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En 3-årig naturlig kohorteundersøgelse af Altis Single Incision-slyngesystem til kvindelig stressurininkontinens

22. maj 2026 opdateret af: Coloplast A/S

En 3-årig naturalistisk kohorteundersøgelse af Altis Single Incision-slyngesystem til kvindelig stressurininkontinens En post-marketing og multicenter prospektiv observationel kohorteundersøgelse i forsøgspersoner med kvindelig stressurininkontinens

Formålet med denne undersøgelse er at overvåge brugen af ​​Altis Single Incision Sling (SIS) i en virkelig verdensbefolkning og indsamle medicinske data om effektiviteten og at overvåge sikkerheden af ​​Altis SIS 12 og 36 måneder efter implantation af enheden hos kvinder med stress-urininkontinens .

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Dette projekt er blevet lanceret efter introduktionen af ​​Altis i Europa. Denne undersøgelse er en multicenter prospektiv, observationel (dvs. naturalistisk) post-marketing klinisk opfølgning af kvinder, for hvem stressinkontinens blev diagnosticeret og vil blive behandlet med Altis Single Incision Sling System. Derfor vil disse patienter blive bedt om at tillade at bruge deres kliniske data og besvare nogle spørgeskemaer. Patienternes data vil blive indsamlet i rutinemæssig klinisk praksis før, under og efter operationen indtil 12 måneder. Derefter vil spørgeskemaer blive sendt til deltagerne årligt i 2 yderligere år.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

598

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Hun implanteret med Altis Single Incision Sling System til behandling af stressurininkontinens

Beskrivelse

Inklusionskriterier:

  • Implanteret med Altis Single Incision Sling System

Ekskluderingskriterier:

  • Nægter at blive inkluderet i undersøgelsen, eller at deres medicinske data vil blive brugt til forskningsformål
  • Indikation for implantation af Altis Single Incision Sling System er ikke til behandling af kvindelig urininkontinens.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kun etui
  • Tidsperspektiver: Fremadrettet

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Treatment Success
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Treatment Success
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Coloplast A/S

Efterforskere

  • Ledende efterforsker: Grégoire Capon, MD, CHU Pellegrin, Bordeaux, France

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

23. maj 2015

Primær færdiggørelse (Faktiske)

22. september 2021

Studieafslutning (Faktiske)

24. juni 2022

Datoer for studieregistrering

Først indsendt

23. juli 2015

Først indsendt, der opfyldte QC-kriterier

3. oktober 2019

Først opslået (Faktiske)

4. oktober 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SU017

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Urininkontinens, stress

Kliniske forsøg med Altis Single Incision Sling

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