Desara ® One Single Incision Sling 522 Study

NCT04772131 | Recruiting DMC FDA Device

• 1 other identifier: PS200005
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 15

Brief Summary

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.

Conditions

Stress Urinary Incontinence

Keywords

stress urinary incontinence; female stress urinary incontinence; single incision sling; transobturator sling; Desara® One; Desara® Blue

Outcome Measures

Primary Outcomes (2)

• 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

  36 months

• 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

  36 months

Secondary Outcomes (7)

• Composite outcome success rates

  6 weeks, 6, 12, 18, 24, 36 months

• Sexual Function Assessment

  6 weeks, 6, 12, 18, 24, 36 months

• Improvement in Incontinence

  6 weeks, 6, 12, 18, 24, 36 months

• Improvement in Urinary Symptoms

  6 weeks, 6, 12, 18, 24, 36 months

• Improvement in Urge and Stress Incontinence

  6 weeks, 6, 12, 18, 24, 36 months

Study Arms (2)

Desara® One

EXPERIMENTAL

Single Incision Sling

Device: Desara® One Single Incision Sling

Desara® Blue

ACTIVE COMPARATOR

Transobturator Sling

Device: Desara® Blue Transobturator Sling

Interventions

Desara® One Single Incision Sling DEVICE

Single incision sling

Desara® One

Desara® Blue Transobturator Sling DEVICE

Standard mid-urethral sling

Desara® Blue

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Subject has confirmed stress incontinence greater than urge incontinence per MESA questionnaire.
• 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:
• A hysterectomy or
• Tubal ligation or
• Is otherwise incapable of pregnancy or has
• Negative pregnancy test prior to study entry and has decided to cease childbearing
• Subject has been offered and either failed or refused alternative non-invasive SUI treatment options and has elected to proceed with a surgical intervention.
• 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).

You may not qualify if:

• 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.
• Subject has a history of chronic opioid, or narcotic use for:
• pain or
• any other specified reason
• 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.
• Subject is on chronic (\> 3 months) systemic steroid treatment (except for inhalational use as indicated for pulmonary conditions).
• Subject has uncontrolled diabetes defined as A1c ≥ 7% or fasting serum glucose \> 130mg/dl at screening/baseline.
• Subject has an active lesion or skin infection of the perineum, urethra, or vagina as noted per visual pelvic exam.
• Subject has active UTI which requires treatment, as determined by the Investigator.
• Subject has pattern of recurrent UTIs, defined as ≥ 3 culture-proven UTIs during the 6-month period prior to surgery.
• Subject has a urethral obstruction or other anatomic defects of the urethra (inclusive of urethral diverticulum or stricture or bladder neck contracture).
• The subject has had:
• any prior surgical stress urinary incontinence treatment or

Sponsors & Collaborators

• Caldera Medical, Inc.: lead

Study Sites (15)

Valley Urogynecology Associates, Inc.

Phoenix, Arizona, 85016, United States

RECRUITING

University of Arizona College of Medicine

Tucson, Arizona, 85724, United States

NOT YET RECRUITING

Urological Research Center Corp

Hialeah, Florida, 33016, United States

RECRUITING

Women's Health Care Associates P.A. dba Rosemark Women Care Specialists

Idaho Falls, Idaho, 83404, United States

RECRUITING

CMB Research, LLC

Newburgh, Indiana, 47630, United States

RECRUITING

University of Louisville

Louisville, Kentucky, 40202, United States

RECRUITING

Mt. Auburn Hospital Division of Urogynecology

Cambridge, Massachusetts, 02138, United States

RECRUITING

Specialty Clinical Research of St. Louis, LLC

St Louis, Missouri, 631471, United States

RECRUITING

Women's Cancer Center of Nevada

Las Vegas, Nevada, 89169, United States

RECRUITING

University of New Mexico

Albuquerque, New Mexico, 87131, United States

RECRUITING

Novant Health Urogynecology

Charlotte, North Carolina, 28210, United States

RECRUITING

The Lindner Research Center at The Christ Hospital

Cincinnati, Ohio, 45219, United States

RECRUITING

Center for Total Women's Health

Lansdale, Pennsylvania, 19446, United States

RECRUITING

Center for Pelvic Health

Franklin, Tennessee, 37067, United States

RECRUITING

University of Washington Medical Center

Seattle, Washington, 98195, United States

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Vicki Gail

CONTACT

818-483-7602; vgail@calderamedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Adult female subjects, who in the opinion of their physician require surgical treatment or who have already been diagnosed with stress urinary incontinence, will be eligible for study participation. Subjects who provide informed consent will undergo screening and baseline assessments. Subjects who successfully meet the study's inclusion and exclusion criteria will be eligible to undergo a Desara SIS or Desara Blue implant procedure, with subsequent follow-up assessments. The choice of implant, Desara One or Desara Blue, will be determined by the investigator based upon patient pathology and surgical preference.

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: February 26, 2021
• Study Start: November 1, 2021
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (15)