Bladder Instillations vs. Pelvic Floor Therapy for Interstitial Cystitis

Recruiting at 1 trial location

Overseen By Jennifer Giordano, BSN

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Corewell Health East

Disqualifiers: Bladder cancer, Pregnancy, Neurologic disorder, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 17

Duration: 8 weeks

128 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two treatments for women with interstitial cystitis/bladder pain syndrome (IC/BPS), which causes frequent and urgent urination along with pelvic or bladder pain. Researchers aim to determine whether bladder-focused treatments, such as bladder instillations (intravesical therapy), or pelvic floor physical therapy, which targets tight muscles in the pelvic area, are more effective in relieving symptoms. This trial may suit women who have experienced IC/BPS symptoms for at least six months and do not plan to start new medications affecting the bladder or muscles. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial requires that you do not start any new medications that affect bladder or muscle function, and ideally, you should stay on a stable dose of your current medications throughout the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both bladder instillations and pelvic floor physical therapy are generally safe treatments for women with interstitial cystitis/bladder pain syndrome (IC/BPS).

Bladder instillations have been studied and found to be safe and effective for many patients. One study noted that this treatment is well-tolerated and can reduce bladder pain, although it may not help with urinary symptoms like frequent urination or incontinence. Another source confirms that these treatments remain an important option for managing bladder pain.

Pelvic floor physical therapy (PFPT) is also considered safe. Studies have shown that it can improve symptoms by addressing issues with the pelvic floor muscles, which are common in IC/BPS patients. This therapy has been linked to a better quality of life and less pain for many women.

Previous research has demonstrated the safety of both treatments, indicating they are well-tolerated by most patients. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for interstitial cystitis because they offer unique approaches compared to standard care options like oral medications and nerve stimulation. Bladder instillations deliver a mix of lidocaine, kenalog, heparin sulfate, and bicarbonate directly into the bladder, providing targeted relief that can soothe the bladder lining and reduce inflammation. Pelvic floor physical therapy focuses on strengthening and relaxing the pelvic muscles, which can alleviate pressure and pain associated with the condition. Both treatments have the potential to offer relief in ways that are distinct from current oral and systemic therapies.

What evidence suggests that this trial's treatments could be effective for interstitial cystitis?

This trial will compare Bladder Instillations with Pelvic Floor Physical Therapy (PFPT) for treating interstitial cystitis/bladder pain syndrome (IC/BPS). Research has shown that bladder instillations can reduce bladder pain, with about 78% of patients reporting moderate to significant symptom improvement. Meanwhile, studies have found that PFPT can greatly enhance the quality of life for those with IC/BPS, with more women responding positively to PFPT compared to other treatments. Both treatments show promise in managing symptoms, but they address different potential causes of the condition. ^{1 2 3 6 7}

Who Is on the Research Team?

Kenneth M Peters, MD

Principal Investigator

Corewell Health William Beaumont University Hospital

Are You a Good Fit for This Trial?

This trial is for women aged 18-85 with interstitial cystitis/bladder pain syndrome (IC/BPS) symptoms for at least 6 months. They must not be pregnant, breastfeeding, or starting new medications affecting bladder/muscle function and should maintain a stable dose of current meds.

Inclusion Criteria

I am female.

I agree not to start new meds that could affect my bladder or muscles and to keep my other meds stable.

I am using birth control, am surgically sterile, or have not had a period for 12 months.

Exclusion Criteria

I haven't had bladder treatments for IC/BPS symptoms in the last 3 months.

I've had physical therapy with internal manual techniques for my symptoms in the last 3 months.

You are unable to tolerate having one or two fingers inserted into your vagina for examination.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either bladder instillations or pelvic floor physical therapy twice weekly for 8 weeks

8 weeks

16 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Bladder Instillations
• Pelvic Floor Physical Therapy

Trial Overview

The study compares bladder instillations (bladder directed therapy) with pelvic floor physical therapy to see which is more effective in treating pelvic pain and voiding dysfunction caused by IC/BPS in adult women without ulcerative conditions.

