The Effect of Pudendal Blocks on Voiding Dysfunction Following Slings (PUBS)

Michael Flynn

Status: Completed

Conditions: Stress Urinary Incontinence

Treatments: Other: Pudendal block

Study type: Interventional

Funder types: Other

Identifiers

NCT03353714

H00013722

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 2 patient groups, including a placebo group

Pudendal block with saline

Placebo Comparator group

Description:

Pudendal block with normal saline

Treatment:

Other: Pudendal block

Pudendal block with bupivacaine

Active Comparator group

Description:

Pudendal block with bupivacaine

Treatment:

Other: Pudendal block