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临床试验/NCT00617786
NCT00617786已完成不适用

Current Perception Threshold Testing for Sacral Neuuromodulation Outcomes

Corewell Health East2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2008年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
13
试验地点
2
主要终点
The primary endpoint is the change in CPT measurement after placement of SNM therapy as compared to baseline CPT measurements.

研究概览

简要总结

This is a prospective study. Subjects will be recruited from the urology practices of Dr. Ken Peters and Dr. Ananias Diokno at William Beaumont Hospital. Subjects will be referred to the study by the clinician recommending Sacral NeuroModulation therapy (SNM).

This pilot study is to explore the effect of SNM on sensory pathways by measuring CPT values pre and post SNM treatment.

详细描述

Patients will be scheduled 1-2 weeks prior to planned implantation of the SNM wire electrode (Stage 1). Patients that do not have a 50% improvement in their symptoms in Stage 1 will not go on to Stage II procedures and will not undergo further CPT testing.

After enrollment, the subjects will complete a short medical history questionnaire confirming that they meet inclusion criteria and do not fall under exclusion criteria. This will include review of recent urinalysis and/or urine culture confirming the absence of a recent urinary tract infection. Participants will be given information on the relevant CPT testing including the need for bladder/urethra catheterization as part of that testing pre and post SNM therapy.

At the baseline testing visit, subjects will undergo CPT testing using transcutaneous stimulation in the distribution of the pudendal nerve on the perineum. Subjects will undergo bladder/urethral catheterization in using standard sterile technique. Once the bladder/urethral catheter is in place CPT testing will be conducted at various frequencies of to identify the current perception thresholds of each nerve fiber.

At the conclusion of the testing the catheter will be removed and the subjects will be given a single dose of an oral antibiotic to minimize infection. This meeting and testing will require approximately 60 minutes.

Patients will undergo Stage I of the SNM procedure with their own physician at a subsequent appointment.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • Established diagnosed overactive bladder
  • Scheduled to receive SMN therapy by Dr. Peters or Dr. Diokno
  • Women at least 18 years of age
  • Capable of giving informed consent
  • Capable and willing to follow all study related procedures (e.g. bladder and urethral catheterization, answering questions during CPT testing, complete questionnaires regarding pertinent medical history).

排除标准

  • Current Urinary tract infection
  • Currently participating or have participated within the past 30 days in any clinical investigation involving or impacting urinary or renal function.
  • Pregnancy or intending to become pregnant during the study
  • Cannot independently comprehend and complete relevant medical history questionnaires.
  • The subject is deemed unsuitable for enrollment in this study by the investigators based on their history.
  • Men are excluded
  • TENS, PTNS or acupuncture therapy currently being used for symptoms

结局指标

主要结局

The primary endpoint is the change in CPT measurement after placement of SNM therapy as compared to baseline CPT measurements.

时间窗: visit 1

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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