Desara ® One Single Incision Sling 522 Study

September 15, 2025 updated by: Caldera Medical, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a prospective, non-randomized, parallel cohort, multi-center study of Desara® One single incision sling (SIS) compared to Desara® Blue sling systems implanted via the transobturator-route (TOR) for the treatment of women with stress urinary incontinence (SUI). The study will compare results from SIS patients (N=150) and TOR patients (N=150) at up to 40 sites for a total period of 36 months, with follow-up visits at 2 and 6 weeks, 6, 12, 18, 24 and 36 months. This study will enroll adult females who are clinically indicated for a mid-urethral implant for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
      • Tucson, Arizona, United States, 85724
        • Not yet recruiting
        • University of Arizona College of Medicine
        • Contact:
        • Principal Investigator:
          • llana Addis, MD
    • Florida
      • Hialeah, Florida, United States, 33016
        • Recruiting
        • Urological Research Center Corp
        • Contact:
        • Principal Investigator:
          • Edward L Gheiler, MD
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Recruiting
        • Women's Health Care Associates P.A. dba Rosemark Women Care Specialists
        • Principal Investigator:
          • Ty Erickson, MD
        • Contact:
    • Indiana
      • Newburgh, Indiana, United States, 47630
        • Recruiting
        • CMB Research, LLC
        • Contact:
        • Principal Investigator:
          • Cindy Basinski, MD
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • University Of Louisville
        • Principal Investigator:
          • Sean Francis, MD
        • Contact:
          • Gena Sayat, LPN
          • Phone Number: 502-588-4400
    • Massachusetts
      • Cambridge, Massachusetts, United States, 02138
        • Recruiting
        • Mt. Auburn Hospital Division of Urogynecology
        • Contact:
        • Principal Investigator:
          • Peter Rosenblatt, MD
    • Missouri
      • St Louis, Missouri, United States, 631471
    • Nevada
      • Las Vegas, Nevada, United States, 89169
        • Recruiting
        • Women's Cancer Center of Nevada
        • Principal Investigator:
          • Geoffrey Hsieh, MD
        • Contact:
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • Recruiting
        • University of New Mexico
        • Principal Investigator:
          • Kate Meriwether, MD
        • Contact:
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
        • Recruiting
        • Novant Health Urogynecology
        • Contact:
        • Principal Investigator:
          • William Porter, MD
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • The Lindner Research Center at The Christ Hospital
        • Principal Investigator:
          • Mickey Karram, MD
        • Contact:
    • Pennsylvania
      • Lansdale, Pennsylvania, United States, 19446
        • Recruiting
        • Center for Total Women's Health
        • Contact:
        • Principal Investigator:
          • Donald DeBrakeleer, MD
    • Tennessee
      • Franklin, Tennessee, United States, 37067
        • Recruiting
        • Center for Pelvic Health
        • Principal Investigator:
          • Barry Jarnagin, MD
        • Contact:
    • Washington
      • Seattle, Washington, United States, 98195
        • Recruiting
        • University of Washington Medical Center
        • Contact:
          • Katie Wicklander, CRCC
          • Phone Number: 206-616-8766
          • Email: kwick11@uw.edu
        • Principal Investigator:
          • Suzette Sutherland, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Desara® One
Single Incision Sling
Device: Desara® One Single Incision Sling
Single incision sling
Active Comparator: Desara® Blue
Transobturator Sling
Device: Desara® Blue Transobturator Sling
Standard mid-urethral sling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success rate of negative standing cough stress test (CST)
Time Frame: 36 months
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
36 months
Device and Procedure-related serious adverse events
Time Frame: 36 months
  • 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
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite outcome success rates
Time Frame: 6 weeks, 6, 12, 18, 24, 36 months
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
6 weeks, 6, 12, 18, 24, 36 months
Sexual Function Assessment
Time Frame: 6 weeks, 6, 12, 18, 24, 36 months
Use of PISQ-12: Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire to assess subject changes in sexual function
6 weeks, 6, 12, 18, 24, 36 months
Improvement in Incontinence
Time Frame: 6 weeks, 6, 12, 18, 24, 36 months
Use of PGI-I: Patients Global Impression of Improvement index for incontinence to assess subject improvement post-implant
6 weeks, 6, 12, 18, 24, 36 months
Improvement in Urinary Symptoms
Time Frame: 6 weeks, 6, 12, 18, 24, 36 months
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
6 weeks, 6, 12, 18, 24, 36 months
Improvement in Urge and Stress Incontinence
Time Frame: 6 weeks, 6, 12, 18, 24, 36 months
Use of UDI-6 SF: Urinary Distress Inventory, Short Form to assess subject improvement in urge and stress incontinence post-implant
6 weeks, 6, 12, 18, 24, 36 months
Subject pain assessment
Time Frame: 6 weeks, 6, 12, 18, 24, 36 months
Use of Numeric Rating 10-point scale (NRS) to assess post-operative pain. Pain scale is 0= no pain to 10 = worst pain
6 weeks, 6, 12, 18, 24, 36 months
Time to void post-implant
Time Frame: 6 weeks, 6, 12, 18, 24, 36 months
Perform a standard post void residual test to confirm that the subject's residual urine volume is ≥150 mL
6 weeks, 6, 12, 18, 24, 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Caldera Medical, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2021

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

February 5, 2021

First Submitted That Met QC Criteria

February 22, 2021

First Posted (Actual)

February 26, 2021

Study Record Updates

Last Update Posted (Estimated)

September 19, 2025

Last Update Submitted That Met QC Criteria

September 15, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PS200005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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