Pilot Study of the ARTUS® Artificial Urinary Sphincter on Women (SPHIN-X)
2026년 6월 8일 업데이트: Myopowers Medical Technologies France SAS
Pilot Clinical Investigation of the ARTUS® Artificial Urinary SPHincter (AUS) for the Treatment of Stress UrInary iNcontinence (SUI) in Women
The subjects will be implanted with the ARTUS® medical device and then be followed up to 2 years post-implantation, with the primary endpoints measured at 3-month post-implantation.
Safety and Clinical performance outcomes will be measured for each subject at baseline (before implantation) and post-implantation.
연구 개요
연구 유형
중재적
등록 (추정된)
6
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Jean-Christophe PERLES
- 전화번호: +33 04 42 95 12 20
- 이메일: jcperles@carvolix.eu
연구 연락처 백업
- 이름: Federica Azzimonti
- 이메일: federica.azzimonti@carvolix.eu
연구 장소
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Paris, 프랑스
- Cochin Hospital, APHP
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연락하다:
- Nicolas Barry Delonghchamps, MD, PHD
- 전화번호: +33 1 58 41 27 83
- 이메일: nicolas.barry-delongchamps@aphp.fr
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Paris, 프랑스
- Tenon Hospital, APHP
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연락하다:
- Véronique Phé, MD, PHD
- 전화번호: +33 01 56 01 70 00
- 이메일: veronique.phe@aphp.fr
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Female subject over 18 years of age at the time of consent signature
Subject with persistent severe urinary incontinence:
- at least 3 months after failed pelvic floor muscle training OR
- at least 6 months after a failed surgical treatment (e.g. slings)
- Subject with severe Stress Urinary Incontinence, defined as a mean value of 3 consecutive 24-hour Pad Weight Test > 100 grams
- Subject willing and able to provide written informed consent and having signed the informed consent
- Subject having understood and accepted to be unable to proceed to an MRI examination after the surgical procedure due to the non-MRI compatibility of the device
- Subject having a life expectancy ≥ 5 years as assessed by the investigator
Exclusion Criteria:
- Subject currently enrolled or plans to participate in another investigational study of a drug, biologic, or medical device from the point of enrolment through the 12 months post device activation period
- Subject deprived of liberty by administrative or judicial decision or under legal guardianship
- Subject who is unwilling or deemed by the investigator to be unwilling to comply with the clinical study requirements, including attending follow-up visits.
- Subject having inadequate cognitive or capabilities to use the Artus device as assessed by the investigator
- Pregnant subject, or subject willing to be pregnant during the study duration, or subject of child-bearing potential with non-stable medication contraception
- Subject with urge incontinence due to hyperactive bladder not adequately controlled by drug therapy
- Subject with overflow urinary incontinence
- Subject with Significant Neuro-urological disorders: elevated detrusor pressure, Detrusor sphincter desinergy
- Subject with history of pelvic radiotherapy
- Subject with any planned procedure requiring urethral catheterization 12 months after implant procedure (include intermittent catheterization) except for diagnostic purposes
- Subject with known allergy to any components of the device
- Subject with history of Artificial Urinary Sphincter
- Subject with severe congenital or acquired haemorrhagic disease, haemophilia, or another coagulopathy
- Subject under anti-coagulation or anti-platelet medication that cannot be discontinued at least 5 days prior to surgery and restarted at least 5 days after surgery
- Subject having a Body Mass Index (BMI) > 40
- Subject with uncontrolled diabetes, defined as HbA1c > 9.0% within the past 6 months
- Subject with history of urethral fistula
- Subject with history of bladder tumor
- Subject with severe urethral stenosis.
- Subject with currently active infection, including urinary tract infection
- Subject with severe renal failure or obstructive pathologies of the upper urinary tract with severe renal failure
- Subject with congenital or acquired immunodeficiency, including those who are immunocompromised or immunosuppressed
- Subject with post void residual volume greater than 200 mL within the past 6 months
- Subject with history of recurrent bladder stones or history of failed bladder stone treatment within the past 12 months
- Subject in emergency situation (caused by a sudden life threatening or other sudden serious medical condition including but not limited to heart attack, stroke, coma, epileptic seizure, heavy bleeding, severe pain, trouble breathing…)
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: ARTUS
The subjects will be implanted with the ARTUS Artificial Urinary Sphincter to treat Stress Urinary Incontinence
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The subjects will be implanted by the ARTUS Artificial Urinary Sphincter (AUS).
