Desara ® One Single Incision Sling 522 Study
ConditionStress Urinary Incontinence
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorCaldera Medical, Inc.
About this trial
A post-market study to compare the safety and effectiveness of the Desara® One Single Incision Sling (SIS), when compared to that of an FDA cleared transobturator sling over a period of 36 months.
Eligibility criteria
Qualifiers
Female ≥ 18 of age.
Subject agrees that she is willing and able to return for all study related procedures and evaluations.
Subject has provided signed informed consent.
Subject has stress urinary incontinence (SUI) confirmed by either supine or standing cough stress test (CST) with bladder pre-fill to subjective fullness with 200-300 mL, or with bladder fullness confirmed via ultrasound.
Disqualifiers
Subject reports baseline pelvic pain ≥ 2 on 10 point Numeric Rating Scale (NRS).
Subject has a known neurological disease (with or without signs/symptoms of neurogenic bladder).
Subject has known pre-existing pain syndrome and/or has been evaluated by an interventional pain management physician.
pain or
Trial design
Treatments tested in this trial
- Desara® One Single Incision Sling
- Desara® Blue Transobturator Sling
Treatment groups
300 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov