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ALTIS®
522 POST-MARKET
SURVEILLANCE STUDY

 

THE FIRST AND ONLY 522 STUDY TO INCLUDE A SINGLE INCISION SLING AND FULL-LENGTH RETROPUBIC AND TRANSOBTURATOR SLINGS.

The investigators believe that by allowing all FDA-cleared retropubic and transobturator slings and including a heterogenous patient population with a variety of characteristics, the Altis 522 study helps to reflect real clinical practice and optimizes the usability of the Altis 522 12-month study results in the counseling of future patients worldwide.

At 12-Months, the Altis® Single Incision Sling is Comparable to Full-Length Retropubic and Transobturator Slings

Open access of the 12-month results are available for immediate review in the Journal of Minimally Invasive Gynecology in April 2020

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Download the 12-Month Report

To optimally reflect real clinical practice, a nonrandomized study was performed, and the selection of the surgical intervention was based on surgeon expertise and shared decision-making between the patient and physician.

The Altis® 522 study is a prospective, post-market, multi-center, comparative cohort study performed in adult female patients with SUI who are clinically indicated for mid-urethral sling surgery.

Consistent Results

At 12-months, 24-hour pad weight success (≥50% reduction), negative CST, PGI-I, UDI-6, and IIQ-7 were similar between Altis and full-length retropubic and transobturator slings.

Altis product design (i.e. elastic properties similar to the pubourethral ligament and intraoperative adjustability post-deployment) and surgical reproducibility attributed to high objective and subjective cure rates at 12-months, comparable to full-length retropubic and transobturator slings.

The Altis 522 study was designed to have a full range of objective and subjective outcome measurements, included full-length retropubic and transobturator slings in the comparator arm, and did not exclude ISD patients.

The same rigorous and robust protocol and testing methods utilized in Altis IDE study were included in the Altis 522 study.

All commercially available full-length retropubic and transobturator slings were allowed in the comparator group.

By allowing a heterogenous group of full-length retropubic and transobturator slings in the comparator arm, and enrolling patients with a variety of characteristics, the Altis 522 study is more reflective of real world clinical practices.

The aim of the Altis 522 study is to compare the safety and effectiveness of the Altis Single Incision Sling to full-length retropubic and transobturator slings through 36-months.

Subsequent reports will follow at 24- and 36-months.

Primary Effectiveness Objective

 

*Results compared to baseline collected at 12-months

The primary efficacy objective was to demonstrate that the reduction from baseline in 24-hour pad weight associated with Altis SIS is noninferior to the rate associated with the use of transobturator and/or retropubic slings at 6 months.

At 12-months, Altis is comparable to full-length retropubic and transobturator slings.

Secondary Effectiveness Objective

Secondary efficacy measures included objective dryness (defined as pad weight ≤4.0 g) and negative CST with comparative assessments between groups at 6, 12, 18, 24, and 36 months.

At 12-months, Altis is comparable to full-length retropubic and transobturator slings.

Subjective Outcomes

Subjective outcome measures collected included patient global impression of improvement (PGI-I), urogenital distress inventory (UDI-6), Incontinence Impact Questionnaire − Short Form (IIQ-7), Surgical Satisfaction Questionnaire (SSQ-8), and visual analog scale for pain (VAS).

At 12-months, Altis is comparable to full-length retropubic and transobturator slings.

Safety and Efficacy Outcome Measures

References

 

ClinicalTrials.gov Identifier: NCT02348112

Altis® 522 Trial – Treatment of Female Stress Urinary Incontinence

 

Erickson, T., Roovers, J. P., Gheiler, E., Parekh, M., Parva, M., Hanson, C., McCrery, R., & Tu, L. M. (2020). A Multicenter Prospective Study Evaluating Efficacy and Safety of a Single-incision Sling Procedure for Stress Urinary Incontinence. Journal of Minimally Invasive Gynecology. S1553-4650(20): 30189-8.

