~10 spots leftby Dec 2025

Bladder Instillation for Urinary Incontinence

Recruiting in Palo Alto (17 mi)
JA
Overseen byJennifer Anger, MD, MPH
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Cedars-Sinai Medical Center
Disqualifiers: Pregnancy, Urinary retention, others
No Placebo Group
Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Bladder Instillation for Urinary Incontinence?

Research shows that intravesical (directly into the bladder) instillation of oxybutynin is effective in reducing symptoms like frequent urination and improving bladder capacity, with minimal side effects, in patients with bladder instability.12345

Is bladder instillation generally safe for humans?

Bladder instillation treatments, such as those using BCG or oxybutynin, are generally considered safe but can have side effects. BCG instillation may cause rare complications like reactive arthritis or vascular issues, while oxybutynin instillation is well tolerated with minimal side effects.26789

How does bladder instillation differ from other treatments for urinary incontinence?

Bladder instillation is unique because it involves directly introducing medication into the bladder, which can provide high drug concentration at the site with reduced systemic exposure. This method can be more effective and have fewer side effects compared to oral medications, as seen with treatments like intravesical oxybutynin, which is well-tolerated and minimizes side effects.210111213

Research Team

JA

Jennifer Anger, MD, MPH

Principal Investigator

Cedars-Sinai Medical Center

Eligibility Criteria

This trial is for women aged 18 or older with stress urinary incontinence who are scheduled for an outpatient mid-urethral sling procedure. It's not suitable for those under 18, pregnant, unable to consent, or with a history of urinary retention.

Inclusion Criteria

I am scheduled for a sling procedure to support my urethra.
I am 18 years old or older.
I am female.
See 1 more

Exclusion Criteria

I have had problems with not being able to empty my bladder fully.
I am unable to understand and give consent for treatment.
I am under 18 years old.
See 1 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Surgery and Immediate Recovery

Participants undergo mid-urethral sling surgery and immediate postoperative recovery

1 day
1 visit (in-person)

Postoperative Monitoring

Participants are monitored for time to discharge and recovery efficiency

2 days

Follow-up

Participants are monitored for safety and effectiveness after discharge

2-4 weeks

Treatment Details

Interventions

  • Filled bladder arm (Other)
Trial OverviewThe study is testing if filling the bladder with fluid during surgery can shorten hospital stay after sling surgery for urinary incontinence. The cost impact due to reduced time spent in recovery will also be assessed.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Filled bladder armExperimental Treatment1 Intervention
Instilled bladder with fluid.
Group II: Emptied bladder armActive Control1 Intervention
No instillation of fluid into bladder.

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
Cedars-Sinai Medical CenterBeverly Hills, CA
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Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials
523
Patients Recruited
165,000+

