Altis® 522 Trial - Treatment of Female Stress Urinary Inc... | NCT02348112

Label	Type	Description	Intervention Names
Altis arm		Subjects will have an Altis sling placed to treat stress urinary incontinence.	Device: Altis Single Incision Sling
Comparator arm		Subjects will have a transobturator or retropubic sling placed to treat stress urinary incontinence.	Device: Transobturator or Retropubic Sling

Name	Type	Description	Arm Group Labels	Other Names
Altis Single Incision Sling	Device	Altis is a minimally invasive, adjustable incontinence sling that is placed through a single incision in the vaginal wall and anchored inside the body. The sling has an integrated tensioning system eliminating the need for additional skin exits.

Measure	Description	Time Frame
Primary Effectiveness Endpoint	Observed effectiveness, defined as a reduction from baseline in 24 hour pad weight of at least 50% at 6 months.	6 months
Primary Safety Endpoint	Observed device and/or procedure-related serious adverse events through 36 months.	36 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The subject is female and at least 18 years of age.
The subject is able and willing to complete all procedures and follow-up visits indicated in this protocol.
The subject has confirmed stress urinary incontinence (SUI) through cough stress test or urodynamics.
The subject has failed two non-invasive incontinence therapies (such as Kegel exercise, behavior modification, pad use, biofeedback, etc.) for > 6 months.

Exclusion Criteria:

The subject has an active urogenital infection or active skin infection in region of surgery.
The subject has confirmed Pelvic Organ Prolapse (POP) of Stage 2 or higher as determined by POP-Q prolapse grading.
The subject is having a concomitant pelvic floor procedure.
The subject has incontinence due to neurogenic causes (e.g. multiple sclerosis, spinal cord/brain injury, cerebrovascular accident, detrusor-external sphincter dyssynergia, Parkinson's disease, or similar conditions).
The subject had a prior surgical stress urinary incontinence (SUI) treatment.
The subject has undergone radiation or brachy therapy to treat pelvic cancer.
The subject has urge predominant incontinence by MESA assessment.
The subject has an atonic bladder or post void residual (PVR) above 100 cc on ≥ 2 occasions.
The subject is pregnant and/or is planning to get pregnant in the future.
The subject has a contraindication to the surgical procedure or the product Instructions for Use (IFU).
The subject is enrolled in a concurrent clinical trial of any treatment (drug or device) that could affect continence function, without the sponsors approval.

Name	Affiliation	Role
Ty Erickson, MD	Rosemark WomenCare Specialists	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University		Stanford	California	94305	United States
Pelvic Solutions Center

PubMed Identifier	Type	Citation	Retractions
39423154	Derived	Erickson T, Gheiler E, Hanson CE, McCrery R, Parekh M, Parva M, Tu LM. Patient Satisfaction and QoL in SUI: Results With Single-Incision or Full-Length Slings. Urogynecology (Phila). 2025 Oct 1;31(10):942-951. doi: 10.1097/SPV.0000000000001586.
32320798	Derived	Erickson T, Roovers JP, Gheiler E, Parekh M, Parva M, Hanson C, McCrery R, Tu LM. A Multicenter Prospective Study Evaluating Efficacy and Safety of a Single-incision Sling Procedure for Stress Urinary Incontinence. J Minim Invasive Gynecol. 2021 Jan;28(1):93-99. doi: 10.1016/j.jmig.2020.04.014. Epub 2020 Apr 19.

ID	Title	Description
FG000	Altis Arm	Subjects will have an Altis sling placed to treat stress urinary incontinence.
FG001	Comparator Arm	Subjects will have a transobturator or retropubic sling placed to treat stress urinary incontinence.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Nov 1, 2018	Nov 30, 2022

ID	Title	Description
BG000	Altis Arm	Subjects will have an Altis sling placed to treat stress urinary incontinence.
BG001	Comparator Arm	Subjects will have a transobturator or retropubic sling placed to treat stress urinary incontinence.
BG002	Total	Total of all reporting groups

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Primary Effectiveness Endpoint

Observed effectiveness, defined as a reduction from baseline in 24 hour pad weight of at least 50% at 6 months.

All enrolled subjects (Intent-to-Treat (ITT) analysis population) who have undergone a sling implant attempt for stress urinary incontinence using either Altis SIS or an FDA cleared transobturator or retropubic sling (modified Intent-to-Treat (mITT) analysis population). The mITT analysis population is a subset of the ITT population. The mITT analysis population is the primary analysis population for the assessment of all safety and effectiveness endpoints.

Posted

Count of Participants

Participants

6 months

ID	Title	Description
OG000	Altis Arm	Subjects will have an Altis sling placed to treat stress urinary incontinence.
OG001	Comparator Arm	Subjects will have a transobturator or retropubic sling placed to treat stress urinary incontinence.

Units	Counts
Participants	OG000167 OG001143

Title

Denominators

Categories

Title	Measurements
	OG000130 OG001119

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Normal approximation test (Z-test)		0.013		Difference in Proportions	-0.054			2-Sided	95	-0.139	0.031					Non-Inferiority	The number and proportion of subjects experiencing a 50% or greater reduction in pad weight at 6 months were compared, and non-inferiority assessed using a normal approximation test (Z-test) for a difference in binomial proportion. Non-inferiority was considered achieved if the 95% confidence interval for the difference in proportions (Comparator - Altis) was less than 0.15.

Primary

Primary Safety Endpoint

Observed device and/or procedure-related serious adverse events through 36 months.

Posted

Count of Participants

Participants

36 months

ID	Title	Description
OG000	Altis Arm	Subjects will have an Altis sling placed to treat stress urinary incontinence.
OG001	Comparator Arm	Subjects will have a transobturator or retropubic sling placed to treat stress urinary incontinence.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Bleeding, hematoma or hemorrhage	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected184 at risk EG0011 events1 affected171 at risk
Delayed wound healing	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected184 at risk EG0011 events1 affected171 at risk
Mesh exposure (extrusion)	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected184 at risk EG0011 events1 affected171 at risk
Shortness of breath, chest pain, L jaw/neck pain	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected184 at risk EG0011 events1 affected171 at risk
Pelvic / urogenital pain (groin)	Reproductive system and breast disorders	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected171 at risk
Perforation, bladder	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected184 at risk EG0011 events1 affected171 at risk
Urinary retention/obstruction	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected171 at risk
Abdominal Abscess following appendectomy	Infections and infestations	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected171 at risk
Acute pancreatitis	Endocrine disorders	Systematic Assessment	EG0000 events0 affected184 at risk EG0011 events1 affected171 at risk
Acute renal failure	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected184 at risk EG0011 events1 affected171 at risk
Adenomyosis	Reproductive system and breast disorders	Systematic Assessment	EG0000 events0 affected184 at risk EG0012 events2 affected171 at risk
Appendicitis	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected184 at risk EG0011 events1 affected171 at risk
Broke left arm	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected171 at risk
Broke right arm	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected171 at risk
Broken left ankle	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected171 at risk
Broken right ankle	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected171 at risk
Cervical Spinal Stenosis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected171 at risk
Cholelithiasis	Hepatobiliary disorders	Systematic Assessment	EG0000 events0 affected184 at risk EG0011 events1 affected171 at risk
Diverticular stenosis	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected171 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected171 at risk
Elective surgery of total prosthesis right knee	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected171 at risk
Exacerbation of COPD	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected184 at risk EG0014 events1 affected171 at risk
Femur fracture	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected171 at risk
Hydrocephalus	Nervous system disorders	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected171 at risk
Intra-abdominal abscess	Infections and infestations	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected171 at risk
Left Carotid Stenosis	Vascular disorders	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected171 at risk
Left Humerus Fracture	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected171 at risk
Metastatic cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected184 at risk EG0011 events1 affected171 at risk
Morbid Obesity	General disorders	Systematic Assessment	EG0000 events0 affected184 at risk EG0011 events1 affected171 at risk
Non STEMI myocardial Infarction	Cardiac disorders	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected171 at risk
Parastomal abscess and cellulitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected184 at risk EG0011 events1 affected171 at risk
Paroxysmal Atrial Fibrillation	Cardiac disorders	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected171 at risk
Partial small bowel obstruction	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected184 at risk EG0011 events1 affected171 at risk
Patient hurt her shoulder	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected171 at risk
Perianal abscess	Infections and infestations	Systematic Assessment	EG0000 events0 affected184 at risk EG0011 events1 affected171 at risk
Pre-Cancerous Cells Removed From Left Breast	Reproductive system and breast disorders	Systematic Assessment	EG0000 events0 affected184 at risk EG0011 events1 affected171 at risk
Rectal Bleeding	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected171 at risk
Retro-sternal pain	Cardiac disorders	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected171 at risk
Right Elbow fracture	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected171 at risk
Right Shoulder Reconstructive Surgery	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected184 at risk EG0011 events1 affected171 at risk
Right bimalleolar ankle fracture, fibular fracture	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected171 at risk
Right carpal tunnel release surgery	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected184 at risk EG0011 events1 affected171 at risk
Small bowel obstruction and fistula	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected184 at risk EG0011 events1 affected171 at risk
Thoracic Degenerative Discs	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected171 at risk
Total right knee prothesis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected171 at risk
Vomiting	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected171 at risk
Worsening Right knee pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected184 at risk EG0011 events1 affected171 at risk
Abdominal tenderness	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected184 at risk EG0011 events1 affected171 at risk
Abnormal cardiac stress test	Cardiac disorders	Systematic Assessment	EG0000 events0 affected184 at risk EG0011 events1 affected171 at risk
Abnormal mammogram	Reproductive system and breast disorders	Systematic Assessment	EG0000 events0 affected184 at risk EG0011 events1 affected171 at risk
Back pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected184 at risk EG0011 events1 affected171 at risk
Bilateral knee pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected171 at risk
Deep vein thrombosis	Vascular disorders	Systematic Assessment	EG0000 events0 affected184 at risk EG0011 events1 affected171 at risk
Drug overdose	General disorders	Systematic Assessment	EG0000 events0 affected184 at risk EG0011 events1 affected171 at risk
Endometrial cancer	Reproductive system and breast disorders	Systematic Assessment	EG0000 events0 affected184 at risk EG0011 events1 affected171 at risk
Increased blood sugars	Endocrine disorders	Systematic Assessment	EG0000 events0 affected184 at risk EG0011 events1 affected171 at risk
Left femur fracture	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected184 at risk EG0011 events1 affected171 at risk
Medial meniscus tear of right knee	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected184 at risk EG0011 events1 affected171 at risk
Ocular migraine	General disorders	Systematic Assessment	EG0000 events0 affected184 at risk EG0011 events1 affected171 at risk
Pneumonia	Infections and infestations	Systematic Assessment	EG0000 events0 affected184 at risk EG0011 events1 affected171 at risk
Pulmonary thromboembolism	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected184 at risk EG0011 events1 affected171 at risk
Recurrent gluteus Medius tear	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected184 at risk EG0011 events1 affected171 at risk
Right coronary occlusion	Cardiac disorders	Systematic Assessment	EG0000 events0 affected184 at risk EG0011 events1 affected171 at risk
Right index finger and thumb injury	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected184 at risk EG0011 events1 affected171 at risk
Sepsis	Infections and infestations	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected171 at risk
Small bowel obstruction	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected184 at risk EG0011 events1 affected171 at risk
Spinal cord stimulator	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected184 at risk EG0011 events1 affected171 at risk
Total left knee prothesis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected171 at risk
Unstable angina / chest pains	Cardiac disorders	Systematic Assessment	EG0000 events0 affected184 at risk EG0011 events1 affected171 at risk
Wound necrosis	Infections and infestations	Systematic Assessment	EG0001 events1 affected184 at risk EG0010 events0 affected171 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Urinary retention/obstruction	Renal and urinary disorders	Systematic Assessment	EG00011 events11 affected184 at risk EG0013 events3 affected171 at risk
Hip pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0008 events8 affected184 at risk EG0012 events2 affected171 at risk
Pelvic / urogenital pain (groin)	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG00010 events10 affected184 at risk EG0015 events5 affected171 at risk
Nausea	Gastrointestinal disorders	Systematic Assessment	EG0005 events5 affected184 at risk EG0010 events0 affected171 at risk
Dyspareunia, de novo	Reproductive system and breast disorders	Systematic Assessment	EG00016 events16 affected184 at risk EG0015 events5 affected171 at risk
Leg pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0004 events4 affected184 at risk EG0010 events0 affected171 at risk
Hip and leg pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0003 events3 affected184 at risk EG0010 events0 affected171 at risk
Recurrent incontinence	Renal and urinary disorders	Systematic Assessment	EG0007 events7 affected184 at risk EG00112 events12 affected171 at risk
Dyspareunia, worsening	Reproductive system and breast disorders	Systematic Assessment	EG0003 events3 affected184 at risk EG0011 events1 affected171 at risk
Urgency, worsening	Renal and urinary disorders	Systematic Assessment	EG0002 events2 affected184 at risk EG00115 events14 affected171 at risk
Infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected184 at risk EG0012 events2 affected171 at risk
Urinary tract infection	Renal and urinary disorders	Systematic Assessment	EG00061 events39 affected184 at risk EG00196 events39 affected171 at risk
Urgency, de novo	Renal and urinary disorders	Systematic Assessment	EG0005 events5 affected184 at risk EG0010 events0 affected171 at risk
Vaginal discharge	Reproductive system and breast disorders	Systematic Assessment	EG0003 events3 affected184 at risk EG0011 events1 affected171 at risk

ID	Term
D014555	Urination Disorders
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases
D059411	Lower Urinary Tract Symptoms
D020924	Urological Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Altis Arm	Subjects will have an Altis sling placed to treat stress urinary incontinence.	0	184	24	184	74	184
EG001	Comparator Arm	Subjects will have a transobturator or retropubic sling placed to treat stress urinary incontinence.	1	171	29	171	66	171

ID	Term
D014550	Urinary Incontinence, Stress
D014549	Urinary Incontinence