Does Bladder Instillation Reduce Time to Discharge After Sling Surgery

Stress Urinary Incontinence Clinical Trial

Official title:

Does Intraoperative Bladder Instillation Decrease Outpatient Recovery Time After Mid-Urethral Sling

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02277288
• Other study ID #: Pro00026292
• Status: Recruiting
• Phase: N/A
• Start date: December 2011
• Est. completion date: December 2025

Study information

• Verified date: July 2018
• Source: Cedars-Sinai Medical Center
• Contact: Jennifer Anger, MD, MPH
• Phone: 3103852992
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this randomized control trial study is to determine if intraoperative bladder instillation of fluid decreases the time to discharge after having an outpatient mid-urethral sling procedure, and to measure the cost savings of this decrease in hospital stay. Charges will be broken down between recovery room charges and discharge area, as recovery room charges are significantly higher. The investigators suspect that a shorter time in the recovery room will translate into fewer charges.

Description:

Urinary stress incontinence affects 4-35% of women. Due to the large economic impact and prevalence of the disease, urinary incontinence is a significant public health issue. With rising healthcare costs it has become increasingly important to manage patient care in the most cost-efficient manner. Considering the increasing number of women undergoing mid-urethral sling procedures, it is imperative that perioperative care is streamlined in order to minimize cost. The Cedars-Sinai Center for Continence and Women's Pelvic Health instituted a new practice pattern that enables patients to complete a voiding trial sooner after surgery compared to previous practice patterns thus allowing patients to be discharged earlier and ultimately decreasing cost. The purpose of this study is to compare the previous voiding trial practice (emptying the bladder at the end of surgery) versus the newly instituted practice (filling with bladder with 250cc) and perform a cost benefit analysis to determine if there is a significant decrease in recovery and discharge time. Both of these practices fall under the standard-of-care. However, of the several standard-of-care procedures, none have been tested for superiority. To date there are no randomized control trials that address this issue in female mid-urethral sling surgery.

Boccola et al showed in a study of 60 men who had undergone transurethral resection of the prostate (TURP) that by instilling the bladder with 300-500cc of warm saline the time to void was significantly decreased compared to standard indwelling catheter removal. It was also shown that the bladder instillation group had a significantly shorter time to discharge. The study suggested that given the significant decrease in time in recovery, this would be an ideal practice for many other outpatient procedures. Willson, et al, in another randomized trial of 75 men who underwent TURP, found that bladder infusion allowed early decision-making for discharge on the second postoperative day. Finally, McAchran and Goldman found that when patients were managed using a fast-track regimen in the outpatient setting after mid-urethral sling procedures the median time from the recovery area to discharge was less than 3 hours.

For our study, if a significant decrease in the time to discharge with the newly instituted practice pattern is demonstrated, then this practice can be adopted by other institutions and become the new standard of care to help decrease both cost and patient time in the hospital.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Female

2. Age 18 years or older

3. History of stress urinary incontinence

4. Scheduled for outpatient mid-urethral sling procedure, any approach

Exclusion Criteria:

1. Age less than 18 years

2. Pregnancy

3. Inability to give informed consent

4. History of urinary retention

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Other:
• Filled bladder arm
Bladder to be instilled with 200 cc fluid during cystoscopy and no catheter for all mid-urethral sling procedures.

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Beverly Hills	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (5)

Boccola MA, Sharma A, Taylor C, Wong LM, Travis D, Chan S. The infusion method trial of void vs standard catheter removal in the outpatient setting: a prospective randomized trial. BJU Int. 2011 Apr;107 Suppl 3:43-6. doi: 10.1111/j.1464-410X.2011.10044.x. — View Citation

Luber KM. The definition, prevalence, and risk factors for stress urinary incontinence. Rev Urol. 2004;6 Suppl 3:S3-9. — View Citation

McAchran SE, Goldman HB. Contemporary length of stay and resource utilization when using a fast-track regimen for mid-urethral sling surgery. Urology. 2009 Sep;74(3):531-4. doi: 10.1016/j.urology.2009.04.039. Epub 2009 Jul 9. — View Citation

Wilson ID, Bramwell SP, Hollins GW. A randomized trial comparing bladder infusion with standard catheter removal after transurethral resection of the prostate. BJU Int. 2000 Dec;86(9):993-5. — View Citation

Wilson L, Brown JS, Shin GP, Luc KO, Subak LL. Annual direct cost of urinary incontinence. Obstet Gynecol. 2001 Sep;98(3):398-406. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time between surgery and discharge home	Will analyze if the time to discharge is shorter in those patients who have had bladder instillation versus those with an indwelling catheter postoperatively.	2 Days
Secondary	Hospital charges		1 Month