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Completed

NCT Number: NCT03353714

The Effect of Pudendal Blocks on Voiding Dysfunction Following Slings

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pudendal block

Other

Pudendal block with normal saline (for control group) and bupivacaine (for intervention group)

Primary outcomes

  1. Postoperative voiding dysfunction

    Time frame: Prior to discharge home (within 24 hours)

    Postoperative void trial (discharge home with or without Foley catheter)

Sponsors and collaborators

Lead sponsor

Michael Flynn

Other

Registry information

Acronym: PUBS

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 27, 2017
Registry last updated
Oct 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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