Anorectal Expulsion Balloon Catheter Reusable

The CR1B is a reusable anorectal expulsion balloon catheter for the Balloon Expulsion Test (BET) and balloon-based biofeedback using air inflation. One catheter can be cleaned, high-level disinfected and reused for up to 50 procedures, making it a cost-effective option for GI motility labs and pelvic floor therapy programs that test or train patients with chronic constipation, dyssynergic defecation, fecal incontinence and other defecatory disorders.

Key features and benefits

• Reusable for up to 50 procedures or 5 years, whichever comes first, when reprocessed according to the Instructions for Use (IFU) — one catheter, not 50.
• Non-latex, non-DEHP balloon with up to 400 mL capacity for air-based BET and rectal balloon therapy protocols.
• Markings for balloon placement to support consistent positioning across operators and visits.
• Specially designed flexible tubing for easy intubation and patient comfort.
• Can be used with solid-state or water-perfused motility systems and with handheld biofeedback devices through a standard 3-way stopcock and extension tube.

Clinical indications and use cases

The CR1B is indicated when there is a need to evaluate a suspected anorectal disorder. Typical patients include adults with chronic constipation, suspected dyssynergic defecation, pelvic floor dysfunction or fecal incontinence referred for anorectal function testing or biofeedback-based rectal balloon training.

• Balloon Expulsion Test to assess whether patients can expel a simulated stool, helping identify impaired evacuation and dyssynergic defecation alongside anorectal manometry.
• Rectal balloon therapy and biofeedback for defecation training, sensory training, and urge-resistance or coordination programs in fecal incontinence.
• Pressure biofeedback with handheld devices, where the patient's squeeze pressure is displayed while the air-filled balloon is in place.
• Pelvic floor physical therapy programs that use rectal balloon work repeatedly and want a reusable alternative to single-use catheters.

How the CR1B is used

For a balloon expulsion test, the CR1B is lubricated with a water-based lubricant and inserted 8–10 cm into the rectum. A 3-way stopcock is attached, the balloon is filled with 30–60 mL of air, the port is closed and the syringe removed. The patient then attempts to expel the catheter on a toilet or commode while you record the time and symptoms; per the IFU, expulsion within 2–5 minutes indicates normal function. Fill the CR1B with air only — water can cause balloon detachment or rupture.

For biofeedback, the catheter, a syringe and an extension tube are connected through the 3-way stopcock, the extension tube is attached to the handheld biofeedback device, and the balloon is filled with 30–60 mL of air. Each use should not exceed 30 minutes inside the gastrointestinal tract.

How CR1B compares to other catheters

• CR1B: Reusable, air-only catheter that requires cleaning and high-level disinfection between patients according to the IFU, for up to 50 uses.
• SR1B: Single-use catheter for air-only protocols, used for BET and related anorectal procedures.
• SR2B: Single-use catheter with the same 400 mL balloon volume that allows either air or water inflation.

Choose CR1B when your program runs air-based BET or rectal balloon therapy regularly and has a validated reprocessing workflow. If your protocol uses a water-filled balloon, choose the SR2B instead.

Technical specifications

Cleaning, disinfection and storage

• Clean immediately after each procedure: attach and close the stopcock so no liquid enters the balloon, wash in warm water with an enzymatic detergent, rinse with clean water and wipe the external surface.
• High-level disinfect by fully submerging the catheter (stopcock closed) in a compatible disinfectant according to the disinfectant manufacturer's instructions. The IFU lists Sporox, Korsolex Extra, OPTIM CS and Adaspor Plus Ready to Use as compatible.
• Do not use Cidex products, do not soak in alcohol and do not steam autoclave.
• Rinse with sterile water, wipe dry and store in a clean, dry location.
• Use water-based lubricants only; silicone-based lubricants should not be used on the balloon.

Ordering information

• Product code: CR1B – Anorectal Expulsion Balloon Catheter, reusable, air only, PVC manometric catheter.
• Packaging: sold individually (1 catheter, rated for up to 50 uses).
• Related products: SR1B (single-use, air only), SR2B (single-use, air or water) – see related product pages for full details.

Regulatory and safety information

• For use only under medical supervision by personnel trained in gastrointestinal manometry and anorectal testing.
• Contraindicated in the presence of any rectal stenosis, structural deformity or disease that increases the risk of distention, perforation or other adverse consequences.
• Inspect the catheter and packaging before each use and do not use if damaged. Do not alter or modify the catheter, and do not use it beyond its validated lifetime or number of uses.
• Follow institutional protocols and the Instructions for Use, and dispose of the catheter at end of life according to local regulations.

FAQs

What is the CR1B used for?

The CR1B is used for the Balloon Expulsion Test and balloon-based biofeedback in patients with suspected defecatory disorders, dyssynergic defecation, fecal incontinence or pelvic floor dysfunction.

How many times can the CR1B be reused?

One CR1B catheter can be reused for up to 50 procedures or 5 years, whichever comes first, provided it is cleaned and high-level disinfected between patients according to the IFU. Your facility tracks the number of uses.

Can the CR1B be filled with water?

No. The CR1B is an air-only catheter; filling it with water risks balloon detachment or rupture. For water-filled protocols, use the single-use SR2B.

Ready to add the CR1B Reusable Anorectal Expulsion Balloon Catheter to your GI motility or pelvic floor therapy program?