N/A
Completed N=153
Clinical Evaluation of Ajust™ in Stress Urinary Incontinence
Source: ClinicalTrials.gov NCT01290796 ↗Enrolled (actual)
153
Serious AEs
1.3%
Results posted
May 2014
Primary outcomePrimary: Percentage of Patients Free of Stress Urinary Incontinence — 92.8 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients Free of Stress Urinary Incontinence |
92.8 | — |
| PRIMARY Percentage of Subjects Who Showed Improvement in Self-reported SUI Symptoms at 12 Months |
79.3 | — |
| SECONDARY Operative, Perioperative and Long-Term Complications During Operative Procedure |
11.8 | — |
| SECONDARY Operative, Perioperative and Long-Term Complications Perioperatively |
2.6 | — |
| SECONDARY Operative, Perioperative and Long-term Complications Through 36 Months |
8.5 | — |
| SECONDARY Change in Post-operative Pain |
-79.7 | — |
| SECONDARY Percentage of Subjects Who Showed Improvement in Self-reported SUI Symptoms at 36 Months |
55.3 | — |
| SECONDARY Change in Incontinent Impact Questionnaire at 12 Months |
-32.9 | — |
| SECONDARY Change in Incontinent Impact Questionnaire at 36 Months |
-29.7 | — |
| SECONDARY Percentage of Patients With Impression of Improvement With Procedure at 12 Months |
94.9 | — |
| SECONDARY Percentage of Patients With Impression of Improvement With Procedure at 36 Months |
81.3 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
- 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
Data sourced from ClinicalTrials.gov (NCT01290796). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.