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

• ClinicalTrials.gov Identifier: NCT02049840
• Recruitment Status: Completed
• First Posted: January 30, 2014
• Last Update Posted: September 28, 2021
• Sponsor: Coloplast A/S
• Information provided by (Responsible Party): Coloplast A/S

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

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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"

Eligibility Criteria

• 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.

Contacts and Locations

Locations

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

• Principal Investigator: Jean-Nicolas Cornu, Pr; Centre Hospitalier Universitaire de Rouen - Hôpital Charles Nicolle

More Information

• Responsible Party: Coloplast A/S
• ClinicalTrials.gov Identifier: NCT02049840
• Other Study ID Numbers: SU016
• First Posted: January 30, 2014
• 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:

Urinary Incontinence; Enuresis; Urinary Incontinence, Stress; Urination Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Behavioral Symptoms; Elimination Disorders; Mental Disorders