders | Systematic Assessment | Patient urine cultures came back positive for asymptomatic bacteuria. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christina Hicks, MS, APRN, WHNP-BC, FAUNA | UT Southwestern Medical Center | 2146453848 | christy.hicks@utsouthwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 22, 2019 | Mar 1, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 29, 2022 | Mar 1, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| D014549 | Urinary Incontinence |
| D052858 | Cystocele |
| D014596 | Uterine Prolapse |
| D059952 | Pelvic Floor Disorders |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014555 | Urination Disorders |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| lidocaine topical | Drug | 5cc 2% lidocaine jelly applied intraurethral |
|
| 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. | 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. | 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. | 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). | 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. | 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. | 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. | 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. | 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. | Within same visit, approximately 90-120 minutes. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Insurance Type | One participant in the water based lubricant group had both Medicare and private insurance. | Count of Participants | Participants |
|
| Current smoker | Count of Participants | Participants |
|
| Parous | Count of Participants | Participants |
|
| Prior surgery for Stress Urinary Incontinence (SUI) | Count of Participants | Participants |
|
| Prior surgery for prolapse | Count of Participants | Participants |
|
| Prior hysterectomy | Count of Participants | Participants |
|
| >3 UTIs in the past year | Count of Participants | Participants |
|
| Diabetes | Count of Participants | Participants |
|
| Stage of most severely prolapsed compartment | Stages of prolapse were graded using the pelvic organ prolapse staging system as follows: Stage 0 - No prolapse.
| Count of Participants | Participants |
|
| Detrusor overactivity on UDS #1 | Presence or absence of bladder detrusor overactivity (bladder spasm) during urodynamic bladder test #1. | Count of Participants | Participants |
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | mm on a VAS Pain Scale | Change from cystometrogram 1 to cystometrogram 2 within same visit, approximately 90-120 minutes. |
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | mm on a VAS Pain Scale | Change from cystometrogram 1 to cystometrogram 2 within same visit, approximately 90-120 minutes. |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | Cystometrogram 2 within same visit, approximately 90-120 minutes. |
|
|
|
| Secondary | 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. | *There were 3 missing data values in our data. | Posted | Count of Participants | Participants | Within same visit, approximately 90-120 minutes. |
|
|
|
| Secondary | Voiding Metrics: Maximum Flow Rate | Determine whether the use of intraurethral 2% lidocaine jelly meaningfully impacts maximum flow rate (mL/sec). | Posted | Median | Inter-Quartile Range | mL/sec | Within same visit, approximately 90-120 minutes. |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | within same visit, approximately 90-120 minutes. |
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | mL | Within same visit, approximately 90-120 minutes. |
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | percentage of voiding efficiency | Cystometrogram 2 within same visit, approximately 90-120 minutes. |
|
|
|
| Secondary | Voiding Metrics: Pdet Max | Determine whether the use of intraurethral 2% lidocaine jelly meaningfully impacts Pdet Max (cm/H2O) on UDS #2. | Posted | Median | Inter-Quartile Range | cm/H2O | Within same visit, approximately 90-120 minutes. |
|
|
|
| Secondary | Voiding Metrics: Pdet Peak Flow | Determine whether the use of intraurethral 2& lidocaine jelly meaningfully impacts Pdet Peak Flow (cm/H2O) on UDS #2. | Posted | Median | Inter-Quartile Range | cm/H2O | Within same visit, approximately 90-120 minutes. |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Lidocaine 2% Jelly | 5ml of Lidocaine 2% Jelly lidocaine topical: 5cc 2% lidocaine jelly applied intraurethral | 0 | 33 | 0 | 33 | 2 | 33 |
|
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| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D001745 | Urinary Bladder Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D000091662 | Genital Diseases |
| D011248 | Pregnancy Complications |
| Aniline Compounds |
| D000588 | Amines |
| Pressure flow study |
|
| Overall participant discomfort |
|
| Interrupted |
|
| Prolonged |
|