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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02049840
Recruitment Status : Completed
First Posted : January 30, 2014
Last Update Posted : September 28, 2021
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S

Brief Summary:
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 or disease Intervention/treatment Phase
Stress Urinary Incontinence Device: Altis Single Incision Sling System Not Applicable

Detailed Description:
This study is a prospective, European Post-Market, one non-controlled arm, multi-centre clinical trial conducted at up to 10 centers in Europe. It is designed to get more clinical information for users (uro-gynecologists) of the Altis Single Incision Sling System for female stress urinary incontinence treatment in terms of objective and subjective cure rate, quality of life improvement, patient satisfaction and safety, especially in long term follow-up (3 years). Clinical data will be collected at baseline, implantation procedure, post-operative at 6 weeks, 6 months, 1, 2 and 3 years

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 153 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective, post-market, single arm, mutlicenter
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The European Study of Altis Single Incision Sling System for Female Stress Urinary Incontinence
Actual Study Start Date : December 16, 2013
Actual Primary Completion Date : November 4, 2019
Actual Study Completion Date : July 21, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 :
  1. 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 ]
  2. Proportion of subjects who meet the criteria of cure at each other visit [ Time Frame: 6 weeks, 6 months, 2 year, 3 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

  3. Subject continence status measured by the 24-hour pad weight [ Time Frame: 6 weeks, 1 year ]
    The continence status will be described : Proportion of subjects who meet the criteria of dryness defined as a pad weight of less than 8 grams for the current practice Proportion of subjects who meet the criteria of improvement defined as at least a 50% reduction in pad weight from baseline

  4. 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 ]
    The scores of ICIQ-UI short form, I-QOL, UDI-6 and IIQ-7 will be describe at each visit as continuous variables. The evolution of scores from baseline will be presented

  5. 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 ]
  6. Assessment of Qmax variations [ Time Frame: 6 weeks, 1year ]
    Qmax (maximum flow rate in uroflowmetry section) raw value (at baseline, 6 weeks and 12 months) and absolute and relative variations from baseline et 6 weeks and 12 months will be described

  7. Assessment of PVR variations [ Time Frame: 6 weeks, 1 year ]
    PVR (Post void residual urine volume) raw value (at baseline, 6 weeks and 12 months) and absolute and relative variations from baseline et 6 weeks and 12 months will be described

  8. Assessment of the operation duration and the type of anaesthesia used [ Time Frame: Operative period ]
  9. Assessment of device and procedure related adverse events [ Time Frame: Operative period, 6 weeks, 6 months, 1 year, 2 year, 3 year ]
    All device or procedure related Adverse Events (AE) will be summarized and reported as the number and percentage of subjects having this AE and as the number and percentage of AE in Safety population.

  10. 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"



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02049840


Locations
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France
Hôpital Femme Mère Enfant
Bron, France, 69677
Hôpital de la Conception
Marseille, France, 13005
Centre Hospitalier Universitaire Carémeau - Gyneacology
Nîmes, France, 30029
Centre Hospitalier Universitaire Carémeau
Nîmes, France, 30029
Centre Hospitalier Universitaire de Rouen - Hôpital Charles Nicolle
Rouen, France, 76031
Nouvel Hôpital Civil
Strasbourg, France, 67091
Germany
Isarklinikum
München, Germany, 80331
Chirurgische Klinik München - Bogenhausen GmbH
München, Germany, 81679
Italy
Ospedale Garibaldi-Nesima
Catania, Italy, 95122
Netherlands
Isala Klinieken Locatie Sophia
Zwolle, Netherlands, 8025
Spain
Hospital Universitario La Ribera
Alcira, Valencia, Spain, 46600
Hospital de Sagunto
Sagunto, Valencia, Spain, 46520
Fundacion Jimenez Diaz
Madrid, Spain, 28040
Sponsors and Collaborators
Coloplast A/S
Investigators
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Principal Investigator: Jean-Nicolas Cornu, Pr Centre Hospitalier Universitaire de Rouen - Hôpital Charles Nicolle
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Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT02049840    
Other Study ID Numbers: SU016
First Posted: January 30, 2014    Key Record Dates
Last Update Posted: September 28, 2021
Last Verified: September 2021
Keywords provided by Coloplast A/S:
Female sling
Stress Urinary Incontinence
Urination Disorders
Urologic Diseases
Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Behavioral Symptoms
Elimination Disorders
Mental Disorders