The Effect of Pudendal Blocks on Voiding Dysfunction Foll... | NCT03353714

Studies
The Effect of Pudendal Blocks on Voiding Dysfunction Following Slings

NCT03353714

Sponsor

Michael Flynn

Status

Completed

Last Update Posted

Oct 21, 2019Actual

Enrollment

90Actual

Phase

Not Applicable

Conditions

Stress Urinary Incontinence

Interventions

Pudendal block

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2017Actual

Primary Completion Date

Apr 15, 2019Actual

Completion Date

Jul 1, 2019Actual

First Submitted Date

Nov 4, 2017

First Submission Date that Met QC Criteria

Nov 22, 2017

First Posted Date

Nov 27, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 18, 2019

Last Update Posted Date

Oct 21, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Michael Flynn, MD, University of Massachusetts, WorcesterSponsor-Investigator

Lead Sponsor

Michael FlynnOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pudendal block with saline	Placebo Comparator	Pudendal block with normal saline	Other: Pudendal block
Pudendal block with bupivacaine	Active Comparator	Pudendal block with bupivacaine	Other: Pudendal block

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pudendal block	Other	Pudendal block with normal saline (for control group) and bupivacaine (for intervention group)	Pudendal block with bupivacaine Pudendal block with saline

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Deepali Maheshwari, DO	UMass Medical School	Principal Investigator
Michael K Flynn, MD	UMass Medical School	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Massachusetts		Worcester	Massachusetts	01605	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33009265	Derived	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.

ID	Term
D014549	Urinary Incontinence
D014555	Urination Disorders
D014570	Urologic Diseases
D052776	Female Urogenital Diseases