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

Primary Purpose

Stress Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pudendal block
Sponsored by
Michael Flynn
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stress Urinary Incontinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts 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

Sites / Locations

  • University of Massachusetts

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Pudendal block with saline

Pudendal block with bupivacaine

Arm Description

Pudendal block with normal saline

Pudendal block with bupivacaine

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 4, 2017
Last Updated
October 18, 2019
Sponsor
Michael Flynn
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1. Study Identification

Unique Protocol Identification Number
NCT03353714
Brief Title
The Effect of Pudendal Blocks on Voiding Dysfunction Following Slings
Acronym
PUBS
Official Title
The Effect of Pudendal Blocks on Voiding Dysfunction Following Slings
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
April 15, 2019 (Actual)
Study Completion Date
July 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Michael Flynn

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pudendal block with saline
Arm Type
Placebo Comparator
Arm Description
Pudendal block with normal saline
Arm Title
Pudendal block with bupivacaine
Arm Type
Active Comparator
Arm Description
Pudendal block with bupivacaine
Intervention Type
Other
Intervention Name(s)
Pudendal block
Intervention Description
Pudendal block with normal saline (for control group) and bupivacaine (for intervention group)
Primary Outcome Measure Information:
Title
Postoperative voiding dysfunction
Description
Postoperative void trial (discharge home with or without Foley catheter)
Time Frame
Prior to discharge home (within 24 hours)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deepali Maheshwari, DO
Organizational Affiliation
UMass Medical School
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael K Flynn, MD
Organizational Affiliation
UMass Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Massachusetts
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
33009265
Citation
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.
Results Reference
derived

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The Effect of Pudendal Blocks on Voiding Dysfunction Following Slings

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