The Effect of Gentamicin Intravesical Installations on Decreasing Urinary Tract Infections in Patients With Neurogenic Bladder After Spinal Cord Injury: A Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Number of Urinary Tract Infections (UTI) Over Time
研究概览
简要总结
A non-randomized study evaluating the efficacy of intravesical gentamicin on the occurrence rate of urinary tract infections and bladder complications in patients after spinal cord injury (SCI), and to assess its effectiveness in promoting overall quality of life (QOL), community living, and participation.
详细描述
Intervention: Participants' number of UTIs during the six-month treatment period will be compared to the number they incurred during the six months prior to treatment. Participants complete a baseline visit which consists of medical history, informed consent, urinalysis/culture indicating no active UTIs, metabolic panel, and self-reported measures about complications, symptoms, community participation and quality of life. Similar information is collected at the end of treatment. At a 3-month follow up visit, all available data is obtained through phone interviews and/or medical chart reviews except for self-report measures. Participants begin active treatment using Gentamicin plus saline solution after they have completed all requirements. Instillations of treatment solution occur nightly after the participant's last evening catheterization. Bi-weekly calls are conducted to ensure compliance, answer questions and document adverse events. Participants will stop the trial if they develop an UTI. After receiving treatment for the UTI by their physician, they will go into a washout period of a week before resuming the trial with Gentamicin instillations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form and agreement to complete the daily dosing log as instructed by the study coordinator.
- •History of traumatic spinal cord injury (SCI) or non-traumatic spinal cord disease, (SCD) with sustained neurological dysfunction
- •At least 6 months post-initial hospital discharge following SCI/SCD onset
- •Neurogenic bladder
- •Ability to perform daily instillation on self or with help of others and willingness to adhere to the study regiment.
- •History of at least 2 documented urinary tract infection (UTI) during the previous 6 months (prior to screening)
- •Have a designated physician or health care provider for routine care
- •Use of clean intermittent catheterization or catheterization through a stoma (i.e. Mitrofanoff) as their primary method of bladder management
排除标准
- •Concurrent use of systemic oral or intravesical antibiotic prophylaxis
- •Documented or self-reported history of gentamicin allergy
- •Female patients who are currently pregnant or attempting to become pregnant
- •Patients with a history of 8th cranial nerve disorder
- •Co-morbidities like cancer and chronic disease that could impact patient safety OR significantly affect the rate of UTIs and/or quality of life (QOL) substantially
- •Urological co-morbidities like bladder cancer and history of kidney disease.
- •Current UTI at screening (assessed via urine analysis and culture and symptoms)
- •Concurrent enrollment in a similar clinical trial
- •Concurrent use of contraindicated diuretics (ethacrynic acid, furosemide)
- •Current use of other contraindicated or disallowed concomitant medications or receiving treatments that may influence the results from this study.
- •Known allergy to aminoglycoside antibiotics; Otological symptoms at baseline (i.e. tinnitus. severe dizziness/vertigo)
- •At the discretion of study team, individuals who are unable or unlikely to comply with procedures and/or for whom study participation is not recommended (e.g. unable to arrange transportation, cognitive and/or behavioral challenges that preclude meaningful participation, poor health, etc.)
研究组 & 干预措施
Gentamicin sulfate
Participants initiate Gentamicin instillations every night for a treatment period of 6 months. Instillations are stopped if they developed a UTI. After receiving treatment for this UTI, they resume the Gentamicin instillations. After baseline screening and being consented, they are instructed on how to do the instillations through a catheter, once they receive the drug and aid equipment (i.e. syringes) to do installations. Remaining drug from syringes are to be disposed after each use. Participants use their own catheters. In-dwelling catheters are not allowed.
干预措施: Gentamicin Sulfate (Drug)
结局指标
主要结局
Number of Urinary Tract Infections (UTI) Over Time
时间窗: 6 months prior to treatment and 6 months during treatment
Number of reported urinary tract infections (UTI) by participants and documented in medical chart, per person across months pre and post treatment. The number of UTIs over time was determined by establishing a per person-month rate made up of the total number of UTIs pre and during treatment (numerator) for the sample divided by the total number of persons/ 6 months (11 participants over 6 months period = 66) as the denominator. The unit of measure is defined as pre and during treatment number of UTI events per person months. These appear below under outcome measure data table.
次要结局
- Change in Score of Neurogenic Bladder Symptom Severity (NBSS) Scale(Baseline to 6 months)
- Change in Score of Neurogenic Bowel Dysfunction (NBD)(Baseline to 6 months)
研究者
Denise Tate, PhD
Professor of Physical Medicine and Rehabilitation
University of Michigan