Clinical Trials Directory

Trials / Completed

CompletedNCT03353714

The Effect of Pudendal Blocks on Voiding Dysfunction Following Slings

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
90 (actual)
Sponsor
Michael Flynn · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERPudendal blockPudendal block with normal saline (for control group) and bupivacaine (for intervention group)

Timeline

Start date
2017-10-01
Primary completion
2019-04-15
Completion
2019-07-01
First posted
2017-11-27
Last updated
2019-10-21

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03353714. Inclusion in this directory is not an endorsement.