The Effect of Pudendal Blocks on Voiding Dysfunction Following Slings

Study Overview
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Brief Summary
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To determine the effect of a bilateral pudendal block on voiding dysfunction following midurethral slings.

Detailed Description
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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.

Official Title
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The Effect of Pudendal Blocks on Voiding Dysfunction Following Slings

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Other: Pudendal block


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Pudendal block with saline<br>Pudendal block with normal saline | Other: Pudendal block<br>* Pudendal block with normal saline (for control group) and bupivacaine (for intervention group)<br>|
| Active Comparator: Pudendal block with bupivacaine<br>Pudendal block with bupivacaine | Other: Pudendal block<br>* Pudendal block with normal saline (for control group) and bupivacaine (for intervention group)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative voiding dysfunction | Postoperative void trial (discharge home with or without Foley catheter) | Prior to discharge home (within 24 hours) |