Real-World Evidence
Vibrant Delivers Durable Efficacy with Exceptionally Low Diarrhea Rates in Adults with Constipation*
• Sustained improvement in bowel habits and stool form at 3 and 6 months
• Diarrhea in only 0.64% of patients, far below rates reported with commonly used pharmacologic options
New real-world evidence on the Vibrant System™ has been published in Clinical and Translational Gastroenterology, presenting outcomes from 1,722 adults treated across U.S. community practices.
Among patients who completed 3 or 6 months of therapy and used the electronic stool diary, treatment with Vibrant demonstrated consistent, clinically meaningful improvements:
• More than one additional complete spontaneous bowel movement per week on average (p<0.0001)
• Stool form improved from a mean of 2.9 at baseline to 4.1 during treatment
• Straining decreased by 45%, and average toileting time was cut by more than half (from ~33 minutes to ~15 minutes)
These improvements were sustained at both 3- and 6-month follow-up.
Tolerability is where Vibrant clearly stands out. Diarrhea rates in this real-world cohort were markedly lower than those reported with commonly used pharmacologic options for chronic idiopathic constipation (CIC):
| Therapy | Mechanism | Reported diarrhea rate |
|---|---|---|
| Vibrant System™ (real-world) | Non-drug, mechanized colonic stimulation | 0.64% |
| Linaclotide | GC-C agonist | ≈ 15–20% in CIC trials |
| Plecanatide | GC-C agonist | ≈ 5–6% in CIC trials |
| Lubiprostone | Chloride channel (ClC-2) activator | ≈ 10–15% in CIC trials |
Approximate rates shown for adults with chronic idiopathic constipation (CIC) based on published clinical trial data for pharmacologic agents and real-world observational data for Vibrant.
In the Vibrant real-world cohort, diarrhea occurred in only 0.64% of patients, with abdominal pain and bloating/distention each ≤~2%. For patients who have cycled through secretagogues or GC-C agonists due to tolerability concerns, these data highlight Vibrant as an effective, well-tolerated, drug-free option to consider earlier in the treatment journey.
Long-Term, Real-World Evidence of Vibrating Capsule Treatment
Real-world outcomes demonstrate sustained clinical benefits, improved quality of life, and strong tolerability for patients using Vibrant® for chronic idiopathic constipation (CIC).
Improved Bowel Frequency
Patients using Vibrant experienced a >1 additional complete spontaneous bowel movement (CSBM) per week compared to baseline over 3 and 6 months.
Enhanced Stool Consistency
Average Bristol Stool Form Scale (BSFS) scores improved from approximately 2.9 → 4.1, indicating softer, more normal stool form and easier passage.
Reduced Straining and Toileting Time
Patients reported less straining (2.9 → 1.6) and shorter time spent on the toilet (p < 0.0001), reflecting improved bowel efficiency and comfort.
Well-Tolerated and Safe
Adverse events were rare — only 0.64% of patients reported diarrhea, and no serious device-related adverse events occurred.
“The other striking thing was the side effects. Virtually none. ‘Hardly anybody felt this.’ ‘There was no diarrhea.’ The combination of highly efficacious data with very minimal or no side effects is a brilliant package.”
Hear from Leading Gastroenterologists
“The phase three data show that this treatment is both effective and well-tolerated by our patients.”
- Darren M. Brenner, MDNorthwestern Medical Group Gastroenterology
“I feel like a normal human being again”
- Cherie F, Chicago, a patient with chronic constipation
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“I love the fact that it’s not another drug. I’ve eaten handfuls of laxatives & drank every nasty liquid solution there is – without success… With Vibrant, I now have bowel movements 3 – sometimes 4 – times each week. My stomach is not as distended; I’ve lost at least 20 pounds, & I feel like a normal human being again.”— Cherie F., a patient from Chicago
Request a 1-on-1 Clinician Walkthrough
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Vibrant demonstrated significant improvement in:
- stool frequency, which was seen as early as week 1 and continued throughout the study.
- other bowel and abdominal symptoms and quality of life.
The regimen established tolerability with no significant adverse events.
Vibrant provides a novel, non-pharmacological, intraluminal therapy that is effective, safe, and well tolerated in patients with CIC.2
Adverse events/side effects:
- Potential adverse events associated with the use of this device may include abdominal pain, abdominal distension, abdominal discomfort, vomiting, nausea, blood in stool, diarrhea, flatulence, and proctalgia. In rare cases, obstruction may occur.
- Note that the safety and effectiveness of the Vibrant System for long-term use in the indicated population, i.e., for more than 8 weeks, has not been evaluated.
Vibrant should not be used if your patient
- has a history of complicated/obstructive diverticular disease.
- has a history of intestinal or colonic obstruction, or suspected intestinal obstruction.
- currently has clinical evidence of significant gastroparesis.
- has a history of significant gastrointestinal disorder, including any form of inflammatory bowel disease or gastrointestinal malignancy (celiac disease is excepted if the subject has been treated and is in remission), and/or anal fissures and fistulas.
- has a history of Zenker's diverticulum, dysphagia, esophageal stricture, eosinophilic esophagitis, or achalasia.
- is pregnant or lactating.
- The Vibrant Capsule is MR unsafe. The device has not been evaluated for safety and compatibility in the MR (magnetic resonance) environment. It has not been tested for heating, migration, or image artifact in the MR environment. If patient requires an MRI, verify Capsule expulsion via abdominal X-ray before undergoing an MRI examination.
- The Capsule should be kept away from implants such as pacemakers, defibrillators, nerve stimulators, and other devices that could be affected by proximity to a DC (direct current) magnetic field.
- Vibrant Capsules must be stored in a safe place, out of the reach of children and/or infants.
- If a child has accidentally swallowed an unused Vibrant Capsule, he/she should be brought immediately to a hospital.