The Effect of Pudendal Blocks on Voiding Dysfunction Following Slings

Not Applicable

Completed

• Conditions: Stress Urinary Incontinence
• Interventions: Other: Pudendal block

• Registration Number: NCT03353714
• Lead Sponsor: Michael Flynn

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.

Study Timeline

• Study Start: 2017-10-01
• Study First Submitted: 2017-11-04
• Study First Submitted QC: 2017-11-22
• Study First Posted: 2017-11-27
• Primary Completion: 2019-04-15
• Study Completion: 2019-07-01
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-18
• Last Update Posted: 2019-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pudendal block with bupivacaine	Pudendal block	Pudendal block with bupivacaine
Pudendal block with saline	Pudendal block	Pudendal block with normal saline

Primary Outcome Measures

Name	Time	Method
Postoperative voiding dysfunction	Prior to discharge home (within 24 hours)	Postoperative void trial (discharge home with or without Foley catheter)

Trial Locations

Locations (1)

University of Massachusetts; 🇺🇸 Worcester, Massachusetts, United States