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.
Is bladder instillation a promising treatment for urinary incontinence?Yes, bladder instillation is a promising treatment for urinary incontinence. It allows for direct delivery of medication into the bladder, which can be effective for conditions like overactive bladder and bladder pain syndrome. This method can reduce the need for injections and minimize side effects compared to oral medications. It also offers high drug concentration in the bladder, making it a potentially effective option for managing urinary incontinence.1471113
What safety data exists for bladder instillation treatments?Bladder instillation treatments have been evaluated for various conditions, showing different safety profiles. Intravesical BCG instillation for bladder cancer is generally safe but can cause rare complications like vascular issues and reactive arthritis. Intravesical oxybutynin is well tolerated with minimal side effects compared to oral administration. Bladder instillation of hyaluronic acid is considered acceptable for bladder pain syndrome, though it has a high non-responder rate. Liposome-encapsulated onabotulinumtoxinA instillation is safe and effective for overactive bladder, with fewer risks than traditional botulinum toxin injections.156910
What data supports the idea that Bladder Instillation for Urinary Incontinence is an effective treatment?The available research shows that intravesical instillation, a method of delivering medication directly into the bladder, is effective for treating bladder instability. In one study, children who had side effects from oral medication experienced fewer side effects and better results with bladder instillation. Another study with women showed that this treatment significantly reduced frequent urination and nighttime urination, and improved bladder capacity, without causing side effects. This suggests that bladder instillation is a promising treatment for urinary incontinence, especially when oral medications cause problems.123812
Do I need to stop taking my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications.
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.
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.
Treatment Details
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.
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 CenterLead Sponsor
References
The pharmacokinetics of intravesical and oral oxybutynin chloride. [2019]In 8 children with cystometric evidence of bladder instability and marked systemic side effects to oral oxybutynin we investigated the efficacy of intravesical instillation and compared the pharmacokinetics of both routes of delivery. In addition, 4 healthy dogs underwent intravesical instillation for pharmacokinetic studies. Intravesical oxybutynin was well tolerated, efficacious and rapidly absorbed, resulting in plasma concentrations markedly higher than after oral administration. In only 2 patients did this method of instillation result in side effects, and both had previously undergone bladder augmentation. This lack of significant systemic side effects despite high plasma concentrations suggests that a metabolite may be generated after oral administration that is responsible for the side effects. These studies demonstrate that the mode of administration affects the mechanism of action, side effects, pharmacokinetics and metabolism of oxybutynin, and that intravesical instillation is clinically effective and results in minimal side effects.
Functional results after ileocystoplasty. [2019]The functional results after ileocystoplasty were studied in seven patients with interstitial cystitis, irradiated bladder and neurogenic bladder dysfunction. None of the patients had had symptomatic improvement by medical or surgical means. All patients were suffering from urinary frequency and five patients had severe urge incontinence or suprapubic pains. Postoperatively the patients were followed from 8 to 66 months and evaluated by urodynamic examinations and interviews. Urinary frequency was improved in all patients but one with interstitial cystitis who had persisting suprapubic pains. None had residual urine volume greater than 30 ml postoperatively. It is concluded that bladder augmentation by ileocystoplasty is an excellent method of treatment for patients with contracted bladder secondary to interstitial cystitis, irradiated bladder, and detrusor hyperreflexia and sphincter dyssynergia.
[Topical use of oxybutynin hydrochloride in women with urge incontinence]. [2018]In 36 women with cystometric evidence of bladder instability we investigated the efficacy of intravesical instillation of oxybutynin. The intravesical application of oxybutynin had a significant effect regarding the reduction of pollakiuria and nocturia and an improvement of bladder capacity. No local or systemic side effects were noted.
