Phoenix, AZNCT04772131Now EnrollingIRB Ready

Stress Urinary Incontinence Clinical Trial in Phoenix, AZ

Access cutting-edge stress urinary incontinence treatment through this clinical trial at a research site in Phoenix. Study-provided care at no cost to qualified participants.

Sponsored by Caldera Medical, Inc.

Quick Self-Assessment

See if you qualify for this Phoenix location

Preparing your pre-screening questions…

Expert Care in Phoenix

Access stress urinary incontinence specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related stress urinary incontinence treatment provided free

Apply for This Phoenix Location

Check if you qualify for this stress urinary incontinence clinical trial in Phoenix, AZ

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Phoenix

    Convenient for AZ residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Phoenix site if eligible
  4. 4Begin participation

About This Stress Urinary Incontinence Study in Phoenix

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.

Sponsor: Caldera Medical, Inc.

Who Can Participate

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 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).

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:
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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Phoenix?

Yes, this clinical trial (NCT04772131) has an active research site in Phoenix, AZ that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Stress Urinary Incontinence Treatment Options in Phoenix, AZ

If you're searching for stress urinary incontinence treatment options in Phoenix, AZ, this clinical trial (NCT04772131) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Phoenix research site is actively enrolling participants for this clinical trial. You'll receive care from experienced stress urinary incontinence specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all stress urinary incontinence clinical trials near you to find additional studies recruiting in your area.

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Secure · Expert Care · Phoenix, AZ