First RCT Shows Similar Efficacy Among Nonsurgical Treatments for Stress Urinary Incontinence
By Fran Lowry
Medscape Medical News
September 28, 2009 (Hollywood, Florida) — Behavioral therapy resulted in fewer bothersome incontinence symptoms and greater patient satisfaction than a continence pessary for the treatment of stress urinary incontinence (SUI) in the short term. However, these differences did not persist with longer follow-up. Moreover, combining the 2 treatments was not superior to single-modality therapy.
The results, from the first randomized controlled trial (RCT) to compare these nonsurgical treatments for SUI, provide evidence-based data that can now be used to counsel patients, Holly E. Richter, PhD, MD, from the University of Alabama at Birmingham, said at the American Urogynecologic Society 30th Annual Scientific Meeting.
"Expert consensus groups have recommended that we discuss and educate patients about the nonsurgical treatment options that are available and offer them to our patients," Dr. Richter said. "Behavioral therapy is effective, but women have to be motivated to adhere to the therapy, and there might not be certified behavioral therapists in every clinician's office. Continence pessaries are an alternative that we've all used in the treatment of stress incontinence for decades. Surprisingly, there are no randomized trials comparing pessaries with evidence-based behavioral therapy."
To address this void, Dr. Richter and her colleagues from the Pelvic Floor Disorders Network randomized 446 women with SUI to receive behavioral therapy, continence pessary, or both treatments combined. The women were recruited from 10 clinical sites across the United States.
Behavioral therapy was administered in 4 visits at 2-week intervals by certified behavioral therapists. The pessaries were fitted by nurses or physicians in up to 3 clinic visits to ensure optimum fitting.
Primary outcomes assessed were the Patient Global Impression of Improvement (PGI-I) scale, where success was defined as "much" or "very much better," and the stress incontinence subscale of the Pelvic Floor Distress Inventory (PFDI). The analysis was intention to treat. The primary outcome timepoint was determined at 3 months.
The investigators also performed a secondary per-protocol analysis in subjects who persisted with their assigned therapy 12 months after randomization.
The patients were similar in all 3 groups. The mean age was 50 years, 85% were white, 46% had stress only incontinence, 54% had a mix of stress and urge incontinence, 21% had tried some type of nonsurgical therapy in the past, and 6% had undergone surgery for incontinence.
At 3 months, 47% of participants reported on the PGI-I measure that they were "much better" or "very much better." Rates of improvement were 53.3% for the combination group, 49.3% for the behavioral group, and 39.6% for the pessary group. The PGI-I outcomes did not differ between the behavioral and pessary groups (P?=.10).
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 3 months (49% vs 33%; P?<.01). However, by 12 months, there was no difference between the 2 groups (54.1% vs 50.3%; P?= –.53).
Combined therapy was not superior to either of the single therapies on any outcome measure at any of the timepoints. Therefore, initiating treatment with combined therapy is not recommended.
In an interview with Medscape Ob/Gyn Women's Health, Dr. Richter said that the study results will change how clinicians counsel their patients, because now there are more data to offer in terms of actual outcomes with respect to the 2 treatment modalities. "Essentially, we are trying to practice evidence-based medicine but we really didn't have any data with which to counsel women about the use of pessaries. We did have level?1 data for behavioral therapy, but nothing on pessaries."
She added that "those of us who use pessaries and behavioral therapy in our practices know that there are certain types of women who gravitate toward one [or the other] of these approaches.?.?.?. Even though at 3 months there seemed to be an advantage for behavioral therapy over pessary, as time goes on, the women who like the pessary and stay with it gain benefit. We hope to characterize factors or variables in women that predict success with pessary vs behavioral therapy use. However, as with any treatment modality, individualization of care continues to be important."
"I think it's an excellent study," Karen Noblett, MD, from the University of California at Irvine, said in an interview with Medscape Ob/Gyn Women's Health after Dr. Richter's presentation. "There are very few studies that look at the treatments of stress incontinence that are nonsurgical. Being able to have some validated and comparative data looking at the 2 nonsurgical options and then looking at the 2 therapies combined gives us good evidence that both are effective."
Elisa Trowbridge, MD, from the University of Virginia in Charlottesville, added that she was "thrilled" to hear that behavioral therapy was helpful, but admitted that she was a "very avid user of pessaries."
Pessaries are particularly useful in women who have comorbidities, she said. "They do work in a group of our patients. These are women have other medical problems and Kegels are just not an option for them. They have heart failure, mobility problems. Forget about trying to get to a therapist every week. So the continence pessary is still a great option for someone who has a lot of disability."
She added that weight loss is an excellent treatment for SUI. "I would have liked the study to have mentioned that."
The study was sponsored by the Eunice Kennedy Shriver National Institutes of Child Health and Human Development, the National Institute of Diabetes and Digestive and Kidney Diseases, and the National Institutes of Health Office of Research on Women's Health, National Institutes of Health. Dr. Richter, Dr. Noblett, and Dr. Trowbridge have disclosed no relevant financial relationships.
American Urogynecologic Society (AUGS) 30th Annual Scientific Meeting: Paper 1. Presented September 24, 2009.
