Novel approach improved symptoms and quality of life in women not helped by traditional therapy.
Injecting autologous muscle-derived cells (AMDCs) into the bladder may significantly improve symptoms and quality of life (QOL) in patients with stress urinary incontinence (SUI), according to Canadian researchers.
Investigators at the University of Toronto and the University of Calgary conducted a two-phase study which enrolled 29 women with SUI symptoms that had not improved within a year of undergoing standard therapy.
The group had a mean age of 49.5 years (range 36-73 years). In the first phase, which was double-blinded, investigators randomized 20 patients into five groups to receive cystoscope-assisted injections of 1×106, 2 ×106 , 4 ×106, 8 ×106, or 16 ×106 AMDCs. The second phase, which was single-blinded, randomized nine patients into three groups to receive 32 ×106, 64 ×106, or 128 ×106 AMDCs. To date, 17 patients have reached the 12-month follow-up appointment.
At the three-month follow-up appointment, the subjects could elect to receive a second injection of the same dose. Of the 29 patients, 25 (86.2%) opted to have a second injection. Follow-up occurred at one, three, six, and 12 months after the last injection. Clinical outcomes were evaluated with a pad weight test, a voiding diary, and validated QOL) questionnaires. Investigators reported findings here at the American Urological Association Annual Meeting.
“So far our primary outcome measure has been safety, and we have had no significant, unexpected adverse events in the cohort of patients,” said Lesley K. Carr, MD, Assistant Professor of Urology at the University of Toronto. “This is exciting, the concept that you can restore function with autologous tissue. This is certainly a big boon to patients, who [will be able to] avoid foreign materials like mesh or bovine collagen.”
To date, no serious adverse events have been reported, Dr. Carr said. Minor events have occurred at similar rates among all the dose groups. These included pain and bruising at the muscle biopsy site, pain at the injection site, and mild and self-limiting urinary retention and UTIs. One patient reported notably worsened incontinence.
QOL measures improved in 68% of patients three months after the first injection and in 67% of patients three months after the second injection.
Symptoms improved in 61% of patients at three months after the first injection and three months after the second injection. Urinary leaks were reduced after both injections. At 12 months, 13 of 17 patients (76.5%) reported an overall reduction in stress leaks and urgency compared with baseline. Four patients reported no leaks.
“This study confirms that autologous muscle-derived cells constitute a safe and effective treatment for incontinence at various dosages,” said AUA spokesperson Anthony Atala, MD, Professor and Chair of Urology at Wake Forest University in Winston-Salem, N.C. “It is important to note that this therapy has few side effects and seems to improve symptoms for most patients in whom other therapies failed.”