Winston Salem, NCNCT05396456Now EnrollingIRB Ready

Fecal Incontinence Clinical Trial in Winston Salem, NC

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

Sponsored by Wake Forest University Health Sciences

Quick Self-Assessment

See if you qualify for this Winston Salem location

Preparing your pre-screening questions…

Expert Care in Winston Salem

Access fecal incontinence specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related fecal incontinence treatment provided free

Apply for This Winston Salem Location

Check if you qualify for this fecal incontinence clinical trial in Winston Salem, NC

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

Why Participate?

  • No-Cost Study Care

  • Local to Winston Salem

    Convenient for NC 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 Winston Salem site if eligible
  4. 4Begin participation

About This Fecal Incontinence Study in Winston Salem

To regenerate functional anal sphincter muscle using muscle fiber fragments that contain muscle precursor cells (MPCs)

Sponsor: Wake Forest University Health Sciences

Who Can Participate

Inclusion Criteria

18 years of age
participants must experience 4 or more Fecal Incontinence (FI) episodes per 2 week period
participants must score \>10 on Cleveland Clinic Fecal Incontinence Severity Scoring System (CCIS)
participants must have had symptoms for at least 12 months
participants who have failed standard medical and surgical treatments for FI
participant will undergo anorectal manometry (ARM) testing
participants will undergo endoscopic anal ultrasound and demonstrate an anatomic defect of the anal sphincter complex of at least 30 degrees
women of childbearing potential must use acceptable contraceptives during this study

Exclusion Criteria

participants with symptomatic anorectal disease including symptomatic hemorrhoid disease, anal fissure or fistula causing symptoms such as bleeding, swelling, pain, or drainage
participants with pre-existing ano-rectal pain of any cause
participants with incontinence of flatus only
chronic watery diarrhea which is the primary cause for fecal incontinence
acute or chronic anorectal infections (including proctitis, recurrent abscesses, fistulae)
presence of anorectal tumors
active proctitis or inflammatory bowel disease
previous injection of internal anal sphincter (IAS) with bulking agents
participants requiring immunosuppression or who have any malignant disease within 3 years of enrollment
participants with a defined bleeding disorder diagnosed and treated by a hematologist
other exclusions include history of pelvic radiation, rectal prolapse, anorectal malformations, anorectal surgery within the previous 12 months, or treatments using injection or infrared coagulation for treatment of hemorrhoids
participants with neurologic disease characterized by significant peripheral neuropathy or spinal cord dysfunction
women who are pregnant, breastfeeding, or have had a child within the last year
participants with a history of unstable cardiac function (New York Heart Association Functional Classification III or IV) or unstable pulmonary function requiring home oxygen, or abnormal kidney function (Cr \>1.5 mg/dl or on dialysis) or uncontrolled diabetes (Hemoglobin A1C \> 8 mg/dl)
participants with anemia (hemoglobin \<10g, increased alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \>2 times normal) or increased bilirubin \>1.5mg/dl
participants with Hepatitis B or C, or human immunodeficiency virus (HIV)-1 or 2
rectal prolapse
vaginal prolapse beyond the hymen
unable to understand informed consent information even with provision of a medical translator

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 Winston Salem?

Yes, this clinical trial (NCT05396456) has an active research site in Winston Salem, NC 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.

Fecal Incontinence Treatment Options in Winston Salem, NC

If you're searching for fecal incontinence treatment options in Winston Salem, NC, this clinical trial (NCT05396456) 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 Winston Salem research site is actively enrolling participants for this clinical trial. You'll receive care from experienced fecal 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.

Ready to Join in Winston Salem?

Take the first step toward participating in this groundbreaking clinical trial

Secure · Expert Care · Winston Salem, NC