An intravesical device for the sustained delivery of lidocaine to the bladder. [2013]Intravesical instillation is a single compartment therapy providing high drug concentration at the bladder and reduced systemic exposure. Therapies based on this method, however, often require repeated instillations with intermittent transurethral catheterizations due to the short drug residence time in the bladder. Here we describe an intravesical device to achieve extended and localized delivery of lidocaine to the bladder. The device is a non-resorbable system that can be non-surgically deployed into the bladder. An in vivo rabbit study showed that lidocaine concentration in the bladder tissue was higher than 0.1μg/g during the 3 day period of device release while a single instillation yielded immeasurable amounts within 24h. The device can be used for the delivery of other therapeutic agents, currently delivered to the bladder by intravesical instillations.
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]Intravesical BCG-instillation for bladder cancer is considered safe but is not without risk. While most side-effects are localised and self-limiting, the development of secondary vascular pathology is a rare but significant complication.
Reactive arthritis induced by intravesical BCG therapy for bladder cancer: our clinical experience and systematic review of the literature. [2021]Intravesical instillation of BCG (ivBCG) is an effective and safe immunotherapy of bladder carcinoma but it may have, as side effect, a reactive arthritis (ReA). The authors describe 5 cases observed during their own clinical experience along with the updated review of the literature on this topic.
Current recommendations for bladder instillation therapy in the treatment of interstitial cystitis/bladder pain syndrome. [2021]Bladder instillation therapy refers to the direct introduction of medication into the bladder and is a common treatment modality for patients with interstitial cystitis/bladder pain syndrome (IC/BPS) who have failed conservative and oral therapies. The current American Urological Association (AUA) recommendations list three medications as options for IC/BPS instillation therapy: dimethyl sulfoxide, heparin, and lidocaine. The purpose of this review is to examine the evidence behind the recommendations for these medications. We also examine several historical or experimental therapies that do not hold recommendations but are still used on rare occasion. Finally, we discuss our bladder instillation strategies as well as potential future research and development in intravesicular therapy.
Long-term outcome of intravesical oxybutynin in children with detrusor-sphincter dyssynergia: with special reference to age-dependent parameters. [2015]Intravesical instillation of oxybutynin is an accepted and effective treatment in children with neuropathic bladder-sphincter dysfunction, when oral oxybutynin results in inadequate suppression of detrusor overactivity or intolerable side effects. However, as yet no data are available on long-term use and outcome.
Bladder instillation of liposome encapsulated onabotulinumtoxina improves overactive bladder symptoms: a prospective, multicenter, double-blind, randomized trial. [2022]Cystoscopic intradetrusor injection of botulinum toxin has helped patients with refractory overactive bladder but with the increased risks of urinary tract infection and urinary retention. We assessed whether catheter instillation of 200 U onabotulinumtoxinA formulated with liposomes is safe and effective for the treatment of overactive bladder.
Factors associated with treatment outcomes after intravesical hyaluronic acid therapy in women with refractory interstitial cystitis: A prospective, multicenter study. [2021]Bladder instillation of hyaluronic acid (HA) is an acceptable treatment for bladder pain syndrome/interstitial cystitis (BPS/IC). The treatment is limited by a high proportion of non-responders (~30%-40%). Here, we aimed to evaluate predisposing factors associated with treatment outcomes.
Bladder instillation for urinary tract infection prevention in neurogenic bladder patients practicing clean intermittent catheterization: A systematic review. [2022]To assess the efficacy and safety of different modalities of bladder instillation in patients with neurogenic bladder practicing intermittent catheterization.
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]This study analyzes the long-term results of supratrigonal cystectomy and augmentation cystoplasty in patients with severe ulcerative interstitial cystitis/bladder pain syndrome (IC/BPS) and reduced bladder capacity.
Intravesical Instillation of OnabotulinumtoxinA in the Treatment of Refractory Overactive Bladder in Participants with Urinary Incontinence. [2022]Intradetrusor injections of onabotulinumtoxinA are efficacious for the treatment of overactive bladder with urgency urinary incontinence in adults refractory to or intolerant of anticholinergics. Delivery of onabotulinumtoxinA via instillation would reduce the need for intradetrusor injections. The objective of this trial was to assess the efficacy and safety of intravesical instillation of an onabotulinumtoxinA + hydrogel admixture.