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

208 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Active Void Trial for postoperative urinary retention?

The research highlights the importance of managing postoperative urinary retention through strategies like encouraging urination soon after surgery and using catheters when necessary, which may indirectly support the effectiveness of the Active Void Trial treatment by aligning with these practices. ^{1 2 3 4 5}

How is the Active Void Trial treatment different from other treatments for postoperative urinary retention?

The Active Void Trial is unique because it focuses on optimizing the timing and criteria for voiding trials, which are tests to see if a patient can urinate on their own after surgery, rather than relying solely on medications or catheters. This approach aims to reduce the burden on patients and healthcare providers by improving the process of assessing urinary function post-surgery. ^{2 3 6 7 8}

What is the purpose of this trial?

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 answer is the comparison in pass rate during active void trial between women who are given 30 minutes versus 60 minutes to void following urogynecologic surgery. Patient will be randomized to two arms prior to scheduled surgery. During the active void trial, women will be allotted up to 30 minutes or up to 60 minutes to void depending on respective randomization.

Eligibility Criteria

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.

Imprisoned patients

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

National incidence and outcomes of postoperative urinary retention in the Surgical Care Improvement Project. [2022]

2. Korea (South) pubmed.ncbi.nlm.nih.gov

Predictors of Successful Trial without Catheter for Postoperative Urinary Retention Following Non-Urological Surgery. [2021]

3. United States 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. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Postoperative urinary retention. Guidelines and an algorithm. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Patients' experiences of urinary retention and bladder care - A qualitative study in orthopaedic care. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Methods of postoperative void trial management after urogynecologic surgery: a systematic review and meta-analysis. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Predictive Value of Voiding Efficiency After Active Void Trial in Men Undergoing BPH Surgery. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Tamsulosin for prevention of postoperative urinary retention: A systematic review and meta-analysis. [2023]