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New treatment option for Urgency Urinary Incontinence
Official title Reduction in Number of Botox Injections for Urgency Urinary Incontinence
ClinicalTrials.gov ID: NCT04731961
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older, women only
You may be able to join if
- 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...
- Urge predominant (urge \>50% of total incontinent episodes) urinary incontinence based on self-reported characterization of incontinent episodes on...
- Patient or caregiver willing to perform clean intermittent catheterization, or patient willing to have indwelling Foley catheter in the event this...
You likely can't join if
- 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...
- Any prior intra-detrusor botulinum toxin A injections
- Previous or currently implanted neuromodulation (sacral or tibial).
See the full eligibility 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...
- 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...
- 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.
- 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.
- people 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
The study team makes the final eligibility decision.
Where it's taking place
- Charlottesville, Virginia, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 21 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Charlottesville, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.