NCT02815046已完成不适用
Prospective, Non-randomized, Single-center Observational Study of Outcome Measures of Patients Suffering From Mixed Urinary Incontinence Before and After Surgical Procedure With Botulinum Toxin and Polyacrylamide Hydrogel (PAHG)
Prof. Dr. Volker Viereck1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2016年8月最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Cure rates for stress urinary incontinence (SUI)
研究概览
简要总结
This study compares mixed urinary incontinence symptoms before and after a combined treatment with Botox and Bulkamid. Eligible for the study are adult females with a mixed urinary incontinence, having both urgency urinary symptoms and stress urinary symptoms.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged ≥ 18 years.
- •Clinically diagnosed therapy-refractory mixed urinary incontinence (MUI) based on cough test, urodynamic evaluation, 3-day micturition diary, incontinence-questionnaire with visual analog scales for SUI and UUI.
- •All criteria for the indication to treat patient with Botox are met.
- •All criteria for the indication to treat patient with Bulkamid are met.
- •Participant has given informed consent
排除标准
- •All contraindications for Bulkamid or Botox
- •Previous treatment with Botulinum toxin (within last 3 months)
- •Previous treatment with Bulkamid or other bulking agent (within last 3 months)
- •Participant is pregnant or lactating
- •Current urinary tract infection (in which case this has to be treated first before patient might be included)
- •Residual urine of > 100 ml
结局指标
主要结局
Cure rates for stress urinary incontinence (SUI)
时间窗: 6 months
Number of participants with negative cough stress test and 90 % improved SUI-visual analog scale.
Change from baseline in number of micturitions per day
时间窗: Baseline, 6 months
次要结局
- UUI-visual analog scale(Baseline, 6 months, 12 months)
- Change from baseline in number of urgency episodes per day(Baseline, 6 months, 12 months)
- Frequency of complications(intra-operative and post-operative follow-up up to 12 months)
- Frequency of cough stress test levels(Baseline, 6 months, 12 months)
- SUI-visual analog scale(Baseline, 6 months, 12 months)
- Change from baseline in number of urgency urinary incontinence episodes per 3 days(Baseline, 6 months, 12 months)
- Change from baseline in urine volume per micturition(Baseline, 6 months, 12 months)
- Change from baseline in number of micturitions per day(Baseline, 6 months, 12 months)
研究者
Prof. Dr. Volker Viereck
Professor, MD
Cantonal Hospital, Frauenfeld
研究点 (1)
Loading locations...
相似试验
撤回
4 期
Pharmacological vs Surgical Treatment for Mixed IncontinenceMixed Urinary IncontinenceUrinary Incontinence, StressUrinary Incontinence, UrgeNCT00523068Imperial College London
已完成
不适用
Comparing Use of a Digital Health System of Pelvic Floor Exercise Program to Kegel Exercises in Stress Urinary IncontinenceMixed Urinary IncontinenceStress Urinary IncontinenceNCT03632447Renovia, Inc.77
已完成
4 期
Posterior Tibial Nerve Stimulation (PTNS) Plus Mirabegron to Treat Refractory OAB Symptoms (PTNS-M Study)Overactive BladderNCT04907032University of Alabama at Birmingham54
已完成
4 期
Efficacy of a Combined Surgical and Pharmacological Therapy to Treat Mixed Urinary Incontinence.Urinary Incontinence Mixed (Stress and Urge)NCT01899794Jewish General Hospital66
终止
4 期
Mixed Incontinence: Medical Or Surgical Approach?Urinary IncontinenceNCT00803270Carelon Research27