Overactive Bladder (OAB), Urge Incontinence
Conditions
Keywords
onabotulinum toxin type A
Brief summary
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
Detailed description
Participants will be recruited from MedStar Urogynecology clinics. English-speaking postmenopausal natal female \> 55 years old scheduled to undergo BTX for treatment of overactive bladder (OAB) will be eligible for enrollment. All subjects will be scheduled to undergo Onabotulinum toxin type A intradetrusor injection for management of OAB. On Day 0, subjects will undergo BTX injection by a licensed clinical provider and receive a one-time dose of Nitrofurantoin for infection prevention per standard clinic protocol. Per standard clinic protocol, all patients undergoing BTX receive a one-time dose of oral nitrofurantoin for infection prevention unless they have allergy/contraindication to nitrofurantoin or they are at high risk of UTI (3 or more culture-proven UTIs in the past year). BTX dose, any prior BTX treatments and time since last BTX injection will be recorded. Voided urine specimens will be collected at the baseline and follow-up visits. Each subject will be asked to complete one self-collection and one clinic-collection at each time point for a total of four collections over the course of the study Sample size is 40 subjects in this pilot feasibility study. Subjects will be followed for approximately 1 month after BTX injection. Self-collected and clinic-collected urine specimens will be obtained at baseline and 4 weeks after BTX injection. Subjects will also complete baseline questionnaires and validated patient reported outcome measures at baseline and 4 weeks follow-up. Subjects will be provided reimbursement for parking costs ($17/visit) for the procedure visit and for the follow-up visit. Subjects will be provided a payment of $50 upon completion of the follow-up visit activities.
Interventions
DRUGonabotulinum toxin type a
All 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.
Sponsors
Medstar Health Research Institute
Alexis Dieter
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * Planning one dose nitrofurantoin for antibiotic prophylaxis at time of onabotulinum toxin type A injection per clinic protocol
Exclusion criteria
* 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 * Current systemic immunosuppressive therapy (i.e. prednisone or immunomodulators) immunotherapy, chemotherapy or radiation treatment * Prior pelvic radiation * Indwelling catheter or intermittent catheterization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment | 6 months | recruitment of 40 eligible subjects from our diverse population of postmenopausal women undergoing BTX for OAB |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Urine sample collection and comparison | 4 weeks | 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 | 4 weeks | To assess response to Onabotulinum toxin type A treatment 4-weeks after Onabotulinum toxin type A |
| Onabotulinum toxin type A adverse events | 4 weeks | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Accountable Health Communities Health-Related Social Needs Screening Tool (AHC HRSN) | Baseline | 10-item screening tool designed by the Centers for Medicare & Medicaid Services Center for Medicare and Medicaid Innovation to assess health-related social needs across five core domains - housing instability, food insecurity, transportation problems, utility help needs, and interpersonal safety. Higher score = worse score. |
| International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms (ICIQ-FLUTS) score | 4 weeks | 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. |
| Patient Global Impression of Improvement (PGI-I) | 4 weeks | a single item questionnaire to assess an individual's impression of change in urinary symptoms on a 7-point Likert scale ranging from (1) very much better to (7) very much worse. The PASS threshold for the PGI-I is \< 3. Lower score = more improvement. |
| Pelvic Floor Distress Inventory-20 (PFDI-20) score | 4 weeks | 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 | 4 weeks | 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) | 4 weeks | 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. |
Countries
United States
Outcome results
None listed