Prospective, Randomized, Multicentric, Comparative Trial of Two Devices in Surgical Treatment of Post-radical Prostatectomy Stress Urinary Incontinence: Periurethral Pro-ACTTM Balloons and AdvanceXP(TM) Retrourethral Male Sling
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- failure of the treatment, defined by reduction of less than 50% of incontinence on 24-hr pad test, explantation of the device or implantation of a new surgical device for SUI management in the year after operation
研究概览
简要总结
Background: Periurethral Pro-ACT balloons and retrourethral AdvanceXP(TM) male sling have been presented as efficient treatments for management of stress urinary incontinence (SUI) following radical prostatectomy (RP), but no comparative study of these two techniques has been published. The investigators aims were to compare the efficacy of the two devices and provide data about their cost effectiveness.
Hypothesis: The study is based on the superiority hypothesis that AdvanceXP male slings is more efficacious than Pro-ACT balloons at one year follow-up.
Primary objective: The primary objective of this study is to compare the efficacy of the AdvanceXP retrourethral male sling and periurethral Pro-ACT balloons management of SUI after RP at one year follow-up.
Secondary objectives:
- Comprehensive comparative medical evaluation of the two devices in terms of efficacy
- Complete evaluation of the side effects of the two techniques
- Evaluation of the quality of life
- Evaluation of patient satisfaction
- Cost-effectiveness study of the device (total cost over one year of each of the two techniques, differential cost-effectiveness ratio (cost adjusted by QALY), differential cost-effectiveness ratio in terms adjusted to success rate, recommendations that can be made for assessing the potential coverage by the French healthcare system) Population: Patients with history of RP without cancer recurrence, presenting pure SUI on urodynamics (without detrusor overactivity), of mild to moderate degree (24hour pad-test < 300g).
Study design: This is a prospective, randomized, multicentric (9 tertiary reference centers), comparative trial of the two devices (with a superiority hypothesis). The total number of subjects required is 240 and inclusion period is 12 months. Follow-up consists in 4 visits at 1, 3, 6 and 12 months, with data collection (pad use, uroflowmetry, quality of life validated questionnaires ICIQ-SF and EQ-5D, 24-hr pad test, patient satisfaction with PGI-I and report of any secondary effect). Statistical evaluation is carried out at the end of the follow-up, in intent to treat.
Medical evaluation:
Main criterion:failure of the treatment, defined by reduction of less than 50% of incontinence on 24-hr pad test, explantation of the device or implantation of a new surgical device for SUI.
Secondary outcome criteria
- pad usage per day
- quantitative reduction of the 24hr-pad test
- complications (infection, erosion, hematoma, acute urinary retention)
- number of re-interventions or re-admissions during follow-up
- quality of life measured by the ICIQ-SF questionnaire
- patient satisfaction by the PGI-I questionnaire
Economic evaluation:
- Study of the total cost over one year in each case
- Adjustment of cost of each device to quality of life (QALY evaluation)
- Cost effectiveness study
- Proposals will be made to state at which level the two devices should be covered by the healthcare system.
详细描述
Background: Stress urinary incontinence (SUI) is a common adverse event of radical prostatectomy (RP) for localized prostate cancer and can dramatically impact quality of life. Management of SUI after RP is based on conservative measures and pelvic floor muscle training. In case of failure of this first line therapy, surgical treatment is required. In recent years, periurethral Pro-ACT balloons and retrourethral AdvanceXP male sling have been proven to be efficient to manage SUI after RP in case of mild to moderate symptoms. Pro-ACT balloons are placed under general anesthesia via a perineal approach, laterally to the membranous urethra under the bladder neck. This device results in an external compression of the urethra. Further adjustment of the compression is possible under local anesthesia since the balloons are linked to a subcutaneous titanium port. AdvanceXP male sling is placed under general anesthesia via a perineal approach, by transobturator route, and results in a suspension of the membranous urethra relocating the bladder neck. If multiple reports have claimed for the efficacy of these two devices, they have never been compared in a prospective comparative trial. Our aims were to compare the efficacy of the two devices and provide data about their cost effectiveness.
Hypothesis: The study is based on the superiority hypothesis that Advance male slings is more efficacious than Pro-ACT balloons at one year follow-up.
Objectives:
The primary objective of this study is to compare the efficacy of the Advance retrourethral male sling and periurethral Pro-ACT balloons for post-prostatectomy stress urinary incontinence (SUI) management.
The secondary objectives of this work are:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Patient presenting mild to moderate stress urinary incontinence (20g < 72 hours pad-test < 300g) following radical prostatectomy more than 1 year ago.
- •Patient capable of roaming, independent and capable of using toilet without any trouble.
- •Patients able to answer to questionnaire and communicate in French
- •Informed consent
- •Patients with social security
排除标准
- •Uncontrolled prostatic adenocarcinoma or PSA > 1 ng/ml
- •Maximum urinary flow rate < 15 ml/sec
- •Postvoid residual volume > 150 ml
- •Urinated volume in 24h > 3000 ml
- •Uninhibited detrusor contractions associated with leakage during the preoperative urodynamic assessment (realized under anticholinergic if the patient is usually under this medication)
- •Severe incontinence (Pad test > 300g/24h)
- •History of artificial urinary sphincter
- •Known neurologic bladder dysfunction
- •History of neurological disease which can interfere with the urinary symptoms
- •Presence of a urethral stenosis or of an anastomotic stricture during the preoperative endoscopy.
- •Previous treatment with pelvic radiation therapy in 6 months before inclusion
- •Uncontrolled urinary tract infection
- •Patients affected by an infiltrative bladder tumour
- •Patients with bladder stones
- •Severe constitutional hemorrhagic disease or haemophilia
- •Deep depression of immune system
- •Severe renal impairment or obstructive pathology of the upper urinary tract with severe renal impairment
结局指标
主要结局
failure of the treatment, defined by reduction of less than 50% of incontinence on 24-hr pad test, explantation of the device or implantation of a new surgical device for SUI management in the year after operation
时间窗: 12 months after surgical treatment
次要结局
- Cost-effectiveness study of the device(12 months after surgical treatment)
- complications(1, 3 6 and 12 months after surgical treatment)