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One Year Outcome Using the Ajust System for Treatment of Urinary Stress Incontinence

1 mai 2014 mis à jour par: Martin Rudnicki, Zealand University Hospital

During the last decade numerous new procedures have been presented regarding surgical treatment of urinary stress incontinence (1,2). Development of the midurethral tape procedure (TVT) changed the surgical procedure dramatically both regarding the extent of the surgical procedure and also decreased the morbidity remarkably. The success rate of the TVT procedure has been proven to be high (1,2 ). However, the development of the TOT/TVT-O procedures disclosed a new fixation point and further decreased the risk of bladder injury (1,2). Since the introduction of trans-obturator slings several mini-slings have been introduced in order to reduce the need of perforation of the skin and muscles (3,4,5). Although some systems seem promising (5) others have disclosed a long learning curve, pain problems following the procedure and lower success rates, compared to the traditional sling procedures. None of these mini-slings have been adjustable.

Recently the Ajust system for treatment of stress urinary incontinence was introduced. The system is a single incision sling procedure and consists of an adjustable Polypropylene mesh sling with self fixation anchors (6). In a feasibility study (6), the 6 months objective cure rate was 82%, but there is a lack of information regarding adverse events and durability of treatment success. Our preliminary experiences suggest, that the procedure has a rapid learning curve, low pain scores postoperatively and a 94% cure rate at 3 months follow-up (personal observation). Recently, several abstracts have indicated that the cure rate obtained by Ajust is comparable to TVT or TVT-O (10-12).

The purpose of the present study is (primary outcome):

To test the hypothesis that the Ajust and TVT, TVT-O and TOT, respectively are equal regarding subjective cure rate (cure is defined as subjectively not incontinent at all), i.e. the study is designed as a non-inferiority study. The study is performed as a randomised controlled trial without blinding. The study is powered to detect a 9% difference between the two groups. The subjective cure rate is based on ICIQ measurement

Secondary outcome:

  • To test the hypothesis that Ajust is associated with a significantly lower postoperative pain perception.
  • To test the hypothesis that antibiotic treatment is not necessary

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

Primary endpoint: A cured patients is defined as no subjective symptoms (ICIQ-UI SF and ICIQ-OAB) and no objective detectable urinary leakage during coughing (300cc in the bladder and no leakage during coughing)

Secondary outcome: Pain-perception is evaluated by VAS scoring daily during the first postoperative week, including assessing the need for painkilling medication

The endpoint regarding the use of antibiotics is based on the number of urinary tract infections and infections related to the vaginal closure during the first postoperative months. All patients will evaluated postoperative by physical examination and by urinary dipstick

Type d'étude

Interventionnel

Inscription (Anticipé)

500

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Danemark
      • Roskilde, Danemark, 4000
        • martin Rudnicki

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 60 ans (Adulte)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Femelle

La description

Inclusion Criteria:

- 1. A medical history of stress urinary incontinence, i.e. leakage during coughing, sneezing or leakage during physical exertion. OR 2. A medical history of mixed urinary stress incontinence defined as complaint of involuntary leakage associated with urgency and stress incontinence. Stress incontinence has to the dominating symptom defined as more episodes of leakage due to coughing or physical exertion than with urgency.

3. A provocative stress test up to ten coughs at a standardized bladder volume (300 ml) confirming urinary leakage from the urethra while the patient is asked to cough or perform a Valsalva manoeuvre standing or lying (7). Furthermore, the patient has to present hypermobility of the urethra/bladder neck defined as significant downward rotation when coughing or during Valsalva.?

Exclusion Criteria:

  1. Previous anti-incontinence surgery.
  2. Residual urine volume >100 ml
  3. Bladder capacity <200ml according to diary.
  4. Planned or current pregnancy
  5. Repeated urinary tract infections (>4 cystitis last year )
  6. Current anticoagulation therapy that can´t be interrupted in due time prior to surgery
  7. Known abnormal coagulation
  8. Allergy to local anaesthetics
  9. Co-existing pelvic pathology, such as ovarian mass etc
  10. Vaginal POPQ anterior prolapse grade >=2
  11. A medical history of predominantly urge urinary incontinence.
  12. Patients unable to understand the protocol and a follow up
  13. Patients younger than 18 and above or equal to 60 years.
  14. Known or suspected neurological condition
  15. Patients who have not paused acethylsalicylic acid (ASA) medication 7 days prior to surgery

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Ajust sling
The sling a a new device for stress urinary incontinence. The sling is ajustable and is not penetrating the skin, i.e. is only attached to the obturator membrane
Procédure: Ajust system
The use of Ajust system for stress incontinence
Procédure: TVT/TVT-O
sling surgery
Expérimental: TVT/TVT-O, polypropylne slings
TVT/TVT-O system. These two systems is wellknown and used for treatment of stress urinary incontinence. The sling penetrate the skin in order to secure adjustment.
Procédure: Ajust system
The use of Ajust system for stress incontinence
Procédure: TVT/TVT-O
sling surgery

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
A change in number of cured patients
Délai: Up to 1 year

Primary endpoint: A change in number of cured patients. The number of patients cured is anticipated to be equal in each group.

A cured patients is defined as having no subjective symptoms (i.e. no scores on the ICIQ-UI SF and ICIQ-OAB) and no objective detectable urinary leakage during coughing (300cc in the bladder and no leakage during coughing.
Up to 1 year

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Pain-perception following surgery
Délai: Evaluated the first week following surgery, and at three and 12 months follow-up

Secondary outcome: Pain-perception is evaluated by VAS scoring daily during the first postoperative week, including assessing the need for painkilling medication

The endpoint regarding the use of antibiotics is based on the number of urinary tract infections and infections related to the vaginal closure during the first postoperative months. All patients will evaluated postoperative by physical examination and by urinary dipstick
Evaluated the first week following surgery, and at three and 12 months follow-up

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
number of urinary tract infections and infections related to the vaginal closure during the first postoperative months.
Délai: Evaluated during the first week of follow-up and at 3 months follow-up
The endpoint regarding the use of antibiotics is based on the number of urinary tract infections and infections related to the vaginal closure during the first postoperative months. All patients will evaluated postoperative by physical examination and by urinary dipstick
Evaluated during the first week of follow-up and at 3 months follow-up

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Zealand University Hospital

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 mai 2012

Achèvement primaire (Réel)

1 avril 2014

Achèvement de l'étude (Réel)

1 avril 2014

Dates d'inscription aux études

Première soumission

28 décembre 2011

Première soumission répondant aux critères de contrôle qualité

20 décembre 2012

Première publication (Estimation)

21 décembre 2012

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

2 mai 2014

Dernière mise à jour soumise répondant aux critères de contrôle qualité

1 mai 2014

Dernière vérification

1 mai 2014

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • SJ-252

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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