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

NCT02049840 | Completed

• 1 other identifier: SU016
• Study Type: interventional
• Target: 153
• Locations: 5 countries
• Sites: 13

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

Conditions

Stress Urinary Incontinence

Keywords

Female sling; Stress Urinary Incontinence; Urination Disorders; Urologic Diseases

Outcome Measures

Primary Outcomes (1)

• 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

  1 year

Secondary Outcomes (10)

• Proportion of subjects who have a negative cough stress test at each visit

  6 weeks, 6 months, 1 year, 2 year, 3 year

• Proportion of subjects who meet the criteria of cure at each other visit

  6 weeks, 6 months, 2 year, 3 year

• Subject continence status measured by the 24-hour pad weight

  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

  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

  6 weeks, 6 months, 1 year, 2 year, 3 year

Study Arms (1)

Altis Single Incision Sling System

EXPERIMENTAL

Altis Single Incision Sling System

Device: Altis Single Incision Sling System

Interventions

Altis Single Incision Sling System DEVICE

Altis Single Incision Sling (SIS) System is a permanently implantable synthetic sling for the surgical treatment of Stress Urinary Incontinence

Altis Single Incision Sling System

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (13)

Hôpital Femme Mère Enfant

Bron, 69677, France

Location

Hôpital de la Conception

Marseille, 13005, France

Location

Centre Hospitalier Universitaire Carémeau - Gyneacology

Nîmes, 30029, France

Location

Centre Hospitalier Universitaire Carémeau

Nîmes, 30029, France

Location

Centre Hospitalier Universitaire de Rouen - Hôpital Charles Nicolle

Rouen, 76031, France

Location

Nouvel Hôpital Civil

Strasbourg, 67091, France

Location

Isarklinikum

München, 80331, Germany

Location

Chirurgische Klinik München - Bogenhausen GmbH

München, 81679, Germany

Location

Ospedale Garibaldi-Nesima

Catania, 95122, Italy

Location

Isala Klinieken Locatie Sophia

Zwolle, 8025, Netherlands

Location

Hospital Universitario La Ribera

Alzira, Valencia, 46600, Spain

Location

Hospital de Sagunto

Sagunto, Valencia, 46520, Spain

Location

Fundacion Jimenez Diaz

Madrid, 28040, Spain

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress; Urination Disorders; Urologic Diseases

Condition Hierarchy (Ancestors)

Urinary Incontinence; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jean-Nicolas Cornu, Pr

  Centre Hospitalier Universitaire de Rouen - Hôpital Charles Nicolle

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, post-market, single arm, mutlicenter

Study Record Dates

• First Submitted: January 28, 2014
• First Posted: January 30, 2014
• Study Start: December 16, 2013
• Primary Completion: November 4, 2019
• Study Completion: July 21, 2021
• Last Updated: September 28, 2021

Record last verified: 2021-09

Locations

FR (6); NL (1); DE (2); IT (1); ES (3)