Open-access of the manuscript is available here: https://www.jmig.org/article/S1553-4650(20)30189-8/fulltext

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 or their representatives, 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 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)
•  Intraoperative urethral injury
•  Any condition, including known or suspected pelvic pathology, which could compromise implant or implant placement
• Sensitivity/allergy to polypropylene

Warnings and Precautions: It is the responsibility of the physician to advise the prospective patients or their representatives, prior to surgery, of the warnings and precautions associated with the use of this product and the associated surgical risks.

Warnings: The Altis Single Incision Sling System should only be used by physicians familiar with the surgical procedures and techniques involving transvaginal placement of non-absorbable, synthetic mesh slings and who have adequate education and experience in the treatment of female SUI.

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, and the reason for choosing a mesh sling procedure should be explained.

Obtain patient consent prior to surgery and ensure that the patient has an understanding of the postoperative risks and potential complications of transvaginal mesh sling surgery.

Patient counseling should include a discussion that the sling to be implanted is a permanent implant and that some complications associated with the implanted mesh sling may require additional surgery; repeat surgery may not resolve these complications. Serious adverse tissue responses or infection may require removal of mesh, and complete removal of the sling may not always be possible. Individuals may have varying degrees of collagen laydown that may result in scarring.

As with all surgical procedures, patients with certain underlying conditions may be more susceptible to postoperative bleeding, impaired blood supply, compromised/delayed healing, or other complications and adverse events. The risks and benefits of using Altis should be considered in patients. Any future pregnancy could negate the benefits of this surgical procedure. Patients should report any bleeding, pain, abnormal vaginal discharge or sign of infection that occur at any time. Do not use product that has damaged or opened packaging, or has expired, as sterility may be compromised. The procedure to insert the Altis sling requires good knowledge of pelvic anatomy and the correct use of the introducer needles in order to avoid damage to adjacent anatomical structures. Cystoscopy should be performed to confirm bladder and urethral integrity. Avoid placing excessive tension on the Altis sling during placement and adjustment to maintain sling integrity and to avoid compression of the urethra when tensioning.

Precautions: The Altis Sling and Altis introducers are provided sterile (ethylene oxide sterilization) and are for single-use only. Use caution to prevent intraoperative injury to adjacent pelvic structures. Do not let the Altis sling come into contact with sharp objects (e.g., staples, clips, or clamps) which could cause damage to the mesh, suture and anchors.

Potential Complications: Potential complications include mesh extrusion, pelvic/urogenital pain, groin pain, hip pain (maybe related to patient positioning), urinary retention, bleeding, de novo urgency, delayed wound healing, dyspareunia, hip/groin pain, inflammation, nausea, overactive bladder, pain, pelvic hematoma, reaction to antibiotic, slight discomfort upon return to work, urinary tract infection, urine stream decreased, and voiding dysfunction.

Adverse events are known to occur with transvaginal synthetic sling procedures and implants. Adverse events following mesh implantation may be de novo, persistent, worsening, transient, or permanent. Additional potential complications include, but are not limited to, abscess (acute or delayed), adhesion/scar formation, allergy, hypersensitivity or other immune reaction, bleeding, hemorrhage or hematoma, dehiscence, delayed wound healing, extrusion, erosion or exposure of mesh sling into the vagina or other structures or organs, fistula formation, infection, inflammation (acute or chronic), local irritation, necrosis, de novo and/or worsening dyspareunia, neuromuscular symptoms (acute or chronic), partner pain and/or discomfort during intercourse, perforation or injury of soft tissue (e.g., muscles, nerves, vessels), structures, or organs (e.g., bone, bladder, urethra, ureters, vagina), seroma, sling migration, suture erosion, bladder storage dysfunction (e.g., increased daytime frequency, urgency, nocturia, overactive bladder, urinary incontinence), ureteral obstruction, voiding symptoms (e.g., dysuria, urinary retention, incomplete emptying, straining, positional voiding, weak stream), granulation tissue formation, palpable mesh (patient and/or partner), sexual dysfunction, vaginal discharge (abnormal) and vaginal scarring or tightening. The occurrence of these events may require one or more revision surgeries, including removal of the sling. Complete removal of the sling may not always be possible, and additional surgeries may not always fully correct the complications. There may be unresolved pain with or without mesh sling explantation.

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.us.

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