How Is the Trial Designed?

Group I: Pelvic Floor Physical Therapy Active Control 1 Intervention

One hour of pelvic floor physical therapy twice weekly for 8 weeks

Group II: Bladder Instillations Active Control 1 Intervention

Bladder instillation of lidocaine, kenalog, heparin sulphate, and bicarbonate twice weekly for 8 weeks

Bladder Instillations is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Bladder Instillations for:

• Interstitial cystitis/bladder pain syndrome (IC/BPS)

Approved in Canada as Bladder Instillations for:

• Interstitial cystitis/bladder pain syndrome (IC/BPS)

Approved in European Union as Bladder Instillations for:

• Interstitial cystitis/bladder pain syndrome (IC/BPS)

Who Is Running the Clinical Trial?

Corewell Health East

Lead Sponsor

William Beaumont Hospitals

Lead Sponsor

Trials

153

Recruited

113,000+

Baylor College of Medicine

Collaborator

Trials

1,044

Recruited

6,031,000+

Published Research Related to This Trial

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]

Unsupervised behavioral and pelvic floor muscle training (B-PFMT) programs significantly improve urinary incontinence (UI) outcomes and pelvic floor muscle strength in middle-aged women, as shown in a review of 13 studies, including 10 randomized controlled trials.

Two months after the intervention, participants experienced a reduction in incontinent episodes and improved quality of life scores, indicating the effectiveness of B-PFMT for managing UI symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unsupervised behavioral and pelvic floor muscle training programs for storage lower urinary tract symptoms in women: a systematic review. Wu, C., Newman, DK., Palmer, MH.[2021]

In a study involving 5 female patients with interstitial cystitis, prolonged intravesical instillation of resiniferatoxin (RTX) significantly reduced urinary frequency from 11.3 to 7.4 and nocturia from 3.6 to 1.2 after 30 days, indicating its efficacy in managing symptoms.

Patients also experienced a significant decrease in pain scores from 6.7 to 2.4, with effects lasting up to three months, and no side effects were reported during or after the treatment, highlighting the safety of this delivery method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravesical infusion of resiniferatoxin by a temporary in situ drug delivery system to treat interstitial cystitis: a pilot study. Lazzeri, M., Spinelli, M., Beneforti, P., et al.[2019]

The O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) and Interstitial Cystitis Problem Index (ICPI) effectively measure treatment outcomes for interstitial cystitis (IC) after hydrodistention (HD) and bladder training (BT), showing significant improvement in scores from pre-treatment to three months post-treatment.

In a study of 108 patients, the average scores for both ICSI and ICPI dropped dramatically after treatment, indicating that these questionnaires are not only useful for screening but also for assessing the efficacy of IC treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of treatment outcomes of interstitial cystitis with hydrodistention and bladder training by O'Leary-Sant Interstitial Cystitis Symptom and Problem Indices. Huang, MC., Hsieh, CH., Chang, WC., et al.[2019]

Intravesical therapy, particularly using liposomes and polymers, has shown promise in enhancing the delivery and efficacy of treatments for urinary tract disorders like interstitial cystitis and overactive bladder, with improvements noted in rodent models.

The review highlights the potential of repurposing existing drugs, such as tacrolimus, for intravesical use, which may lead to better clinical outcomes and safety profiles for patients with lower urinary tract conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in intravesical therapy for urinary tract disorders. Tyagi, P., Kashyap, M., Hensley, H., et al.[2018]

Pelvic floor muscle training (PFMT) is an effective and comprehensive treatment for pelvic floor disorders like urinary incontinence and pelvic organ prolapse, involving exercises tailored by trained clinicians.

Despite its proven efficacy and cost-effectiveness, PFMT is not widely adopted as a first-line treatment in the USA, highlighting a gap in clinical practice that could improve women's health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pelvic Floor Muscle Training: Underutilization in the USA. Lamin, E., Parrillo, LM., Newman, DK., et al.[2018]

Biofeedback pelvic floor muscle training (PFMT) was found to be effective for treating dysfunctional voiding (DV) in women, with 80.6% of participants showing significant improvements in symptoms and quality of life after a 3-month program involving 31 patients.

