Urethra Issue, Pelvic Organ Prolapse, Urinary Incontinence, Vaginal Vault Prolapse, Cystocele, Uterine Prolapse, Vaginal Prolapse, Pelvic Floor Disorders
Conditions
Brief 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 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.
Interventions
DRUGWater-Based Vaginal Lubricant
5cc water based jelly applied intraurethral
5cc 2% lidocaine jelly applied intraurethral
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female patients * \>18 years of age * Already scheduled (or being scheduled) for UDS to assess urinary incontinence * Able to speak and read in English
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). | Change from cystometrogram 1 to cystometrogram 2 within same visit, approximately 90-120 minutes. | 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. |
| 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). | Change from cystometrogram 1 to cystometrogram 2 within same visit, approximately 90-120 minutes. | Determine whether the use of intraurethral 2% lidocaine jelly meaningfully impacts provider perception of patient discomfort. |
| Filling Metrics: Number of Participants With Detrusor Overactivity | Cystometrogram 2 within same visit, approximately 90-120 minutes. | 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. |
| Filling Metrics: Number of Participants With Normal Bladder Compliance | Within same visit, approximately 90-120 minutes. | 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. |
| Voiding Metrics: Maximum Flow Rate | Within same visit, approximately 90-120 minutes. | Determine whether the use of intraurethral 2% lidocaine jelly meaningfully impacts maximum flow rate (mL/sec). |
| Voiding Metrics: Voided Volume and Post-void Residual | Within same visit, approximately 90-120 minutes. | Determine whether the use of intraurethral 2% lidocaine jelly meaningfully impacts voided volume and post-void residual (mL) as recorded during UDS #2. |
| Voiding Metrics: Percentage of Voiding Efficiency | Cystometrogram 2 within same visit, approximately 90-120 minutes. | 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. |
| Voiding Metrics: Pdet Max | Within same visit, approximately 90-120 minutes. | Determine whether the use of intraurethral 2% lidocaine jelly meaningfully impacts Pdet Max (cm/H2O) on UDS #2. |
| Voiding Metrics: Pdet Peak Flow | Within same visit, approximately 90-120 minutes. | Determine whether the use of intraurethral 2& lidocaine jelly meaningfully impacts Pdet Peak Flow (cm/H2O) on UDS #2. |
| 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. | within same visit, approximately 90-120 minutes. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Water Based Lubricating Jelly 5ml of Water Based Lubricating Jelly
Water-Based Vaginal Lubricant: 5cc water based jelly applied intraurethral | 30 |
| Lidocaine 2% Jelly 5ml of Lidocaine 2% Jelly
lidocaine topical: 5cc 2% lidocaine jelly applied intraurethral | 33 |
| Total | 63 |
Baseline characteristics
| Characteristic | Water Based Lubricating Jelly | Total | Lidocaine 2% Jelly |
|---|---|---|---|
| >3 UTIs in the past year | 4 Participants | 6 Participants | 2 Participants |
| Age, Continuous | 62.9 years STANDARD_DEVIATION 11.2 | 61.5 years STANDARD_DEVIATION 11.3 | 60.2 years STANDARD_DEVIATION 11.4 |
| Current smoker | 3 Participants | 6 Participants | 3 Participants |
| Detrusor overactivity on UDS #1 | 8 Participants | 17 Participants | 9 Participants |
| Diabetes | 2 Participants | 6 Participants | 4 Participants |
| Insurance Type Medicare | 14 Participants | 26 Participants | 12 Participants |
| Insurance Type Private | 16 Participants | 37 Participants | 21 Participants |
| Insurance Type Self-pay | 1 Participants | 1 Participants | 0 Participants |
| Parous | 27 Participants | 56 Participants | 29 Participants |
| Prior hysterectomy | 14 Participants | 28 Participants | 14 Participants |
| Prior surgery for prolapse | 3 Participants | 7 Participants | 4 Participants |
| Prior surgery for Stress Urinary Incontinence (SUI) | 5 Participants | 12 Participants | 7 Participants |
| Race/Ethnicity, Customized Black, non-Hispanic | 4 Participants | 9 Participants | 5 Participants |
| Race/Ethnicity, Customized Hispanic | 2 Participants | 7 Participants | 5 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 3 Participants | 2 Participants |
| Race/Ethnicity, Customized White, non-Hispanic | 23 Participants | 44 Participants | 21 Participants |
| Region of Enrollment United States | 30 participants | 63 participants | 33 participants |
| Sex: Female, Male Female | 30 Participants | 63 Participants | 33 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Stage of most severely prolapsed compartment Stage 0 or 1 | 12 Participants | 21 Participants | 9 Participants |
| Stage of most severely prolapsed compartment Stage 2 | 12 Participants | 21 Participants | 9 Participants |
| Stage of most severely prolapsed compartment Stage 3 or 4 | 6 Participants | 20 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 33 |
| other Total, other adverse events | 0 / 30 | 2 / 33 |
| serious Total, serious adverse events | 0 / 30 | 0 / 33 |
Outcome results
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).
Time frame: Within same visit, approximately 90-120 minutes.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Water Based Lubricating Jelly | 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. | First Sensation | 17 mL |
| Water Based Lubricating Jelly | 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. | First Urge to Void | 137 mL |
| Water Based Lubricating Jelly | 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. | Strong Urge to Void | 243 mL |
| Water Based Lubricating Jelly | 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. | Maximum Capacity | 344 mL |
| Lidocaine 2% Jelly | 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. | Maximum Capacity | 365 mL |
| Lidocaine 2% Jelly | 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. | First Sensation | 18 mL |
| Lidocaine 2% Jelly | 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. | Strong Urge to Void | 263 mL |
| Lidocaine 2% Jelly | 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. | First Urge to Void | 107 mL |
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.
Time frame: Cystometrogram 2 within same visit, approximately 90-120 minutes.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Water Based Lubricating Jelly | Filling Metrics: Number of Participants With Detrusor Overactivity | 10 Participants |
| Lidocaine 2% Jelly | Filling Metrics: Number of Participants With Detrusor Overactivity | 6 Participants |
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.
Time frame: Within same visit, approximately 90-120 minutes.
Population: \*There were 3 missing data values in our data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Water Based Lubricating Jelly | Filling Metrics: Number of Participants With Normal Bladder Compliance | 28 Participants |
| Lidocaine 2% Jelly | Filling Metrics: Number of Participants With Normal Bladder Compliance | 32 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.
Time frame: Change from cystometrogram 1 to cystometrogram 2 within same visit, approximately 90-120 minutes.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Water Based Lubricating Jelly | 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). | Catheter insertion | 7 mm on a VAS Pain Scale |
| Water Based Lubricating Jelly | 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). | Maximum capacity | 8 mm on a VAS Pain Scale |
| Water Based Lubricating Jelly | 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). | Pressure flow study | 7 mm on a VAS Pain Scale |
| Water Based Lubricating Jelly | 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). | Overall participant discomfort | 9 mm on a VAS Pain Scale |
| Lidocaine 2% Jelly | 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). | Overall participant discomfort | 4 mm on a VAS Pain Scale |
| Lidocaine 2% Jelly | 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). | Catheter insertion | 4.5 mm on a VAS Pain Scale |
| Lidocaine 2% Jelly | 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). | Pressure flow study | 3 mm on a VAS Pain Scale |
| Lidocaine 2% Jelly | 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). | Maximum capacity | 10 mm on a VAS Pain Scale |
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.
Time frame: Change from cystometrogram 1 to cystometrogram 2 within same visit, approximately 90-120 minutes.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Water Based Lubricating Jelly | 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). | 9 mm on a VAS Pain Scale |
| Lidocaine 2% Jelly | 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). | 6 mm on a VAS Pain Scale |
Secondary
Voiding Metrics: Maximum Flow Rate
Determine whether the use of intraurethral 2% lidocaine jelly meaningfully impacts maximum flow rate (mL/sec).
Time frame: Within same visit, approximately 90-120 minutes.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Water Based Lubricating Jelly | Voiding Metrics: Maximum Flow Rate | 18.2 mL/sec |
| Lidocaine 2% Jelly | Voiding Metrics: Maximum Flow Rate | 16.5 mL/sec |
Secondary
Voiding Metrics: Pdet Max
Determine whether the use of intraurethral 2% lidocaine jelly meaningfully impacts Pdet Max (cm/H2O) on UDS #2.
Time frame: Within same visit, approximately 90-120 minutes.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Water Based Lubricating Jelly | Voiding Metrics: Pdet Max | 37 cm/H2O |
| Lidocaine 2% Jelly | Voiding Metrics: Pdet Max | 28.5 cm/H2O |
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.
Time frame: Within same visit, approximately 90-120 minutes.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Water Based Lubricating Jelly | Voiding Metrics: Pdet Peak Flow | 20 cm/H2O |
| Lidocaine 2% Jelly | Voiding Metrics: Pdet Peak Flow | 13 cm/H2O |
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.
Time frame: Cystometrogram 2 within same visit, approximately 90-120 minutes.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Water Based Lubricating Jelly | Voiding Metrics: Percentage of Voiding Efficiency | 94.6 percentage of voiding efficiency |
| Lidocaine 2% Jelly | Voiding Metrics: Percentage of Voiding Efficiency | 95.9 percentage of voiding efficiency |
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.
Time frame: Within same visit, approximately 90-120 minutes.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Water Based Lubricating Jelly | Voiding Metrics: Voided Volume and Post-void Residual | Post Void Residual | 29 mL |
| Water Based Lubricating Jelly | Voiding Metrics: Voided Volume and Post-void Residual | Voided Volume | 278 mL |
| Lidocaine 2% Jelly | Voiding Metrics: Voided Volume and Post-void Residual | Voided Volume | 318 mL |
| Lidocaine 2% Jelly | Voiding Metrics: Voided Volume and Post-void Residual | Post Void Residual | 15 mL |
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.
Time frame: within same visit, approximately 90-120 minutes.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Water Based Lubricating Jelly | 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. | Normal | 3 Participants |
| Water Based Lubricating Jelly | 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. | Intermittent | 15 Participants |
| Water Based Lubricating Jelly | 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. | Interrupted | 14 Participants |
| Water Based Lubricating Jelly | 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. | Prolonged | 17 Participants |
| Lidocaine 2% Jelly | 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. | Prolonged | 24 Participants |
| Lidocaine 2% Jelly | 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. | Normal | 3 Participants |
| Lidocaine 2% Jelly | 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. | Interrupted | 18 Participants |
| Lidocaine 2% Jelly | 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. | Intermittent | 21 Participants |