A 3 Years Naturalistic Cohort Survey of Altis Single Incision Sling System For Female Stress Urinary Incontinence

A 3 Years Naturalistic Cohort Survey of Altis Single Incision Sling System For Female Stress Urinary Incontinence A Post-marketing and Multicenter Prospective Observational Cohort Study in Subjects With Female Stress Urinary Incontinence

The purpose of this study is to monitor the use of Altis Single Incision Sling (SIS) in a real world population and collect medical data on effectiveness and to monitor safety of Altis SIS at 12 and 36 months post device implantation in women with stress urinary incontinence.

Study Overview

• Status: Active, not recruiting
• Conditions: Urinary Incontinence, Stress
• Intervention / Treatment: Device: Altis Single Incision Sling

Detailed Description

This project has been launched after the introduction of Altis in Europe. This study is a multicenter prospective, observational (i.e. naturalistic) post-marketing clinical follow-up of women for who stress urinary incontinence was diagnosed and will be treated with Altis Single Incision Sling System. Therefore these patients will be asked to allow to use their clinical data and answer some questionnaires. The patients'data will be collected in routine clinical practice before, during and after surgery until 12 months. Then, questionnaires will be mailed to the participants annually during 2 additional years.

• Study Type: Observational
• Enrollment (Actual): 599

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • UZ Leuven
• France
  • Angers, France, 49933
    • CHRU Hôtel Dieu
  • Avignon, France, 84082
    • Clinique Rhône Durance
  • Bordeaux, France, 33076
    • CHU Pellegrin-Urology Departement
  • Bordeaux, France, 33076
    • CHU Pellegrin_Gyneacology Departement
  • Bruges, France, 33523
    • Polyclinique Jean Villars
  • Béziers, France, 34535
    • Clinique Champeau Mediterranée
  • Castres, France, 81108
    • Hôpital du Pays d'Autan
  • Chambray-lès-Tours, France, 37170
    • Pole Sante Leonard de Vinci
  • Clermont-Ferrand, France, 63003
    • CHU Clermont Ferrand
  • Dreux, France, 28102
    • Hopital Victor Jousselin
  • Issoire, France, 63503
    • CH Paul Ardier
  • La Roche sur Yon, France, 85106
    • Clinique Saint-Charles
  • La Rochelle, France, 17019
    • Centre hospitalier Saint Louis
  • La Rochelle, France, 17087
    • Clinique du Mail La Rochelle
  • Lambres lez douai, France, 59552
    • Clinique Saint-Amé
  • Libourne, France, 33500
    • Ch Libourne
  • Lorient, France, 56100
    • Clinique Mutualiste de la Porte de l'Orient
  • Massy, France, 91349
    • Hôpital privé Jacques Cartier
  • Nogent-sur-Marne, France, 94130
    • Armand Brillart Hospital
  • Poissy, France, 78303
    • Chi Poissy Saint Germain En Laye
  • Rouen, France, 76044
    • Clinique St Hilaire
  • Soyaux, France, 16800
    • Centre Clinical
  • Toulouse, France, 31082
    • Clinique Ambroise Pare
  • Toulouse, France, 31077
    • Clinique Saint Jean Languedoc
• Germany
  • Gunzenhausen, Germany, 91710
    • Frauenärzte im Seenland
  • Memmingen, Germany, 87700
    • Klinikum Memmingen
  • Worms, Germany, 67550
    • Klinikum Worms gGmbH
• Italy
  • Aosta, Italy, 11100
    • Azienda USL Valle d'Aosta
• Spain
  • Barcelona, Spain, 08035
    • Hospital Vall d'Hebron
  • Tarragona, Spain, 43005
    • Hospital Univeritario Joan XXIII
  • Valencia, Spain, 46026
    • Hospital La Fe
  • Valladolid, Spain, 47003
    • Hosital Clinico de Valladolid

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Female implanted with Altis Single Incision Sling System to treat stress urinary incontinence

Description

Inclusion Criteria:

• Implanted with Altis Single Incision Sling System

Exclusion Criteria:

• Refuses to be included in the survey or that their medical data will be used for research purposes
• Indication for Altis Single Incision Sling System implantation is not for the treatment of female urinary incontinence.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Global Impression of Improvement (PGI-I)	PGI-I is a validated question that collects the patient's impression of improvement after the surgery. Among this 7 point-scale (very much better, much better, a little better, no change, a little worse, much worse and very much worse), the patients are asked to check the one number that describes how their urinay tract condition is now, compared with how it's was before the surgery. Patients who score little or much or very much better without serious or severe related adverse events will be considered a treatment success. The percentage of patients who describe the treatment success is measured	12 months
Adverse events	Adverse events are any toward medical occurrence, unintended disease or injury or any untoward clinical signs in subjects. Adverse events will be categorized according to relatedness to device or procedure, severity and frequency. At 12-months, The percentage of patients without any device related severe or serious adverse events is measured.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cough stress test (CST)	CST provides the means for documenting stress urinary incontinence. CST is considered "positive" if any leakage is noted with cough or valsava. The percentage of patients with positive and negative test will be calculated at baseline, at the post-operative visit and at one year	Baseline, 8 weeks and 12 months
Post-void residual (PVR) volume	PVR volume will be collected pre- and post implant procedure up to 12 months. If the PVR volume is considered normal by the physician after the procedure it is not necessary to collect these data at the subsequent follow-up visits.	Baseline, 8 weeks and 12 months
Pad Use	The number of pads used will be collected. Patients will be considered to be pad free if they report never wearing pads or wear pads just for a sense of security.	Baseline, 8 weeks, 12, 24 and 36 months
International Consultation on Incontinence Questionnaire (ICIQ-UI)	The ICIQ-UI Short Form is a seft-administred questionnaire to evaluate the frequency, severity and impact on quality of life of urinary incontinence. Question 1 asked, "How often do you leak urine?" Subjects were instructed to select among "none" (0), "about once a week or less often" (1), "2 or 3 times a week" (2), "about once a day" (3), "several times a day" (4), and "all the time" (5). Question 2 asked, "How much urine do you usually leak (whether you wear protection or not)?" Patients responded with "none" (0), "a small amount" (2), "a moderate amount" (4) or "a large amount (6). Question 3 asked, "Overall, how much does leaking urine interfere with your everyday life?" Participants chose a number from 0 (not at all) to 10 (a great deal). Question 1, 2 and 3 are summed to compute the total ICIQ score.The total score range is then a minimum of 0 to a maximum of 21. The mean score, aboslute and relative change compared to baseline will be measure	Baseline, 8 weeks, 12, 24 and 36 months
Subject global satisfaction questionnaire	This non-validated questionnaire provides additional information concerning patient satisfaction. This survey consists of two questions: Question 1 "how satisfied are you with your surgery?". Among 5 point-scale (very satisfied, satisfied, not satisfied-not dissatisfied, dissatisfied and very dissatified), patient check the one items that best describes the subject satisfaction. We measure the percentage the patients who very satisfied and satisfied. The patients answer the question "Do you recommend this operation to a friend?" by "yes" or "no". We measure the percentage of patients who answer "yes".	8 weeks, 12, 24, 36 months
Incontinence quality of life questionnaire (I-QoL)	The Incontinence quality of life questionnaire (I-QoL) is a validated survey questionnaire with 22 items that are scored on a 5-point Likert scale. The I-QOL ans its subcale scores are computed by adding each item's reponse, subtracting the lowest possible score and diving that sum by the possible raw score range. The scores are then transformed to have a range from 0 (maximum problem) to 100 (no problem at all). The mean score, absolute and relative change compared to baseline	Baseline, 8 weeks, 12, 24, 36 months
Impact on sexual function assessed by the Pelvic organ/urinary incontinence sexual questionnaire (PISQ 12)	The Pelvic organ/urinary incontinence sexual questionnaire (PISQ-12) is a validated and reliable short form questionnaire including 12 questions that evaluates sexual function in heterosexual women with urinary incontinence and/or pelvic oragn prolapse. Reponses are graded on a 5-point Likert scale from "never" to "always". The scores will be calculated at each assessment visit. The mean score, absolute and relative change compared to baseline	Baseline, 8 weeks, 12, 24, 36 months
Patient Global Impression of Improvement (PGI-I)	PGI-I is a validated question that collects the patient's impression of improvement after the surgery. Among this 7 point-scale (very much better, much better, a little better, no change, a little worse, much worse and very much worse), the patients are asked to check the one number that describes how their urinay tract condition is now, compared with how it's was before the surgery. The percentage of patients who describe very much better or much better or little better is measured	8 weeks, 24, 36 months
Adverse events	Adverse events are any toward medical occurrence, unintended disease or injury or any untoward clinical signs in subjects. Adverse events will be categorized according to relatedness to device or procedure, severity and frequency. The percentage of patients without any device related severe or serious adverse events is measured.	8 weeks, 24, 36 months

Collaborators and Investigators

• Sponsor: Coloplast A/S
• Investigators: Principal Investigator: Grégoire Capon, MD, CHU Pellegrin, Bordeaux, France

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2015
• Primary Completion (Actual): September 22, 2021
• Study Completion (Anticipated): September 22, 2023

Study Registration Dates

• First Submitted: July 23, 2015
• First Submitted That Met QC Criteria: October 3, 2019
• First Posted (Actual): October 4, 2019

Study Record Updates

• Last Update Posted (Actual): March 28, 2022
• Last Update Submitted That Met QC Criteria: March 11, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Single Incision Sling
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: SU017