Single-site prospective observational pilot feasibility study of women with overactive bladder/urge urinary incontinence undergoing onabotulinum toxin type A intradetrusor injections in order to achieve the following objectives:
* Establish a record of successful collaboration with Dr. Ravel, an expert researcher in the female microbiome based at the University of Maryland * Demonstrate the investigators' ability to recruit subjects from the diverse population of postmenopausal women undergoing BTX for OAB within MedStar Health Urogynecology clinics * Collect, process and analyze urine specimens collected prior to and 4-weeks after BTX injection, and to compare the GU microbiome of self-collected versus clinic-collected samples * Assess response to BTX treatment and explore rates of and risk factors for urinary tract infection and incomplete voiding requiring catheterization within the first 4-weeks after BTX
Natal female > 55 years old
English-speaking
Scheduled to undergo onabotulinum toxin type A for treatment of OAB
No menses for >1 year if uterus in situ
Diagnosis of painful bladder syndrome
Current symptomatic or clinically-suspected UTI within 30 days prior to onabotulinum toxin type A injection procedure*
Systemic antibiotic exposure within 30 days^
Prophylactic antibiotic treatment for recurrent UTI within the last 12 months
Subjects from the patient population treated at a MedStar Urogynecology clinics located across DC, Maryland and Virginia will be recruited and eligible for enrollment. Potential subjects will be identified both via provider referral and through electronic medical record review to identify patients scheduled for onabotulinum toxin type A injection.
Cohort
Prospective
onabotulinum toxin type a
DrugAll subjects will be scheduled to undergo Onabotulinum toxin type A intradetrusor injection for management of OAB. On Day 0, subjects will undergo Onabotulinum toxin type A injection by a licensed clinical provider and receive a one-time dose of Nitrofurantoin for infection prevention per standard clinic protocol.
Recruitment
recruitment of 40 eligible subjects from our diverse population of postmenopausal women undergoing BTX for OAB
Urine sample collection and comparison
To collect, process and analyze urine specimens collected prior to and 4-weeks after BTX injection, and to compare the GU microbiome of self-collected versus clinic-collected samples
Onabotulinum toxin type A response
To assess response to Onabotulinum toxin type A treatment 4-weeks after Onabotulinum toxin type A
Onabotulinum toxin type A adverse events
To explore rates of and risk factors for UTI and incomplete voiding requiring catheterization within the first 4-weeks after Onabotulinum toxin type A injection
International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms (ICIQ-FLUTS) score
Validated questionnaire score used to evaluate female lower urinary tract symptoms and impact on quality of life using the International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms (ICIQ-FLUTS), a 12-item questionnaire used to evaluate female lower urinary tract symptoms and impact on quality of life. The ICIQ-FLUTS asks respondents to rate the frequency of a specific lower urinary tract symptom (such as urgency, frequency, pain, etc.) on various five-point scales and then asks the subject to rate the level of bother from that specific symptom on a Likert scale from (0) "not at all" to (10) "a great deal." Higher score = more bother.
Pelvic Floor Distress Inventory-20 (PFDI-20) score
20-item condition-specific quality-of-life instrument with three scales (6-item Urinary Distress Inventory, 6-item Pelvic Organ Prolapse Distress Inventory, and 8-item Colorectal-Anal Distress Inventory) used to evaluate the impact of pelvic floor disorders on quality of life. The UDI-6 is a preferred PRO for assessing female UI. A higher score = more distress. The patient acceptable symptom state (PASS) for the UDI-6 is \< 37.5.
Incontinence Impact Questionnaire Short Form (IIQ-7) score
7-item condition-specific quality-of-life instrument assessing impact of urinary symptoms on quality of life. Higher score = more impact (worse symptoms). The PASS threshold for the IIQ-7 is \< 33.3
Patient Global Impression of Severity (PGI-S)
A single item questionnaire to assess a person's impression of disease severity. Higher score = more severe disease. The PASS threshold for the PGI-S is \< 3.
Click on the lead sponsor to view all of their trials.
Alexis Dieter
Lead sponsor
MedStar Health
Sponsor institution
Medstar Health Research Institute
Collaborator
