RECRUITING

Desara ® One Single Incision Sling 522 Study

Conditions

Stress Urinary Incontinence female stress urinary incontinence single incision sling transobturator sling Desara® One Desara® Blue

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-11-01

Study Completion:2026-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04772131

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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).	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.

Inclusion Criteria

Exclusion 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).

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.

Contacts and Locations

Study Contact

Vicki Gail

CONTACT

818-483-7602

vgail@calderamedical.com

Study Locations (Sites)

Valley Urogynecology Associates, Inc.

Phoenix, Arizona, 85016

United States

University of Arizona College of Medicine

Tucson, Arizona, 85724

United States

Urological Research Center Corp

Hialeah, Florida, 33016

United States

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

Idaho Falls, Idaho, 83404

United States

CMB Research, LLC

Newburgh, Indiana, 47630

United States

University of Louisville

Louisville, Kentucky, 40202

United States

Mt. Auburn Hospital Division of Urogynecology

Cambridge, Massachusetts, 02138

United States

Specialty Clinical Research of St. Louis, LLC

Saint Louis, Missouri, 631471

United States

Women's Cancer Center of Nevada

Las Vegas, Nevada, 89169

United States

University of New Mexico

Albuquerque, New Mexico, 87131

United States

Novant Health Urogynecology

Charlotte, North Carolina, 28210

United States

The Lindner Research Center at The Christ Hospital

Cincinnati, Ohio, 45219

United States

Center for Total Women's Health

Lansdale, Pennsylvania, 19446

United States

Center for Pelvic Health

Franklin, Tennessee, 37067

United States

University of Washington Medical Center

Seattle, Washington, 98195

United States

Collaborators and Investigators

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 Registration Dates

Study Start Date2021-11-01

Study Completion Date2026-11

Study Record Updates

Study Start Date2021-11-01

Study Completion Date2026-11

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Stress Urinary Incontinence