Trial record 6 of 125 for:    Open Studies | "Urinary Incontinence"

The European Study of Altis Single Incision Sling System for Female Stress Urinary Incontinence (EASY)

This study is currently recruiting participants.
Verified January 2014 by Coloplast A/S
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S
ClinicalTrials.gov Identifier:
NCT02049840
First received: January 28, 2014
Last updated: NA
Last verified: January 2014
History: No changes posted
  Purpose

This is a prospective, post-market, single arm, multicenter study comparing Baseline data to the 12 month and 36 month data in 136 female patients with Stress Urinary Incontinence


Condition Intervention
Stress Urinary Incontinence
Device: Altis Single Incision Sling System

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The European Study of Altis Single Incision Sling System for Female Stress Urinary Incontinence

Resource links provided by NLM:


Further study details as provided by Coloplast A/S:

Primary Outcome Measures:
  • Proportion of subjects who meet the criteria of cure at 12 months [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Cure is defined as negative Cough Stress Test (CST) and an answer "no" to question 3 "Do you usually experience urine leakage related to coughing, sneezing, or laughing?" of the UDI-6 questionnaire


Secondary Outcome Measures:
  • Proportion of subjects who have a negative cough stress test at each visit [ Time Frame: 6 weeks, 6 months, 1 year, 2 year, 3 year ] [ Designated as safety issue: No ]
  • Proportion of subjects who meet the criteria of cure at each other visit [ Time Frame: 6 weeks, 6 months, 2 year, 3 year ] [ Designated as safety issue: No ]
  • Subject continence status measured by the 24-hour pad weight [ Time Frame: 6 weeks, 1 year ] [ Designated as safety issue: No ]
  • Assessment of self reported symptoms and subject QoL through the scoring of validated questionnaires: ICIQ-UI SF, I-QOL, UDI-6 and IIQ-7 [ Time Frame: 6 weeks, 6 months, 1 year, 2 year, 3 year ] [ Designated as safety issue: No ]
  • Postoperatively subject impression of improvement (via PGI-I questionnaire) and satisfaction at each post-operative visit [ Time Frame: 6 weeks, 6 months, 1 year, 2 year, 3 year ] [ Designated as safety issue: No ]
  • Assessment of Qmax variations [ Time Frame: 6 weeks, 1year ] [ Designated as safety issue: No ]
  • Assessment of PVR variations [ Time Frame: 6 weeks, 1 year ] [ Designated as safety issue: No ]
  • Assessment of the operation duration and the type of anaesthesia used [ Time Frame: Operative period ] [ Designated as safety issue: No ]
  • Assessment of device and procedure related adverse events [ Time Frame: Operative period, 6 weeks, 6 months, 1 year, 2 year, 3 year ] [ Designated as safety issue: Yes ]
  • Assessment of postoperative pain [ Time Frame: operative period, 6 weeks, 6 months, 1 year ] [ Designated as safety issue: Yes ]
    Visual Analogue Scale from 0 "no pain" to 10 "extreme pain"


Estimated Enrollment: 136
Study Start Date: December 2013
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Altis Single Incision Sling System
Altis Single Incision Sling System
Device: Altis Single Incision Sling System
Altis Single Incision Sling (SIS) System is a permanently implantable synthetic sling for the surgical treatment of Stress Urinary Incontinence

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The subject is female at least 18 years of age
  • The subject uses a method of contraception considered effective by the investigator or is not of child-bearing potential
  • The subject is able and willing to complete all procedures and follow-up visits indicated in this protocol.
  • The subject has confirmed stress urinary incontinence (SUI) through cough stress test at baseline.
  • The subject has failed first line treatments (non-invasive therapies, eg. behavioral modification, Pelvic Floor/Kegel exercises, or biofeedback) with good compliance for the treatment

Exclusion Criteria:

  • The subject had a prior surgical SUI treatment (including bulking agent).
  • The subject is having a concomitant Pelvic Organ Prolapse repair or hysterectomy during Altis procedure.
  • The subject has incontinence due to neurogenic causes (e.g. multiple sclerosis, spinal cord/brain injury, cerebrovascular accident, detrusor-external sphincter dyssynergia, Parkinson's disease, or similar conditions).
  • The subject has predominant or uncontrolled or primary urge incontinence according to investigator judgment
  • The patient has detrusor overactivity determined through urodynamics
  • The subject has intrinsic sphincter deficiency defined urodynamically as a Maximal Urethral Closure Pressure < 20 cm H2O and/or Valsalva Leak Point Pressure < 60 cm H2O
  • The subject has atonic bladder, a persistent post void residual (PVR) > 100 ml or chronic urinary retention.
  • The subject has untreated urinary malignancy
  • The subject has undergone radiation or brachy therapy or chemotherapy to treat pelvic cancer.
  • The subject has urethrovaginal fistula or urethral diverticulum or congenital urinary anomalies
  • The subject has serious bleeding disorder or requires anticoagulant therapy
  • The subject is pregnant and/or is planning to get pregnant in the future.
  • The subject has a Body Mass Index ≥ 35 (obese class II).
  • The subject has a contraindication to the surgical procedure according to the the Altis SIS System IFU.
  • The subject has an active urogenital infection or active skin infection in region of surgery mainly at the time of implantation.
  • The subject is enrolled in a concomitant clinical trial.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02049840

Contacts
Contact: Hugo Ryckebusch, MD +33 (0)1 40 83 68 52 frhr@coloplast.com

Locations
France
Hôpital de la Conception Not yet recruiting
Marseille, France, 13005
Contact: Gilles Karsenty         
Principal Investigator: Gilles Karsenty, MD         
Centre Hospitalier Universitaire Carémeau Not yet recruiting
Nîmes, France, 30029
Contact: Brigitte Fatton, MD         
Principal Investigator: Brigitte Fatton, MD         
Centre Hospitalier Universitaire de Rouen - Hôpital Charles Nicolle Recruiting
Rouen, France, 76031
Contact: Philippe Grise, MD         
Principal Investigator: Philippe Grise, MD         
Germany
Chirurgische Klinik München - Bogenhausen GmbH Active, not recruiting
München, Germany, 81679
Italy
Ospedale Garibaldi-Nesima Not yet recruiting
Catania, Italy, 95122
Contact: Giuseppe Ettore, MD         
Principal Investigator: Giuseppe Ettore, MD         
Netherlands
Isala Klinieken Locatie Sophia Recruiting
Zwolle, Netherlands, 8025
Contact: Hugo van Eijndhoven, MD         
Principal Investigator: Hugo van Eijndhoven, MD         
Spain
Hospital Universitario La Ribera Active, not recruiting
Alzira - Valencia, Spain, 46600
Hospital Germans Trias i Pujol Not yet recruiting
Badalona - Barcelona, Spain, 08916
Contact: Jose Luis Gago         
Principal Investigator: Jose Luis Gago, MD         
Fundacion Jimenez Diaz Recruiting
Madrid, Spain, 28040
Contact: Carmen Gonzalez Enguita         
Principal Investigator: Carmen Gonzalez Enguita, MD         
Sponsors and Collaborators
Coloplast A/S
  More Information

No publications provided

Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT02049840     History of Changes
Other Study ID Numbers: SU016
Study First Received: January 28, 2014
Last Updated: January 28, 2014
Health Authority: France: ANSM - Agence Nationale de Sécurité du Médicament et des produits de santé (Saint-Denis)

Keywords provided by Coloplast A/S:
Female sling
Stress Urinary Incontinence
Urination Disorders
Urologic Diseases

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014