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

Urinary Incontinence,Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03620604
• Other study ID #: ALTIS STUDY
• Status: Active, not recruiting
• Start date: January 1, 2014
• Est. completion date: December 31, 2020

Study information

• Verified date: August 2018
• Source: Instituto de Investigacion Sanitaria La Fe
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 110
• Est. completion date: December 31, 2020
• Est. primary completion date: February 27, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Enuresis
• Surgical Wound
• Urinary Incontinence
• Urinary Incontinence, Stress
• Urinary Incontinence,Stress

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Universitario y Politecnico La Fe	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Investigacion Sanitaria La Fe

Country where clinical trial is conducted

Spain, 

References & Publications (3)

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. — View Citation

Kocjancic E, Erickson T, Tu LM, Gheiler E, Van Drie D. Two-year outcomes for the Altis(®) 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mid term Efficacy/continence	Mid term Efficacy and continence measured with cough test ( Positive or negative)	Assessed at 24 months of follow up
Secondary	Voiding disfunction	Difficulty to void assessed by uroflowmetry (mL/s)	Assessed every visit at 1,6,12,24 months
Secondary	De novo urgency	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
Secondary	Safety and adverse events	Safety was assessed by physical examination to rule out vaginal extrusion (yes/no)	Assessed every visit at 1,6,12,24 months