ProACT™ Brief Summary of Safety Information for Patients
Patients should always discuss the potential risks and benefits with a physician.
Indications (when to use): The ProACT system is indicated for use in the correction of stress urinary incontinence in males arising from intrinsic sphincter deficiency following an operation performed on the prostate for cancer or for BPH.
Contraindications (when not to use): Contraindications include active systemic or urinary tract infections, unmanageable detrusor instability, reduced bladder compliance, residual volume greater than 100 ml after voiding, pelvic-region radiotherapy within 6 months of ACT system implantation, bladder cancer, unsuccessfully treated bladder stones, hemophilia or bleeding disorders.
Warnings/Precautions/Adverse Events:
The ProACT device is intended for single use only. Do not re-sterilize. Resterilization could result in mechanical failure of the device and place the patient at undue risk. Placement of the ProACT device must be performed by a physician. The ACT system should only be used by a physician who has completed appropriate training. Patients should be pre-medicated with an antibiotic to reduce the possibility of postoperative infection. If bladder perforation occurs, do not implant the ProACT device on the affected side for at least sixty days. An effective procedure calls for two devices to be placed. ProACT balloons should be filled with saline instead of isotonic contrast solution if the patient is allergic to contrast media.
Potential adverse events include, but are not limited to tissue perforation (tear), device migration (movement), post-operative urgency, frequency or retention, tissue erosion/infection at the implant site, device failure, and non-response to treatment.
Patients should always discuss the potential risks and benefits with a physician.
Indications (when to use): The ProACT system is indicated for use in the correction of stress urinary incontinence in males arising from intrinsic sphincter deficiency following an operation performed on the prostate for cancer or for BPH.
Contraindications (when not to use): Contraindications include active systemic or urinary tract infections, unmanageable detrusor instability, reduced bladder compliance, residual volume greater than 100 ml after voiding, pelvic-region radiotherapy within 6 months of ACT system implantation, bladder cancer, unsuccessfully treated bladder stones, hemophilia or bleeding disorders.
Warnings/Precautions/Adverse Events:
The ProACT device is intended for single use only. Do not re-sterilize. Resterilization could result in mechanical failure of the device and place the patient at undue risk. Placement of the ProACT device must be performed by a physician. The ACT system should only be used by a physician who has completed appropriate training. Patients should be pre-medicated with an antibiotic to reduce the possibility of postoperative infection. If bladder perforation occurs, do not implant the ProACT device on the affected side for at least sixty days. An effective procedure calls for two devices to be placed. ProACT balloons should be filled with saline instead of isotonic contrast solution if the patient is allergic to contrast media.
Potential adverse events include, but are not limited to tissue perforation (tear), device migration (movement), post-operative urgency, frequency or retention, tissue erosion/infection at the implant site, device failure, and non-response to treatment.