Description

Bulkamid is a specialized urethral bulking agent designed to address stress urinary incontinence (SUI) in adult women. This condition often affects those who have not found relief through conservative treatments. Composed of a transparent, hydrophilic gel, Bulkamid consists of approximately 97.5% non-pyrogenic water and 2.5% cross-linked polyacrylamide. Its unique composition ensures that it is non-resorbable, non-biodegradable, biocompatible, and non-allergenic.

Key Features

• Long-Lasting Results: Bulkamid maintains its volume over time, providing durable and lasting results without migrating or breaking down in the body.
• Sterile Packaging: It is supplied in pre-filled syringes intended for single use, ensuring sterility and convenience.

Procedure Overview

The administration of Bulkamid is a minimally invasive procedure typically performed on an outpatient basis. It can be conducted under local or general anaesthesia or sedation. The process involves 3–4 injections into the submucosal tissue of the proximal urethra using a fine needle, often guided by a cystoscope or telescope. The procedure usually takes 10–15 minutes, with most women requiring 1–2 treatments.

Recovery and Effectiveness

Patients often experience immediate improvement in continence, with a short recovery time that allows them to resume normal activities within 24 hours. Bulkamid works by increasing tissue bulk around the urethra, enhancing resistance to urine outflow and preventing leakage during physical activities.

Patient Suitability

Bulkamid is suitable for adult women with SUI, particularly those with intrinsic sphincter deficiency or urethral hypermobility. It is an appropriate option for patients at higher risk from more invasive surgeries. However, it is not indicated for male patients, except in specific post-prostate surgery cases, and is not recommended for those with acute urinary tract infections, active genital herpes, or damaged urethral tissue.

Administration Guidelines

The procedure should be performed by qualified physicians such as gynecologists, urologists, or urogynecologists. Prophylactic antibiotics may be advised, and care should be taken to avoid intravascular injection or mixing with other substances.

Potential Side Effects

Common side effects include transient dysuria, haematuria, oedema, urinary tract infections, and injection site pain. These are generally mild and resolve within 24 hours. Less common effects may include bladder spasms or vaginal infections, while rare complications could involve abscess formation or persistent urinary retention.

Special Considerations

No special preparation is needed unless sedation is used. Patients are typically discharged the same day after urination. While Bulkamid is not a permanent solution, repeat injections are possible if needed, and it does not preclude future treatments.

Storage Instructions

Bulkamid should be stored without freezing and used before its expiration date. It is intended for single-patient use only, aligning with best practices for medical device handling.