The FDA has approved the injection of soft hydrogel spacers designed to help firm up the walls of the urethra in women with stress urinary incontinence. By supporting the urethra’s volume and increasing its natural closing pressure, the injections aim to prevent urine leakage during daily activities.
Developed by the London-based Contura, the Bulkamid hydrogel also acts as a scaffold for growing cells, to provide longer-lasting treatment. The injection was first granted a CE mark in 2003, and the company says that over 70,000 women have been treated to date in more than 25 countries.
"We are extremely proud to have gained Bulkamid’s approval in the U.S.,” Chief Operating Officer Rakesh Tailor said in a statement (PDF). “We are particularly excited that Bulkamid will, in the coming weeks, be available to women in the U.S. suffering from symptoms that significantly affect their day-to-day lives.”
The company plans to officially launch the product at the end of this month—at the winter meeting of the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction in Scottsdale, Arizona—in parallel with an expansion of its U.S. commercial operations to a new office in Irvine, California.
Contura estimates that stress urinary incontinence affects a large percentage of women, though only a small number go on to receive treatment beyond physiotherapy—potentially in part due to the infamous risks of harmful side effects related to past surgical methods such as transvaginal mesh.
“There is a degree of patient apprehension with the currently available treatments for [stress urinary incontinence] and Bulkamid, with its excellent safety and effectiveness profile, supported by recent clinical data, is now a true first-line alternative for those women,” said Tailor.
In early January, a randomized study published in The Journal of Urology compared the polyacrimide hydrogel injection to the implantation of tension-free vaginal tape. While Contura’s injection did not perform as well as the sling procedure in cure rates or patient satisfaction, it saw much fewer post-operative complications after one year—with no need for revision surgeries compared to six with the tension-free vaginal tape.