Findings from Research

Supratrigonal cystectomy and augmentation cystoplasty with ileum or ileocecum in the treatment of ulcerative interstitial cystitis/bladder pain syndrome: a 14-year follow-up.Queissert, F., Bruecher, B., van Ophoven, A., et al.[2023]
The pharmacokinetics of intravesical and oral oxybutynin chloride.Massad, CA., Kogan, BA., Trigo-Rocha, FE.[2019]
Ileocystoplasty significantly improved urinary frequency in six out of seven patients with severe bladder dysfunction due to interstitial cystitis, irradiation, or neurogenic causes, with follow-up periods ranging from 8 to 66 months.
Post-surgery, all patients had a residual urine volume of less than 30 ml, indicating effective bladder function restoration, making ileocystoplasty a promising treatment for contracted bladders.
Functional results after ileocystoplasty.Myrén, CJ., Beuke, HP., Thybo, E.[2019]
Long-term outcome of intravesical oxybutynin in children with detrusor-sphincter dyssynergia: with special reference to age-dependent parameters.Humblet, M., Verpoorten, C., Christiaens, MH., et al.[2015]
[Topical use of oxybutynin hydrochloride in women with urge incontinence].Enzelsberger, H., Kurz, C., Helmer, H.[2018]
Aorto-enteric fistula development secondary to mycotic abdominal aortic aneurysm following intravesical bacillus Calmette-Guerin (BCG) treatment for transitional cell carcinoma of the bladder.Roylance, A., Mosley, J., Jameel, M., et al.[2021]
Bladder instillation of liposome encapsulated onabotulinumtoxina improves overactive bladder symptoms: a prospective, multicenter, double-blind, randomized trial.Chuang, YC., Kaufmann, JH., Chancellor, DD., et al.[2022]
Intravesical instillation of BCG (ivBCG) is an effective immunotherapy for bladder cancer, but it can lead to reactive arthritis (ReA) in some patients, with symptoms typically appearing after an average of 5.8 instillations.
Among 89 analyzed cases, polyarthritis was the most common form of ReA, occurring in 55.1% of patients, and the condition is usually benign, resolving within 6 months in 93.2% of cases, often treated effectively with NSAIDs and corticosteroids.
Reactive arthritis induced by intravesical BCG therapy for bladder cancer: our clinical experience and systematic review of the literature.Bernini, L., Manzini, CU., Giuggioli, D., et al.[2021]
Factors associated with treatment outcomes after intravesical hyaluronic acid therapy in women with refractory interstitial cystitis: A prospective, multicenter study.Tsai, CP., Yang, JM., Liang, SJ., et al.[2021]
Intravesical Instillation of OnabotulinumtoxinA in the Treatment of Refractory Overactive Bladder in Participants with Urinary Incontinence.Chermansky, CJ., Richter, HE., Jacoby, K., et al.[2022]
Bladder instillation for urinary tract infection prevention in neurogenic bladder patients practicing clean intermittent catheterization: A systematic review.Ziadeh, T., Chebel, R., Labaki, C., et al.[2022]
An intravesical device for the sustained delivery of lidocaine to the bladder.Lee, H., Cima, MJ.[2013]
Current recommendations for bladder instillation therapy in the treatment of interstitial cystitis/bladder pain syndrome.Colaco, MA., Evans, RJ.[2021]

References

Supratrigonal cystectomy and augmentation cystoplasty with ileum or ileocecum in the treatment of ulcerative interstitial cystitis/bladder pain syndrome: a 14-year follow-up. [2023]
The pharmacokinetics of intravesical and oral oxybutynin chloride. [2019]
Functional results after ileocystoplasty. [2019]
Long-term outcome of intravesical oxybutynin in children with detrusor-sphincter dyssynergia: with special reference to age-dependent parameters. [2015]
[Topical use of oxybutynin hydrochloride in women with urge incontinence]. [2018]
Aorto-enteric fistula development secondary to mycotic abdominal aortic aneurysm following intravesical bacillus Calmette-Guerin (BCG) treatment for transitional cell carcinoma of the bladder. [2021]
Bladder instillation of liposome encapsulated onabotulinumtoxina improves overactive bladder symptoms: a prospective, multicenter, double-blind, randomized trial. [2022]
Reactive arthritis induced by intravesical BCG therapy for bladder cancer: our clinical experience and systematic review of the literature. [2021]
Factors associated with treatment outcomes after intravesical hyaluronic acid therapy in women with refractory interstitial cystitis: A prospective, multicenter study. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Intravesical Instillation of OnabotulinumtoxinA in the Treatment of Refractory Overactive Bladder in Participants with Urinary Incontinence. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Bladder instillation for urinary tract infection prevention in neurogenic bladder patients practicing clean intermittent catheterization: A systematic review. [2022]
An intravesical device for the sustained delivery of lidocaine to the bladder. [2013]
13.United Statespubmed.ncbi.nlm.nih.gov
Current recommendations for bladder instillation therapy in the treatment of interstitial cystitis/bladder pain syndrome. [2021]