Clinical trial NCT04772131: Desara ® One Single Incision Sling 522 Study
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stress Urinary Incontinence
Keywords: stress urinary incontinence
female stress urinary incontinence
single incision sling
transobturator sling
Desara® One
Desara® Blue
Lead sponsor: Caldera Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2021-02-26
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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).

Eligibility 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.

Primary outcomes:
measure: Success rate of negative standing cough stress test (CST)
timeFrame: 36 months
measure: Device and Procedure-related serious adverse events
timeFrame: 36 months
Secondary outcomes:
measure: Composite outcome success rates
timeFrame: 6 weeks, 6, 12, 18, 24, 36 months
measure: Sexual Function Assessment
timeFrame: 6 weeks, 6, 12, 18, 24, 36 months
measure: Improvement in Incontinence
timeFrame: 6 weeks, 6, 12, 18, 24, 36 months
measure: Improvement in Urinary Symptoms
timeFrame: 6 weeks, 6, 12, 18, 24, 36 months
measure: Improvement in Urge and Stress Incontinence
timeFrame: 6 weeks, 6, 12, 18, 24, 36 months
measure: Subject pain assessment
timeFrame: 6 weeks, 6, 12, 18, 24, 36 months
measure: Time to void post-implant
timeFrame: 6 weeks, 6, 12, 18, 24, 36 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Valley Urogynecology Associates, Inc.
state: Arizona
city: Tucson
country: United States
facility: University of Arizona College of Medicine
state: Arizona
city: Hialeah
country: United States
facility: Urological Research Center Corp
state: Florida
city: Idaho Falls
country: United States
facility: Women's Health Care Associates P.A. dba Rosemark Women Care Specialists
state: Idaho
city: Newburgh
country: United States
facility: CMB Research, LLC
state: Indiana
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Cambridge
country: United States
facility: Mt. Auburn Hospital Division of Urogynecology
state: Massachusetts
city: Saint Louis
country: United States
facility: Specialty Clinical Research of St. Louis, LLC
state: Missouri
city: Las Vegas
country: United States
facility: Women's Cancer Center of Nevada
state: Nevada
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: Charlotte
country: United States
facility: Novant Health Urogynecology
state: North Carolina
city: Cincinnati
country: United States
facility: The Lindner Research Center at The Christ Hospital
state: Ohio
city: Lansdale
country: United States
facility: Center for Total Women's Health
state: Pennsylvania
city: Franklin
country: United States
facility: Center for Pelvic Health
state: Tennessee
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
Study officials:
References: