Phase 4
Completed N=63
Lessons on Urethral Lidocaine in Urodynamics
Urethra Issue · pelvic organ prolapse · Urinary Incontinence · Vaginal Vault Prolapse
Source: ClinicalTrials.gov NCT04038099 ↗
Enrolled (actual)
63
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcomePrimary: 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. — 17; 18; 137; 107 mL
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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. |
17; 18; 137; 107; 243; 263 | — |
| 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). |
7; 4.5; 8; 10; 7; 3 | — |
| 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). |
9; 6 | — |
| SECONDARY Filling Metrics: Number of Participants With Detrusor Overactivity |
10; 6 | — |
| SECONDARY Filling Metrics: Number of Participants With Normal Bladder Compliance |
28; 32 | — |
| SECONDARY Voiding Metrics: Maximum Flow Rate |
18.2; 16.5 | — |
| 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. |
3; 3; 15; 21; 14; 18 | — |
| SECONDARY Voiding Metrics: Voided Volume and Post-void Residual |
278; 318; 29; 15 | — |
| SECONDARY Voiding Metrics: Percentage of Voiding Efficiency |
94.6; 95.9 | — |
| SECONDARY Voiding Metrics: Pdet Max |
37; 28.5 | — |
| SECONDARY Voiding Metrics: Pdet Peak Flow |
20; 13 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04038099). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.