The Effect of Pudendal Blocks on Voiding Dysfunction Following Slings

NCT03353714 | Completed

• 1 other identifier: H00013722
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• Postoperative voiding dysfunction

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

  Prior to discharge home (within 24 hours)

Study Arms (2)

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

Pudendal block OTHER

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

Pudendal block with bupivacaine; Pudendal block with saline

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women undergoing a midurethral sling without concomitant procedures under general anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Michael Flynn: lead

Study Sites (1)

University of Massachusetts

Worcester, Massachusetts, 01605, United States

Location

Related Publications (1)

• 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.

  PMID: 33009265 DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Deepali Maheshwari, DO

  UMass Medical School

  PRINCIPAL INVESTIGATOR

• Michael K Flynn, MD

  UMass Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 4, 2017
• First Posted: November 27, 2017
• Study Start: October 1, 2017
• Primary Completion: April 15, 2019
• Study Completion: July 1, 2019
• Last Updated: October 21, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose.

Locations

US (1)