Source: J Psychopharmacol  |  Posted 7 years ago

By Paula Moyer

SAN DIEGO, CA -- July 30, 2004 -- Botulinum-A toxin (Botox) may be an effective therapy for the treatment of urge incontinence, according to findings that Swiss investigators presented here July 29th at the 2004 American Urogynecologic Society/Society of Gynecologic Surgeons Joint Scientific Meeting.

"This therapy seems to be safe and effective in treating urge incontinence," said presenting investigator Bernhard Schuessler, MD, head, department of obstetrics and gynaecology, Cantonal Hospital, Lucerne, Switzerland. "This is one of the first pilot studies showing that botulinum-A injections into the detrusor muscle ? offers at least short-term efficacy."

Since February 2003, the investigators conducted an ongoing, open-label, prospective, nonrandomized study, recruiting 26 patients with idiopathic motor or sensory urge incontinence that had not responded to high doses of anticholinergic medication and that has a high impact on their quality of life. Patients are an average of 66 years old and range from 48 to 84 years old.

Before treating patients, the investigators took their medical histories and gave them an urodynamic evaluation and obtained urinalyses and urine cultures for each patient. The patients kept a voiding diary. Pre-treatment urodynamic evaluations focused on maximal bladder capacity, bladder compliance, residual volume, volume during first desire to void, daytime frequency and frequency of urge incontinence episodes frequency.

Patients received approximately 100 units of botulinum-A toxin injected into the detrusor muscle at 30 different sites. Dr. Schuessler noted that the investigators avoided injecting the trigone. Clinical and urodynamic evaluations were conducted at 4, 12, and 36 weeks after treatment. The investigative team used the King?s Health Questionnaire to obtain quality-of-life assessments; the version they used had been validated in German.

All patients have received a 4-week evaluation, while 20 have undergone a 12-week evaluation and 5 a 36-week evaluation. At 4 weeks, 69.2% of 26 patients had a significant increase in maximum bladder capacity, which increased from a baseline average of 224 mL to 343 mL. Compliance had increased from a baseline average of 14 mL/cm of water to 43 mL/cm of water. The volume during the first desire to void had increased from a baseline average of 103 mL to 191 mL. Daytime frequency had decreased from an average of 12 to 4 voids per day.

All patients were free of incontinence episodes. Two patients (7.7%) required self-catheterization for 1 week after treatment to address residual volume, which ranged from 130 mL to 230 mL.

At 12 weeks, 80% of 20 patients had responded significantly in similar manner. At 36 weeks, the significant responses were 1 in 5 (20%). However, data for these time points are still being evaluated, Dr. Schuessler said.

The King's Health Questionnaire evaluated the level of bothersome intrusion. At baseline, none of the 19 patients whose questionnaires were evaluated said that their symptoms were "no bother at all" or "a little bother," 52.6% reported that the symptoms were moderately bothersome, and 47.4% reported that they were extremely bothersome. At the 4-week evaluation, 6 patients reported that their symptoms were "no bother at all" and 8 reported that they were "a little bother," while 5 patients considered their symptoms a "moderate bother," and no patients reported that they were extremely bothersome.

After the initial effects of treatment diminished, 2 patients received repeat injections, at 5 and 10 months of the initial treatment. All responders said that they would be willing to undergo repeat treatment. Patients' acceptance of and satisfaction with treatment are high, Dr. Schuessler said, noting that he and coinvestigators are continuing to recruit patients for ongoing study of botulinum-A toxin as a treatment for urge incontinence.

[Presentation title: Efficacy of Botulinum-A Toxin in the Treatment of Motor Urge Incontinence: A Prospective Non-Randomized Study. Abstract 12]