RECRUITING

Reduction in Number of Botox Injections for Urgency Urinary Incontinence

Talk to us

Conditions

Urgency Urinary Incontinence

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Reduced Site Injection Protocol of Intra-detrusor Onabotulinumtoxin-A for Treatment of Idiopathic Refractory Urgency Urinary Incontinence

Quick Facts

Study Start:2021-02-23
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04731961

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Females at least 21 years of age
  2. * English speaking
  3. * 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
  4. * Urge predominant (urge \>50% of total incontinent episodes) urinary incontinence based on self-reported characterization of incontinent episodes on diary
  5. * Patient or caregiver willing to perform clean intermittent catheterization, or patient willing to have indwelling Foley catheter in the event this would be required
  6. * 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.
  7. * Subject has undergone 3-week washout period if subject were on anticholinergic therapy prior to enrollment
  8. * Subject is able to complete all study related items and interviews
  9. * Willingness and ability to comply with scheduled visits and study procedures.
  1. * Current symptomatic urinary tract infection that has not resolved prior to randomization.
  2. * Baseline need for intermittent self-catheterization
  3. * PVR (Post void residual) \>150 mL on 2 occasions with void(s) of greater than 150 mL
  4. * Surgical treatment for stress incontinence (sling, Burch or urethral injection) or pelvic organ prolapse recommended or planned at enrollment by study investigator(s).
  5. * Any prior intra-detrusor botulinum toxin A injections
  6. * Previous or currently implanted neuromodulation (sacral or tibial).
  7. * Surgically altered detrusor muscle, such as augmentation cystoplasty.
  8. * Known allergy to botulinum toxin A.
  9. * 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).
  10. * Known allergy to lidocaine.
  11. * Currently pregnant or lactating patients or patients planning pregnancy within the next year.
  12. * 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.
  13. * Cystoscopic findings that preclude injection, in the opinion of the investigator.
  14. * Current or prior bladder malignancy.
  15. * Inability to understand diary instructions and complete 3-day voiding diary.
  16. * Subject has been previously diagnosed with interstitial cystitis or chronic pelvic pain syndrome.
  17. * Subjects with hematuria who have not undergone a clinically appropriate evaluation.
  18. * Serum creatinine level greater than twice the upper limit of normal within the previous year.
  19. * Two or more hospitalizations for medical conditions in the previous years
  20. * Plans to move out of area in the next 6 months

Contacts and Locations

Study Contact

Monique Vaughan, MD
CONTACT
4349241955
MV4W@hscmail.mcc.virginia.edu
amanda r urban, MS
CONTACT
14344093100
amandareeferurban@gmail.com

Principal Investigator

Monique J Vaughan, MD
PRINCIPAL_INVESTIGATOR
University of Virginia

Study Locations (Sites)

University of Virginia
Charlottesville, Virginia, 22903
United States

Collaborators and Investigators

Sponsor: University of Virginia

  • Monique J Vaughan, MD, PRINCIPAL_INVESTIGATOR, University of Virginia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-02-23
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2021-02-23
Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Urgency Urinary Incontinence