Bulkamid Urethral Bulking System and Bulkamid Cystoscope​

Product

Bulkamid Urethral Bulking System, Instructions for Use – 10114-001 FEB 2025

Bulkamid Cystoscope, Instructions for Use – TPA729-159-01 Version A (14-May-2025)

Rx statement

CAUTION: The law restricts these devices to sale by or on the order of a physician. Products described for INFORMATION purposes only and may not be approved or for sale in certain countries.

Prior to use, please refer to all applicable “Instructions for Use” for more information on Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential Adverse Events, and Operator’s Instructions.

Intended use/Indications for use

Bulkamid Urethral Bulking System is intended to be used as a urethral bulking agent for the treatment of female urinary incontinence where the stress component is significant. The Bulkamid Cystoscope is intended to be used to provide visualization of the urethra and urinary bladder during the Bulkamid procedure.

The device is intended to be used by trained healthcare professionals in accordance with the Instructions for Use.

Contraindications

Bulkamid Urethral Bulking System is contraindicated in patients with:

• Acute cystitis or urethritis
• Active Herpes genitalis
• Damaged tissue in the urethra
  

Contraindications may also exist depending on the patient’s general condition or specific symptoms. The decision to perform the procedure remains with the responsible physician and must be based on an individual risk/benefit assessment.

Cystoscopy may be contraindicated by the following clinical conditions, depending on their severity or extent:

• Acute urethritis
• Acute cystitis
• New urethral trauma
• Acute pelvic inflammatory disease

Warnings

• Do not inject Bulkamid Hydrogel intravascularly. It is possible that accidental vascular injection will cause embolism.
• During the bulking procedure, the blood vessels must always remain visible at the site of injection to avoid the risk of necrosis.
• Evaluate the condition of the tissue (e.g. hardness, oedema, haematoma, atrophy) at the site of injection prior to treatment.
• Patients receiving treatment interfering with blood coagulation have an increased risk of haematoma or urethral bleeding

Precautions

• Do not inject Bulkamid Hydrogel into sites previously injected with other bulking agents or vice versa.
• If the patient has undergone major dental work or surgery, Bulkamid Hydrogel should not be injected until the patient is fully recovered.
• If the patient needs surgery or major dental work post Bulkamid Hydrogel injection, antibiotic treatment to reduce risk of infection should be considered by physician.
• Patients with acute or chronic infection in other sites of the body must be treated with caution.
• Only patients with well-controlled diabetes should be considered for Bulkamid Hydrogel injection.
• Do not inject Bulkamid Hydrogel into other sites of the body.
• The procedure may cause urinary tract infections and scratches in urethra and bladder. Prophylactic antibiotic prior to the procedure is recommended.
• It is possible that inflammatory changes seen at the site of implant may later be misinterpreted for other pathology.
• Do not mix Bulkamid Hydrogel with any other substances.Bulkamid Hydrogel should be used with caution in patients on immunosuppressive therapy. Safety has not been established for patients with autoimmune diseases.
• Safety and effectiveness of Bulkamid Hydrogel has not been established in patients with any of the following conditions:
  
  • Under 18 years 
  • Fragile urethral mucosal lining 
  • Urethral hypermobility 
  • Detrusor overactivity 
  • Known polyuria
  • Unevaluated haematuria 
  • Prolapse stage greater than Stage 11
  • BMI >35 kg/m2
  • Neurogenic bladder

Adverse events

General side effects normally associated with any surgical implantation procedure or local anaesthesia also apply to the placement of Bulkamid Hydrogel. Specifically, the following side effects may be associated with the use of the device system:

• Postoperatively, transient symptoms such as dysuria, stranguria, haematuria, urinary tract infection, and acute retention may occur.
• Scratching of the urethral mucosa! may occur during the procedure.
• Long-term side effects such as non-acute retention, abscess formation, fibrosis (tissue hardening), de novo urgency, and necrosis are possible, but rare.