Voiding Function After Mid-Urethral Slings With and Without Local Anesthetic: Randomized Controlled Trial

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2016-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine if there is a difference in post-operative voiding function between subjects receiving local anesthetic and those receiving placebo at the time of mid-urethral sling placement. The secondary objective is to evaluate pain after the procedure in the two groups.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Retropubic Hydrodissection and Trocar-induced Bladder Perforation During Retropubic Midurethral Slings

NCT07208682

Bladder Perforation Retropubic Midurethral Sling Retropubic Hydrodissection

RECRUITING NA

Treatment of Stress Urinary Incontinence by Injection of Autologous Muscle Fibers Into the Urethral Sphincter.

NCT01323426

Urinary Incontinence, Stress

UNKNOWN PHASE1/PHASE2

The Effect of Pudendal Blocks on Voiding Dysfunction Following Slings

NCT03353714

Stress Urinary Incontinence

COMPLETED NA

The Impact of Retropubic Lidocaine vs Saline on Postoperative Urinary Retention Following Midurethral Sling

NCT03913845

Stress Urinary Incontinence

COMPLETED PHASE4

Autologous Stem Cells for Urinary Incontinence: Single Patient Compassionate Use

NCT01648491

Stress Urinary Incontinence

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stress Urinary Incontinence

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Bupivacaine + epinephrine

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

10ml 0.5% bupivacaine

Epinephrine

Intervention Type DRUG

1:200,000 epinephrine

Saline + epinephrine

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

10ml 0.9% sodium chloride

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bupivacaine

10ml 0.5% bupivacaine

Intervention Type DRUG

Saline

10ml 0.9% sodium chloride

Intervention Type DRUG

Epinephrine

1:200,000 epinephrine

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Marcaine Sodium Chloride

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Scheduled to undergo mid-urethral sling for incontinence without concomitant procedures

Exclusion Criteria

* Undergoing procedure in addition to the sling
* Not competent to give consent
* Using intermittent self catheterization pre-operatively
* Known allergy to local anesthetic
* Undergoing spinal anesthesia for the procedure
* Prisoners
* Non-English speaker
* Under 18 years of age
* Has a condition that would contra-indicate the use of local anesthetic or epinephrine

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No