When was solesta approved

Developed as a minimally invasive treatment for fecal incontinence, Solesta is injected in the deep submucosal layer in the proximal part of the anal canal and is the only injectable gel to be administered in an outpatient setting without the need for anesthesia. While the exact mechanism of action has not been identified, it is hypothesized that the Solesta injections may narrow the anal canal, allowing for better sphincter control.

According to the National Institutes of Health, there are more than 5. The study included patients. In the primary study, most patients received 2 treatments, consisting of 4 injections each, for a total of 8 injections. The entire procedure takes only about 10 minutes and is performed by colorectal surgeons.

It is believed that the injection of Solesta builds up the tissue lining the anus, creating a narrower opening and therefore helping the muscles in the anus to retain fecal material. This then reduces the likelihood of involuntary passage of feces.

Solesta has been approved for use in Europe since and in the U. The FDA has approved Solesta for use by individuals over the age of 18 whose symptoms have not been improved by dietary changes or diarrhea medications.

The main research support for the use of Solesta comes from a study in which the gel was used on approximately patients in both the U. Patients were randomly assigned to receive injections of Solesta or a "sham" used to assess any placebo effect.

It may be that Solesta, while not necessarily a "miracle cure," does have the potential to offer some symptom relief to some people. However, the study had certain limitations, and as a result its results are difficult to interpret. There is a need for a well-designed study of Solesta in fecal incontinence patients who are well-characterized clinically passive vs.

Solesta is generally seen as safe and well-tolerated. The FDA reports the following possible side effects:. According to the FDA, Solesta cannot be administered to individuals with the following health conditions:. Gas pain? Stool issues? Sign up for the best tips to take care of your stomach.

Your Privacy Rights. To change or withdraw your consent choices for VerywellHealth. Time to Fecal Incontinence Reintervention [ Time Frame: Assessed from 6 to 36 months after last Solesta treatment ] For patients who undergo Fecal Incontinence Reintervention the effectiveness endpoint of Time to Fecal Incontinence Reintervention will be measured from the date of last treatment with Solesta to the date of first Fecal Incontinence Reintervention.

Fecal incontinence reinterventions will include any of the following FI treatments: sphincteroplasty, implantation of artificial bowel sphincter, retreatment with Solesta, graciloplasty, SNS or other surgical interventions. Anatomic stability of the Solesta [ Time Frame: Assessed at time of Solesta treatment and again at 6 and 36 months after the last Solesta treatment. Solesta will be assessed by comparing anatomical positioning of the Solesta implant, as determined by transrectal ultrasound at Visit 3a for patients who did not receive a second Solesta treatment or Visit 3b for patients who received a second Solesta treatment at Visit 3a to positioning at 6 and 36 months after the last Solesta treatment.

Occurrence of any peri-injection device related infectious adverse events. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below.

For general information, Learn About Clinical Studies. Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information. Search for terms. Save this study. Warning You have reached the maximum number of saved studies Listing a study does not mean it has been evaluated by the U. Federal Government. Read our disclaimer for details. Last Update Posted : November 25, Study Description.

The purpose of this observational study is to evaluate the safety and effectiveness of the Solesta Injectable Bulking Agent in the treatment of fecal incontinence through 3 years in a real world setting. Detailed Description:. This observational study is to evaluate the safety and effectiveness of the Solesta Injectable Bulking Agent in the treatment of fecal incontinence through 3 years in a real world setting.

FDA Resources. Outcome Measures. Primary Outcome Measures : Freedom from fecal incontinence reintervention [ Time Frame: Through 36 months after the last Solesta treatment ] The primary effectiveness endpoint is freedom from Fecal Incontinence Reintervention.