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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Desara® One Single Incision Sling
DeviceSingle incision sling
Desara® Blue Transobturator Sling
DeviceStandard mid-urethral sling
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Desara® OneExperimental treatment 1 intervention
Group B: Desara® BlueActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Success rate of negative standing cough stress test (CST)
Negative standing cough stress test (CST) with bladder pre-fill to subjective fullness with 200-300 mL, or with bladder fullness confirmed via ultrasound, evaluated at the 36-month post-implant follow-up visit. The success rate is defined as the proportion of subjects with a negative CST at the 36-month post-implant follow-up
Time frame
36 months2
Device and Procedure-related serious adverse events
* Device- and/or procedure-related adverse event rates at the post-implant follow-up visits * Revision/re-surgery rates at post-implant follow-up visits * Device and/or procedure-related serious adverse events
Time frame
36 monthsSecondary outcomes
1
Composite outcome success rates
Defined by the primary effectiveness endpoint and subjective measure of Improvement in the Patient Global Impression of Improvement (PGI-I) index for incontinence post-implant
Time frame
6 weeks, 6, 12, 18, 24, 36 months2
Sexual Function Assessment
Use of PISQ-12: Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire to assess subject changes in sexual function
Time frame
6 weeks, 6, 12, 18, 24, 36 months3
Improvement in Incontinence
Use of PGI-I: Patients Global Impression of Improvement index for incontinence to assess subject improvement post-implant
Time frame
6 weeks, 6, 12, 18, 24, 36 months4
Improvement in Urinary Symptoms
Use of IIQ-7: Incontinence Impact Questionnaire, Short Form and ICIQ-UI: International Consultation on Incontinence Questionnaire-Urinary Incontinence to assess improvement in urinary symptoms post-implant
Time frame
6 weeks, 6, 12, 18, 24, 36 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov