Hi, I'm Dr Mitchell Bernstein, and I'm here to talk to you today about Solesta. If you're watching this video, you've probably seen many patients who suffer from fecal incontinence. We all know how difficult fecal incontinence can be for patients. Now there's help, with Solesta.
Solesta is a treatment for patients 18 years and older who suffer from fecal incontinence. It is indicated in patients who have failed conservative measures, including dietary and behavioral modifications, antidiarrheal and other medications, and biofeedback. Solesta is an office-based procedure that requires no anesthesia and can be performed in about 10 minutes. Let's take a closer look.
There are a few important things you should know before injecting Solesta. Solesta should be administered by qualified physicians with experience in the treatment of anorectal conditions and who have successfully completed a comprehensive training and certification program in the injection of Solesta. Solesta should only be administered after a thorough history and physical examination to exclude other underlying causes of fecal incontinence. Because treatment with Solesta involves four 1-mL injections of Solesta into the anal canal, patients taking certain medications, such as anticoagulants and antiplatelet agents, may experience bleeding at the injection sites. The use of prophylactic oral antibiotics is recommended with this procedure. The rectum should be evacuated with a saline enema immediately prior to the procedure.
Solesta comes in 4 prefilled syringes in sterilized pouches. Also included in the kit are 5 needles, patient record labels, and a package insert. As mentioned, 4 submucosal injections are given into the anal canal. The needle is unmarked; however, the depth of penetration into the submucosal layer should be about 5 mm.
The plastic Luer-lock at the end of the syringe also deserves some attention. The Luer-lock is a little different than the standard one. The docking here is not attached to the syringe; it is only press-fitted. Hold only the plastic end of the syringe to remove the plastic Luer-lock cap, and attach the needle as shown. Push and rotate the syringe and needle firmly together.
Do not attach the needle by holding on to the glass barrel of the syringe. This can cause an improper fit between the syringe and the needle, resulting in an extrusion of Solesta and less than 1 mL of it being delivered submucosally. It's a good idea to assemble all 4 syringes before the procedure.
You've prepped your patient and assembled the 4 Solesta syringes. Now, here's what you'll need for the procedure: the assembled Solesta syringes and needles, swabs, suction, an anoscope, and lots of good light. I prefer to put my patient in the prone jackknife position, but the left lateral position is perfectly acceptable.
Through a side-viewing anoscope, a total of 4 injections are given. Insert a lubricated anoscope into the anal canal. The obturator is removed, then the anoscope is withdrawn, until the dentate line is clearly identified. As mentioned, the injections are given about 5 mm proximal to the dentate line.
The first injections should be made in the posterior midline position. With the bevel facing the lumen, position the needle at a 30° angle to the anal wall to ensure a submucosal injection. For reference, the length of the bevel is 2 mm.
Once it is no longer in view, insert it an additional 3 mm along the submucosal plane, for a total depth of 5 mm. If your patient experiences pain upon puncture, remove the needle and reinsert it a few millimeters more proximal in the anal canal. If the puncture is painless—and usually it will be—inject Solesta into the submucosal layer.
Since Solesta is a viscous gel, inject it slowly and steadily, with constant pressure. This will allow it to come out of the narrow gauge needle correctly. Make sure that your needle is 5 mm into the submucosal layer before injecting or Solesta will extrude into the anal canal.
As you inject Solesta, you will often see a bulge form beneath the submucosal layer, but sometimes you will not see the bulge. This will not hinder its effectiveness, and it doesn't mean you've injected improperly. After each injection, hold the needle in place for at least 15 seconds to prevent extrusion of the gel. Following the posterior injection, repeat in the left lateral position, anterior position, and right lateral position.
Once the anoscope is removed the patient can get dressed. Here are a few key points to remember about the procedure.
- Insert the bevel facing toward the lumen.
- The bevel is 2 mm long; once in, insert an additional 3 mm to get into the submucosal layer.
- You may see a bulge or a wheal form after the injection or you may not, but this does not determine efficacy either way.
Next, we'll talk about what happens after the procedure.
Ideally, once the procedure is over, you should have your patient remain in the waiting room for a short period of time to make sure that there were no immediate adverse effects from the injection. Your patient should contact you immediately if symptoms of rectal bleeding, bloody diarrhea, fever, tenesmus, or problems with urination occur.
For 24 hours after treatment, your patient should avoid hot baths and limit physical activities. Stool softeners may be used until the first bowel movement occurs. For 1 week after treatment, patients should avoid sexual intercourse, antidiarrheal medications, and strenuous physical activities, such as horseback riding, bicycling, and jogging. For 1 month after treatment, your patient should avoid anal manipulation of any kind, including enemas, suppositories, or anal temperature recording. Analgesics other than NSAIDs may be prescribed if needed.
Following these instructions should help you to administer Solesta successfully. I wish you all the best in treating your patients with fecal incontinence. If you have questions about Solesta, or if you'd like to see the full package insert, visit www.solestainfo.com. Please see the important safety information about Solesta that follows.
Solesta should only be administered by physicians experienced in performing anorectal
procedures and who have successfully completed a comprehensive training and certification
program on the Solesta injection procedure.
SOLESTA® is indicated for the treatment of fecal incontinence in patients 18 years and older who have failed conservative therapy (eg. diet, fiber therapy, anti-motility medications).
Important Safety Information about SOLESTA
SOLESTA® (hyaluronic acid/dextranomer) is contraindicated in patients with active inflammatory bowel disease, immunodeficiency disorders or ongoing immunosuppressive therapy, previous radiation treatment to the pelvic area, significant mucosal or full thickness rectal prolapse, active anorectal conditions (including abscess, fissures, sepsis, bleeding, proctitis, or other infections), anorectal atresia, tumors, or malformation, rectocele, rectal varices, presence of existing implant (other than SOLESTA) in anorectal region, or allergy to hyaluronic acid-based products.
SOLESTA must not be injected intravascularly as injection of SOLESTA into blood vessels may cause vascular occlusion. Injection in the midline of the anterior wall of the rectum should be avoided in men with an enlarged prostate.
SOLESTA should only be administered by physicians experienced in performing anorectal procedures and who have successfully completed a comprehensive training and certification program on the SOLESTA injection procedure.
The most common adverse reactions with SOLESTA (incidence >4%) in the clinical study were proctalgia, anorectal hemorrhage, injection site hemorrhage, pyrexia, injection site pain, diarrhea, and anorectal discomfort.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit
www.fda.gov/medwatch/ or call 1-800-FDA-1088.
For product information, adverse event reports, and product complaint reports, please contact:
Salix Product Information Call Center
Please see complete Prescribing Information for SOLESTA.