NL-OMON53594招募中不适用
Safety and Performance of UCon for Management of Non-Neurogenic OAB in Males - An Early Feasibility Study - UCon Treatment of OAB in Males
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
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
- •- Subject is >= 18 years of age.
- •- Subject is male.
- •- Subject is diagnosed with OAB
- •- Subject is able to communicate, provide feedback, understand and follow
- •instructions during the course of the investigation.
排除标准
- •1. Subject is medically unstable (acute illness or complications of a chronic
- •condition that might affect the subject*s participation in the investigation).
- •2. Subject has a Post Void Residual (PVR) of more than 100 ml or a Bladder
- •Voiding Efficiency (BVE) of less than 75% (measured by uroflowmetry as the
- •ratio of voided volume (VV) and total bladder capacity (VV+PVR)).
- •3. Subject has an active infection in the genital area incl. skin infections
- •4. Subject has had botulinum toxin (BOTOX) treatment in the pelvic region
- •within 6 months.
- •5. Subject has used antimuscarinics or β3 agonists within 14 days weeks*.
- •6. Subject has an implanted pacemaker, implantable drug pump or other active
- •medical device (any medical device that uses electrical energy or other source
- •of power to make it function).
- •7. Subject is enrolled or planning to enrol in another clinical investigation
- •or was enrolled in an investigational drug study or medical device
- •investigation within four weeks to enrolment.
- •8. Subject has neuropathy to a degree that is presumed to diminish the effect
- •of the electrical stimulation.
- •9. Subject has a history of cancer in the pelvic region, are currently
- •receiving cancer treatment, or has radiation-induced damage to the pelvic
- •10. Subject has addictive behaviour defined as abuse of alcohol, cannabis,
- •opioids, or other intoxicating drugs.
- •11. Subject does not speak and understand Dutch.
- •*If a subject is currently being treated with antimuscarinics or β3 agonists,
- •he is allowed to be included in the investigation, however, a washout period of
- •14 days is required before baseline can be established.
研究者
相似试验
进行中（未招募）
1 期
The assessment of effectiveness and safeness of utilizing empagliflozin in the treatment of neutropenia of patients suffering from glycogenolysis type Ibneutropenia and / or abnormal neutrophil function in glycogenosis I bEUCTR2021-000580-78-PLThe Children’s Memorial Health Institute20
招募中
不适用
The evaluation for safety and effectiveness of the laparoscopic radical hysterectomy and pelvic lymphadenectomy for stage IA, IB and IIA uterine cervical cancer.terine cervical cancerJPRN-UMIN000016183agoya University Graduate School of Medicine, Department of Obstetrics and Gynecology10
进行中（未招募）
不适用
An Evaluation of the Safety and Tolerability of Multiple Dose Regimens of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis and Stable Lung DiseaseEUCTR2005-004344-30-ATAOP Orphan Pharmaceuticals AG18
进行中（未招募）
不适用
An Evaluation of the Safety and Tolerability of Multiple Dose Regimens of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis and Stable Lung DiseaseEUCTR2005-004344-30-HUAOP Orphan Pharmaceuticals AG18
已完成
4 期
Evaluation of the TEKTONA® system designed to restore vertebral height in the treatment of vertebral fractures by compressioVertebral compression fracture, stable type, without neurological deficitMusculoskeletal DiseasesISRCTN10328801Spineart (Switzerland)37