Evaluation of the Safety of the Treatment of Benign Prostatic Hyperplasia by High Intensity Focused Ultrasound.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- The safety of HIFU treatment will be assessed by analyzing adverse events (serious and non-serious) reported during follow-up.
研究概览
简要总结
Prostate adenoma or benign prostatic hypertrophy (BPH) is a benign disease of the prostate gland. It results in an increase in the volume of the prostate area located in contact with the urethra. Compression of the prostatic urethra by the adenoma can cause lower urinary tract disorders.
The classic treatments in case of failure of medical treatment are endoscopic resection of the prostate and adenomectomy, but these techniques are characterized by a significant hemorrhagic risk that may require transfusions and prolonged hospitalization.
Minimally invasive treatments with low morbidity have been developed to overcome these drawbacks. They allow to propose a therapeutic solution adapted to patients: not tolerating their medical treatment, wishing to keep antegrade ejaculation, elderly and/or frail, at risk of bleeding, wishing an ambulatory treatment, refusing the conventional surgical techniques.
The Focal One® device was developed to treat prostate cancer using ultrasound energy. This energy is delivered through a probe placed in your rectum. Connected to this probe, an ultrasound machine will allow your doctor to see precisely which part of your prostate is being treated. By heating the prostate tissue to a very high temperature in one treatment session, the energy delivered will then destroy the tissue. Ultrasound guidance coupled with the localized nature of the treatment allows the targeted area to be treated while respecting the prostate tissue and structures adjacent to the prostate and thus reducing side effects.
Treatment of prostate adenoma with HIFU would allow for localized destruction to reduce prostate volume. The reduction of the compression of the prostatic urethra thus obtained would allow an improvement of the urinary disorders. The treatment is performed transrectally under real-time ultrasound control, which allows the adjacent structures to be respected, thus preserving antegrade ejaculation and limiting the side effects.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Over 50 years of age,
- •BPH greater than 30 cc confirmed by endorectal ultrasound
- •IPSS score > 7, Qol-IPSS > 2, IIEF-5 score > 11
- •Qmax < 15 ml/s or urinary retention (in indwelling catheter, self-catheterization, or with an RPM > 300 cc).
- •In failure or intolerance of drug treatment(s) for BPH
- •negative cytobacteriological examination of the urine
排除标准
- •Prostate volume > 80 ml
- •Presence of a median lobe
- •Men allergic to latex
- •Contraindication to the insertion of a transrectal HIFU probe: rectal fistula, anal or rectal fibrosis, or other abnormalities
- •History of prostate surgery
- •History of prostate radiation therapy
- •History of bladder cancer
- •Current anti-coagulant treatment with a stopping window that cannot exceed 48 hours at the time of the HIFU procedure
- •Presence of a urinary tract fistula
- •History of inflammatory bowel disease
- •Ongoing urogenital infection
- •Neurological bladder pathology
- •History of urethral stenosis
- •Confirmed or suspected prostate cancer
- •Contraindication to surgery (including anesthesia)
- •Contraindication to pelvic MRI
- •Presence of metallic implants or stents in the urethra
- •Presence of prostatic calcification whose location interferes with HIFU treatment
- •Patients with renal failure with a GFR <35ml/min
结局指标
主要结局
The safety of HIFU treatment will be assessed by analyzing adverse events (serious and non-serious) reported during follow-up.
时间窗: 3 months
次要结局
- Evaluation of continence with ICIQ-SF questionnaire(1 and 3 months)
- Evaluation of the global impression of improvement scale with PGI-1 questionnaire(1 and 3 months)
- Evaluation of treatment performance by maximum urine output (Qmax)(1 and 3 months)
- Evaluation of voiding symptomatology with IPSS questionnaire(1 and 3 months)
- Evaluation of ejaculation quality with MSHQ-SF questionnaire(1 and 3 months)
- Evaluation of treatment performance by residual post-void volume (RPM)(1 and 3 months)
- Evaluation of quality of erection with IIEF-5 questionnaire(1 and 3 months)
- Evaluation of quality of urinary life with Qol-IPSS score(1 and 3 months)
- Evaluation of the change in the PSA rate(3 months)