The Effect of Pudendal Blocks on Voiding Dysfunction Following Slings

Stress Urinary Incontinence Clinical Trial

— PUBS  

Official title:

The Effect of Pudendal Blocks on Voiding Dysfunction Following Slings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03353714
• Other study ID #: H00013722
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: July 1, 2019

Study information

• Verified date: October 2019
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 1, 2019
• Est. primary completion date: April 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

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

Locations

Country	Name	City	State
United States	University of Massachusetts	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Michael Flynn

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative voiding dysfunction	Postoperative void trial (discharge home with or without Foley catheter)	Prior to discharge home (within 24 hours)