Consistent results. Rigorous testing. Gold standard comparisons.

This compendium summarizes the clinical evidence for safety, efficacy and quality of life impact of the Altis Single Incision Sling, which is indicated for the surgical treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Altis is the most rigorously studied single incision sling on the market with numerous studies demonstrating noninferiority to standard full length midurethral slings. Altis is also the only sling with prospective, multicenter clinical trial data reviewed by the FDA to support market  clearance.

Predictability and control for female urinary incontinence

Predictability and control for female urinary incontinence

The Altis® Single Incision Sling System is a minimally invasive solution purposefully designed to provide predictability and control. This makes the surgical procedure simple and reproducible.

Matthews et al. <br>AJOG 2024

Matthews et al.
AJOG 2024

A randomized trial of retropubic versus single-incision sling amongst patients undergoing vaginal prolapse repair 

Erickson et al.<br>Urogynecology 2024

Erickson et al.
Urogynecology 2024

Patient Satisfaction and QoL in SUI: Results with Single-Incision or Full-Length Slings

Tu et al. Neurourology & Urodynamics 2023

Tu et al. Neurourology & Urodynamics 2023

Management of female stress urinary incontinence with single-incision mini-sling (Altis®): 36 month multicenter outcomes

Abdel-Fattah et al.  <br>NEJM 2022

Abdel-Fattah et al.
NEJM 2022

Single-Incision Mini-Slings for Stress Urinary Incontinence in Women

More published clinical studies

Patient Satisfaction and QoL in SUI: Results with Single-Incision or Full-Length Slings
Lead author: Erickson
Publication: Urogynecology; 2024
Coloplast sponsored? Yes

View study

A randomized trial of retropubic versus single-incision sling amongst patients undergoing vaginal prolapse repair
Lead author: Matthews
Publication: American Journal of Obstetrics and Gynecology; 2024
Coloplast sponsored? No

View study

Management of female stress urinary incontinence with single-incision mini-sling (Altis®): 36 month multicenter outcomes
Lead author: Tu
Publication: Neurourology and Urodynamics; 2023
Coloplast sponsored? Yes
View study

Single-Incision Mini-Slings for Stress Urinary Incontinence in Women
Lead author: Abdel-Fattah
Publication: New England Journal of Medicine; 2022
Coloplast sponsored? No
View study

Single-incision mini-sling and transobturator sling for stress urinary incontinence: A 5-year comparison
Lead author: Ruffolo
Publication: European Journal of Obstetrics & Gynecology and Reproductive Biology; 2022
Coloplast sponsored? No
View study

Six-year follow-up in patients with urinary stress incontinence treated with Altis® single incision sling: a prospective singlecenter study
Lead author: Viruega-Cuaresma

Publication: Obstetrics & Gynecology International Journal; 2021

Coloplast sponsored? No

View study

Evaluation of the long-term effect and complication rate of single-incision slings for female stress urinary incontinence 
Lead author: Osse


Publication: European Journal of Obstetrics & Gynecology and Reproductive Biology; 2021
Coloplast sponsored? No

View study

Long-term outcomes of Altis® single-incision sling procedure for stress urinary incontinence
Lead author: Gromicho
Publication: International Urogynecology Journal; 2021
Coloplast sponsored? No

View study

A multi-center prospective study evaluating efficacy and safety of a single-incision sling procedure for stress urinary incontinence
Lead author: Erickson
Publication: Journal of Minimally Invasive Gynecology; 2020
Coloplast sponsored? Yes
View study

Three-year follow-up in patients with urinary stress incontinence treated with Altis® single incision sling
Lead author: D’Alessandro

Publication: Minerva Obstetrics and Gynecology; 2020
Coloplast sponsored? No

View study

Mid-term safety and efficacy of the Altis® single-incision sling for female stress urinary incontinence – less mesh, same results
Lead author: Moran


Publication: BJU International; 2019
Coloplast sponsored? No

View study

Mini-sling versus transobturator sling: Efficiency and morbidity
Lead author: Grison

Publication: Gynécologie Obstétrique Fertilité & Sénologie; 2018

Coloplast sponsored? No

View study

Two-year outcomes for the Altis® adjustable single incision sling system for treatment of stress urinary incontinence
Lead author: Kocjancic
Publication: Neurourology and Urodynamics; 2016

Coloplast sponsored? Yes

View study

Short-term outcomes of Altis single-incision sling procedure for stress urinary incontinence: a prospective single-center study
Lead author: Dias

Publication: International Urogynecology Journal; 2014

Coloplast sponsored? No

View study

The safety and efficacy of a new adjustable single incision sling for treatment of female stress urinary incontinence through 12 months of follow up
Lead author: Kocjancic
Publication: Journal of Urology; 2014

Coloplast sponsored? Yes

View follow up

 

Other publications

Altis® Single Incision Sling System

 

BRIEF STATEMENT

 

Indications

The Altis Single Incision Sling System is indicated for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).

