ATLANTA — Botox may be the answer for women with detrusor overactivity incontinence who have failed to respond to conservative therapy.
A cystoscopic technique that uses intradetrusor injections of botulinum toxin A injections to decrease bladder muscle overactivity associated with this type of incontinence was demonstrated in a video presented by Sangeeta Mahajan, M.D., at the annual meeting of the American Urogynecologic Society.
The in-office procedure, performed under local anesthesia, is proving safe and effective for women with resistant incontinence—both those with neurogenic bladders and those with neurologically normal bladders—said Dr. Mahajan of MacDonald Women's Hospital, Cleveland, Ohio.
She and her colleagues use a flexible or rigid cystoscope and the Wolf collagen-injection system with disposable needles, although comparable systems can be used. A total of 30 cc of 1% lidocaine is instilled into the bladder for anesthesia.
An additional 10 cc of 2% lidocaine can be placed in the urethra for more anesthesia. The lidocaine is left in place for 10 minutes to allow adequate anesthesia, but it does not have to be removed before injecting the toxin.
The Botox (Allergan, Inc.) is prepared using injectable saline and methylene blue to allow visualization of injection sites, and is placed into two 3-cc syringes for a total of 200 units in 6 cc of saline.
Cystoscopy is performed in a routine fashion with adequate bladder distention to visualize the urothelium. An initial Botox injection is completed at the midline of the bladder, just above the trigone, and the scope is carefully moved laterally left or right to allow additional injections at 4- to 5-cm intervals until four or five have been completed. Mirror-image injections are then performed on the opposite side, followed by a second row of injections 1 cm above the first row, for a total of about 20 injections.
Additional rows may be needed to disperse the total amount of toxin throughout the posterior bladder wall. Care should be taken not to inject the trigone to prevent any possible risk of urethral reflux due to toxin exposure.
A final survey of the bladder wall will ensure that the injections—visible because of the methylene blue wheals that form at the injection sites—are well distributed.
Cystoscopy is then completed, and the bladder is drained. The patient should be monitored for 15 minutes, during which time she can be instructed on the use of intermittent self-catheterization, which may be needed if urinary retention occurs in the weeks after treatment. An appropriate urinary antibiotic is prescribed for 3 days.
The procedure is well tolerated and is technically feasible in the office setting, Dr. Mahajan said.
She and her colleagues have performed the procedure on 50–60 patients, and other centers in the United States have been using it for several years.
“Patients are so happy—[the procedure] revolutionizes their lives,” she said, noting that these are patients who have failed all other treatment, including medical, behavioral, and physical therapy.
This technique provides an alternative to major surgery such as sacral neuromodulation or urinary diversion, she said.
However, it has been studied in a randomized, controlled setting only in Europe and only in patients with neurogenic bladders.
Interim results of an open-label trial in Europe in women with neurologically normal bladders were presented last year by Dr. Bernhard Schuessler of Cantonal Hospital, Lucerne, Switzerland, at another meeting of the American Urogynecologic Society, and also showed that the treatment was safe and effective.
A randomized trial in the United States is also in the works, and will be conducted by the National Institutes of Health-funded Pelvic Floor Disorders Network in a neurologically normal population of women.