Clostridium Histolyticum Collagenase Injection Treatment for Urethral Disease: a Prospective, Single-center, Open-label Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Number of Subjects With Complication After Treatment
研究概览
简要总结
The purpose of this study is to assess the efficacy of clostridium histolyticum collagenase (XIAFLEX®) in treating urethral strictures.
详细描述
This is an open-label, pilot study to explore the efficacy of clostridium histolyticum collagenase (XIAFLEX®) in treating urethral strictures. Subjects will be followed for 2 years from the initial drug treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Failed prior proven conservative measures, including DVIU or balloon dilation of the stricture will be included in this study
- •Able and willing to undergo regular intervention as well as evaluation as described below will be included in the study
- •With a single stricture <2cm in size that can be identified on retrograde urethrogram or voiding cystourethrogram will be included in the study.
- •Must agree not to participate in a clinical study involving another investigational drug or device throughout the duration of this study
- •Must be competent to understand the information given in IRB approved ICF and must sign the form prior to the initiation of any study procedure
排除标准
- •Has not yet undergone proven non-invasive measures, including DVIU or balloon dilation.
- •Multiple strictures or a single stricture larger than 2cm in size, measured with retrograde urethrogram, voiding cystourethrogram, or urethral ultrasonography.
- •Corporal spongiosum tissues < 5 mm in depth at proposed injection site
- •Grade 5 spongiofibrosis
- •Prior urethroplasty
- •Urethral fistula
- •History of penile cancer, prostate cancer, or urinary tract malignancy (bladder, urethral, ureteral, or kidney).
- •History of radiation (external or brachytherapy) to the pelvic organs, penis or groin.
- •History of autoimmune or inflammatory bowel disease
- •Contraindication to suprapubic tube placement
- •Pre-procedure PVR >250mL
- •Allergy or sensitivity to CHC
- •Bleeding disorder or anticoagulant use other than aspirin up to 150mg/day
- •Untreated urinary tract infection
- •Inability to perform intermittent self-catheterization
- •Participation in another clinical study or treatment with an investigational drug or device
- •Serious or active medical or psychiatric condition which, in the opinion of the Investigator, may interfere with treatment, assessment, or compliance with the protocol
研究组 & 干预措施
Treatment Group
Patients will undergo instillation of local anesthesia (20 mL of 2% urethral lidocaine jelly), the patient will undergo cystoscopy, transurethral injection (via a 70 cm 4.8 Fr flexible cystoscopic needle with a 23 gauge needle tip manufactured by Laborie®, Ontario, Canada) of 0.08ml of XIAFLEX® (0.58 mg of XIAFLEX® mixed with 0.39 mL of sterile diluent) in a single location within the stricture, chased by an additional 0.25 mL of reconstituted XIAFLEX® to allow for clearance of the original 0.08 mL of reconstituted XIAFLEX® from the transurethral syringe into the urethral stricture.
干预措施: Clostridium Histolyticum Collagenase (Drug)
Treatment Group
Patients will undergo instillation of local anesthesia (20 mL of 2% urethral lidocaine jelly), the patient will undergo cystoscopy, transurethral injection (via a 70 cm 4.8 Fr flexible cystoscopic needle with a 23 gauge needle tip manufactured by Laborie®, Ontario, Canada) of 0.08ml of XIAFLEX® (0.58 mg of XIAFLEX® mixed with 0.39 mL of sterile diluent) in a single location within the stricture, chased by an additional 0.25 mL of reconstituted XIAFLEX® to allow for clearance of the original 0.08 mL of reconstituted XIAFLEX® from the transurethral syringe into the urethral stricture.
干预措施: Saline (Other)
结局指标
主要结局
Number of Subjects With Complication After Treatment
时间窗: 84 days
Number of subjects with complication after treatment with clostridium histolyticum collagenase
次要结局
- Change From Baseline and 6 Months: American Urology Association Questionnaire Scores(6 months)
- Change From Baseline and 6 Months: Obstructive Voiding Dysfunction (Uroflow)(6 months)
- Change From Baseline and 9 Months: Obstructive Voiding Dysfunction (Uroflow)(9 months)
- Change From Baseline and 12 Months: Obstructive Voiding Dysfunction (Uroflow)(12 months)
- Change From Baseline and 6 Weeks: American Urology Association Questionnaire Scores(6 weeks)
- Change From Baseline and 2 Years: American Urology Association Questionnaire Scores(2 years)
- Time to Urethral Stricture Recurrence(2 years)
- Change From Baseline and 18 Months: Obstructive Voiding Dysfunction (Uroflow)(18 months)
- Change From Baseline and 2 Years: Obstructive Voiding Dysfunction (Uroflow)(2 years)
- Change From Baseline and 6 Months: Obstructive Voiding Dysfunction (Post-void Residual Measurements)(6 months)
- Number of Patients Needing Further Intervention for Treatment of Urethral Stricture(2 years)
- Number of Subjects With Recurrence of Urethral Stricture(2 years)
- Change From Baseline and 6 Weeks: Obstructive Voiding Dysfunction (Post-void Residual Measurements)(6 weeks)
- Change From Baseline and 9 Months: American Urology Association Questionnaire Scores(9 months)
- Change From Baseline and 12 Months: American Urology Association Questionnaire Scores(12 months)
- Time to Additional Intervention for Urethral Stricture(2 years)
- Change From Baseline and 6 Weeks: Obstructive Voiding Dysfunction (Uroflow)(6 weeks)
- Change From Baseline and 12 Months: Obstructive Voiding Dysfunction (Post-void Residual Measurements)(12 months)
- Change From Baseline and 18 Months: Obstructive Voiding Dysfunction (Post-void Residual Measurements)(18 months)
- Change From Baseline and 9 Months: Obstructive Voiding Dysfunction (Post-void Residual Measurements)(9 months)
- Change From Baseline and 2 Years: Obstructive Voiding Dysfunction (Post-void Residual Measurements)(2 years)