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Altis 单切口吊带系统治疗女性压力性尿失禁的 3 年自然队列调查

2026年5月22日 更新者：Coloplast A/S

一项针对女性压力性尿失禁的 Altis 单切口吊带系统的 3 年自然队列调查一项针对女性压力性尿失禁受试者的上市后多中心前瞻性观察队列研究

本研究的目的是监测 Altis 单切口吊带 (SIS) 在现实世界人群中的使用情况并收集有关有效性的医学数据，并监测 Altis SIS 在设备植入后 12 个月和 36 个月对患有压力性尿失禁的女性的安全性.

研究概览

地位

终止

条件

干预/治疗

详细说明

该项目是在欧洲引进 Altis 之后启动的。 本研究是一项多中心前瞻性、观察性（即 对被诊断为压力性尿失禁的女性进行自然主义的）上市后临床随访，并将使用 Altis 单切口吊带系统进行治疗。 因此，将要求这些患者允许使用他们的临床数据并回答一些问卷。 患者的数据将在术前、术中和术后的常规临床实践中收集，直至 12 个月。 然后，在接下来的 2 年中，问卷将每年邮寄给参与者。

研究类型

观察性的

注册 (实际的)

598

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 德国
      • Gunzenhausen、德国、91710
        • Frauenärzte im Seenland
      • Memmingen、德国、87700
        • Klinikum Memmingen
      • Worms、德国、67550
        • Klinikum Worms gGmbH
  • 意大利
      • Aosta、意大利、11100
        • Azienda USL Valle d'Aosta
  • 比利时
      • Leuven、比利时、3000
        • UZ Leuven
  • 法国
      • Angers、法国、49933
        • CHRU Hôtel Dieu
      • Avignon、法国、84082
        • Clinique Rhône Durance
      • Bordeaux、法国、33076
        • CHU Pellegrin-Urology Departement
      • Bordeaux、法国、33076
        • CHU Pellegrin_Gyneacology Departement
      • Bruges、法国、33523
        • Polyclinique Jean Villars
      • Béziers、法国、34535
        • Clinique Champeau Mediterranée
      • Castres、法国、81108
        • Hôpital du Pays d'Autan
      • Chambray-lès-Tours、法国、37170
        • Pole Sante Leonard de Vinci
      • Clermont-Ferrand、法国、63003
        • Chu Clermont Ferrand
      • Dreux、法国、28102
        • Hôpital Victor Jousselin
      • Issoire、法国、63503
        • CH Paul Ardier
      • La Roche-sur-Yon、法国、85106
        • Clinique Saint-Charles
      • La Rochelle、法国、17019
        • Centre Hospitalier Saint Louis
      • La Rochelle、法国、17087
        • Clinique du Mail La Rochelle
      • Lambres-lez-Douai、法国、59552
        • Clinique Saint-Amé
      • Libourne、法国、33500
        • CH Libourne
      • Lorient、法国、56100
        • Clinique Mutualiste de la Porte de l'Orient
      • Massy、法国、91349
        • Hôpital Privé Jacques Cartier
      • Nogent-sur-Marne、法国、94130
        • Armand Brillart Hospital
      • Poissy、法国、78303
        • Chi Poissy Saint Germain En Laye
      • Rouen、法国、76044
        • Clinique St Hilaire
      • Soyaux、法国、16800
        • Centre Clinical
      • Toulouse、法国、31082
        • Clinique Ambroise Pare
      • Toulouse、法国、31077
        • Clinique Saint Jean Languedoc
  • 西班牙
      • Barcelona、西班牙、08035
        • Hospital Vall d'hebrón
      • Tarragona、西班牙、43005
        • Hospital Univeritario Joan XXIII
      • Valencia、西班牙、46026
        • Hospital La Fe
      • Valladolid、西班牙、47003
        • Hosital Clinico de Valladolid

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

取样方法

非概率样本

研究人群

女性植入 Altis 单切口吊带系统治疗压力性尿失禁

描述

纳入标准：

  • 植入 Altis 单切口吊带系统

排除标准：

  • 拒绝被包括在调查中或他们的医疗数据将用于研究目的
  • Altis 单切口吊带系统植入的适应症不适用于治疗女性尿失禁。

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 观测模型：仅案例
  • 时间观点：预期

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Treatment Success
大体时间：12 months
Treatment success is a composite criterion defined in the protocol as condition improvement by Patient Global Impression of Improvement (PGI-I) reported as "a little better", "much better" or "very much better" and absence of serious or severe related Adverse Events (AEs) one year after implantation. As this definition of success was not restrictive enough, the Scientific Committee proposed a new definition for the treatment success for the statistical analysis, which was defined by PGI-I reported as "very much better" or "much better" and absence of any severe or serious or grade ≥ III of the Clavien-Dindo classification related AEs one year after implantation.
12 months
Patient Global Impression of Improvement (PGI-I)
大体时间：12 months
PGI-I is one of the two outcome measures of the composite primary endpoint. It is a validated question that collects the patients' impression of improvement after the surgery. Among this 7 point-scale ("very much better", "much better", "a little better", "no change", "a little worse", "much worse" and "very much worse"), the patients are asked to check the one number that describes how their urinay tract condition is now, compared with how it's was before the surgery. The percentage of patients who describes "very much better" or "much better" or "little better" and the percentage of patients who describes "very much better" or "much better" were measured.
12 months
Related Adverse Events
大体时间：12 months
Related Adverse Events (AEs) are one of the two outcome measures of the composite primary endpoint. All AEs related or judged related to the procedure or the device were reported. The percentage of patients without any severe or serious related AEs and the percentage of patients without any severe or serious or grade ≥ III of the Clavien-Dindo classification related AEs were measured.
12 months