Improvements were also noted in uroflowmetry parameters, such as maximum flow rate and voiding efficiency, but a history of recurrent urinary tract infections within the past year negatively impacted treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic efficacy of biofeedback pelvic floor muscle exercise in women with dysfunctional voiding. Chiang, CH., Jiang, YH., Kuo, HC.[2021]

In a study involving 14 subjects with interstitial cystitis/bladder pain syndrome, intravesical instillation of sphingomyelin liposomes was found to be safe, with no treatment-related adverse events reported during the 4-week treatment period.

The treatment led to significant improvements in pain and urinary urgency, as measured by visual analog scales and symptom indices, indicating potential efficacy for managing symptoms of IC/BPS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liposomal bladder instillations for IC/BPS: an open-label clinical evaluation. Peters, KM., Hasenau, D., Killinger, KA., et al.[2021]

Intravesical instillation of botulinum toxin A (BoNTA) is the most effective treatment for interstitial cystitis/painful bladder syndrome (IC/PBS), showing an 81.7% probability of being the best option based on global response assessments from a network meta-analysis of 16 trials involving 905 patients.

Both BoNTA and bacillus Calmette-Guerin (BCG) treatments significantly improve bladder capacity and urinary urgency symptoms compared to placebo, while pentosan polysulfate (PPS) effectively reduces urinary frequency and urgency in IC/PBS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravesical treatment for interstitial cystitis/painful bladder syndrome: a network meta-analysis. Zhang, W., Deng, X., Liu, C., et al.[2018]

A new non-invasive method for instilling bladder cocktails through a specially designed adapter allows for effective treatment of interstitial cystitis/bladder pain syndrome without the need for catheterization, achieving a 98% success rate in female patients and 100% in male patients.

This method significantly reduces pain and complications associated with traditional catheterization, as no infections or adverse effects were reported, making it a preferred option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimally invasive device for intravesical instillation by urological syringe adapter (MID-ii U.S.A.) for catheter-free instillation therapy of the bladder in interstitial cystitis/bladder pain syndrome. Lovasz, S.[2020]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5522791/

Interstitial cystitis intravesical therapy - PMC

These studies found no improvement in urinary frequency, nocturia, incontinence or bladder capacity but bladder pain was found to be reduced. Botulinum toxin A.

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Bladder instillations vs onabotulinumtoxinA injection for ...

Both bladder instillation and onabotulinumtoxinA injection therapy are effective for treatment of interstitial cystitis (IC)/bladder pain ...

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clinicaltrials.gov

clinicaltrials.gov/study/NCT03463915

Clinical Trial Comparing Two Bladder Instillations for IC/BPS

The study hypothesis is that women with IC/BPS treated with bladder instillations that contain a steroid will have improved outcomes compared to women treated ...

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ics.org

ics.org/2024/abstract/607

The effectiveness of intravesical cocktail therapy in ...

With this cocktail regimen, almost 77.7% of patients have shown moderate to marked improvements in their symptoms during the follow-up period ...

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sciencedirect.com

sciencedirect.com/science/article/pii/S2772973725006563

Intravesical cocktail instillation: A Viable Adjunct to first line ...

Patients receiving intravesical cocktail instillation as an adjunct to first-line therapy experienced significant symptomatic relief and overall improvement in ...

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sciencedirect.com

sciencedirect.com/science/article/pii/S0090429521004660

Current Status of Intravesical Therapies for Bladder Pain ...

Intravesical treatments such as instillation therapies remain a cornerstone of most treatment algorithms and there are a range of agents that can be selected.

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ics.org

ics.org/2024/abstract/489

Lessons learned from using intravesical hyaluronic acid ...

After the review, we found the treatment is safe and effective for most (60-70%) of our patients and the results are consistent among the ...