NL-OMON43352已完成4 期
INJECTABLE BULKING AGENT FOR MALE URINARY INCONTINENCE TREATMENT: A MULTI-CENTRE EFFECTIVENESS AND SAFETY PILOT STUDY - Opsys bulking agent for male incontinence
Ziekenhuisgroep Twente0 个研究点目标入组 30 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* Male, aged between 18 and 85 years old.
- •* Subject remains dry at night.
- •* Ability to voluntarily stop micturition.
- •* Stress Urinary Incontinence caused by Intrinsic sphincter deficiency ISD secondary to a post RP, refractory to conservative treatment with a post-operative of at least 12 months.
- •* Urinary incontinence classified as minimal to mild incontinence level by a 24 h pad weight test mentioned in the clinical data (less than 30 g per day urine loss on 24 h pad weight test), and quality of life has deteriorated so as to require surgery as a method of treatment.
- •* Consent informed signed.
排除标准
- •* Post-prostatectomy radiotherapy or brachytherapy.
- •* Subject radiated as treatment of Prostate Cancer, being this interstitial or external, neo-adjuvant, therapeutic or adjuvant.
- •* Bladder neck sclerosis or urethral stricture.
- •* Detrusor hyperactivity.
- •* Lower Urinary Tract Infections
- •* Urge Incontinence.
研究者
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