Stress Urinary Incontinence, Intrinsic Sphincter Deficiency
Conditions
Brief summary
While recommended pre-anesthesia for polyacylamide hydrogel (PAHG, Bulkamid) injections for stress urinary incontinence and intrinsic sphincter deficiency can include intraurethral anesthetic gel with or without periurethral block, there is no existing literature to guide choice of anesthesia. This is a single-blinded randomized control trial to evaluate post-procedure pain with choice of anesthesia before PAHG injection.
Interventions
PROCEDURETopical lidocaine
Topical anesthetic
PROCEDUREEMLA cream
Topical anesthetic
PROCEDUREPeriurethral block
5 cc 1% lidocaine or 0.25% bupivacaine at 3 and 9 o'clock (periurethral tissues) to depth of 1.5 cm using 25G needle
Sponsors
Medstar Health Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women ≥ 18 years old with stress urinary incontinence, intrinsic sphincter deficiency, or stress-predominant mixed urinary incontinence desiring PAHG * English-speaking * Scheduled in outpatient clinic or OR without sedation, general, or neuraxial anesthesia
Exclusion criteria
* Pregnancy * Neurogenic bladder * Pre-existing need for intermittent catheterization or indwelling catheter * Bladder or urothelial malignancy * Prior radiation to pelvic floor * Known allergy/sensitivity to PAHG
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual analog scale (VAS) for pain | Ascertained at end of procedure (withdrawal of cystoscope) | Visual analog scale for pain uses a scale from 0-10 corresponding to reported pain levels with 0 indicating no pain and 10 indicating most severe pain possible |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of procedure | Ascertained at end of procedure (within 5 minutes of withdrawal of cystoscope) | in seconds |
| Incomplete bladder emptying | Ascertained on day-of-procedure (within 1 hour of withdrawal of cystoscope) | Inability to void after procedure |
| Need for re-injection of PAHG | Assessed at follow-up 2 weeks post-procedure | Requirement for top-off or repeat injection due to persistent symptoms |
| International Consultation on Incontinence Questionnaire for Urinary Incontinence (ICIQ-UI) | Assessed at baseline and at two-week and twelve-week follow-up visit | 3 items on frequency/quantity of leakage and impact on quality on life (range 0-21 with lower score indicating lower severity of incontinence symptoms and higher score indicating higher severity of incontinence symptoms) |
| Patient Global Impression of Improvement scale (PGI-I) | Assessed at two-week and twelve-week follow-up visit | 1 item on relative change in symptoms following treatment (range 1-7 with lower score indicating greater improvement in incontinence symptoms following intervention and higher score indicating lower improvement in incontinence following intervention) |
Countries
United States
Outcome results
None listed