Long-term Efficacy of Percutaneous Tibial Nerve Stimulation for Faecal Incontinence and New Approach for Partial Responders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 139
- 试验地点
- 1
- 主要终点
- Change in faecal incontinence assessed by Wexner Score
研究概览
简要总结
Percutaneous tibial nerve stimulation (PTNS) is an ambulatory therapy validated for patients with Faecal Incontinence (FI) refractory to conservative treatment with proved short and mid-term efficacy.
The investigators therefore aimed to evaluate the long-term efficacy of PTNS, considered 3 years of follow-up. The investigators also aimed to identify predictors of responses and suggest a new approach for partial responders.
详细描述
Prospective single-centre cohort of patients with FI treated with PTNS was analysed.
PTNS sessions were performed in three phases: weekly for three months in the first phase, biweekly for three months in the second phase, and monthly for six months in the third and final phase.
Clinical control at the end of each phase and an additional follow-up was performed at 36 months. Wexner score, faecal urgency, bowel habits and quality of life for FI were assessed.
Patients were categorized in three groups: optimal responders when there was an improvement in Wexner score > 50%; partial responders if the improvement in Wexner score was 25-50%; and non-responders, when the improvement of Wexner score was < 25%.
Optimal responders and partial responders progressed into successive phases, whereas non-responders abandoned PTNS and other treatment options were offered.
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
- •Diagnosis of faecal incontinence for more than 6 months, refractory to conservative treatment.
排除标准
- •Anatomic injuries that require surgery.
- •External anal sphincter lesion of > 180º.
- •Unavailability to attend regularly outpatient clinic.
- •Major psychologic or psychiatric comorbidities
结局指标
主要结局
Change in faecal incontinence assessed by Wexner Score
时间窗: Baseline compared to 3, 6, 12 and 36 months after start of PTNS
Rate of patients with improvement in faecal incontinence assessed by Wexner score (Maximum punctuation: 20 being severe incontinence. Minimum punctuation: 0, no incontinence).
次要结局
- Predictors of good long-term improvement in Wexner score(At 3, 6 and 12 months after start of PTNS)
- Partial Responders(At 3, 6 and12 months after start of PTNS)
研究者
Luis Sánchez Guillen
Clinical Professor Luis Sánchez-Guillén
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana