Charlottesville, VANCT04731961Now EnrollingIRB Ready

Urgency Urinary Incontinence Clinical Trial in Charlottesville, VA

Access cutting-edge urgency urinary incontinence treatment through this clinical trial at a research site in Charlottesville. Study-provided care at no cost to qualified participants.

Sponsored by University of Virginia

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Expert Care in Charlottesville

Access urgency urinary incontinence specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related urgency urinary incontinence treatment provided free

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Check if you qualify for this urgency urinary incontinence clinical trial in Charlottesville, VA

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Why Participate?

  • No-Cost Study Care

  • Local to Charlottesville

    Convenient for VA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Charlottesville site if eligible
  4. 4Begin participation

About This Urgency Urinary Incontinence Study in Charlottesville

The overall objective of this study is to determine if a reduced injection site protocol (5 injection sites) using an equivalent amount of Botox provides comparable relief of Urgency Urinary Incontinence (UUI) symptoms compared to the standard injection site protocol (15-20 injection sites). Our central hypothesis is that the 5-site injection protocol is non-inferior in terms of relief of UUI symptoms compared to the standard injection site protocol, measured by a non-inferior reduction in the number of UUI episodes per day.

Sponsor: University of Virginia

Who Can Participate

Inclusion Criteria

Females at least 21 years of age
English speaking
Five or more urge urinary incontinence episodes on a three-day voiding diary. Urge incontinence episodes will be determined based on voiding diary and subject indication of coincident urge symptoms, allowing for self-characterization of incontinence type
Urge predominant (urge \>50% of total incontinent episodes) urinary incontinence based on self-reported characterization of incontinent episodes on diary
Patient or caregiver willing to perform clean intermittent catheterization, or patient willing to have indwelling Foley catheter in the event this would be required
Request for treatment for urgency urinary incontinence. The patient may have tried other pharmacologic treatments for urge incontinence, such as antispasmodic agents or non-pharmacologic treatments, such as supervised behavioral therapy, supervised physical therapy, unsupervised physical therapy, supervised biofeedback, and transvaginal electrical stimulation.
Subject has undergone 3-week washout period if subject were on anticholinergic therapy prior to enrollment
Subject is able to complete all study related items and interviews
Willingness and ability to comply with scheduled visits and study procedures.

Exclusion Criteria

Current symptomatic urinary tract infection that has not resolved prior to randomization.
Baseline need for intermittent self-catheterization
PVR (Post void residual) \>150 mL on 2 occasions with void(s) of greater than 150 mL
Surgical treatment for stress incontinence (sling, Burch or urethral injection) or pelvic organ prolapse recommended or planned at enrollment by study investigator(s).
Any prior intra-detrusor botulinum toxin A injections
Previous or currently implanted neuromodulation (sacral or tibial).
Surgically altered detrusor muscle, such as augmentation cystoplasty.
Known allergy to botulinum toxin A.
Women with known neurologic disease believed to potentially affect urinary function (history of stroke, Parkinson's disease, multiple sclerosis, spinal cord injuries, myasthenia gravis, Charcot-Marie-Tooth disease).
Known allergy to lidocaine.
Currently pregnant or lactating patients or patients planning pregnancy within the next year.
Sexually active premenopausal women with a uterus who have either not had a tubal ligation or are not on a medically approved form of contraception for at least 3 months prior to and throughout the duration of the study.
Cystoscopic findings that preclude injection, in the opinion of the investigator.
Current or prior bladder malignancy.
Inability to understand diary instructions and complete 3-day voiding diary.
Subject has been previously diagnosed with interstitial cystitis or chronic pelvic pain syndrome.
Subjects with hematuria who have not undergone a clinically appropriate evaluation.
Serum creatinine level greater than twice the upper limit of normal within the previous year.
Two or more hospitalizations for medical conditions in the previous years
Plans to move out of area in the next 6 months

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Charlottesville?

Yes, this clinical trial (NCT04731961) has an active research site in Charlottesville, VA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Urgency Urinary Incontinence Treatment Options in Charlottesville, VA

If you're searching for urgency urinary incontinence treatment options in Charlottesville, VA, this clinical trial (NCT04731961) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Charlottesville research site is actively enrolling participants for this clinical trial. You'll receive care from experienced urgency urinary incontinence specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all urgency urinary incontinence clinical trials near you to find additional studies recruiting in your area.

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