Contraindications

It is the responsibility of the physician to advise the prospective patients prior to surgery, of the contraindications associated with the use of this product.  The Altis Single Incision Sling System is contraindicated for use in patients with one or more of the following conditions:

  • Pregnancy or desire for future pregnancy
  • Potential for further growth (e.g., adolescents)
  • Known active urinary tract infection and/or infection in operative field
  • Taking anti-coagulant therapy
  • Abnormal urethra (e.g., fistula, diverticulum)
  • Any condition, including known or suspected pelvic pathology, which could compromise implant or implant placement
  • Documented hypersensitivity or allergic reaction to polypropylene or polyurethane

Warnings

It is the responsibility of the physician to advise prospective patients prior to surgery, of the warnings associated with the use of this product and the associated surgical risks.

The Altis Single Incision Sling System should only be used by physicians experienced in the surgical procedures involving transvaginal placement of non-absorbable, synthetic mesh slings.  A thorough assessment of each patient should be made to determine the suitability of a synthetic mesh sling procedure.

The patient should be counseled that alternative incontinence treatments may be appropriate prior to surgical intervention.

Obtain patient consent prior to surgery and ensure that the patient understands the postoperative risks and potential complications of transvaginal mesh sling surgery and that the Altis implant is permanent.

Serious mesh associated complications may result in one or more revision surgeries which may lead to partial or complete removal of the mesh. Complete removal of the mesh may not always be possible or advisable, and removal may not fully correct these complications. There may be unresolved pain with or without mesh explant. De novo complications and recurrence or worsening of SUI can occur.

 

Patient-Related Warnings

As with all surgical procedures, patients with certain underlying conditions may be more susceptible to postoperative bleeding, impaired blood supply, compromised/delayed healing, mesh sling exposure or other complications and adverse events.

 

The risks and benefits of using Altis should be considered in patients with:

  •   Age-related underlying conditions  
  •   Autoimmune disease  
  •   Coagulation disorder  
  •   Connective tissue disorder  
  •   Debilitated or immunocompromised state  
  •   Diabetes  
  •   Pelvic radiation therapy or chemotherapy 
  •   Physical characteristics (e.g., body mass index)
  •   Renal insufficiency 
  •   Smoking-related underlying conditions  
  •   Urinary tract anomalies  

Future pregnancy could negate the benefits of this surgical procedure.  Patients should report bleeding, pain, abnormal vaginal discharge or signs of infection at any time.

Potential Complications

Adverse events are known to occur with transvaginal synthetic sling procedures and implants and may include:

Abnormal vaginal discharge, abscess, adhesion, allergic reaction, hypersensitivity, or maladaptive immune response, bladder storage symptoms (e.g., increased daytime frequency, urgency, nocturia, overactive bladder, urinary incontinence), bleeding/hemorrhage or hematoma, delayed/impaired/abnormal wound healing, dyspareunia, exposure, extrusion, or erosion of mesh sling or suture into the vagina or other structures and organs, fistula formation, granuloma/scar tissue formation, hispareunia (male partner pain with intercourse), infection, inflammation/irritation, necrosis, neuromuscular disorder, pain, palpable mesh (patient and/or partner), pelvic/urogenital pain, perforation or injury to adjacent muscles, nerves, vessels, structures, or organs (e.g., bone, bladder, urethra, ureters, bowel, vagina), scarring, seroma, sexual dysfunction, sling migration, tensioning suture exposure, ureteral obstruction, urinary tract infection, vaginal tightening/shortening, voiding symptoms (e.g., dysuria, urinary retention, incomplete emptying, bladder outlet obstruction, straining, position-dependent voiding, slow stream) or wound dehiscence.

The information provided is not comprehensive with regard to product risks.  For a comprehensive listing of indications, contraindications, warnings, precautions, and adverse events refer to the product’s Instructions for Use.  Alternatively, you may contact a Coloplast representative at 1-800-258-3476 and/or visit the company Website at www.coloplast.com.

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

 

Minneapolis, MN

PM-03363 04/2024