Desara ® One Single Incision Sling 522 Study

Sponsor

Caldera Medical, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04772131

Collaborator

(none)

300

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stress Urinary Incontinence	Device: Desara® One Single Incision Sling Device: Desara® Blue Transobturator Sling	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

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.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.

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Nov 1, 2021

Anticipated Primary Completion Date :

Nov 1, 2026

Anticipated Study Completion Date :

Nov 1, 2026

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Success rate of negative standing cough stress test (CST) [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
Device and Procedure-related serious adverse events [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

Secondary Outcome Measures

Composite outcome success rates [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
Sexual Function Assessment [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
Improvement in Incontinence [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
Improvement in Urinary Symptoms [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
Improvement in Urge and Stress Incontinence [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
Subject pain assessment [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
Time to void post-implant [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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 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 (mesh) or vaginal apical, anterior or posterior prolapse concomitant surgical repair procedures (non-mesh) before the SUI implant procedure.

Exclusion criteria:

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 defined by a positive urinalysis with ≥ +5 leukocytes and confirmed with urine culture finding of 10² CFUs (colony forming units).
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
any prior surgery on their urethra or
any prior surgery to distal anterior vaginal wall, including fistula repair or prior cystocele repair
any previous pelvic floor mesh complication
Subject has any of the following confounding conditions:
bladder stones or tumors
pathology that in the opinion of the Investigator would compromise implant placement
pathology that would limit pelvic blood supply
pathology that would require chemotherapy and systemic use of immunosuppressants
Subject has abnormal bladder capacity <300 mL.
Subject has a post void residual volume ≥ 150 mL on two different measurements.
Subject has had previous radiation therapy or brachytherapy to the pelvis.
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.
Subject has known reaction, sensitivity or allergy to polypropylene.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Valley Urogynecology Associates, Inc.	Phoenix	Arizona	United States	85016
2	University of Arizona College of Medicine	Tucson	Arizona	United States	85724
3	Urology Associates of Norwalk	Norwalk	Connecticut	United States	06850
4	Women's Health Care Associates P.A. dba Rosemark Women Care Specialists	Idaho Falls	Idaho	United States	83404
5	CMB Research, LLC	Newburgh	Indiana	United States	47630
6	University of Louisville	Louisville	Kentucky	United States	40202
7	Mt. Auburn Hospital Division of Urogynecology	Cambridge	Massachusetts	United States	02138
8	Women's Cancer Center of Nevada	Las Vegas	Nevada	United States	89169
9	Saint Mary's Regional Medical Center	Reno	Nevada	United States	89503
10	University of New Mexico	Albuquerque	New Mexico	United States	87131
11	Novant Health Urogynecology	Charlotte	North Carolina	United States	28210
12	The Lindner Research Center at The Christ Hospital	Cincinnati	Ohio	United States	45219
13	Center for Total Women's Health	Lansdale	Pennsylvania	United States	19446
14	Center for Pelvic Health	Franklin	Tennessee	United States	37067
15	University of Washington Medical Center	Seattle	Washington	United States	98195