Physical Therapy vs Medication for Overactive Bladder in Older Women

Overseen By Steve Fisher, PT, PhD

Age: 18+

Sex: Female

Trial Phase: Phase < 1

Sponsor: The University of Texas Medical Branch, Galveston

Must not be taking: Antimuscarinics, Digoxin

Disqualifiers: Psychiatric conditions, Genitourinary cancer, Neurologic conditions, others

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

Compensation: Varies

Number of Visits: 18

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether physical therapy or medication more effectively treats overactive bladder (OAB) in older women at high risk of falling. Participants will receive either pelvic floor muscle training with a physical therapist, a medication called Mirabegron (for OAB), or another medication called Trospium Chloride, over a 12-week period. Researchers aim to determine if these treatments can improve bladder symptoms and reduce fall-related risks. Women aged 60 and older with frequent urges to urinate and a high risk of falling may be suitable for this study. As an Early Phase 1 trial, this research focuses on understanding how these treatments work in people, offering participants a chance to contribute to groundbreaking insights.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking other antimuscarinic drugs or Digoxin.

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

Research shows that all three treatments in this trial have shown promise in previous studies for people with overactive bladder (OAB).

First, studies lasting up to 12 months have shown that Mirabegron is well tolerated. The FDA approved it for OAB in 2012, indicating it has passed many safety checks. Some studies even highlight its effectiveness and safety for older adults, which is encouraging for participants in this trial.

Next, Trospium Chloride has also proven safe and effective for OAB. It helps reduce symptoms like frequent bathroom trips and sudden urges. With careful patient selection, the risk of trouble emptying the bladder seems low.

Lastly, Pelvic Floor Muscle Training (PFMT) has improved the quality of life for women with urinary incontinence. Although some studies mention side effects, they are generally not severe.

Overall, these treatments have a track record of safety and effectiveness for OAB, which is promising for their use in this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they offer diverse approaches to managing overactive bladder in older women. Pelvic Floor Muscle Training (PFMT) is unique because it empowers patients through a physical therapy approach, strengthening muscles to naturally control bladder function without medication. Mirabegron stands out by focusing on relaxing the bladder muscle, using a novel mechanism that may reduce side effects associated with traditional anticholinergic drugs. Trospium Chloride, an extended-release formulation, offers a convenient once-daily dosing, potentially improving adherence while minimizing systemic side effects due to its limited ability to cross the blood-brain barrier. Together, these treatments could provide more personalized and effective options for patients.

What evidence suggests that this trial's treatments could be effective for overactive bladder in older women?

This trial will compare different treatments for overactive bladder (OAB) in older women. Participants may receive Pelvic Floor Muscle Training (PFMT), which research has shown can strengthen muscles to prevent urine leakage, with success rates between 29% and 59%. Another group will receive the medication Mirabegron, which can reduce incontinence by about half and decrease the number of bathroom visits. A third group will receive Trospium Chloride, which effectively helps with urgency and frequent urination and is generally well-tolerated. Each treatment offers potential benefits for managing OAB in older women. ^{3 5 6 7 8}

Who Is on the Research Team?

Steve Fisher

Principal Investigator

University of Texas Medical Branch at Galveston

Are You a Good Fit for This Trial?

This trial is for women aged 60 or older who can walk, have overactive bladder (OAB) or urinary incontinence, and are at high risk of falling. They must be able to consent, have tried lifestyle changes for their bladder condition, and have Medicare or private insurance. It excludes those with certain medical conditions like glaucoma, severe psychiatric issues, chronic liver/kidney diseases, or on conflicting medications.

Inclusion Criteria

I have a bladder control problem confirmed by a score or doctor's advice.

You answered "yes" to one of the questions on the 3-Key Questions form.

I am a woman aged 60 or older.

Exclusion Criteria

I am not planning any new treatments for overactive bladder in the next 6 months.

I have very high blood pressure that isn't controlled with medication.

I have a neurological condition like MS, Parkinson's, brain injury, dementia, or stroke that affects my bladder control.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to one of three 12-week treatment arms: Pelvic Floor Muscle Training, Mirabegron, or Trospium Chloride

12 weeks

6 visits (in-person) for PFMT; medication adherence monitored for Mirabegron and Trospium

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of urinary incontinence and fall risk

6 months

Follow-up assessments at the end of the 12-week intervention and at 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Mirabegron
• Pelvic Floor Muscle Training
• Trospium Chloride

Trial Overview The study compares pelvic floor muscle training by physical therapists against two drug treatments—Mirabegron and Trospium Chloride—for managing OAB in older women prone to falls. Each participant will receive one treatment randomly for 12 weeks to assess the feasibility of a larger trial and impact on OAB symptoms.

How Is the Trial Designed?

Group I: Pelvic Floor Muscle Training Experimental Treatment 1 Intervention

A 12-week, 6 visit, outpatient program of physical therapist delivered behavioral and pelvic floor muscle training (PFMT)

Group II: Mirabegron Active Control 1 Intervention

Individually titrated Mirabegron, starting at 25 mg daily and increased to 50 mg daily at 6-weeks, during the 12-week intervention period.

Group III: Trospium Chloride Active Control 1 Intervention

A 12-week course of Trospium -extended release, 60mg once daily.

Mirabegron is already approved in United States, European Union for the following indications:

Approved in United States as Myrbetriq for:

• Overactive bladder (OAB)
• Neurogenic detrusor overactivity (NDO)

Approved in European Union as Mirabegron for:

• Overactive bladder (OAB)
• Neurogenic detrusor overactivity (NDO)

Who Is Running the Clinical Trial?

The University of Texas Medical Branch, Galveston

Lead Sponsor

Trials

263

Recruited

55,400+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

Both solifenacin and mirabegron are effective in relieving symptoms of overactive bladder (OAB), with significant improvements in OABSS scores after 4 weeks of treatment in a study of 60 female patients.

Mirabegron is associated with fewer treatment-related side effects compared to solifenacin, suggesting it may be a better first-line treatment option for OAB.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison Of Solifenacin And Mirabegron For The Treatment Of Overactive Bladder. Jamil, MN., Irum, S., Islam, EU.[2023]

Mirabegron is as effective as traditional antimuscarinic agents for treating overactive bladder (OAB), based on a meta-analysis of 10 clinical trials involving 12-week treatment periods.

For patients at risk of cognitive issues or with certain conditions, starting treatment with mirabegron (at 25 mg or 50 mg) may be safer than antimuscarinics, especially in elderly patients or those with urinary retention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How to choose appropriate medication for overactive bladder: Findings from the largest integrated clinical trial database analysis of mirabegron studies. Kuo, HC.[2022]

Mirabegron is an effective once-daily oral treatment for overactive bladder (OAB) that works by activating β3 adrenoceptors, leading to improved bladder filling and reduced urination frequency, with a better safety profile compared to traditional antimuscarinic drugs.

The drug is generally well tolerated, with common side effects including hypertension and urinary tract infections, and its pharmacokinetics can vary based on dose and gender, which may have implications for cardiovascular safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The pharmacokinetic evaluation of mirabegron as an overactive bladder therapy option. Kashyap, M., Tyagi, P.[2013]

Mirabegron is the first beta-3 adrenergic agonist approved for treating overactive bladder (OAB), showing efficacy in reducing symptoms like urge incontinence and urinary frequency in both men and women.

The drug has a favorable safety profile, lacking the common side effects associated with traditional anticholinergic treatments, making it a suitable option for patients who did not respond to those medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[MIRABEGRON--A NEW DRUG FOR TREATMENT OF OVERACTIVE BLADDER]. Kasjan, GR.[2015]

In a study of 50 sexually active women with overactive bladder (OAB), treatment with Mirabegron for 12 weeks significantly improved OAB symptoms, with 59.5% achieving complete urinary continence.

