Clinical trial NCT03620604: Mid Term Safety and Efficacy of ALTIS® Single Incision Sling for Female Stress Urinary Incontinence (SUI).
Official title: Mid Term Safety and Efficacy of ALTIS® Single Incision Sling for Female SUI. Less Mesh, Same Results.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Urinary Incontinence,Stress
Keywords: single incision sling
safety
efficacy
Lead sponsor: Instituto de Investigacion Sanitaria La Fe
Sponsor class: OTHER
First posted: 2018-08-08
Enrollment: 110
Sex: FEMALE
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mid term Efficacy/continence
timeFrame: Assessed at 24 months of follow up
Secondary outcomes:
measure: Voiding disfunction
timeFrame: Assessed every visit at 1,6,12,24 months
measure: De novo urgency
timeFrame: Assessed at visit 6,12,24 months
measure: Safety and adverse events
timeFrame: Assessed every visit at 1,6,12,24 months
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Hospital Universitario y Politecnico La Fe
Study officials:
affiliation: Hospital Universitario La Fe
name: Eduardo J Moran Pascual, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.