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Procedure
Timing of Voiding Trials for Postoperative Urinary Retention
N/A
Recruiting
Research Sponsored by University of South Florida
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 2 years
Awards & highlights
Study Summary
This trial is testing if 30 or 60 minutes is best for patients to pass urine after surgery.
Who is the study for?
This trial is for women who can consent, speak English/Spanish, are having urogynecologic surgery at Tampa General Hospital and need a postoperative void trial. It's not for those under 18, unable to consent, staying overnight in the hospital, with urinary retention or neurogenic bladder history, imprisoned, or having certain non-standard procedures.Check my eligibility
What is being tested?
The study is testing if there's a difference in the ability to urinate after surgery between women given either 30 minutes or 60 minutes. Participants will be randomly assigned to one of these two groups before their scheduled urogynecologic procedure.See study design
What are the potential side effects?
Since this trial involves timing rather than medication or invasive therapy, there are no direct side effects from interventions being tested. However, general risks associated with postoperative care may still apply.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pass Rate
Secondary outcome measures
Pass Rate After Failing
Surgical Procedures Performed Prior to Active Void Trial
Time in PACU
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: ImmediateExperimental Treatment1 Intervention
Patients will be given up to 30 minutes to void during the active void trial postoperatively.
Group II: ExtendedExperimental Treatment1 Intervention
Patients will be given up to 60 minutes to void during the active void trial postoperatively.
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Who is running the clinical trial?
University of South FloridaLead Sponsor
416 Previous Clinical Trials
188,757 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a woman scheduled for pelvic surgery and will need a test to check bladder function afterwards.I am a woman planning to stay in the hospital overnight.I am not willing or able to agree to join this study.I am scheduled for surgery that will happen and end on the same day.I am a female and under 18 years old.I speak English or Spanish.I am a woman who can make my own medical decisions.I have had issues with not being able to empty my bladder or nerve-related bladder problems.I am a woman having a non-standard procedure for bladder control issues.
Research Study Groups:
This trial has the following groups:- Group 1: Immediate
- Group 2: Extended
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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