Timing of Voiding Trials for Postoperative Urinary Retention

Overseen By Simone Fertel, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of South Florida

Disqualifiers: Under 18, Urinary retention, Neurogenic bladder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the optimal waiting time for women to successfully pass urine on their own after urogynecologic surgery. Researchers aim to determine whether allowing women 30 minutes or 60 minutes to attempt urination post-surgery yields better outcomes. Women scheduled for urogynecologic surgery with same-day discharge may be suitable candidates for this trial. Participants will be randomly assigned to either a 30-minute or 60-minute timeframe to attempt urination after surgery. As an unphased trial, this study provides participants the chance to contribute to significant research that could enhance post-surgery recovery protocols for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this protocol is safe for patients undergoing urogynecologic surgery?

Research has shown that active void trials, like those in this study, are generally safe for patients after surgery. For instance, one study found that passive voiding trials (where the body naturally empties the bladder) are safe for patients who have undergone non-cancerous gynecologic surgeries. This finding suggests that active void trials, where patients are asked to try urinating at specific times, are also likely to be well-tolerated.

Some patients might experience difficulty urinating after surgery, known as postoperative urinary retention, but research indicates this is common and often resolves on its own. Studies have found no significant differences in urinary retention based on the timing of the void trial. Whether patients are asked to urinate within 30 or 60 minutes, the safety remains similar.

Overall, active void trials help manage and identify any urination issues after surgery without adding extra risk, making them a safe option for those recovering from urogynecologic procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores new ways to manage postoperative urinary retention, a common issue after surgery. Unlike traditional methods that often rely on catheterization, this trial investigates the timing of allowing patients to void naturally. The "Immediate" approach gives patients up to 30 minutes, while the "Extended" approach allows up to 60 minutes. By finding the optimal timing, the trial aims to reduce discomfort, lower the risk of infection, and enhance recovery, potentially offering a more patient-friendly alternative to current practices.

What evidence suggests that this trial's methods could be effective for postoperative urinary retention?

Research has shown that active voiding trials help identify women who might have trouble urinating after urogynecologic surgery. One study found that about 44.3% of patients experienced difficulty urinating post-surgery, and the type of voiding trial used did not significantly alter this outcome. However, another study found that on the first day after surgery, most patients could empty about 75% of their bladder, indicating that many can urinate effectively soon after surgery. In this trial, participants will be assigned to either an "Immediate" arm, with up to 30 minutes to void, or an "Extended" arm, with up to 60 minutes. While the time allowed for urination might affect comfort and efficiency, the data does not show a clear difference in results based on the trial duration. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Women undergoing a urogynecologic surgery at Tampa General Hospital and who are seen preoperatively at the University of South Florida Urogynecology clinic

I am a woman scheduled for pelvic surgery and will need a test to check bladder function afterwards.

I am scheduled for surgery that will happen and end on the same day.

Exclusion Criteria

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 a female and under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Randomization

Patients undergo urogynecologic surgery and are randomized to either 30-minute or 60-minute void trial arms

1 day

1 visit (in-person)

Active Void Trial

Participants are given up to 30 or 60 minutes to void postoperatively, depending on randomization

60 minutes

1 visit (in-person)

Follow-up

Participants are monitored for urinary tract infection and other outcomes after surgery

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Active Void Trial

Trial Overview

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.

How Is the Trial Designed?

Group I: Immediate Experimental Treatment 1 Intervention

Patients will be given up to 30 minutes to void during the active void trial postoperatively.

Group II: Extended Experimental Treatment 1 Intervention

Patients will be given up to 60 minutes to void during the active void trial postoperatively.

Who Is Running the Clinical Trial?

University of South Florida

Lead Sponsor

Trials

433

Recruited

198,000+

Published Research Related to This Trial

In a study of 78 women with urinary retention after urogynecologic surgery, patient satisfaction was similar whether the indwelling catheter was removed at home or in the office, with median satisfaction scores of 95 in both groups.

However, the home catheter removal group experienced significantly fewer urinary tract infections (8.3%) compared to the office group (26.3%), suggesting a potential safety advantage for home removal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of patient satisfaction with home vs office indwelling catheter removal placed for urinary retention after female pelvic floor surgery: a randomized controlled trial. Popiel, P., Swallow, C., Choi, JE., et al.[2023]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10327332/

Methods of postoperative void trial management after ...

Voiding trials are used to identify women at risk for postoperative urinary retention while performing optimal voiding trial management with minimal burden to ...

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S009082582401059X

Postoperative urinary retention by void trial methodology ...

44.3% of patients developed postoperative urinary retention with no differences based on void trial (p = 0.17). Urinary retention was more likely to resolve by ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04487600

The Impact of Post-operative Voiding Trial on Length ...

The aim of this study is to determine the difference in time to discharge following an active voiding trial with bladder backfill in the post-operative recovery ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/35697225/

Predictive Value of Voiding Efficiency After Active Void Trial ...

On post-operative day one, the median voiding efficiency was 75% (IQR 55%-94%). On multivariable analysis, patients with a voiding efficiency ...

5.

ajog.org

ajog.org/article/S0002-9378(24)00251-5/fulltext

a cost analysis of second postoperative void trials

Clinical demographic and postoperative outcome data regarding PACU duration, TOV pass rates, UTI rates, and distance from clinic was obtained from a review of ...

6.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1553465021003563

Active versus Passive Voiding Protocols after Same-day ...

This study shows that in a large community setting, it is safe to perform a passive voiding trial after an MIH for benign gynecologic conditions.

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05885958

Timing of Active Void Trials After Urogynecologic Procedures

The goal of this clinical trial is to learn about active void trial pass rates in patients undergoing urogynecologic surgery. The main question it aims to ...