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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03353714
Recruitment Status : Completed
First Posted : November 27, 2017
Last Update Posted : October 21, 2019
Sponsor:
Information provided by (Responsible Party):
Michael Flynn, University of Massachusetts, Worcester

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

Condition or disease Intervention/treatment Phase
Stress Urinary Incontinence Other: Pudendal block Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Pudendal Blocks on Voiding Dysfunction Following Slings
Actual Study Start Date : October 1, 2017
Actual Primary Completion Date : April 15, 2019
Actual Study Completion Date : July 1, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Postoperative voiding dysfunction [ Time Frame: Prior to discharge home (within 24 hours) ]
    Postoperative void trial (discharge home with or without Foley catheter)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03353714


Locations
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United States, Massachusetts
University of Massachusetts
Worcester, Massachusetts, United States, 01605
Sponsors and Collaborators
Michael Flynn
Investigators
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Principal Investigator: Deepali Maheshwari, DO UMass Medical School
Principal Investigator: Michael K Flynn, MD UMass Medical School
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Responsible Party: Michael Flynn, MD, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT03353714    
Other Study ID Numbers: H00013722
First Posted: November 27, 2017    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in the article after de-identification.
Supporting Materials: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations