Female Stress Urinary IncontinenceCEASeNCT01290796
Clinical Evaluation of Ajust™ in Stress Urinary Incontinence
A study testing Ajust Adjustable Single-Incision Sling in people with Female Stress Urinary Incontinence, run by C. R. Bard at 6 sites in United States.
Trial summary
The purpose of this study is to assess the overall effectiveness of the Ajust Adjustable Single-Incision Sling in the surgical treatment of female stress urinary incontinence. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Female Stress Urinary Incontinence
- What is being tested?
- Ajust Adjustable Single-Incision Sling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 6 sitesUnited States
- Study dates
- Jan 2011to Oct 2015
- Phase
- Interventional
- 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
Who may be able to join
- Female, age at least 18 years
- Have signed an Informed Consent Form
- Has been diagnosed with stress urinary incontinence as documented by: a minimum 30-degree urethral deflection, considered to be a candidate for transobturator repair by consulting surgeon (investigator), has a positive CST
- Desires surgical correction of SUI using the Ajust™ Adjustable Single-Incision Sling
Who cannot join
- Patient is actively participating in any other genitourinary clinical trial of an experimental drug or device
- Patient is known to be pregnant or desiring future childbearing
- Patient has a known urinary tract infection, or known infection in the operative field at the time of device implantation
- Patient is unable to have their anticoagulation therapy suspended for the completion of the surgical procedure
- Patient requires concurrent correction of pelvic organ prolapse
- Patient has a history of previous sling procedure
Show all 12Show fewer
- Patient has known history of detrusor overactivity demonstrated by urodynamics
- Patient has known urinary retention
- Patient has a current genitourinary fistula or urinary diverticulum
- Patient has a prior history of pelvic radiation
- Patient has a MESA urge symptom score (% of total possible urge score) that is greater than their MESA stress symptom score (% of total possible stress score)
- Any condition in the opinion of the Investigator that would preclude the use of the Ajust™ Adjustable Single-Incision Sling, or preclude the subject from completing the follow-up requirements
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Institute for Female Pelvic Medicine and Reconstructive Surgery
Allentown, Pennsylvania, 18105
Female Pelvic & Urogynecology Institute of Michigan, Grand Rapids Womens Health
Grand Rapids, Michigan, 49503
Manjon Gynecology
Harrisburg, Pennsylvania, 17110
Clark Center for Urogynecology
Newport Beach, California, 92663
Princeton Urogynecology
Princeton, New Jersey, 08540
Southern Uroynecology
West Columbia, South Carolina, 29169
About this study
Official title: Clinical Evaluation of Ajust™ in Stress Urinary Incontinence (CEASe)
The purpose of this study is to assess the overall effectiveness of the Ajust Adjustable Single-Incision Sling in the surgical treatment of female stress urinary incontinence.
Read the detailed description
Urinary incontinence (UI), or the complaint of any involuntary loss of urine, ranges in severity from the occasional leaking urine during actions resulting in increased abdominal pressure (coughing, sneezing, laughing, exercise, etc.) to sudden, unpredictable strong urges to void. Female stress urinary incontinence (SUI) is attributed to a weakening of the pelvic floor muscles.
A recent review of literature describing the prevalence of UI calculated the median prevalence of female UI to be 27.6% (4.8-58.4%), with the prevalence of significant incontinence increasing with age. The prevalent cause of UI was further categorized into stress (50%), mixed (32%) and urge (14%).
Nonsurgical treatment of female SUI has traditionally been limited to alpha-adrenergic agonists and estrogens, pelvic floor exercises, biofeedback, electrical stimulation and behavior modification1. Options for surgical treatment consists of periurethral injections of bulking agents, transvaginal suspensions, retropubic suspensions, slings and sphincter prostheses.
The Ajust™ Adjustable Single-Incision Sling is a fully adjustable single-incision sling that anchors in the transobturator membranes, anatomically sufficient spaces for support of the urethra.
- Conditions
- Female Stress Urinary Incontinence
- Being tested
- Ajust Adjustable Single-Incision Sling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ajust Adjustable Single-Incision SlingDevice
The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment.
| Study group | Role | What they receive |
|---|---|---|
| Ajust Adjustable Single-Incision Sling | Other | Urinary incontinence sling Receives: Device: Ajust Adjustable Single-Incision Sling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients Free of Stress Urinary Incontinence
Percentage of patients who are free of stress urinary incontinence, as assessed by a negative (-) Cough Stress Test (CST) and no surgical retreatment, at the 12 month study visit.
Measured: 12-months post surgical procedure
Percentage of Subjects Who Showed Improvement in Self-reported SUI Symptoms at 12 Months
Improvement was defined as a 25-point decrease (improvement) in Urinary Distress Inventory (UDI-6) score (Range: 0 - 100).
Measured: 12-months post procedure
Secondary outcomes (9)
Operative, Perioperative and Long-Term Complications During Operative Procedure
Percentage of Patients with Procedure and/or Device Related Adverse Events During the Operative Procedure
Measured: 1 day
Operative, Perioperative and Long-Term Complications Perioperatively
Percentage of Patients with Procedure and/or Device Related Adverse Events Perioperatively
Measured: 1-15 days
Operative, Perioperative and Long-term Complications Through 36 Months
Percentage of Patients with Procedure and/or Device Related Adverse Events through 36 months
Measured: Day 15 through 36-months post procedure
Change in Post-operative Pain
Mean change in Overall McCarthy Surgical Pain Scale from Day 0 to Day 7. McCarthy Pain Scale is a 50 millimeter line with "No Pain Sensation" noted at the 0 mm mark and "Most Intense Pain Imaginable" noted at the 50 mm mark. Each day, subjects are asked to mark their level of pain somewhere along the line. Change in pain level is reported in millimeters.
Measured: 0-7 days
Percentage of Subjects Who Showed Improvement in Self-reported SUI Symptoms at 36 Months
Improvement was defined as a 25-point decrease (improvement) in Urinary Distress Inventory (UDI-6) score (Range: 0 - 100).
Measured: 0-36 Months
Change in Incontinent Impact Questionnaire at 12 Months
Mean change in overall IIQ-7 summary score (range 0 - 100). Scores on the IIQ-7 range from 0 (best outcome) to 100 (worst outcome). For this outcome measure, IIQ-7 at baseline was compared to that administered at 12-months post-surgery.
Measured: 0-12 months
Change in Incontinent Impact Questionnaire at 36 Months
Mean change in overall IIQ-7 summary score (range 0 - 100). Scores on the IIQ-7 range from 0 (best outcome) to 100 (worst outcome). For this outcome measure, IIQ-7 at baseline was compared to that administered at 36-months post-surgery.
Measured: 0-36 months
Percentage of Patients With Impression of Improvement With Procedure at 12 Months
Patient satisfaction was assessed using the Patient Global Impression of Improvement (PGII) questionnaire. Patients were considered to be "satisfied" if they felt that their urinary tract condition was "very much better" or "much better" than how it felt before the surgery.
Measured: 0-12 Months
Percentage of Patients With Impression of Improvement With Procedure at 36 Months
Patient satisfaction was assessed using the Patient Global Impression of Improvement (PGII) questionnaire. Patients were considered to be "satisfied" if they felt that their urinary tract conditio0n was "very much better" or "much better" than how it felt before the surgery.
Measured: 0-36 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionJun 2013
- Study completionOct 2015
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.
- Other trials for Female Stress Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by C. R. BardThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- C. R. Bard
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vincent Lucente, MD, Principal investigator, Institute for Female Pelvic Medicine and Reconstructive Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01290796
- Sponsor's protocol ID
- BMD-2112
- Acronym
- CEASe
- Status last verified
- Feb 2017
- First submitted
- 4 Feb 2011
- Last updated
- 27 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Ajust™ in Stress Urinary Incontinence (CEASe)
- ClinicalTrials.gov ID
- NCT01290796
- Acronym / sponsor ID
- CEASe / BMD-2112
- Conditions
- Female Stress Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- C. R. BardIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 7 Feb 2011 (estimated)
- Results
- Posted 12 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the overall effectiveness of the Ajust Adjustable Single-Incision Sling in the surgical treatment of female stress urinary incontinence.
Detailed description
Urinary incontinence (UI), or the complaint of any involuntary loss of urine, ranges in severity from the occasional leaking urine during actions resulting in increased abdominal pressure (coughing, sneezing, laughing, exercise, etc.) to sudden, unpredictable strong urges to void. Female stress urinary incontinence (SUI) is attributed to a weakening of the pelvic floor muscles.
A recent review of literature describing the prevalence of UI calculated the median prevalence of female UI to be 27.6% (4.8-58.4%), with the prevalence of significant incontinence increasing with age. The prevalent cause of UI was further categorized into stress (50%), mixed (32%) and urge (14%).
Nonsurgical treatment of female SUI has traditionally been limited to alpha-adrenergic agonists and estrogens, pelvic floor exercises, biofeedback, electrical stimulation and behavior modification1. Options for surgical treatment consists of periurethral injections of bulking agents, transvaginal suspensions, retropubic suspensions, slings and sphincter prostheses.
The Ajust™ Adjustable Single-Incision Sling is a fully adjustable single-incision sling that anchors in the transobturator membranes, anatomically sufficient spaces for support of the urethra.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ajust Adjustable Single-Incision Sling | Other | Device: Ajust Adjustable Single-Incision SlingUrinary incontinence sling |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female, age at least 18 years
- Have signed an Informed Consent Form
- Has been diagnosed with stress urinary incontinence as documented by: a minimum 30-degree urethral deflection, considered to be a candidate for transobturator repair by consulting surgeon (investigator), has a positive CST
- Desires surgical correction of SUI using the Ajust™ Adjustable Single-Incision Sling
Key exclusion criteria (12 listed)
- Patient is actively participating in any other genitourinary clinical trial of an experimental drug or device
- Patient is known to be pregnant or desiring future childbearing
- Patient has a known urinary tract infection, or known infection in the operative field at the time of device implantation
- Patient is unable to have their anticoagulation therapy suspended for the completion of the surgical procedure
- Patient requires concurrent correction of pelvic organ prolapse
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 |
|---|---|---|
| Ajust Adjustable Single-Incision SlingThe Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment. | Device | Ajust Adjustable Single-Incision Sling |
Primary outcome
Percentage of Patients Free of Stress Urinary Incontinence
Time frame: 12-months post surgical procedure
Percentage of patients who are free of stress urinary incontinence, as assessed by a negative (-) Cough Stress Test (CST) and no surgical retreatment, at the 12 month study visit.
Percentage of Subjects Who Showed Improvement in Self-reported SUI Symptoms at 12 Months
Time frame: 12-months post procedure
Improvement was defined as a 25-point decrease (improvement) in Urinary Distress Inventory (UDI-6) score (Range: 0 - 100).
9 secondary outcomes
Operative, Perioperative and Long-Term Complications During Operative Procedure
Time frame: 1 day
Operative, Perioperative and Long-Term Complications Perioperatively
Time frame: 1-15 days
Operative, Perioperative and Long-term Complications Through 36 Months
Time frame: Day 15 through 36-months post procedure
Change in Post-operative Pain
Time frame: 0-7 days
Percentage of Subjects Who Showed Improvement in Self-reported SUI Symptoms at 36 Months
Time frame: 0-36 Months
Change in Incontinent Impact Questionnaire at 12 Months
Time frame: 0-12 months
Change in Incontinent Impact Questionnaire at 36 Months
Time frame: 0-36 months
Percentage of Patients With Impression of Improvement With Procedure at 12 Months
Time frame: 0-12 Months
Percentage of Patients With Impression of Improvement With Procedure at 36 Months
Time frame: 0-36 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Vincent Lucente, MD principal investigator
Institute for Female Pelvic Medicine and Reconstructive Surgery
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ajust Adjustable Single-Incision Sling in people with Female Stress Urinary Incontinence, run by C. R. Bard at 6 sites in United States.
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 12 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 27 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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 12 May 2014). 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?
Percentage of Patients Free of Stress Urinary Incontinence (time frame: 12-months post surgical procedure). 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?
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 27 Mar 2017.