Does Bladder Instillation Reduce Time to Discharge After Sling Surgery

• ClinicalTrials.gov Identifier: NCT02277288
• Recruitment Status: Recruiting
• First Posted: October 29, 2014
• Last Update Posted: July 18, 2018
• Sponsor: Cedars-Sinai Medical Center
• Information provided by (Responsible Party): Jennifer T. Anger, Cedars-Sinai Medical Center

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Stress Urinary Incontinence	Other: Filled bladder arm	Not Applicable

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 250 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Participant)
• Primary Purpose: Other
• Official Title: Does Intraoperative Bladder Instillation Decrease Outpatient Recovery Time After Mid-Urethral Sling
• Study Start Date: December 2011
• Estimated Primary Completion Date: December 2025
• Estimated Study Completion Date: December 2025

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Emptied bladder arm; No instillation of fluid into bladder.
Experimental: Filled bladder arm; Instilled bladder with fluid.	Other: Filled bladder arm; Bladder to be instilled with 200 cc fluid during cystoscopy and no catheter for all mid-urethral sling procedures.

Outcome Measures

Primary Outcome Measures :

1. Time between surgery and discharge home [ Time Frame: 2 Days ]
   Will analyze if the time to discharge is shorter in those patients who have had bladder instillation versus those with an indwelling catheter postoperatively.

Secondary Outcome Measures :

1. Hospital charges [ Time Frame: 1 Month ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Jennifer Anger, MD, MPH; 3103852992

Locations

United States, California

Cedars-Sinai Medical Center; Recruiting

Beverly Hills, California, United States, 90211

Contact: Jennifer Anger, MD, MPH 310-385-2992

Principal Investigator: Jennifer Anger, MD, MPH

Sponsors and Collaborators

Cedars-Sinai Medical Center

Investigators

• Principal Investigator: Jennifer Anger, MD, MPH; Cedars-Sinai Medical Center

More Information

Publications:

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.

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.

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.

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

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

• Responsible Party: Jennifer T. Anger, Principal Investigator, Cedars-Sinai Medical Center
• ClinicalTrials.gov Identifier: NCT02277288
• Other Study ID Numbers: Pro00026292
• First Posted: October 29, 2014
• Last Update Posted: July 18, 2018
• Last Verified: July 2018

Additional relevant MeSH terms:

Urinary Incontinence; Urinary Incontinence, Stress; Urination Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations