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

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

Study Overview

• Status: Completed
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Other: Pudendal block

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Worcester, Massachusetts, United States, 01605
      • University of Massachusetts

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Pudendal block with saline; Pudendal block with normal saline	Other: Pudendal block; Pudendal block with normal saline (for control group) and bupivacaine (for intervention group)
ACTIVE_COMPARATOR: Pudendal block with bupivacaine	Other: Pudendal block; Pudendal block with normal saline (for control group) and bupivacaine (for intervention group)

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Michael Flynn
• Investigators: Principal Investigator: Deepali Maheshwari, DO, UMass Medical School; Principal Investigator: Michael K Flynn, MD, UMass Medical School

Publications and helpful links

General Publications

• Maheshwari D, Sierra T, Leung K, Hall C, Flynn M. Effect of Pudendal Blockade on Bladder Emptying After Midurethral Sling: A Randomized Controlled Trial. Female Pelvic Med Reconstr Surg. 2021 Feb 1;27(2):e465-e468. doi: 10.1097/SPV.0000000000000963.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2017
• Primary Completion (ACTUAL): April 15, 2019
• Study Completion (ACTUAL): July 1, 2019

Study Registration Dates

• First Submitted: November 4, 2017
• First Submitted That Met QC Criteria: November 22, 2017
• First Posted (ACTUAL): November 27, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 21, 2019
• Last Update Submitted That Met QC Criteria: October 18, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Urinary Incontinence; Urinary Incontinence, Stress
• Other Study ID Numbers: H00013722

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in the article after de-identification.
• IPD Sharing Time Frame: Beginning 3 months and ending 5 years following article publication.
• IPD Sharing Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No