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临床试验/NCT07025044
NCT07025044招募中不适用

Characterizing the Postmenopausal Genitourinary Microbiome in Women Undergoing Onabotulinum Toxin Type A for Overactive Bladder - A Feasibility Trial

Alexis Dieter1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年9月3日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
1
主要终点
Recruitment

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
55 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Women >55yo undergoing onabotulinum toxin type A injection for OAB in clinic

干预措施: onabotulinum toxin type a (Drug)

结局指标

主要结局

Recruitment

时间窗: 6 months

recruitment of 40 eligible subjects from our diverse population of postmenopausal women undergoing BTX for OAB

次要结局

  • Urine sample collection and comparison(4 weeks)
  • Onabotulinum toxin type A response(4 weeks)
  • Onabotulinum toxin type A adverse events(4 weeks)

研究者

发起方
Alexis Dieter
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Alexis Dieter

Attending Physician

MedStar Health

研究点 (1)

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