Study asks: Can women stop taking medicine for urinary urge incontinence?

San Antonio (Dec. 21, 2004) – South Texas women who struggle with urinary urge incontinence are invited to call the department of urology at The University of Texas Health Science Center at San Antonio to ask about their eligibility for a new study.

The Behavior Enhances Drug Reduction of Incontinence (BE-DRI) study is testing the hypothesis that the addition of behavioral treatment to drug therapy will enable patients to discontinue their medication and improve or cure their urinary urge incontinence.

Urinary incontinence can be caused by several factors separately or in combination, and it can present with different symptoms. For example, in persons with urge incontinence, the bladder begins to contract without permission or involuntarily, and the person feels a strong sudden urge to urinate wherever they are, whether close to a bathroom or not, said the study’s principal investigator, Stephen Kraus, M.D., assistant professor of urology at the Health Science Center. This often results in urinary accidents while on the way to the bathroom.

This is different from urinary stress incontinence, in which leakage is associated with coughing, sneezing, laughing or other physical activities. Stress incontinence happens because the urethral sphincter or valve opens and allows urine to leak with the increased pressure on the bladder caused by such activities.

Persons who have a combination of both urge and stress incontinence have mixed incontinence. Women with a stress incontinence component can participate in BE-DRI, but they must have urge incontinence and the urge incontinence must be more bothersome to the patient.

Urinary incontinence affects 16 million Americans, two-thirds of whom are women. The results are social isolation, depression, and sexual and relationship problems. The problem is under-reported and under-treated because individuals often do not want to discuss it with a doctor.

Both groups of women in the BE-DRI trial will receive medication that blocks bladder contractions. The duration of the treatment is 10 weeks. Roughly half of the ladies also will receive behavioral treatment. One behavioral tactic is to think about a time when someone opened the door to the occupied bathroom, temporarily stopping the bladder contraction. “Many of us take such maneuvers for granted,” Dr. Kraus said. But it is not known whether adding behavioral therapy will make a difference with regard to getting off medication and staying off.

Eight months after the start of the study – 5 1/2 months after therapy is withdrawn – outcomes of the combination therapy group and the medicine-only group will be compared to see if the women in the combination therapy group have fewer episodes of urge incontinence. “We really don’t know which group will be better,” Dr. Kraus said. “Both groups will get a simplified set of instructions, but the combination therapy group will get more intensive behavioral counseling. There are important ramifications to taking medication for the problem long term.

The most common side effects include dry mouth and constipation, depending on which medication is prescribed. The medication in the BE-DRI study has one of the lowest incidences of side effects.

“And there are financial considerations,” Dr. Kraus said. “If people take the medication chronically, of course the cost adds up. Since no one has ever done a randomized clinical trial to see if patients need to remain on the medications, we really don’t know if they need to remain on them or not. This clinical trial will raise the bar with regard to the quality of the information we have.”

The study is funded by a grant from the National Institute of Diabetes and Digestive and Kidney Diseases. About 35 women from the San Antonio area are sought. The medication, behavioral therapy and all study-related visits are free of charge. Women will be compensated for study activities.

Interested women from Bexar and surrounding counties may call Sylvia Escobedo Sluder at (210) 567-0550 or Caren Prather at 567-0548.



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