Augusta, GANCT05771597Now EnrollingIRB Ready

Fecal Incontinence Clinical Trial in Augusta, GA

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

Sponsored by Augusta University

Quick Self-Assessment

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Preparing your pre-screening questions…

Expert Care in Augusta

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 Augusta Location

Check if you qualify for this fecal incontinence clinical trial in Augusta, GA

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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 Augusta

    Convenient for GA 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 Augusta site if eligible
  4. 4Begin participation

About This Fecal Incontinence Study in Augusta

Biofeedback therapy is an effective treatment for the management of patients with dyssynergic defecation and constipation, urinary incontinence (UI), and fecal incontinence (FI). It is labor-intensive, costly, requires multiple office or hospital visits, is not easily available to the vast majority of patients in the community, and is not covered by many insurance companies. The purpose of this study is to 1. Evaluate home biofeedback therapy for patients with either constipation and dyssynergic defecation or urinary leakage or stool leakage by assessing the efficacy and safety of a wireless anorectal biofeedback device, and a cellphone app-based and voice guided home biofeedback training system 2. To compare the efficacy and safety of home biofeedback therapy system with the standard of care, office biofeedback therapy 3. To assess the cost-effectiveness of home biofeedback therapy.

Sponsor: Augusta University

Who Can Participate

Inclusion Criteria

Minimum age of 18 years
Meet Rome IV criteria for functional constipation (≥ 2 of following 6 symptoms) with symptom onset of 6 months on prospective stool diary
Straining with 25% of bowel movements (BM)
Lumpy or hard stools (Form 1 of 2 on the Bristol Stool Scale) with 25% of BM
Sensation of incomplete evacuation with 25% of BM
Sensation of anorectal obstruction/blockage with 25% of BM
Manual maneuvers to facilitate defecation with 25% of BM
\< 3 Spontaneous bowel movements per week 3. Patients must demonstrate dyssynergic pattern of defecation (Types I-IV), during repeated attempts to defecate, and defined as a paradoxical increase in anal sphincter pressure (anal contraction), or less than 20% relaxation of the resting anal sphincter pressure, or inadequate propulsive forces during anorectal manometry.
Dyssynergic pattern of defecation on anorectal manometry plus one or more of the following criteria:
Inability to expel an artificial stool (50 mL water-filled balloon) within 1 minute.
Prolonged colonic transit time on wireless motility capsule (\>59 hours) or \>5 markers retained on a colonic transit study.
Inability to evacuate or ≥ 50% retention of barium during defecography. Inclusion Criteria for patients with fecal incontinence
Minimum age of 18 years
Recurrent episodes of fecal incontinence for six months
No colonic mucosal disease
On a two-week, prospective stool diary, patient reports at least one episode of fecal incontinence per week Inclusion Criteria for patients with urinary incontinence
Minimum age of 18 years
Recurrent episodes of urinary incontinence for three months
Stress, urge or mixed urinary incontinence, with at least 2 episodes of urinary incontinence on a 14-day urinary incontinence diary

Exclusion Criteria

Evidence of structural or metabolic disease that could cause constipation, as assessed by colonoscopy or barium enema and routine hematological, biochemical, and thyroid function tests
Use of opioids within the previous 2 weeks
Severe cardiac or renal disease
Neurological diseases such as multiple sclerosis or stroke
Rectal prolapse or active anal fissures
Alternating pattern of constipation and diarrhea
Pregnant women or nursing mothers
Continuous urine leakage
Active depression
Comorbid illnesses, severe cardiac disease, chronic renal failure or severe COPD
Rectal prolapse or active anal fissure
Pregnant women or nursing mothers

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 Augusta?

Yes, this clinical trial (NCT05771597) has an active research site in Augusta, GA 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 Augusta, GA

If you're searching for fecal incontinence treatment options in Augusta, GA, this clinical trial (NCT05771597) 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 Augusta 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 Augusta?

Take the first step toward participating in this groundbreaking clinical trial

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