Optimization of Therapy Resistant LUTS (OptiLUTS) Part C: The Development of a Symptom Assessment Tool in Sacral Neuromodulation: A Prospective Single Centre Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- True success ratio
研究概览
简要总结
Sacral neuromodulation (SNM) is a two-staged 2nd-line therapy for therapy-resistant LUTS and fecal incontinence. Currently, the assessment of symptoms at baseline and after stage I is directed towards a discipline related evaluation. The OptiLUTS trial strives for a more holistic approach, taking all pelvic floor dysfunctions into account.
A holistic assessment tool will be developed and SNM-care pathway will be set-up.
详细描述
A prospective single centre trial is set up. Patients planned for the two-staged tined lead procedure are enrolled.
Bladder and bowel diaries and patient reported outcome measures (PROMS) will be collected at baseline and in between stage I and stage II, and PROMS at one month, 6 months and 12 months after definitive implant.
Phase I Step 1: The current implant rate, true success rate, outcomes and false positive rate will be measured.
Step 2: Development of a holistic symptom assessment tool. Phase II Implementation of the SNM care pathway.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects ≥ 18 years presenting with one or more of the following indications: Urinary urgency frequency with or without urinary incontinence (OAB dry or wet), non-obstructive urinary retention, dysfunctional voiding with post void residual volume, faecal incontinence and mixed incontinence
- •Refractory to conservative treatment (i.e. Lifestyle changes, behavioural modification, pelvic floor muscle training, biofeedback) and refractory to pharmacological treatment.
排除标准
- •Neurogenic bladder.
- •Anal sphincter damage more than 120
- •Abnormal sacral anatomy
- •Mentally or physically disabled patients not capable to handle a patient programmer device.
- •Pregnant patients
结局指标
主要结局
True success ratio
时间窗: Through study completion, an average of 3 years
Proportion of patients showing both objective (ObS) and subjective success (SS) during the test phase of SNM.
Implantation ratio
时间窗: Through study completion, an average of 3 years
Proportion of number of patients who received a definitive implant.
False positive ratio
时间窗: One month after definitive implant.
Proportion of patients with discontinued SS although having true success during test phase.
次要结局
- Absolute change in diary variables.(Up to 4 weeks, depending on the duration of the test phase.)
- Revision ratio(Within 12 months after definitive implant.)
- Explantation ratio(Within 12 months after definitive implant.)
- Evolution of PROM scores over time.(At 12 months follow-up.)