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Comparing two types of slings for treating stress urinary incontinence in women

Prospective, Post-market Study of the Desara® One Single Incision Sling vs. Desara® Blue Sling Implanted Via the Transobturator Route for the Treatment of Women With Stress Urinary Incontinence

Not applicable Interventional Caldera Medical, Inc. · NCT04772131

This study is testing which of two different types of slings works better for women with stress urinary incontinence.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment300 (estimated)
Ages18 Years and up
SexFemale
SponsorCaldera Medical, Inc. Industry-sponsored
Drugs / interventionschemotherapy, radiation
Locations15 sites (Phoenix, Arizona and 14 other locations)
Trial IDNCT04772131 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of the Desara® One Single Incision Sling compared to the FDA-cleared transobturator sling in women suffering from stress urinary incontinence. It is a prospective, non-randomized, parallel cohort study involving 300 participants across up to 40 sites, with follow-up assessments at multiple intervals over 36 months. The study aims to gather data on the outcomes of both sling systems to determine which is more effective for treating this condition.

Who should consider this trial

Good fit: Ideal candidates are adult females aged 18 and older with confirmed stress urinary incontinence who have either failed or refused alternative non-invasive treatments.

Not a fit: Patients who are not female, under 18, or those who have not confirmed their stress urinary incontinence may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide women with a more effective treatment option for stress urinary incontinence.

How similar studies have performed: Previous studies on mid-urethral slings have shown promising results, indicating that this approach is supported by existing evidence.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Female ≥ 18 of age.
2. Subject agrees that she is willing and able to return for all study related procedures and evaluations.
3. Subject has provided signed informed consent.
4. 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.
5. Subject has confirmed stress incontinence greater than urge incontinence per MESA questionnaire.
6. Subject no longer has childbearing capacity or has a negative pregnancy test and has decided to cease childbearing. Childbearing capacity to be confirmed by documented history of:

   1. A hysterectomy or
   2. Tubal ligation or
   3. Is otherwise incapable of pregnancy or has
   4. Negative pregnancy test prior to study entry and has decided to cease childbearing
7. Subject has been offered and either failed or refused alternative non-invasive SUI treatment options and has elected to proceed with a surgical intervention.
8. Subject is eligible to undergo laparoscopic/robotic (with or without mesh) or vaginal (with or without mesh) apical, anterior or posterior prolapse concomitant surgical repair procedures (non-mesh).

Exclusion criteria:

1. Subject reports baseline pelvic pain ≥ 2 on 10 point Numeric Rating Scale (NRS).
2. Subject has a known neurological disease (with or without signs/symptoms of neurogenic bladder).
3. Subject has known pre-existing pain syndrome and/or has been evaluated by an interventional pain management physician.
4. Subject has a history of chronic opioid, or narcotic use for:

   1. pain or
   2. any other specified reason
5. Subject is on anti-coagulation therapy that cannot be suspended or adjusted for a minimum of 24-48 hours prior to planned sling implantation surgery.
6. Subject is on chronic (\> 3 months) systemic steroid treatment (except for inhalational use as indicated for pulmonary conditions).
7. Subject has uncontrolled diabetes defined as A1c ≥ 7% or fasting serum glucose \> 130mg/dl at screening/baseline.
8. Subject has an active lesion or skin infection of the perineum, urethra, or vagina as noted per visual pelvic exam.
9. Subject has active UTI which requires treatment, as determined by the Investigator.
10. Subject has pattern of recurrent UTIs, defined as ≥ 3 culture-proven UTIs during the 6-month period prior to surgery.
11. Subject has a urethral obstruction or other anatomic defects of the urethra (inclusive of urethral diverticulum or stricture or bladder neck contracture).
12. The subject has had:

    1. any prior surgical stress urinary incontinence treatment or
    2. any prior surgery on their urethra or
    3. any prior surgery to distal anterior vaginal wall, including fistula repair or prior cystocele repair
    4. any previous pelvic floor mesh use or complication
13. Subject has any of the following confounding conditions:

    1. bladder stones or tumors
    2. pathology that in the opinion of the Investigator would compromise implant placement
    3. pathology that would limit pelvic blood supply
    4. pathology that would require chemotherapy and systemic use of immunosuppressants
14. Subject has abnormal bladder capacity \<300 mL.
15. Subject has a post void residual volume ≥ 150 mL on two different measurements. (Prolapse reduction during PVR measurement is only allowed if a prolapse repair will be performed concomitantly with the sling implantation)
16. Subject has had previous radiation therapy or brachytherapy to the pelvis.
17. Subject is enrolled in a concurrent clinical trial of any treatment (drug or device) that could affect continence function, interfere with clinical outcomes, or impact analysis of this device.
18. Subject has known reaction, sensitivity or allergy to polypropylene.

Where this trial is running

Phoenix, Arizona and 14 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Stress Urinary Incontinencestress urinary incontinencefemale stress urinary incontinencesingle incision slingtransobturator slingDesara® OneDesara® Blue
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.