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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 April 2015 by Coloplast A/S
Information provided by (Responsible Party):
Coloplast A/S Identifier:
First received: January 28, 2014
Last updated: April 22, 2015
Last verified: April 2015
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: 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 ]
    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 ]
  • Proportion of subjects who meet the criteria of cure at each other visit [ Time Frame: 6 weeks, 6 months, 2 year, 3 year ]
  • Subject continence status measured by the 24-hour pad weight [ Time Frame: 6 weeks, 1 year ]
  • 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 ]
  • 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 ]
  • Assessment of Qmax variations [ Time Frame: 6 weeks, 1year ]
  • Assessment of PVR variations [ Time Frame: 6 weeks, 1 year ]
  • Assessment of the operation duration and the type of anaesthesia used [ Time Frame: Operative period ]
  • Assessment of device and procedure related adverse events [ Time Frame: Operative period, 6 weeks, 6 months, 1 year, 2 year, 3 year ]
  • Assessment of postoperative pain [ Time Frame: operative period, 6 weeks, 6 months, 1 year ]
    Visual Analogue Scale from 0 "no pain" to 10 "extreme pain"

Estimated Enrollment: 136
Study Start Date: December 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2016 (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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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 identifier: NCT02049840

Contact: Hugo Ryckebusch, MD +33 (0)1 40 83 68 52

Hôpital de la Conception Recruiting
Marseille, France, 13005
Contact: Gilles Karsenty         
Principal Investigator: Gilles Karsenty, MD         
Centre Hospitalier Universitaire Carémeau Recruiting
Nîmes, France, 30029
Contact: Brigitte Fatton, MD         
Principal Investigator: Brigitte Fatton, MD         
Centre Hospitalier Universitaire Carémeau Recruiting
Nîmes, France, 30029
Contact: Laurent Wagner, MD         
Principal Investigator: Laurent Wagner, MD         
Centre Hospitalier Universitaire de Rouen - Hôpital Charles Nicolle Recruiting
Rouen, France, 76031
Contact: Philippe Grise, MD         
Principal Investigator: Philippe Grise, MD         
Nouvel Hôpital Civil Not yet recruiting
Strasbourg, France, 67091
Contact: Christian Saussine, MD         
Principal Investigator: Christian Saussine, MD         
Chirurgische Klinik München - Bogenhausen GmbH Recruiting
München, Germany, 81679
Contact: Ursula Peschers, MD         
Principal Investigator: Ursula Peschers, MD         
Ospedale Garibaldi-Nesima Recruiting
Catania, Italy, 95122
Contact: Giuseppe Ettore, MD         
Principal Investigator: Giuseppe Ettore, MD         
Isala Klinieken Locatie Sophia Recruiting
Zwolle, Netherlands, 8025
Contact: Hugo van Eijndhoven, MD         
Principal Investigator: Hugo van Eijndhoven, MD         
Hospital Universitario La Ribera Recruiting
Alzira - Valencia, Spain, 46600
Contact: Zaida Furio Bernardo, MD         
Principal Investigator: Zaida Furio Bernardo, MD         
Fundacion Jimenez Diaz Recruiting
Madrid, Spain, 28040
Contact: Carmen Gonzalez Enguita         
Principal Investigator: Carmen Gonzalez Enguita, MD         
Hospital de Sagunto Recruiting
Sagunto - Valencia, Spain, 46520
Contact: Alberto Borrell Palanca, MD         
Principal Investigator: Alberto Borrell Palanca, MD         
Sponsors and Collaborators
Coloplast A/S
  More Information

Responsible Party: Coloplast A/S Identifier: NCT02049840     History of Changes
Other Study ID Numbers: SU016
Study First Received: January 28, 2014
Last Updated: April 22, 2015

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

Additional relevant MeSH terms:
Urinary Incontinence, Stress
Urinary Incontinence
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders processed this record on May 25, 2017