Study Summary
This 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.
Eligible Conditions
- Stress Incontinence
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 1 Secondary · Reporting Duration: 1 Month
1 Month
Hospital charges
2 Days
Time between surgery and discharge home
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Emptied bladder arm
1 of 2
Filled bladder arm
1 of 2
Active Control
Experimental Treatment
250 Total Participants · 2 Treatment Groups
Primary Treatment: Filled bladder arm · No Placebo Group · N/A
Filled bladder arm
Other
Experimental Group · 1 Intervention: Filled bladder arm · Intervention Types: OtherEmptied bladder armNoIntervention Group · 1 Intervention: Emptied bladder arm · Intervention Types:
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 month
Who is running the clinical trial?
Cedars-Sinai Medical CenterLead Sponsor
455 Previous Clinical Trials
143,985 Total Patients Enrolled
Jennifer Anger, MD, MPHPrincipal InvestigatorCedars-Sinai Medical Center
2 Previous Clinical Trials
60 Total Patients Enrolled
Eligibility Criteria
Age 18+ · Female Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are female.
You must be between the ages of 18 and 50 years.
You are scheduled for an outpatient mid-urethral sling procedure, any approach.
References
- Boccola, Mark A., Anant Sharma, Claire Taylor, Lih-Ming Wong, Douglas Travis, and Steven Chan. 2011. “The Infusion Method Trial of Void Vs Standard Catheter Removal in the Outpatient Setting: A Prospective Randomized Trial”. BJU International. Wiley. doi:10.1111/j.1464-410x.2011.10044.x.
- Sangsawang, Bussara. 2014. “Risk Factors for the Development of Stress Urinary Incontinence During Pregnancy in Primigravidae: A Review of the Literature”. European Journal of Obstetrics & Gynecology and Reproductive Biology. Elsevier BV. doi:10.1016/j.ejogrb.2014.04.010.
- McAchran, Sarah E., and Howard B. Goldman. 2009. “Contemporary Length of Stay and Resource Utilization When Using a Fast-track Regimen for Mid-urethral Sling Surgery”. Urology. Elsevier BV. doi:10.1016/j.urology.2009.04.039.
- Wilson, L. 2001. “Annual Direct Cost of Urinary Incontinence”. Obstetrics & Gynecology. Ovid Technologies (Wolters Kluwer Health). doi:10.1016/s0029-7844(01)01464-8.
- Wilson, I.D., S.P. Bramwell, and G.W. Hollins. 2001. “A Randomized Trial Comparing Bladder Infusion with Standard Catheter Removal After Transurethral Resection of the Prostate”. BJU International. Wiley. doi:10.1046/j.1464-410x.2000.00963.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. doi: 10.1046/j.1464-410x.2000.00963.x.
- Wilson L, Brown JS, Shin GP, Luc KO, Subak LL. Annual direct cost of urinary incontinence. Obstet Gynecol. 2001 Sep;98(3):398-406. doi: 10.1016/s0029-7844(01)01464-8.
- Luber KM. The definition, prevalence, and risk factors for stress urinary incontinence. Rev Urol. 2004;6 Suppl 3(Suppl 3):S3-9.
- Jennifer T. Anger 2011. "Does Bladder Instillation Reduce Time to Discharge After Sling Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02277288.
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