← Back to Search

1 for Stress Incontinence

N/A

Waitlist Available

Led By Gena C Dunivan, MD

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* Any female patient, age 18 or older, who elects to have a mid-urethral sling with or without an anterior or posterior repair at the University of North Carolina Hospitals by a member of the Division of Urogynecology.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from after surgery to discharge from hospital.

Awards & highlights

Approved for 10 Other Conditions

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

There are many ways to perform a suprapubic approach pubovaginal sling. Some surgeons inject local pain medical into the retropubic space before placing the sling, others do not. This study is to determine if injection of local pain medication into the retropubic space before placing a mid-urethral sling for urinary stress incontinence results in lower postoperative pain scores, lower use of postoperative narcotic medication and lower rates of urinary retention.

Eligible Conditions

Stress Incontinence

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hours postoperative from mid-urethral sling placement

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 hours postoperative from mid-urethral sling placement

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours postoperative from mid-urethral sling placement for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Difference in Postoperative Pain Using a Visual Analog Scale at 2 Hours.

Difference in Postoperative Pain Using a Visual Analog Scale at 24 Hours.

Difference in Postoperative Pain Using a Visual Analog Scale at 6 Hours.

Secondary study objectives

Difference in Successful Voiding Trial Prior to Discharge Following Placement of Mid-urethral Sling Via the Suprapubic Approach.

In-hospital Medication Amounts

Awards & Highlights

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: 1Experimental Treatment1 Intervention

Patients randomized to this arm will receive 60 cc of 0.125% Marcaine injected into the retropubic space along the tract that the suprapubic mid-urethral trocar will follow (one on each side) for a total of 120 cc of 0.125% Marcaine, prior to the placement of the mid-urethral sling via the suprapubic approach.

Group II: 2Active Control1 Intervention

Patients assigned to this arm will have the mid-urethral sling placed via the suprapubic approach in the standard fashion with no injection of Marcaine into the retropubic space.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bupivacaine

FDA approved

0 / 1Eligibility criteria met