Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

En 3 års naturalistisk kohortundersøkelse av Altis Single Incision Sling System for kvinnelig stressurininkontinens

22. mai 2026 oppdatert av: Coloplast A/S

En 3-årig naturlig kohortundersøkelse av Altis enkeltsnittsslyngesystem for kvinnelig stressurininkontinens En post-markedsføring og multisenter prospektiv observasjonskohortstudie i forsøkspersoner med kvinnelig stressurininkontinens

Hensikten med denne studien er å overvåke bruken av Altis Single Incision Sling (SIS) i en virkelig verdensbefolkning og samle medisinske data om effektivitet og å overvåke sikkerheten til Altis SIS 12 og 36 måneder etter implantasjon av enheten hos kvinner med anstrengelsesurininkontinens .

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Dette prosjektet har blitt lansert etter introduksjonen av Altis i Europa. Denne studien er en multisenter prospektiv, observasjonsbasert (dvs. naturalistisk) post-marketing klinisk oppfølging av kvinner som har stressinkontinens ble diagnostisert og vil bli behandlet med Altis Single Incision Sling System. Derfor vil disse pasientene bli bedt om å tillate å bruke sine kliniske data og svare på noen spørreskjemaer. Pasientens data vil bli samlet inn i rutinemessig klinisk praksis før, under og etter operasjonen inntil 12 måneder. Deretter vil spørreskjemaer bli sendt til deltakerne årlig i 2 ekstra år.

Studietype

Observasjonsmessig

Registrering (Faktiske)

598

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Kvinne implantert med Altis Single Incision Sling System for å behandle stressurininkontinens

Beskrivelse

Inklusjonskriterier:

  • Implantert med Altis Single Incision Sling System

Ekskluderingskriterier:

  • Nekter å bli inkludert i undersøkelsen eller at deres medisinske data vil bli brukt til forskningsformål
  • Indikasjon for implantasjon av Altis Single Incision Sling System er ikke for behandling av kvinnelig urininkontinens.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: Bare etui
  • Tidsperspektiver: Potensielle

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Coloplast A/S

Etterforskere

  • Hovedetterforsker: Grégoire Capon, MD, CHU Pellegrin, Bordeaux, France

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

23. mai 2015

Primær fullføring (Faktiske)

22. september 2021

Studiet fullført (Faktiske)

24. juni 2022

Datoer for studieregistrering

Først innsendt

23. juli 2015

Først innsendt som oppfylte QC-kriteriene

3. oktober 2019

Først lagt ut (Faktiske)

4. oktober 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

26. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

22. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • SU017

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere