Pain
Conditions
Brief summary
We are doing this study to find the best way to manage pain during a procedure called urethral bulking. This procedure treats urine leakage that happens with coughing, laughing, sneezing, or physical activity. It works by injecting a gel-like substance around the urethra (the tube that urine comes out of) to help it stay closed when it should. We use a numbing gel (called lidocaine jelly) inside the urethra to help with pain during the procedure. In this study, we will also be administering lidocaine (numbing medication) injected around the urethra or a saline placebo (medical grade saltwater) injection, which has no numbing effect. A placebo is something that looks like a real treatment but doesn't have any medical effect. Both the lidocaine and the saline would be injected around the urethra using a small needle, and we'll compare how well they work at reducing pain.
Interventions
Sponsors
Northwell Health
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Intervention model description
Single blind RCT
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* SUI based on +CST or UDS
Exclusion criteria
* contraindication to lidocaine, allergy to coaptite, pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain score | Immediately after procedure | 0-100mm visual analog score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| UDI-6 | 2 weeks after procedure | Incontinence scale |
| IIQ-7 | 2 weeks after procedure | Incontinence scale |
| PGI-I | 2 weeks after procedure | overall improvement after procedure |
Countries
United States
Contacts
CONTACTCarly Gridley Co-investigator, MD
Outcome results
None listed