250 Participants Needed

Bladder Instillation for Urinary Incontinence

JA
Overseen ByJennifer Anger, MD, MPH
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Cedars-Sinai Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

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.

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.12345

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.26789

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.210111213

Who Is on the Research Team?

JA

Jennifer Anger, MD, MPH

Principal Investigator

Cedars-Sinai Medical Center

Are You a Good Fit for This Trial?

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 female.
I have had issues with urine leakage when coughing or exercising.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

  • Filled bladder arm
Trial Overview The 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Filled bladder armExperimental Treatment1 Intervention
Group II: Emptied bladder armActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials
523
Recruited
165,000+

Published Research Related to This Trial

In a long-term study of 26 women who underwent supratrigonal cystectomy and augmentation cystoplasty for severe ulcerative interstitial cystitis/bladder pain syndrome, 95.6% reported significant improvement in their condition, with 65.2% feeling 'very much better'.
The use of detubularized ileocecal bowel for augmentation was associated with a lower need for intermittent self-catheterization, suggesting it may enhance voluntary bladder emptying and reduce the risk of late relapse.
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]
In a study of 8 children with bladder instability, intravesical instillation of oxybutynin was found to be well tolerated and effective, with higher plasma concentrations than oral administration, indicating a more efficient delivery method.
The intravesical route resulted in minimal systemic side effects, suggesting that oral administration may produce a metabolite responsible for adverse effects, highlighting the importance of administration methods on drug efficacy and safety.
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]

Citations

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]
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