Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

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

1 maggio 2014 aggiornato da: 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

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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

Tipo di studio

Interventistico

Iscrizione (Anticipato)

500

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Danimarca
      • Roskilde, Danimarca, 4000
        • martin Rudnicki

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 60 anni (Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Femmina

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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
Procedura: Ajust system
The use of Ajust system for stress incontinence
Procedura: TVT/TVT-O
sling surgery
Sperimentale: 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.
Procedura: Ajust system
The use of Ajust system for stress incontinence
Procedura: TVT/TVT-O
sling surgery

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
A change in number of cured patients
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Pain-perception following surgery
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
number of urinary tract infections and infections related to the vaginal closure during the first postoperative months.
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Zealand University Hospital

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 maggio 2012

Completamento primario (Effettivo)

1 aprile 2014

Completamento dello studio (Effettivo)

1 aprile 2014

Date di iscrizione allo studio

Primo inviato

28 dicembre 2011

Primo inviato che soddisfa i criteri di controllo qualità

20 dicembre 2012

Primo Inserito (Stima)

21 dicembre 2012

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

2 maggio 2014

Ultimo aggiornamento inviato che soddisfa i criteri QC

1 maggio 2014

Ultimo verificato

1 maggio 2014

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • SJ-252

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Incontinenza urinaria da sforzo

Prove cliniche su Ajust system

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Oman

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

Sottoscrivi