Bladder Filling for Faster Patient Discharge

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Tennessee

Disqualifiers: Non-laparoscopic surgery, others

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

Compensation: Varies

Number of Visits: 1

112 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether filling the bladder with sterile saline after surgery, a process known as Backfill, can help women recover faster and leave the hospital sooner. It specifically targets women undergoing a planned laparoscopic hysterectomy, a minimally invasive surgery to remove the uterus. Participants will be divided into two groups: one will have their bladder filled with saline, and the other will not. Women aged 18 to 80 undergoing this type of surgery as a day procedure are suitable candidates for the trial. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance recovery processes for future patients.

Do I need to stop my current medications for this trial?

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

What prior data suggests that bladder backfilling is safe?

Research has shown that filling the bladder with 200 mL of saltwater after surgery is usually well-tolerated. In earlier studies, this method helped patients start urinating sooner, allowing them to leave the hospital faster. Importantly, these studies did not find any major safety problems or serious side effects from this treatment, suggesting it is safe for people. However, as with any medical procedure, individual experiences may vary. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial of bladder filling with backfill because it could speed up patient discharge after surgery. Unlike the usual practice of removing a Foley catheter without bladder filling, this method involves instilling 200 mL of sterile saline into the bladder before catheter removal. This simple step might help the bladder regain its function faster, allowing patients to leave the hospital sooner and potentially improving recovery times.

What evidence suggests that bladder backfilling is effective for faster patient discharge?

This trial will compare two approaches: one group will receive bladder backfilling, where 200 mL of sterile normal saline is instilled into the bladder after surgery, and the other group will not receive bladder filling. Research has shown that filling the bladder with a small amount of sterile fluid after surgery can help patients urinate on their own more quickly, often leading to faster discharge times. However, some studies noted that while it sped up the first urination, it didn't always reduce the overall hospital stay. Overall, backfilling might help some patients get home sooner by kick-starting bladder function after surgery. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for patients who have undergone outpatient laparoscopic hysterectomy. Specific eligibility criteria are not provided, so it's assumed that participants should be in stable condition post-surgery and able to undergo the intervention of bladder backfilling.

Inclusion Criteria

I am scheduled for a laparoscopic hysterectomy as an outpatient.

I am a woman aged between 18 and 80.

Exclusion Criteria

I am having an emergency surgery that is not done with a camera.

I am a woman aged between 18 and 80.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Surgery and Immediate Postoperative Care

Participants undergo laparoscopic hysterectomy with or without bladder backfilling and immediate postoperative care

1 day

1 visit (in-person)

Post-anesthesia Care Unit Monitoring

Participants are monitored for time to void and time to discharge from the post-anesthesia care unit

Within 3 days following surgery

Follow-up

Participants are monitored for any postoperative complications and overall recovery

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Backfill

Trial Overview The study is testing whether filling the bladder with fluid after surgery (backfill) can help patients urinate on their own faster and get discharged sooner from the post-anesthesia care unit.

How Is the Trial Designed?

Group I: Backfill Experimental Treatment 1 Intervention

Participants will receive 200 mL of room temperature, sterile normal saline instilled retrograde into the bladder at the completion of the surgery prior to Foley catheter removal and the Foley subsequently removed intraoperatively.

Group II: No bladder filling Active Control 1 Intervention

Participants will have the Foley catheter removed intraoperatively at completion of the procedure.

Who Is Running the Clinical Trial?

University of Tennessee

Lead Sponsor

Trials

202

Recruited

146,000+

Published Research Related to This Trial

Bladder retrofilling in the operating room after outpatient gynecologic surgery significantly reduces the time to first void by an average of 33.5 minutes and time to discharge by 32.0 minutes, based on a meta-analysis of 1,173 patients across eight studies.

There were no significant differences in postoperative urinary retention or urinary tract infections between the retrofilling and passive filling methods, indicating that retrofilling is a safe option with comparable patient satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrograde Bladder Filling After Outpatient Gynecologic Surgery: A Systematic Review and Meta-analysis. Thiel, PS., Mathur, S., Zakhari, A., et al.[2021]

In a study of 82 women undergoing total laparoscopic hysterectomy, the autofill void trial resulted in a significantly faster discharge time from recovery compared to the backfill void trial, with median times of 176 minutes versus 218 minutes, respectively.

There was no significant difference in the rate of postoperative urinary retention (POUR) between the two methods, with 16.7% in the autofill group and 27.5% in the backfill group, indicating that both methods are similarly effective in managing urinary retention post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative Urinary Retention Rates after Autofill versus Backfill Void Trial following Total Laparoscopic Hysterectomy: A Randomized Controlled Trial. Farag, S., Padilla, PF., Smith, KA., et al.[2021]

Retrofilling the bladder with 200 mL of saline after laparoscopic gynecologic surgery significantly reduced the median time to first void (104 minutes) compared to standard care (162 minutes), indicating improved postoperative recovery.

Patients who received retrofilling were discharged from the post-anesthesia care unit faster (155 minutes) than those who had immediate catheter removal (227 minutes), with no urinary tract infections reported in either group, highlighting the safety and efficacy of this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrograde Bladder Filling after Laparoscopic Gynecologic Surgery: A Double-blind Randomized Controlled Trial. Zakhari, A., Paek, W., Chan, W., et al.[2021]

The bladder backfilling technique for trial of void (TOV) after outpatient laparoscopic gynecologic surgery resulted in a significantly shorter time to first spontaneous void compared to standard catheter removal, with an average difference of about 25 minutes.

There were no significant differences in postoperative complications, patient satisfaction, or time to discharge between the bladder backfilling and standard TOV techniques, indicating that while bladder backfilling may speed up the time to void, it does not compromise safety or overall patient experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bladder Backfilling versus Standard Catheter Removal for Trial of Void after Outpatient Laparoscopic Gynecologic Surgery: A Systematic Review and Meta-Analysis. Dong, X., Pan, C., Wang, D., et al.[2022]

The retrograde bladder filling (RF) method significantly reduced the time to void and time to discharge after transurethral prostatectomy (TURP) compared to spontaneous voiding (SV), with times of 67 minutes versus 144 minutes and 168 minutes versus 219 minutes, respectively.

Both RF and SV methods showed comparable rates of immediate postoperative complications and similar satisfaction levels among patients and medical staff, indicating that RF is a safe and effective option for catheter removal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical benefits of retrograde bladder filling method prior to catheter removal after TURP for BPH: A prospective randomized trial. Song, SH., Kim, JH., Kim, JK., et al.[2022]

In a study of 153 women undergoing outpatient laparoscopic hysterectomy, backfilling the bladder before catheter removal significantly reduced the time to first spontaneous void by about 25 minutes (181.1 minutes vs. 206.0 minutes), indicating a potential benefit in postoperative care.

However, the overall time to discharge was not significantly different between the backfill group and the spontaneous voiding group, suggesting that while bladder backfilling aids in quicker voiding, it does not expedite overall discharge from the hospital.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative Bladder Filling After Outpatient Laparoscopic Hysterectomy and Time to Discharge: A Randomized Controlled Trial. Chao, L., Mansuria, S.[2021]

The new backfill void trial (VT) protocol performed in the operating room (OR) led to a significant reduction in postoperative care unit (PACU) stay by an average of 23 minutes without increasing the need for postoperative catheterization.

In a study of 225 women undergoing urogynecologic surgery, the OR backfill VT showed similar rates of VT failure compared to the standard VT, indicating that the new protocol is both effective and efficient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Streamlining Postoperative Void Trials: A Study Comparing Standard Backfill Versus Backfill in the Operating Room. Meekins, AR., Amundsen, CL., Weidner, AC.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6483897/

Postoperative Bladder Filling After Outpatient Laparoscopic ... To determine if backfilling the bladder postoperatively will reduce time to discharge in patients undergoing outpatient laparoscopic hysterectomy.

2. withpower.com withpower.com/trial/phase-patient-discharge-2025-b46bf

Bladder Filling for Faster Patient Discharge In a study of 82 women undergoing total laparoscopic hysterectomy, the autofill void trial resulted in a significantly faster discharge time from recovery ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1553465021004131

Bladder Backfilling versus Standard Catheter Removal for ... Our current study found that bladder backfilling TOV can reduce the time to first spontaneous void, but it does not significantly affect the time to discharge ...

4. systematicreviewsjournal.biomedcentral.com systematicreviewsjournal.biomedcentral.com/articles/10.1186/s13643-023-02233-1

Methods of postoperative void trial management after ... Our current study found that bladder backfill-assisted VT is associated with a lower rate of discharge with a catheter; however, it does not ...

5. researchgate.net researchgate.net/publication/332312567_Postoperative_Bladder_Filling_After_Outpatient_Laparoscopic_Hysterectomy_and_Time_to_Discharge_A_Randomized_Controlled_Trial

Postoperative Bladder Filling After Outpatient Laparoscopic ... ... Some studies have reported that bladder backfilling TOV reduces the time to first spontaneous void formation and is associated with a faster discharge [5][6 ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002937818322853

Effect of postoperative partial bladder filling after minimally ... Based on the findings of this randomized clinical trial, postoperative bladder backfilling to submicturition level shortens the time needed for patients to void ...

7. ovid.com ovid.com/journals/ajog/pdf/10.1016/j.ajog.2018.12.034~effect-of-postoperative-partial-bladder-filling-after

Effect of postoperative partial bladder filling after minimally ... This trial studied the effect of postoperative bladder backfilling to submicturition level in the operating room and its effect on early post- operative patient ...