Clinical trial NCT02049840: The European Study of Altis Single Incision Sling System for Female Stress Urinary Incontinence
Official title: The European Study of Altis Single Incision Sling System for Female Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Keywords: Female sling
Stress Urinary Incontinence
Urination Disorders
Urologic Diseases
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2014-01-30
Enrollment: 153
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, post-market, single arm, mutlicenter
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Proportion of subjects who meet the criteria of cure at 12 months
timeFrame: 1 year
Secondary outcomes:
measure: Proportion of subjects who have a negative cough stress test at each visit
timeFrame: 6 weeks, 6 months, 1 year, 2 year, 3 year
measure: Proportion of subjects who meet the criteria of cure at each other visit
timeFrame: 6 weeks, 6 months, 2 year, 3 year
measure: Subject continence status measured by the 24-hour pad weight
timeFrame: 6 weeks, 1 year
measure: Assessment of self reported symptoms and subject QoL through the scoring of validated questionnaires: ICIQ-UI SF, I-QOL, UDI-6 and IIQ-7
timeFrame: 6 weeks, 6 months, 1 year, 2 year, 3 year
measure: Postoperatively subject impression of improvement (via PGI-I questionnaire) and satisfaction at each post-operative visit
timeFrame: 6 weeks, 6 months, 1 year, 2 year, 3 year
measure: Assessment of Qmax variations
timeFrame: 6 weeks, 1year
measure: Assessment of PVR variations
timeFrame: 6 weeks, 1 year
measure: Assessment of the operation duration and the type of anaesthesia used
timeFrame: Operative period
measure: Assessment of device and procedure related adverse events
timeFrame: Operative period, 6 weeks, 6 months, 1 year, 2 year, 3 year
measure: Assessment of postoperative pain
timeFrame: operative period, 6 weeks, 6 months, 1 year
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Femme Mère Enfant
city: Marseille
country: France
facility: Hôpital de la Conception
city: Nîmes
country: France
facility: Centre Hospitalier Universitaire Carémeau - Gyneacology
city: Nîmes
country: France
facility: Centre Hospitalier Universitaire Carémeau
city: Rouen
country: France
facility: Centre Hospitalier Universitaire de Rouen - Hôpital Charles Nicolle
city: Strasbourg
country: France
facility: Nouvel Hôpital Civil
city: München
country: Germany
facility: Isarklinikum
city: München
country: Germany
facility: Chirurgische Klinik München - Bogenhausen GmbH
city: Catania
country: Italy
facility: Ospedale Garibaldi-Nesima
city: Zwolle
country: Netherlands
facility: Isala Klinieken Locatie Sophia
city: Alcira
country: Spain
facility: Hospital Universitario La Ribera
state: Valencia
city: Sagunto
country: Spain
facility: Hospital de Sagunto
state: Valencia
city: Madrid
country: Spain
facility: Fundacion Jimenez Diaz
Study officials:
affiliation: Centre Hospitalier Universitaire de Rouen - Hôpital Charles Nicolle
name: Jean-Nicolas Cornu, Pr
role: PRINCIPAL_INVESTIGATOR
References: