BIRMINGHAM, Ala. – In the short term, behavioral therapy resulted in fewer bothersome incontinence symptoms and greater patient satisfaction than a continence pessary for the treatment of stress urinary incontinence in women, according to researchers from the University of Alabama at Birmingham (UAB) who presented at the 30th annual Scientific Meeting of the American Urogynecologic Society.
Long term, however, there were no differences in satisfaction or symptoms, and combining the two treatments was not better than using either alone, said Holly E. Richter, Ph.D., M.D., professor of obstetrics and gynecology and director of the Division of Women’s Pelvic Medicine and Reconstructive Surgery at UAB and lead author of the study.
Behavioral therapy is defined as pelvic floor muscle training with learning skills and strategies to prevent urine loss. A continence pessary is a device inserted into the vagina that improves incontinence by stabilizing the proximal urethra and urethrovesical junction.
“What we wanted to do was learn how the two most common nonsurgical treatment modalities work to alleviate stress incontinence symptoms compared to one another, because women want to know, and there haven’t been any trials that compare effectiveness of a continence pessary to standard behavioral therapy.” Richter said. “And, we wanted to find out if, since behavioral therapy and continence pessaries work in different ways, if they would work together to provide even greater benefit to patients.”
Richter and co-investigators, Kathryn L. Burgio, Ph.D. and Patricia S. Goode, M.D. from UAB's Department of Medicine, together with colleagues from the National Institutes of Health-funded Pelvic Floor Disorders Network, randomized 446 women recruited from 10 clinical sites across the United States.
Behavioral therapy was administered in four visits at two-week intervals by nurse practitioners and physical therapists trained at the UAB Continence Center. The pessaries were fitted by nurses or physicians in up to three clinic visits to ensure optimum fitting.
Two primary outcome measures were used: the Patient Global Impression of Improvement (PGI-I), where success was defined as a response of “much better” or “very much better”; and the stress incontinence subscale of the Pelvic Floor Distress Inventory (PFDI), where success was defined as an answer of “no” to all of the seven stress subscale questions or “yes” with a bother component of “not at all” or “somewhat.” The primary outcome was determined at three months. The investigators also performed a secondary analysis in subjects who continued with their assigned therapy 12 months after randomization.
On the PGI-I scale, at three months 47 percent of all participants reported that they were “much better” or “very much better” (53 percent of the combination group, 49 percent of the behavioral group, and 40 percent of the pessary group). On the stress incontinence subscale of the PFDI measure, stress symptoms and satisfaction were significantly better in the behavioral group than in the pessary group at three months (49 percent and 33 percent, respectively). By 12 months, there was no difference between the two groups, but both groups were significantly better than before treatment. Combined behavioral and pessary therapy was not superior to either of the single therapies on any outcome measure at any time during follow up.
“I think for many of us that offer both of these treatment options, we will continue to do so,” Richter said. “Now we have information with which to educate our patients that if you adhere to behavioral therapy in the long term you’ll get significant benefit, and if you adhere to pessary you will get benefit without really much difference between the two.”
The physicians and nurse practitioners in the UAB Urogynecology Care and Continence Center at Kirklin Clinic provide professional and sensitive care for women with incontinence and pelvic floor disorders. Patients in the Center are provided with a variety of highly effective, non-surgical approaches to incontinence, including medications, behavioral therapies and support devices. For women needing surgery, the latest minimally invasive techniques usually allow women to go home the same day and recover quickly. Women will find revolutionary new options available, many of which were researched and developed at UAB.