Defining the Safety and Efficacy of POSterIor Tibial NeRve StimulatiON in Children
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 主要终点
- The frequency of select safety Events of Special Interest.
研究概览
简要总结
The purpose of this study is to find out if overactive bladder (OAB) can be safely treated by stimulating a nerve near the ankle. This procedure is called percutaneous tibial nerve stimulation (PTNS). It will be done by a device called the Urgent PC. The Urgent PC works by sending weak electrical signals through a thin needle to the nerve near the ankle. Stimulating this nerve may change bladder control.
详细描述
This study is a single-arm, open label, prospective, multicenter study of 50 participants aged 5-21 years with OAB. Participants will undergo outpatient PTNS sessions per routine clinical care using Urgent PC once weekly for 12 weeks. Patients, parents and clinicians will not be blinded to treatment or assessments during the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 5-21 years old (inclusive)
- •Obtained legally effective informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization from the participant or the participant's parent/legal guardian/legally authorized representative (LAR)
- •Minor participant is willing and able to provide assent (as applicable)
- •History of primary or secondary non-neurogenic OAB as defined by a VDES score of ≥11 and a positive modified bother score within 30 days of consent
- •Has previously tried and failed standard urotherapy and at least one anticholinergic or beta-3 adrenergic agonist
- •Adequate fluid intake for age as reported by participant or parent/legal guardian/LAR
- •Micturition frequency of at least 8 times (mean)/day for at least 4 weeks prior to enrollment
- •At least 1 daytime incontinence episode (mean)/day for at least 4 weeks prior to enrollment
- •If on allowed treatment for OAB, stable dose for at least 30 days prior to screening and willingness to continue that dose for the duration of the study
排除标准
- •Known or apparent untreated anatomical abnormality of the lower urinary tract (e.g., untreated ureterocele)
- •Known neurogenic bladder (e.g., spina bifida, history of spinal cord injury, tethered cord)
- •Presence of local skin lesions (e.g., rash, skin infections) on the medial surfaces of both ankles at the time of consent
- •Metal implants in the medial ankle area
- •Pacemakers or implantable defibrillators
- •History of excessive bleeding
- •Nerve damage that may impact the percutaneous tibial nerve or pelvic floor function
- •History of chemodenervation of the bladder (e.g., via intravesical instillation or intradetrusor injection of botulinum toxin)
- •Known current, untreated UTI
- •Current or previous pregnancy at screening or planned pregnancy during the duration of the study, for females of childbearing potential
- •Any condition that, in the judgment of the investigator or treating clinician, precludes participation because it could affect participant safety
- •Previous treatment with this device or participation in this study or in any other study for the treatment of OAB
- •High-grade vesicoureteral reflux (grades 4-5)
- •Diagnosed diabetes insipidus (pituitary, nephrogenic, or acquired)
- •Stage 4-5 chronic kidney disease (CKD) (since device may further disrupt or exacerbate abnormal urine flow)
- •Significant post-void residual defined as >60 mL
- •Initiation of or change of OAB treatment during screening or the duration of the study.
研究组 & 干预措施
Single-Arm Cohort
Single Arm Cohort: (n=50) PTNS treatment weekly over 30 minutes for a total of 12 weekly sessions.
干预措施: Urgent PC (Device)
结局指标
主要结局
The frequency of select safety Events of Special Interest.
时间窗: Weekly, Week 1 through Week 16
1. Electrode site reaction (bruising, bleeding, hematoma, or persistent erythema at the electrode site) 2. Electrode site infection 3. Repeated post-void residual \>60 mL (at ≥ 2 consecutive visits) 4. Urinary tract infection 5. Urinary retention/obstruction 6. Toe numbness 7. Stomach and leg cramps
Change in maximum voided volume on the Bladder Diary
时间窗: Week 1, Week 12
The Bladder Diary is a paper diary recommended by the International Children's Continence Society that will be completed by the parent/guardian/LAR or participant. The Bladder Diary includes the following variables: fluid intake, number of voids, volume of voids, degree of urgency, number of incontinent episodes.
次要结局
- Proportion of children who experienced complete response, no response, or partial response on the Vancouver Dysfunctional Elimination Survey (VDES)(Screening, Weekly (Week 1 through Week 12))
- Change in OAB symptoms (Urgency, Frequency and Daytime Incontinence) reported on the VDES(Screening, Weekly (Week 1 through Week 12), Week 16, Week 36)
- Proportion of children who develop a febrile UTI(Weekly, Week 1 through Week 12)
- The change of Pediatric Incontinence Quality of Life (PINQ) score(Week 1, Week 6, Week 12, Week 16, and Week 36)
- The percent of study visits attended within the protocol specified window from baseline through Week 12(Screening, Weekly (week 1 through week 12))
研究者
Chi Dang Hornik
Associate Professor of Pediatrics
Duke University