Medical Device Daily

ATLANTA– The life-altering condition of urinary incontinence is expected to affect 1 billion people worldwide by 2030, according to the World Health Organization (Geneva), but study results presented Sunday by Hannes Strasser, MD, associate professor of urology at the University of Innsbruck (Innsbruck, Austria) suggest one new solution: transurethral ultrasound-guided stem cell therapy.

Standard therapies today include about 100 surgical techniques, Strasser told media at the American Urological Association (Linthicum, Maryland) annual meeting, but urologists are on the look-out for new techniques that are minimally invasive.

“Every year we lose 1% to 2% of our muscle mass,” which inevitably affects the muscles that control the urethra,” Strasser said.

He suggested using adult stem cells, which – unlike embryonic stem cells – are from the patient's own body and are therefore not controversial. He said they are taken from the body, cultured and introduced back into the body.

Specifically, such stem cells, consisting of myoblasts and fibroblasts, are injected into the rhabdosphincter to reconstruct the muscle. A study conducted by Strasser and others stated that “the present data support the conclusion that this new therapeutic concept represents an effective and minimally invasive treatment modality to cure urinary incontinence.”

The study involved 130 incontinent patients age 36-85 years, including 85 women and 45 men, who participated between September 2002 and March 2005. The study said that they suffered from “stress or mixed urinary incontinence.”

Researchers used – before and after therapy – a “defined incontinence score, changes in quality of life as well as morphology and function of urethra and rhabdosphincter” to evaluate the patients. They not only used transurethral ultrasound to visualize the lower urinary tract, but they also used urodynamic and laboratory tests before and after the stem cell injections.

Researchers took “small skeletal muscle biopsies” from the upper arm, and the stem cells were eventually mixed with collagen as a “carrier material.”

“Using a transurethral ultrasound probe and a specifically designed injection device, the fibroblasts were injected into the urethral submucosa to treat atrophies of the mucosa,” the study said. “The myoblasts were directly injected into the rhabdosphincter to reconstruct the muscle.”

Of the 130 patients, in 79 women and 32 men urinary incontinence was “cured” after the stem cell injection.

The result was that the quality of life dramatically improved, the thickness of the urethra was increased and the thickness of the rhabdosphincter was increased, Strasser told an audience during a Sunday morning press conference.

Daniel Schmid Jr., MD, of the department of urology, Universit tsspital (Z rich Switzerland), discussed his and other researchers' study experiences in 150 cases of patients with overactive bladder treated with botulinum-A toxin injections into the detrusor muscle.

The objective of the study was to “evaluate the efficacy and long-term results of botulinum Type-A used in this matter and for this condition,” said Schmid.

Treatment involved injections of 100 IU of botulinum into the detrusor at 30 different sites, according to the study. Prior to the study, patients completed a micturition diary, urodynamic tests, tests of neurological status and urine probes. Clinical and urodynamic checks and quality of life assessment was performed at baseline and intervals of four, 12 and 36 weeks following injection.

“Overall, 88% of our patients showed a significant improvement of their bladder function in regard to symptoms as well as to urodynamic parameters,” he said. “Urgency completely disappeared in 76% and incontinence in 82% within two weeks.”

“After follow-up of 4.5 years, there was a relapse rate of 23% after 11 months, but the remaining 77% of patients did not need additional treatment,” Schmid told the audience.

Schmid concluded that this treatment is “an efficient and safe treatment in patients suffering from severe OAB [overactive bladder].”