Mid Term Safety and Efficacy of ALTIS® Single Incision Sling for Female Stress Urinary Incontinence (SUI).

August 7, 2018 updated by: Eduardo Moran, Instituto de Investigacion Sanitaria La Fe

Mid Term Safety and Efficacy of ALTIS® Single Incision Sling for Female SUI. Less Mesh, Same Results.

Prospective, single-arm, non-sponsored, observational single centre trial in a cohort of patients undergoing stress urinary incontinence surgery with ALTIS® procedure. All patients were diagnosed according to clinical reports, physical exploration and urodynamics. Body mass index(BMI) was categorized according to World Health Organization classification. Valsalva leak point pressure was categorized in three groups <60 cmH2O, 60-90 cmH2O and >90 cmH2O). Participants were evaluated post-operatively at 1, 6, 12 and 24 months with physical examination, ICIQ-SF, visual scale of satisfaction(SVS)(0-10). Adverse events were reported in each visit. Multivariate analysis for risk factors of surgery failure was performed.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, single -arm, non-sponsored observational single centre trial in a cohort of patients undergoing stress urinary incontinence surgery with ALTIS® procedure. Two urologists, experts in female incontinence surgery, performed all procedures. Safety and efficacy were evaluated. All participants provided written informed consent prior to enrolment.

The investigators recruited female patients aged 35 years or more with urodynamically proven stress urinary incontinence and who had failed to 6 months of non-surgical therapies including behavioural changes and drug therapy. Exclusion criteria were pelvic infection, pelvic organ prolapse ≥Stage 2, prior stress urinary incontinence surgery, neurogenic bladder incontinence, previous pelvic radiotherapy, high post-voiding volume (100 mL in two times) or being pregnant.

Demographic variables (age, number of vaginal deliveries, prior stress urinary incontinence surgery, menopause status, BMI and presence of urge incontinence) were collected. BMI was categorized according to World Health Organization in normal (18,5-24,9 Kg/m2), overweight (25-29,9 Kg/m2) and obese (≥ 30 Kg/m2) patients. For statistical purpose the investigators divided patients into two groups, non-obese (18,5-29,9) Kg/m2) and obese (≥ 30 Kg/m2) patients.

Preoperative assessment included urogynecological history, cough test (stress test with at least 300 mL of bladder volume measured by ultrasound), Spanish validated version of the International Consultation on Incontinence Questionnaire sort form (ICIQ-SF) and urodynamic test (Urodynamic parameters as Valsalva leak point pressure (VLPP), non-inhibited detrusor contractions and post-voiding volume were reflected. VLPP was categorized into three groups <60 cmH2O, 60-90 cmH2O and >90 cmH2O).

Follow up was carried out with physical examination, ICIQ-SF, visual scale of satisfaction and physical examination including cough test. Subjects were evaluated post-operatively at 1, 6, 12 and 24 months. Adverse events, such as vaginal erosion or pain related to the procedure or the device were evaluated at each visit.

The primary efficacy measures were objective cure, defined as negative cough test, and subjective cure, defined as ICIQ-SF=0.

Study Type

Observational

Enrollment (Actual)

110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valencia, Spain, 46026
        • Hospital Universitario y Politécnico La Fe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Patients were selected from our National Health System both forwarded from primary care or f from gynecology or other urologist to de Urodynamic Unit

Description

Inclusion Criteria:

  • Urodynamically proven stress urinary incontinence
  • Refractory to 6 months of non-surgical therapies including behavioural changes or drug therapy

Exclusion Criteria:

  • Pelvic infection
  • Pelvic organ prolapse ≥Stage 2
  • Prior stress urinary incontinence surgery
  • Neurogenic bladder incontinence,
  • Previous pelvic radiotherapy,
  • High post-voiding volume (100 mL in two times)
  • Pregnant women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Stress urinary incontinence surgery
This is a single observational study were all patients had stress urinary incontinence. All of them underwent surgery performing a single incision sling type ALTIS
Device: Stress urinary incontinence surgery
All patients were treated according to the Urology protocols of our unit. They were patients with stress urinary incontinence refractory to pelvic floor exercises so they underwent surgery
Other Names:
  • ALTIS device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mid term Efficacy/continence
Time Frame: Assessed at 24 months of follow up
Mid term Efficacy and continence measured with cough test ( Positive or negative)
Assessed at 24 months of follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Voiding disfunction
Time Frame: Assessed every visit at 1,6,12,24 months
Difficulty to void assessed by uroflowmetry (mL/s)
Assessed every visit at 1,6,12,24 months
De novo urgency
Time Frame: Assessed at visit 6,12,24 months
measured by International Consultation on Incontinence Questionnaire Sort Form (ICIQ-SF) ( from 0 to 21 being 0 = to continence and 21= the worse outcome of incontinence)
Assessed at visit 6,12,24 months
Safety and adverse events
Time Frame: Assessed every visit at 1,6,12,24 months
Safety was assessed by physical examination to rule out vaginal extrusion (yes/no)
Assessed every visit at 1,6,12,24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Investigacion Sanitaria La Fe

Investigators

  • Principal Investigator: Eduardo J Moran Pascual, Doctor, Hospital Universitario La Fe

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2014

Primary Completion (Actual)

February 27, 2018

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

July 28, 2018

First Submitted That Met QC Criteria

August 3, 2018

First Posted (Actual)

August 8, 2018

Study Record Updates

Last Update Posted (Actual)

August 9, 2018

Last Update Submitted That Met QC Criteria

August 7, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALTIS STUDY

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

This is a single centre study we don't think it will be useful to make these data available to other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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