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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

Tracking Information
First Submitted Date  ICMJE November 4, 2017
First Posted Date  ICMJE November 27, 2017
Last Update Posted Date October 21, 2019
Actual Study Start Date  ICMJE October 1, 2017
Actual Primary Completion Date April 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 22, 2017)
Postoperative voiding dysfunction [ Time Frame: Prior to discharge home (within 24 hours) ]
Postoperative void trial (discharge home with or without Foley catheter)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Pudendal Blocks on Voiding Dysfunction Following Slings
Official Title  ICMJE The Effect of Pudendal Blocks on Voiding Dysfunction Following Slings
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Stress Urinary Incontinence
Intervention  ICMJE Other: Pudendal block
Pudendal block with normal saline (for control group) and bupivacaine (for intervention group)
Study Arms  ICMJE
  • Placebo Comparator: Pudendal block with saline
    Pudendal block with normal saline
    Intervention: Other: Pudendal block
  • Active Comparator: Pudendal block with bupivacaine
    Pudendal block with bupivacaine
    Intervention: Other: Pudendal block
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 1, 2019)
90
Original Estimated Enrollment  ICMJE
 (submitted: November 22, 2017)
189
Actual Study Completion Date  ICMJE July 1, 2019
Actual Primary Completion Date April 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03353714
Other Study ID Numbers  ICMJE H00013722
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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.
Responsible Party Michael Flynn, University of Massachusetts, Worcester
Study Sponsor  ICMJE Michael Flynn
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Deepali Maheshwari, DO UMass Medical School
Principal Investigator: Michael K Flynn, MD UMass Medical School
PRS Account University of Massachusetts, Worcester
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP