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

NCT03620604 | Unknown FDA Device

• 1 other identifier: ALTIS STUDY
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Urinary Incontinence,Stress

Keywords

single incision sling; safety; efficacy

Outcome Measures

Primary Outcomes (1)

• Mid term Efficacy/continence

  Mid term Efficacy and continence measured with cough test ( Positive or negative)

  Assessed at 24 months of follow up

Secondary Outcomes (3)

• Voiding disfunction

  Assessed every visit at 1,6,12,24 months

• De novo urgency

  Assessed at visit 6,12,24 months

• Safety and adverse events

  Assessed every visit at 1,6,12,24 months

Study Arms (1)

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

Interventions

Stress urinary incontinence surgery DEVICE

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

Also known as: ALTIS device

Stress urinary incontinence surgery

Eligibility Criteria

• Age: 35 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto de Investigacion Sanitaria La Fe: lead

Study Sites (1)

Hospital Universitario y Politecnico La Fe

Valencia, 46026, Spain

Location

Related Publications (3)

• Kocjancic E, Erickson T, Tu LM, Gheiler E, Van Drie D. Two-year outcomes for the Altis(R) adjustable single incision sling system for treatment of stress urinary incontinence. Neurourol Urodyn. 2017 Aug;36(6):1582-1587. doi: 10.1002/nau.23156. Epub 2016 Oct 29.

  PMID: 27794177 BACKGROUND

• Van Drie DM. The Impact of Procedure Setting on Two-Year Outcomes for the Altis Single Incision Sling for Women With Stress Urinary Incontinence. J Minim Invasive Gynecol. 2015 Nov-Dec;22(6S):S243-S244. doi: 10.1016/j.jmig.2015.08.853. Epub 2015 Oct 15. No abstract available.

  PMID: 27679164 BACKGROUND

• Dias J, Xambre L, Costa L, Costa P, Ferraz L. Short-term outcomes of Altis single-incision sling procedure for stress urinary incontinence: a prospective single-center study. Int Urogynecol J. 2014 Aug;25(8):1089-95. doi: 10.1007/s00192-014-2355-4. Epub 2014 Mar 6.

  PMID: 24599178 BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; 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

• Eduardo J Moran Pascual, Doctor

  Hospital Universitario La Fe

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urologist

Study Record Dates

• First Submitted: July 28, 2018
• First Posted: August 8, 2018
• Study Start: January 1, 2014
• Primary Completion: February 27, 2018
• Study Completion: December 31, 2020
• Last Updated: August 9, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)