Description

Bulkamid is a specialized medical device designed to address stress urinary incontinence (SUI) in women, including those with intrinsic sphincter deficiency (ISD) and stress-predominant mixed incontinence. It also plays a role in managing vesicoureteral reflux (VUR) and mixed urinary incontinence. This product is a minimally invasive, injectable urethral bulking agent, offering a unique solution for individuals who have not found success with conservative treatments.

Composition

Bulkamid is composed of a biocompatible polyacrylamide hydrogel (PAHG), consisting of approximately 2.5% cross-linked polyacrylamide and 97.5% non-pyrogenic water. The hydrogel is transparent, hydrophilic, non-biodegradable, and non-allergenic, ensuring long-term stability within the body without significant tissue reactions.

Mechanism of Action

The product is injected into the submucosal tissue of the proximal urethra, enhancing tissue volume and support. This increases urethral coaptation, thereby improving urinary control and reducing leakage during activities that elevate abdominal pressure.

Procedure

• Setting: Outpatient, minimally invasive
• Duration: Approximately 10–15 minutes
• Anesthesia: Local (or general/sedation if necessary)
• Recovery: Most patients resume normal activities within 24 hours

Benefits

• Long-lasting results due to non-absorbable hydrogel
• Suitable for a wide range of patients, including those at higher risk from more invasive surgeries
• Does not interfere with future treatment options

Patient Selection

Bulkamid is intended for adult women (18+) with SUI or mixed incontinence with a stress component. It may also be used in select cases for men and children with VUR. Contraindications include acute urinary tract infections, certain medical conditions, and specific patient demographics such as males with SUI and those under 18.

Administration

• Single-use: Must not be re-sterilized or reused
• Qualified Administrators: Only to be administered by trained physicians such as gynecologists, urologists, or urogynecologists
• Antibiotics: Prophylactic antibiotics are recommended to minimize infection risk

Adverse Events

Common adverse events may include transient dysuria, hematuria, oedema, and urinary tract infections. More rare complications could involve non-acute retention or abscess formation.

Clinical Evidence

Bulkamid is supported by extensive clinical research, demonstrating effectiveness in improving continence and quality of life with a favorable safety profile. Most women require 1–2 treatments, while men may need up to 4 treatments for VUR.

Regulatory Information

Bulkamid is FDA-approved for its indicated uses, with U.S. Federal law restricting its sale and use to qualified healthcare providers. It is supplied in pre-filled, sterile syringes, ensuring ease of use and traceability through comprehensive packaging labels.