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Evaluating Voiding Trial Volume for Urinary Retention

N/A

Waitlist Available

Led By David Lovejoy, MD

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 7

Awards & highlights

Study Summary

This trial found that early identification of urinary retention can prevent bladder over-distention, ischemia & long-term voiding dysfunction.

Who is the study for?

This trial is for nonpregnant women over 18 who are having surgery for pelvic organ prolapse or urinary incontinence. It's not open to those with preoperative voiding issues requiring self-catheterization, recurrent UTIs, bladder injuries during surgery, intolerance to at least 150cc backfill, neuromuscular disorders, or pregnancy.Check my eligibility

What is being tested?

The study is looking at the best volume of fluid to use when testing if patients can urinate properly after urogynecologic surgery. Women will be randomly placed into a control group or a test group to determine this optimal volume.See study design

What are the potential side effects?

While specific side effects aren't detailed here, potential risks may include discomfort from the backfill procedure and symptoms related to urinary retention such as pain or difficulty urinating.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 7

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 7

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 7 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

difference in acute voiding dysfunction between a backfill assisted voiding trial

Secondary outcome measures

average number of days postoperatively, that require catheterization

proportion of patients developing bladder pain or pressure

proportion of patients developing overactive bladder symptoms

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: control group (voids 2/3 of the volume backfilled)Experimental Treatment1 Intervention

control group

Group II: test group (voids ½ of the total volume backfilled)Active Control1 Intervention

test group)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Control Group

2012

Completed Phase 2

~2470

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor

1,243 Previous Clinical Trials

1,004,630 Total Patients Enrolled

3 Trials studying Urinary Retention

153 Patients Enrolled for Urinary Retention

David Lovejoy, MDPrincipal InvestigatorWake Forest University Health Sciences

Media Library

control group (voids 2/3 of the volume backfilled) Clinical Trial Eligibility Overview. Trial Name: NCT05820139 — N/A

Urinary Retention Research Study Groups: control group (voids 2/3 of the volume backfilled), test group (voids ½ of the total volume backfilled)

Urinary Retention Clinical Trial 2023: control group (voids 2/3 of the volume backfilled) Highlights & Side Effects. Trial Name: NCT05820139 — N/A

control group (voids 2/3 of the volume backfilled) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05820139 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings available for individuals to participate in this trial?

"From the clinicaltrials.gov website, this medical trial is not currently seeking candidates having been first posted on May 1st 2023 and edited as recently as April 7th 2023. Nevertheless, there are two other trials that require volunteers presently."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluating the Optimal Volume Voided for Passage of a Backfill-Assisted Voiding Trial Following Urogynecologic Surgery

2023. "Evaluating the Optimal Volume Voided for Passage of a Backfill-Assisted Voiding Trial Following Urogynecologic Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05820139.