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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 30, 2014