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

• ClinicalTrials.gov Identifier: NCT03353714
• Recruitment Status: Completed
• First Posted: November 27, 2017
• Last Update Posted: October 21, 2019
• Sponsor: Michael Flynn
• Information provided by (Responsible Party): Michael Flynn, University of Massachusetts, Worcester

Tracking Information

• First Submitted Date: November 4, 2017
• First Posted Date: November 27, 2017
• Last Update Posted Date: October 21, 2019
• Actual Study Start Date: October 1, 2017
• Actual Primary Completion Date: April 15, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Effect of Pudendal Blocks on Voiding Dysfunction Following Slings
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention
• Condition: Stress Urinary Incontinence

Intervention

Other: Pudendal block

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

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 1, 2019): 90
• Original Estimated Enrollment (submitted: November 22, 2017): 189
• Actual Study Completion Date: July 1, 2019
• Actual Primary Completion Date: April 15, 2019 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03353714
• Other Study ID Numbers: 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

• 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: Michael Flynn
• Collaborators: Not Provided

Investigators

• 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