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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 5, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 26, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 19, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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