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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

153 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-16

Study Completion Date

2021-07-21

Brief Summary

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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

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Detailed Description

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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

Conditions

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Stress Urinary Incontinence

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective, post-market, single arm, mutlicenter

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Altis Single Incision Sling System

Group Type EXPERIMENTAL

Altis Single Incision Sling System

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No