Back to resultsThe European Study of Altis Single Incision Sling System for Female Stress Urinary Incontinence (EASY)
Primary Purpose
Stress Urinary Incontinence
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Altis Single Incision Sling System
Sponsored by
About this trial
This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring Female sling, Stress Urinary Incontinence, Urination Disorders, Urologic Diseases
Eligibility 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.
Sites / Locations
- Hôpital Femme Mère Enfant
- Hôpital de la Conception
- Centre Hospitalier Universitaire Carémeau - Gyneacology
- Centre Hospitalier Universitaire Carémeau
- Centre Hospitalier Universitaire de Rouen - Hôpital Charles Nicolle
- Nouvel Hôpital Civil
- Isarklinikum
- Chirurgische Klinik München - Bogenhausen GmbH
- Ospedale Garibaldi-Nesima
- Isala Klinieken Locatie Sophia
- Hospital Universitario La Ribera
- Hospital de Sagunto
- Fundacion Jimenez Diaz
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Altis Single Incision Sling System
Arm Description
Altis Single Incision Sling System
Outcomes
Primary Outcome Measures
Proportion of subjects who meet the criteria of cure at 12 months
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
Proportion of subjects who meet the criteria of cure at each other visit
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
Subject continence status measured by the 24-hour pad weight
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
Assessment of self reported symptoms and subject QoL through the scoring of validated questionnaires: ICIQ-UI SF, I-QOL, UDI-6 and IIQ-7
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
Postoperatively subject impression of improvement (via PGI-I questionnaire) and satisfaction at each post-operative visit
Assessment of Qmax variations
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
Assessment of PVR variations
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
Assessment of the operation duration and the type of anaesthesia used
Assessment of device and procedure related adverse events
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.
Assessment of postoperative pain
Visual Analogue Scale from 0 "no pain" to 10 "extreme pain"
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02049840
Brief Title
The European Study of Altis Single Incision Sling System for Female Stress Urinary Incontinence
Acronym
EASY
Official Title
The European Study of Altis Single Incision Sling System for Female Stress Urinary Incontinence
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
December 16, 2013 (Actual)
Primary Completion Date
November 4, 2019 (Actual)
Study Completion Date
July 21, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coloplast A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
Keywords
Female sling, Stress Urinary Incontinence, Urination Disorders, Urologic Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective, post-market, single arm, mutlicenter
Masking
None (Open Label)
Allocation
N/A
Enrollment
153 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Altis Single Incision Sling System
Arm Type
Experimental
Arm Description
Altis Single Incision Sling System
Intervention Type
Device
Intervention Name(s)
Altis Single Incision Sling System
Intervention Description
Altis Single Incision Sling (SIS) System is a permanently implantable synthetic sling for the surgical treatment of Stress Urinary Incontinence
Primary Outcome Measure Information:
Title
Proportion of subjects who meet the criteria of cure at 12 months
Description
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
Time Frame
1 year
Secondary Outcome Measure Information:
Title
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
Title
Proportion of subjects who meet the criteria of cure at each other visit
Description
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
Time Frame
6 weeks, 6 months, 2 year, 3 year
Title
Subject continence status measured by the 24-hour pad weight
Description
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
Time Frame
6 weeks, 1 year
Title
Assessment of self reported symptoms and subject QoL through the scoring of validated questionnaires: ICIQ-UI SF, I-QOL, UDI-6 and IIQ-7
Description
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
Time Frame
6 weeks, 6 months, 1 year, 2 year, 3 year
Title
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
Title
Assessment of Qmax variations
Description
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
Time Frame
6 weeks, 1year
Title
Assessment of PVR variations
Description
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
Time Frame
6 weeks, 1 year
Title
Assessment of the operation duration and the type of anaesthesia used
Time Frame
Operative period
Title
Assessment of device and procedure related adverse events
Description
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.
Time Frame
Operative period, 6 weeks, 6 months, 1 year, 2 year, 3 year
Title
Assessment of postoperative pain
Description
Visual Analogue Scale from 0 "no pain" to 10 "extreme pain"
Time Frame
operative period, 6 weeks, 6 months, 1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Nicolas Cornu, Pr
Organizational Affiliation
Centre Hospitalier Universitaire de Rouen - Hôpital Charles Nicolle
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Femme Mère Enfant
City
Bron
ZIP/Postal Code
69677
Country
France
Facility Name
Hôpital de la Conception
City
Marseille
ZIP/Postal Code
13005
Country
France
Facility Name
Centre Hospitalier Universitaire Carémeau - Gyneacology
City
Nîmes
ZIP/Postal Code
30029
Country
France
Facility Name
Centre Hospitalier Universitaire Carémeau
City
Nîmes
ZIP/Postal Code
30029
Country
France
Facility Name
Centre Hospitalier Universitaire de Rouen - Hôpital Charles Nicolle
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
Nouvel Hôpital Civil
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Isarklinikum
City
München
ZIP/Postal Code
80331
Country
Germany
Facility Name
Chirurgische Klinik München - Bogenhausen GmbH
City
München
ZIP/Postal Code
81679
Country
Germany
Facility Name
Ospedale Garibaldi-Nesima
City
Catania
ZIP/Postal Code
95122
Country
Italy
Facility Name
Isala Klinieken Locatie Sophia
City
Zwolle
ZIP/Postal Code
8025
Country
Netherlands
Facility Name
Hospital Universitario La Ribera
City
Alcira
State/Province
Valencia
ZIP/Postal Code
46600
Country
Spain
Facility Name
Hospital de Sagunto
City
Sagunto
State/Province
Valencia
ZIP/Postal Code
46520
Country
Spain
Facility Name
Fundacion Jimenez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
The European Study of Altis Single Incision Sling System for Female Stress Urinary Incontinence
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