BridgeMD
New treatment option for Stress Urinary Incontinence
Official title Desara ® One Single Incision Sling 522 Study
ClinicalTrials.gov ID: NCT04772131
What this study is testing
- What it's testing
- 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.
- Time commitment: about 36 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join 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...
- Subject has confirmed stress incontinence greater than urge incontinence per MESA questionnaire.
You likely can't join 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 treatment pain management physician.
- Subject has a history of chronic opioid, or narcotic use for:
- pain or
- any other specified reason
See the full eligibility 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 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...
- 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).
- 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 treatment 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
- 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 use or 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. (Prolapse reduction during PVR measurement is only allowed if a prolapse repair will be performed concomitantly with the sling implantation)
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Hialeah, Florida, United States
- Idaho Falls, Idaho, United States
- Newburgh, Indiana, United States
- Louisville, Kentucky, United States
- Cambridge, Massachusetts, United States
- St Louis, Missouri, United States
- Las Vegas, Nevada, United States
- Albuquerque, New Mexico, United States
- Charlotte, North Carolina, United States
- Cincinnati, Ohio, United States
- Lansdale, Pennsylvania, United States
- Franklin, Tennessee, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 36 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Tucson, Arizona, United States; Hialeah, Florida, United States; Idaho Falls, Idaho, United States; Newburgh, Indiana, United States; Louisville, Kentucky, United States and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.