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New treatment option for Fecal Incontinence
Official title Home Biofeedback Therapy for Dyssynergic Defecation, Fecal Incontinence and Urinary Incontinence
ClinicalTrials.gov ID: NCT05771597
What this study is testing
- What it's testing
- 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.
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
You may be able to join if
- for patients with constipation and dyssynergic defecation
- 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
You likely can't join if
- Exclusion criteria for patients with constipation and dyssynergic defecation
- Evidence of structural or metabolic disease that could cause constipation, as assessed by colonoscopy or barium enema and routine hematological...
- 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
See the full eligibility criteria
- for patients with constipation and dyssynergic defecation
- 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...
- 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. 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 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 for patients with constipation and dyssynergic defecation
- 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
- Exclusion criteria for patients with fecal incontinence Severe diarrhea with Bristol Stool consistency ≥ Type 6 2. On opioids (except on stable doses \> 3months) 3. Active depression 4. Comorbid illnesses, severe...
- Exclusion criteria for patients with urinary incontinence
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Augusta, Georgia, 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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Augusta, Georgia, United States. 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.