Stress Urinary IncontinenceNCT02348112

Altis® 522 Trial - Treatment of Female Stress Urinary Incontinence

An observational study of Stress Urinary Incontinence, run by Coloplast A/S at 27 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The aim of this postmarket study is to compare the safety and effectiveness of the Altis Single Incision Sling (SIS) to an FDA cleared transobturator and/or retropubic sling through 36 months. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Stress Urinary Incontinence
What is being tested?: Altis Single Incision Sling and Transobturator or Retropubic Sling
Type of treatment: Medical device
How many people: 416 participants
Where: 27 sitesin 2 countries
Study dates: Jan 2015to Sep 2021
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Study population: Participants will be selected from urology or urogynecology specialties.

Who may be able to join

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.

Who cannot join

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.

Show all 11Show fewer

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.

Trial locations and contacts

27 sites in 2 countries.

Country

City, postcode or hospital

27 sites in 2 countries

United States26 sites

Akron Urogynecology Associates
Akron, Ohio, 44313
Albany Medical Center
Albany, New York, 12208
The Institute for Female Pelvic Medicine and Reconstructive Surgery
Allentown, Pennsylvania, 18103
Boston Urogynecology Associates
Cambridge, Massachusetts, 02138
Associated Urologists of North Carolina
Cary, North Carolina, 27511
Novant Health
Charlotte, North Carolina, 28210
Cleveland Clinic
Cleveland, Ohio, 44195
Pelvic Solutions Center
Denver, Colorado, 80218
Women's Health Advantage
Fort Wayne, Indiana, 46825
Carolina Urology Partners
Gastonia, North Carolina, 28054
Female Pelvic Medicine & Urogynecology
Grand Rapids, Michigan, 49503
FirstHealth Urogynecology
Hamlet, North Carolina, 28345
Urology Specialists, LLC
Hialeah, Florida, 33016
Rosemark Women Care Specialists
Idaho Falls, Idaho, 83404
University of Nevada
Las Vegas, Nevada, 89102
Institute of Female Pelvic Medicine & Reconstructive Surgery
North Wales, Pennsylvania, 19454
University of Oklahoma
Oklahoma City, Oklahoma, 73104
Adult and Pediatric Urology & Urogynecology
Omaha, Nebraska, 68114
Associated Urologists of North Carolina
Raleigh, North Carolina, 27612
Sanford Health
Sioux Falls, South Dakota, 57105
Baystate Health System
Springfield, Massachusetts, 01199
Stanford University
Stanford, California, 94305
The Group for Women
Virginia Beach, Virginia, 23456
Lexington Urology
West Columbia, South Carolina, 29169
Lyndhurst Clinical Research
Winston-Salem, North Carolina, 27103
Genesis Healthcare
Zanesville, Ohio, 43701

Other trials in United States

Canada1 site

CHUS Hopital Fleurimont
Sherbrooke, Quebec, J1H 5N4

Other trials in Canada

About this study

Official title: A Post-Market Evaluation of the Altis® Single Incision Sling System Versus Transobturator or Retropubic Mesh Sling in the Treatment of Female Stress Urinary Incontinence

The aim of this postmarket study is to compare the safety and effectiveness of the Altis Single Incision Sling (SIS) to an FDA cleared transobturator and/or retropubic sling through 36 months.

Read the detailed description

This study is a prospective, post-market, multi-center, cohort assessment comparing Altis SIS (n=178) and transobturator and/or retropubic slings (n=178) in the treatment of stress urinary incontinence at up to 40 U.S. and international sites. Subjects will be followed for a total of 36 months with scheduled visits at 6, 12, 18, 24 and 36 months. The study population will consist of adult female subjects with stress urinary incontinence who are clinically indicated for surgical intervention with a mesh sling.

Conditions: Stress Urinary Incontinence
Being tested: Altis Single Incision Sling, Transobturator or Retropubic Sling
Keywords: stress urinary incontinence, Altis 522, urinary incontinence
Medical subject headings: Urinary Incontinence, Stress, Urinary Incontinence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Altis Single Incision SlingDevice
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.
Transobturator or Retropubic SlingDevice
Both transobturator and retropubic slings are a hammock-like mesh placed underneath the urethra to provide support. A single incision is made in the vaginal wall and two incisions in the abdomen. Tensioning of the sling is achieved by pulling the sling through the abdominal incisions.

Study groups in NCT02348112
Study group	Role	What they receive
Altis arm		Subjects will have an Altis sling placed to treat stress urinary incontinence. Receives: Device: Altis Single Incision Sling
Comparator arm		Subjects will have a transobturator or retropubic sling placed to treat stress urinary incontinence. Receives: Device: Transobturator or Retropubic Sling

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2015Sep 2021

First posted28 Jan 2015 (estimated)
Study startJan 2015
Primary completionSep 2021
Study completionSep 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 416 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02348112
Sponsor's protocol ID: SU020
Status last verified: Nov 2023
First submitted: 16 Jan 2015
Last updated: 4 Dec 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 39423154
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.
PubMed 32320798

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight
Urinary Incontinence,Stress
Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
RecruitingPhase 1
Allogeneic Use of Expanded Mesenchymal Stem Cells Derived From Adipose Tissue (HC106), Female Urinary Incontinence Women Over 50 Years Old
Urinary Incontinence Stress
Recruiting
The Application of Somatosensory Interactive Pelvic Floor Muscle Training for Stress Urinary Incontinence in Men Underwent Radical Prostatectomy
Prostate Cancer (Post Prostatectomy)
RecruitingObservational study
Standardized 4D Transperineal Ultrasound Assessment of Urethrovesical Junction Mobility After Vaginal Laser Treatment for Stress Urinary Incontinence.
Urinary Incontinence , Stress, Laser Therapy

All Stress Urinary Incontinence trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Post-Market Evaluation of the Altis® Single Incision Sling System Versus Transobturator or Retropubic Mesh Sling in the Treatment of Female Stress Urinary Incontinence
ClinicalTrials.gov ID: NCT02348112
Acronym / sponsor ID: SU020
Conditions: Stress Urinary Incontinence
Keywords: stress urinary incontinence, Altis 522, urinary incontinence
Study type: Observational
Recruitment status: Completed
Enrolment: 416 participants (actual)
Lead sponsor: Coloplast A/SIndustry (pharma, biotech, devices)
Study start: Jan 2015 (actual)
Primary completion: Sep 2021 (actual)
Study completion: Sep 2021 (actual)
First posted: 28 Jan 2015 (estimated)
Results: Posted 21 Nov 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The aim of this postmarket study is to compare the safety and effectiveness of the Altis Single Incision Sling (SIS) to an FDA cleared transobturator and/or retropubic sling through 36 months.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Altis arm	–	Device: Altis Single Incision SlingSubjects will have an Altis sling placed to treat stress urinary incontinence.
Comparator arm	–	Device: Transobturator or Retropubic SlingSubjects will have a transobturator or retropubic sling placed to treat stress urinary incontinence.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Participants will be selected from urology or urogynecology specialties.

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (11 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Altis Single Incision SlingAltis 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.	Device	Altis arm
Transobturator or Retropubic SlingBoth transobturator and retropubic slings are a hammock-like mesh placed underneath the urethra to provide support. A single incision is made in the vaginal wall and two incisions in the abdomen. Tensioning of the sling is achieved by pulling the sling through the abdominal incisions.	Device	Comparator arm

Primary outcome

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

Results and safety

Results posted to the registry on 21 Nov 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Altis Arm	213	140
Comparator Arm	203	101

Primary outcome: Primary Effectiveness Endpoint

Time frame: 6 months. Count of participants. Unit: Participants

Measure	Altis Arm n = 167	Comparator Arm n = 143
Value	130	119

Altis Arm vs Comparator Arm: Difference in Proportions: -0.054 (95% CI -0.139 to 0.031), p = 0.013, Normal approximation test (Z-test)

Population analysed: 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.

Primary outcome: Primary Safety Endpoint

Time frame: 36 months. Count of participants. Unit: Participants

Measure	Altis Arm n = 184	Comparator Arm n = 171
Value	2	4

Altis Arm vs Comparator Arm: Difference in Proportions: 0.013 (95% CI -0.023 to 0.048), p <0.0001, Normal approximation test (Z-test)

Adverse events

Time frame: Adverse event data was collected through 36 months.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Altis Arm	24 of 184 (13%)	74 of 184 (40.2%)	0 of 184
Comparator Arm	29 of 171 (17%)	66 of 171 (38.6%)	1 of 171

Limitations and caveats (from the sponsor): The strengths of the Altis 522 Study include its large sample size, prospective, multicenter design and use of a wide variety of standardized and validated instruments to collect patient reported outcomes over a 36-month study duration. Potential limitations associated with the study include rates of enrollment, subject attrition rates, and differences in baseline characteristics.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39423154Erickson 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.
Derived from this study: PubMed 32320798Erickson 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.
Individual participant dataSharing planned: No

Related trials for Stress Urinary Incontinence

RecruitingPhase 3
A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight
Urinary Incontinence,Stress
Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
RecruitingPhase 1
Allogeneic Use of Expanded Mesenchymal Stem Cells Derived From Adipose Tissue (HC106), Female Urinary Incontinence Women Over 50 Years Old
Urinary Incontinence Stress
Recruiting
The Application of Somatosensory Interactive Pelvic Floor Muscle Training for Stress Urinary Incontinence in Men Underwent Radical Prostatectomy
Prostate Cancer (Post Prostatectomy)
RecruitingObservational study
Standardized 4D Transperineal Ultrasound Assessment of Urethrovesical Junction Mobility After Vaginal Laser Treatment for Stress Urinary Incontinence.
Urinary Incontinence , Stress, Laser Therapy

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ty Erickson, MD principal investigator

Rosemark WomenCare Specialists

27 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Stress Urinary Incontinence, run by Coloplast A/S at 27 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Effectiveness Endpoint (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02348112, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2023.