The device will be activated 6 weeks after surgery and the tightening will be adjusted by the investigators in order to reach continence.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Adverse Device Effect Incidence
기간: 3 months after implantation
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all adverse device effects (device and/or procedure related) occurring from the implantation up to the 3 months post-operative visit, with their occurrence, severity, and nature.
These events will be analyzed and classified using the Clavien-Dindo classification grading system.
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3 months after implantation
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Adverse Events Incidence
기간: Day 30, 3 months, 6 months, 12 months and 24 months after implantation
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all adverse events (including adverse device effect) occurring peri-operatively, 30 days after implantation and at 3, 6, 12 and 24-months post-operative with their occurrence, severity, and nature.
All adverse events will be analyzed and classified using the Clavien-Dindo classification grading system
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Day 30, 3 months, 6 months, 12 months and 24 months after implantation
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Revision Rate
기간: 30 days, 3 months, 6 months, 12 months and 24 months after implantation
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Proportion of subjects with a revision of the Artificial Urinary Sphincter
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30 days, 3 months, 6 months, 12 months and 24 months after implantation
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Explantation Rate
기간: Day 30, 3 months, 6 months, 12 months and 24 months after implantation
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Proportion of subjects with a definitive explantation of the Artificial Urinary Sphincter
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Day 30, 3 months, 6 months, 12 months and 24 months after implantation
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Evolution of Renal Function
기간: Baseline, Day 1
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Measure of the serum creatinine
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Baseline, Day 1
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Evolution of the pain
기간: Day 1, Day 45, 3 months, 6 months, 12 months and 24 months after implantation
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Measure of the pain using a 10-point numerical scale (from 0 no pain to 10 the maximum pain)
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Day 1, Day 45, 3 months, 6 months, 12 months and 24 months after implantation
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Evolution of uroflowmetry
기간: Baseline, 3 months after implantation
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measure of the voided urine per unit of time, the voided volume and the maximum flow rate
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Baseline, 3 months after implantation
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Bladder Drainage
기간: Baseline, Day 1, 3 months, 6 months, 12 months and 24 months after implantation
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measure of the post-void residual volume
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Baseline, Day 1, 3 months, 6 months, 12 months and 24 months after implantation
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Device Deficiency
기간: Implantation, Day 1, Day 45, 3 months, 6 months, 12 months, 24 months after implantation
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Number of device deficiencies
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Implantation, Day 1, Day 45, 3 months, 6 months, 12 months, 24 months after implantation
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Pad Weight Test
기간: Baseline, 3 months, 6 months, 12 months and 24 months after implantation
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Measure of the daily urine loss in pads during 3 consecutive days
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Baseline, 3 months, 6 months, 12 months and 24 months after implantation
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Pads Usage
기간: Baseline, Day 45, 3 months, 6 months, 12 months and 24 months after -implantation
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Number of pads used per day
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Baseline, Day 45, 3 months, 6 months, 12 months and 24 months after -implantation
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Evolution of Stress Urinary Symptoms
기간: Baseline, 3 months, 6 months, 12 months and 24 months after implantation
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Evolution of the International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF).
The score ranges from 0 (no impact) to 21 (maximal impact).
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Baseline, 3 months, 6 months, 12 months and 24 months after implantation
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Evolution of Urinary Symptoms
기간: Baseline, 3 months, 6 months, 12 months, 24 months after implantation
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Evolution of the Urinary Symptom Profile (USP).
The score ranges from 0 (no symptom) to 9 (maximal symptoms) for the subscore linked to the Stress Urinary Incontinence; from 0 (no symptom) to 21 (maximal symptoms) for the subscore linked to the overactive bladder; from 0 (no symptom) to 9 (maximal symptoms) for the subscore linked to the dysuria.
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Baseline, 3 months, 6 months, 12 months, 24 months after implantation
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Nicolas Barry Delongchamps, MD, PHD, Hôpital Cochin, APHP, Université Paris Cité, Paris, France.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 6월 30일
기본 완료 (추정된)
2027년 3월 30일
연구 완료 (추정된)
2028년 12월 31일
연구 등록 날짜
최초 제출
2026년 6월 1일
QC 기준을 충족하는 최초 제출
2026년 6월 8일
처음 게시됨 (실제)
2026년 6월 11일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 11일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 8일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- SPHIN-X
- 2025-A00257-42 (기타 식별자: ANSM)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .