← Back to Search

Local Anesthetic

Retropubic Lidocaine vs Saline for Stress Urinary Incontinence

Phase 4

Recruiting

Research Sponsored by West Penn Allegheny Health System

Eligibility Criteria Checklist

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

Must have

Age 18 years or older

Be older than 18 years old

Must not have

Preoperative voiding dysfunction as evidenced by a postvoid residual (PVR) of 150 mL or greater.

Planned spinal anesthesia for the procedure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up subjects will be asked to mark their pain on a vas scale administered 2 hours and 6 hours following surgery. the subsequent assessments will be completed by patients with an at-home form through postoperative day #7.

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial is looking at ways to reduce postoperative urinary retention in women who undergo midurethral sling surgery for stress urinary incontinence. The surgery is effective but can lead to urinary retention in

Who is the study for?

This trial is for women aged 18 or older who can give consent and speak English. It's designed for those undergoing midurethral sling surgery to treat stress urinary incontinence, aiming to reduce postoperative urinary retention.

What is being tested?

The study compares the effects of injecting normal saline with epinephrine versus lidocaine with epinephrine during surgery on the duration of postoperative urinary retention in patients receiving a midurethral sling.

What are the potential side effects?

Potential side effects may include discomfort at the injection site, allergic reactions, and temporary numbness. The impact on post-surgery urinary function is also being studied as part of this trial.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have trouble emptying my bladder fully, with more than 150 mL of urine left after voiding.

Select...

I am scheduled to receive spinal anesthesia for my procedure.

Select...

I am scheduled for prolapse repair surgery that is not an anterior repair.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ subjects will be asked to mark their pain on a vas scale administered 2 hours and 6 hours following surgery. the subsequent assessments will be completed by patients with an at-home form through postoperative day #7.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~subjects will be asked to mark their pain on a vas scale administered 2 hours and 6 hours following surgery. the subsequent assessments will be completed by patients with an at-home form through postoperative day #7.

This trial's timeline: 3 weeks for screening, Varies for treatment, and subjects will be asked to mark their pain on a vas scale administered 2 hours and 6 hours following surgery. the subsequent assessments will be completed by patients with an at-home form through postoperative day #7. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

The incidence of urinary retention

Secondary study objectives

Postoperative pain: VAS scale

Other study objectives

Patient satisfaction following surgery: Likert Scale

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: 0.5% lidocaine with epinephrineExperimental Treatment1 Intervention

On the day of surgery, the operating room pharmacist will prepare 20 cc of either study drug (0.5% lidocaine with epinephrine 1:200,000) or normal saline with epinephrine 1:200,000) in identical appearing 20cc syringes to be injected retropubically. Our group's routine clinical practice is to inject 20cc of 0.5% lidocaine with epinephrine 1:200,000 retropubically along the path of the midurethral sling trocars. Suburethral injection of local anesthestic will be performed at surgeon discretion. Surgical teams, anesthesia teams and patients will be blinded to allocation assignment. The investigational drug pharmacist will maintain the randomization sequence.

Group II: Normal saline with epinephrineActive Control1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

lidocaine with epinephrine

2017

N/A

~250

0 / 4Eligibility criteria met