Mirabegron also led to a notable enhancement in female sexual function, with 84% of participants showing improved scores on the Female Sexual Function Index, and 32% reporting no sexual dysfunction after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of Mirabegron on sexual function in women with idiopathic overactive bladder. Gubbiotti, M., Giannantoni, A., Cantaluppi, S., et al.[2020]

A systematic review of 99 studies found that various nonantimuscarinic treatments, including pelvic floor muscle exercises, botulinum toxin A, and mirabegron, are effective in improving symptoms of overactive bladder, such as urgency and incontinence.

Pelvic floor exercises, especially when combined with biofeedback, showed significant improvements in both subjective and objective outcomes, while treatments like sacral neuromodulation were found to be more effective than traditional antimuscarinic medications for enhancing quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonantimuscarinic treatment for overactive bladder: a systematic review. Olivera, CK., Meriwether, K., El-Nashar, S., et al.[2021]

In a study of 85 sexually active women with overactive bladder, those treated with mirabegron for 3 months showed significant improvements in sexual function across all measured domains, including desire, arousal, lubrication, orgasm, satisfaction, and pain.

In contrast, the control group that did not receive treatment showed no significant changes in sexual function, highlighting mirabegron's potential benefits for women experiencing both overactive bladder and sexual dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of mirabegron, used for overactive bladder treatment, on female sexual function: a prospective controlled study. Zachariou, A., Mamoulakis, C., Filiponi, M., et al.[2018]

In a study of 77 women with overactive bladder (OAB), pelvic floor physical therapy (PFPT) led to a reported improvement in symptoms for 71.4% of patients, with better outcomes associated with attending more sessions.

Patients who received myofascial release techniques during PFPT showed a significantly higher improvement rate of 84.7%, compared to only 27.8% for those who did not receive this treatment, highlighting the importance of myofascial release in therapy for OAB.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consideration of pelvic floor myofascial release for overactive bladder. Wolff, BJ., Joyce, CJ., McAlarnen, LA., et al.[2021]

In a study of 89 female patients with overactive bladder, treatment with 50 mg mirabegron once daily effectively reduced symptoms without significant differences compared to 0.1 mg imidafenacin taken twice daily.

Mirabegron was associated with fewer adverse events, particularly a lower incidence of dry mouth, compared to imidafenacin, making it a safer option for managing overactive bladder symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of mirabegron and imidafenacin for efficacy and safety in Japanese female patients with overactive bladder: A randomized controlled trial (COMFORT study). Otsuka, A., Kageyama, S., Suzuki, T., et al.[2018]

In a study of 60 treatment-naïve women with overactive bladder, mirabegron (50 mg daily for 12 weeks) significantly reduced subjective symptoms, as indicated by a decrease in the OAB symptom score from 9.4 to 6.2 points.

Mirabegron improved storage function parameters, such as the first desire to void and maximum cystometric capacity, and led to the disappearance of detrusor overactivity in 40% of patients, while not affecting voiding function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Urodynamic evaluation of the efficacy of mirabegron on storage and voiding functions in women with overactive bladder. Matsukawa, Y., Takai, S., Funahashi, Y., et al.[2015]

Mirabegron, a β3-adrenergic receptor agonist, significantly reduces incontinence and micturition episodes in adults with overactive bladder syndrome, based on three 12-week trials involving multiple countries.

It is generally well tolerated, with a low adverse event rate similar to placebo, and has a lower incidence of dry mouth compared to tolterodine, making it a favorable treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mirabegron: a review of its use in patients with overactive bladder syndrome. Sanford, M.[2021]

In a 12-week study involving Japanese female patients with overactive bladder, both mirabegron and vibegron were found to be effective, showing no significant differences in their ability to improve symptoms based on the total overactive bladder symptom scores (OABSS).

However, mirabegron demonstrated a better safety profile, with significantly fewer treatment-related adverse events (19.1% for mirabegron vs. 38.5% for vibegron), suggesting that mirabegron may be a safer option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mirabegron versus vibegron in previously untreated female patients with overactive bladder: A randomized, single-clinic, open-label trial. Sato, H., Otsuka, S., Tsukada, S.[2023]

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Efficacy and Safety of Mirabegron in Males with Overactive ... Results showed that mirabegron is effective and safe in male OAB patients, with or without BPE or receiving medications for LUTS management. Patient summary. We ...