Bladder Instillation for Urinary Incontinence

Recruiting in Palo Alto (17 mi)

Overseen by Jennifer 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. ^{1 2 3 4 5}

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. ^{2 6 7 8 9}

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. ^{2 10 11 12 13}

Research Team

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.

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.

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 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.

Participant Groups

Group I: Filled bladder arm Experimental Treatment 1 Intervention

Instilled bladder with fluid.

Group II: Emptied bladder arm Active Control 1 Intervention

No instillation of fluid into bladder.

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

David E. Cohen

Cedars-Sinai Medical Center

Chief Medical Officer

MD and PhD in Physiology and Biophysics from Harvard University

Peter L. Slavin

Cedars-Sinai Medical Center

Chief Executive Officer

MD from Harvard Medical School, MBA from Harvard Business School

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional results after ileocystoplasty. Myrén, CJ., Beuke, HP., Thybo, E.[2019]

A long-term study of 10 children with neuropathic bladder-sphincter dysfunction showed that switching from oral to intravesical oxybutynin significantly improved bladder capacity and compliance over 15 years, indicating effective management of detrusor overactivity.

Intravesical oxybutynin resulted in fewer urinary tract infections compared to oral oxybutynin, with only three pyelonephritis episodes reported in 15 years, highlighting its safety and efficacy as a treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study of 36 women with bladder instability, intravesical instillation of oxybutynin significantly reduced symptoms like frequent urination (pollakiuria) and nighttime urination (nocturia), while also improving bladder capacity.

The treatment was found to be safe, with no local or systemic side effects reported, indicating a favorable safety profile for oxybutynin in this application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Topical use of oxybutynin hydrochloride in women with urge incontinence]. Enzelsberger, H., Kurz, C., Helmer, H.[2018]

Intravesical BCG treatment for bladder cancer is generally safe and effective, but it can lead to rare but serious complications, such as a mycotic abdominal aortic aneurysm, as seen in a 77-year-old patient 18 months after treatment.

The exact mechanism of action for BCG is unclear, and while it typically causes localized inflammation, there is a need for updated screening methods and more research on the long-term risks and management of vascular complications associated with BCG therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study involving 62 patients with overactive bladder, a single instillation of liposomal botulinum toxin significantly reduced micturition events and urinary urgency compared to a placebo, indicating its efficacy in managing symptoms.

Importantly, this treatment did not increase the risk of urinary retention, suggesting it may be a safer alternative to traditional botulinum toxin injections for patients with refractory overactive bladder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Intravesical hyaluronic acid (HA) therapy is a safe and effective treatment for bladder pain syndrome/interstitial cystitis, showing significant improvement in symptoms for about 60% of women after 6 months of treatment.

Factors such as baseline functional bladder capacity and initial pain levels can help predict treatment outcomes, with early responses indicating better final results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a trial assessing the efficacy and safety of intravesical instillation of onabotulinumtoxinA with hydrogel for overactive bladder, no significant improvement was found compared to placebo in reducing urinary incontinence episodes after 12 weeks.

The treatment was well tolerated, with similar rates of adverse events across all groups, and no serious complications like urinary retention were reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

A systematic review of 8 studies involving 346 patients with neurogenic bladder found that bladder instillations of gentamicin, hyaluronic acid, and Lactobacillus rhamnosus significantly reduced urinary tract infections, with gentamicin being the most recommended agent.

No major adverse events were reported for any of the bladder instillation modalities, indicating that these treatments are safe for patients practicing intermittent catheterization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

The new intravesical device allows for extended and localized delivery of lidocaine to the bladder, maintaining effective drug concentrations for up to 3 days, compared to traditional methods that only last 24 hours.

This device reduces the need for repeated catheterizations and can potentially be used for other therapeutic agents, enhancing treatment options for bladder conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An intravesical device for the sustained delivery of lidocaine to the bladder. Lee, H., Cima, MJ.[2013]

Bladder instillation therapy is an effective treatment for interstitial cystitis/bladder pain syndrome (IC/BPS) in patients who have not responded to other treatments, with three recommended medications: dimethyl sulfoxide, heparin, and lidocaine.

The review also highlights the need for further research into bladder instillation strategies and potential new therapies, as current recommendations are based on existing evidence but do not encompass all possible treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current recommendations for bladder instillation therapy in the treatment of interstitial cystitis/bladder pain syndrome. Colaco, MA., Evans, RJ.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

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]

2. United States pubmed.ncbi.nlm.nih.gov

The pharmacokinetics of intravesical and oral oxybutynin chloride. [2019]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Functional results after ileocystoplasty. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Long-term outcome of intravesical oxybutynin in children with detrusor-sphincter dyssynergia: with special reference to age-dependent parameters. [2015]

5. Switzerland pubmed.ncbi.nlm.nih.gov

[Topical use of oxybutynin hydrochloride in women with urge incontinence]. [2018]

6. Netherlands pubmed.ncbi.nlm.nih.gov

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]

7. United States pubmed.ncbi.nlm.nih.gov

Bladder instillation of liposome encapsulated onabotulinumtoxina improves overactive bladder symptoms: a prospective, multicenter, double-blind, randomized trial. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Reactive arthritis induced by intravesical BCG therapy for bladder cancer: our clinical experience and systematic review of the literature. [2021]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Factors associated with treatment outcomes after intravesical hyaluronic acid therapy in women with refractory interstitial cystitis: A prospective, multicenter study. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Intravesical Instillation of OnabotulinumtoxinA in the Treatment of Refractory Overactive Bladder in Participants with Urinary Incontinence. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Bladder instillation for urinary tract infection prevention in neurogenic bladder patients practicing clean intermittent catheterization: A systematic review. [2022]

12. Netherlands pubmed.ncbi.nlm.nih.gov

An intravesical device for the sustained delivery of lidocaine to the bladder. [2013]

13. United States pubmed.ncbi.nlm.nih.gov

Current recommendations for bladder instillation therapy in the treatment of interstitial cystitis/bladder pain syndrome. [2021]