Bladder Instillation for Urinary Incontinence

Overseen By Jennifer Anger, MD, MPH

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Cedars-Sinai Medical Center

Disqualifiers: Pregnancy, Urinary retention, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if filling the bladder with fluid during an outpatient mid-urethral sling procedure can expedite hospital discharge, potentially reducing hospital costs. The trial will compare two groups: one receiving bladder instillation and one without. Women with stress urinary incontinence, a condition where physical movement or activity causes involuntary urine leakage, who are scheduled for this specific outpatient procedure, are suitable candidates. As an unphased trial, this study allows participants to contribute to innovative research that could enhance outpatient procedures and shorten hospital stays.

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 prior data suggests that this bladder instillation is safe for urinary incontinence?

Research has shown that bladder instillation treatments are generally safe. For instance, studies have found that using a bladder instillation with botulinum toxin, which relaxes muscles, reduces the risk of urinary tract infections (UTIs) compared to a placebo. Another study on a modified bladder treatment for children found it safe over the long term.

Additionally, a different bladder treatment using a device called the Ialuadapter® proved to be a safe alternative to traditional catheters. These findings suggest that bladder instillation treatments are usually well-tolerated and carry a lower risk of side effects like UTIs.

While each treatment may differ, the overall safety record in these studies remains promising. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for urinary incontinence, which often include medications or surgical options, the bladder instillation method in this trial offers a novel approach by directly filling the bladder with fluid. This method could provide a non-invasive alternative that might alleviate symptoms by physically altering bladder dynamics. Researchers are excited about this approach because it has the potential to offer immediate relief without the need for systemic medication or surgical intervention, which can come with side effects or longer recovery times.

What evidence suggests that intraoperative bladder instillation is effective for reducing discharge time after a mid-urethral sling procedure?

Research has shown that directly instilling fluid into the bladder can reduce pain and burning sensations. One study found this treatment reduced symptoms by 50%. Another study showed that 77.7% of patients experienced relief after the treatment. In this trial, participants in the "Filled bladder arm" will receive this treatment, where fluid is instilled into the bladder. These findings suggest that filling the bladder with fluid might alleviate bladder problems. While these results are promising, effectiveness can vary among individuals. ^{1 6 7 8 9}

Who Is on the Research Team?

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.

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?

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+

Published Research Related to This Trial

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 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]

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 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]

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]

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]

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]

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]

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]

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 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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6368032/

The short-term efficacy of intravesical instillation ... There was also 50% decrease in the frequency of bladder pain and burning (ICSI form q:4) after the treatment. As shown in Table 4, all scores significantly ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2772973724009986

Short and long-term clinical results of a minimally invasive ... Mean follow-up was 4 months. The use of the syringe adapter was successful in 75% and a positive experience in 74% with the latter continuing to use the syringe ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2959205/

New insights into molecular targets for urinary incontinence This article reviews the central and peripheral molecular targets and the potential therapeutic approaches to the treatment of UI.

4. ics.org ics.org/2024/abstract/607

The effectiveness of intravesical cocktail therapy in ... Our findings indicate that following intravesical instillations of a cocktail solution, 77.7% of patients diagnosed with PBS experienced amelioration in their ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1879522614000700

Therapeutic effects and predictive factors for successful ... The study results confirmed that intravesical HA instillation of one course is an effective treatment for 48.4% of patients with IC/BPS refractory to ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0090429518313074

Efficacy and Safety of Noninvasive Intravesical Instillation ... Conclusion. Intravesical instillation of OBTX-A showed limited efficacy with improvement of VV for treatment of overactive bladder or interstitial cystitis/ ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12037478/

Safety and efficacy of intravesical instillation of botulinum toxin ... Regarding safety, intravesical instillation of BTX-A demonstrated a reduced risk of UTI and PVR compared to the placebo group, as illustrated ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6436562/

Long-Term Efficacy, Safety, and Tolerability of Modified ... These results suggest that modified intravesical oxybutynin is an effective and relatively safe long-term therapeutic option for children with neurogenic ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT02277288

Does Bladder Instillation Reduce Time to Discharge After ... The purpose of this randomized control trial study is to determine if intraoperative bladder instillation of fluid decreases the time to discharge after having ...