Stress Urinary Incontinence
Conditions
Brief summary
To determine the effect of a bilateral pudendal block on voiding dysfunction following midurethral slings.
Detailed description
Midurethral slings (MUS) are commonly performed to treat stress urinary incontinence in women. One common complication is short-term postoperative voiding dysfunction. Approximately 20% of patients undergoing MUS have difficulty voiding in the immediate postoperative period and are discharged home with an indwelling bladder catheter. A pudendal block provides analgesia to the vulva, vagina, and perineum and is used in various fields, ranging from obstetrical indications to hemorrhoidectomies. The colorectal literature has demonstrated an improvement in postoperative voiding dysfunction with intraoperative bilateral pudendal blockade, presumably due to pain relief. However, only one study has explored the effect of a pudendal blockade on postoperative voiding in patients undergoing MUS. This was a small French case series of 9 patients, and it concluded that it was a safe procedure with good patient satisfaction. Given the scant literature evaluating voiding dysfunction following pudendal blocks in MUS, and the encouraging data from anorectal surgeries, we aim to study this effect via a randomized, placebo-controlled, double-blinded trial.
Interventions
OTHERPudendal block
Pudendal block with normal saline (for control group) and bupivacaine (for intervention group)
Sponsors
Michael Flynn
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Women undergoing a midurethral sling without concomitant procedures under general anesthesia
Exclusion criteria
* Unable to consent (lacking capacity) * Under 18 years of age * Pregnant women * Prisoners * Using intermittent self-catheterization preoperatively * Neurological disease or spinal cord injury resulting in voiding dysfunction * Allergy to bupivacaine * Diagnosis of chronic pain syndromes * Daily use of narcotics * Intra-operative bladder injury necessitating use of a prolonged indwelling Foley catheter
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative voiding dysfunction | Prior to discharge home (within 24 hours) | Postoperative void trial (discharge home with or without Foley catheter) |
Countries
United States
Outcome results
None listed