次要结果测量

结果测量
措施说明
大体时间
Treatment Success
大体时间：8 weeks, 24, 36 months
Treatment success is a composite criterion defined in the protocol as condition improvement by Patient Global Impression of Improvement (PGI-I) reported as "a little better", "much better" or "very much better" and absence of serious or severe related adverse events one year after implantation. As this definition of success was not restrictive enough, the Scientific Committee proposed a new definition for the treatment success for the statistical analysis, which was defined by PGI-I reported as "very much better" or "much better" and absence of any severe or serious or grade ≥ III of the Clavien-Dindo classification related adverse event one year after implantation.
8 weeks, 24, 36 months
Cough Stress Test (CST)
大体时间：Baseline, 8 weeks and 12 months
CST provides the means for documenting stress urinary incontinence. CST is considered "positive" if any leakage is noted with cough or valsava. The percentage of patients with negative test was calculated at baseline, at the post-operative visit and at one year.
Baseline, 8 weeks and 12 months
Post-void Residual (PVR) Volume
大体时间：Baseline, 8 weeks and 12 months
Post-void residual (PVR) volume was collected pre- and post implant procedure up to 12 months. If the PVR volume was considered normal by the physician after the procedure, it was not necessary to collect this data at the subsequent follow-up visits.
Baseline, 8 weeks and 12 months
Pad Use
大体时间：Baseline, 8 weeks, 12, 24 and 36 months
The number of pads used per patient per day was collected. Patients were considered to be pad free if they reported never wearing pads or wear pads just for a sense of security.
Baseline, 8 weeks, 12, 24 and 36 months
International Consultation on Incontinence Questionnaire (ICIQ-UI)
大体时间：Baseline, 8 weeks, 12, 24 and 36 months
The ICIQ-UI Short Form is a seft-administred questionnaire to evaluate the frequency, severity and impact on quality of life of urinary incontinence. Question 1 asked, "How often do you leak urine?" Subjects were instructed to select among "none" (0), "about once a week or less often" (1), "2 or 3 times a week" (2), "about once a day" (3), "several times a day" (4), and "all the time" (5). Question 2 asked, "How much urine do you usually leak (whether you wear protection or not)?" Patients responded with "none" (0), "a small amount" (2), "a moderate amount" (4) or "a large amount (6). Question 3 asked, "Overall, how much does leaking urine interfere with your everyday life?" Participants chose a number from 0 (not at all) to 10 (a great deal). Question 1, 2 and 3 are summed to compute the total ICIQ score.The total score range is then a minimum of 0 to a maximum of 21.
Baseline, 8 weeks, 12, 24 and 36 months
Subject Global Satisfaction Questionnaire
大体时间：8 weeks, 12, 24, 36 months
This non-validated questionnaire provides additional information concerning patient satisfaction. This survey consists of two questions: Question 1 "how satisfied are you with your surgery?". Among 5 point-scale (very satisfied, satisfied, not satisfied-not dissatisfied, dissatisfied and very dissatified), patient check the one items that best describes the subject satisfaction. We measured the percentage of patients who were very satisfied and satisfied. The patients answer the question "Do you recommend this operation to a friend?" by "yes" or "no". We measured the percentage of patients who answered "yes".
8 weeks, 12, 24, 36 months
Incontinence Quality of Life Questionnaire (I-QoL)
大体时间：Baseline, 8 weeks, 12, 24, 36 months
The Incontinence quality of life questionnaire (I-QoL) is a validated survey questionnaire with 22 items that are scored on a 5-point Likert scale. The I-QOL and its subcale scores are computed by adding each item response, subtracting the lowest possible score and diving that sum by the possible raw score range. The scores are then transformed to have a range from 0 (maximum problem) to 100 (no problem at all).
Baseline, 8 weeks, 12, 24, 36 months
Impact on Sexual Function Assessed by the Pelvic Organ/Urinary Incontinence Sexual Questionnaire (PISQ 12)
大体时间：Baseline, 8 weeks, 12, 24, 36 months
The Pelvic organ/urinary incontinence sexual questionnaire (PISQ-12) is a validated and reliable short form questionnaire including 12 questions that evaluates sexual function in heterosexual women with urinary incontinence and/or pelvic organ prolapse. Reponses are graded on a 5-point Likert scale from "never" to "always". The scores were calculated at each assessment visit.
Baseline, 8 weeks, 12, 24, 36 months
Patient Global Impression of Improvement (PGI-I)
大体时间：8 weeks, 24, 36 months
PGI-I is a validated question that collects the patients' impression of improvement after the surgery. Among this 7 point-scale ("very much better", "much better", "a little better", "no change", "a little worse", "much worse" and "very much worse"), the patients are asked to check the one number that describes how their urinay tract condition is now, compared with how it's was before the surgery. The percentage of patients who describes "very much better" or "much better" or "little better" was measured.
8 weeks, 24, 36 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Coloplast A/S

调查人员

  • 首席研究员：Grégoire Capon, MD、CHU Pellegrin, Bordeaux, France

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2015年5月23日

初级完成 (实际的)

2021年9月22日

研究完成 (实际的)

2022年6月24日

研究注册日期

首次提交

2015年7月23日

首先提交符合 QC 标准的

2019年10月3日

首次发布 (实际的)

2019年10月4日

研究记录更新

最后更新发布 (实际的)

2026年5月26日

上次提交的符合 QC 标准的更新

2026年5月22日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • SU017

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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