Combo Therapy No Better Than Surgery Alone for Incontinence

Veronica Hackethal, MD

September 17, 2019

Adding behavioral and pelvic muscle floor muscle therapy to surgery may not improve outcomes in women with mixed urinary incontinence, according to results from the Effects of Surgical Treatment Enhanced With Exercise for Mixed Urinary Incontinence (ESTEEM) trial published online today in JAMA.

"Among women with mixed urinary incontinence, the addition of perioperative behavioral and pelvic floor muscle therapy to midurethral sling surgery resulted in a difference in urinary incontinence symptoms that may not be clinically important," write Vivian W. Sung, MD, MPH, of Women and Infants Hospital of Rhode Island in Providence, and colleagues with the NICHD Pelvic Floor Disorders Network.

Urinary incontinence affects more than 50% of women, and up to 50% of those affected have mixed urinary incontinence — a combination of stress and urgency incontinence. Stress incontinence refers to involuntary loss of urine upon physical exertion or other effort. Urgency incontinence refers to leakage of urine associated with a feeling of urgency.

Mixed urinary incontinence is thought to be more severe and difficult to treat than either stress or urgency incontinence alone. First-line treatment includes behavioral and pelvic floor muscle training, followed by overactive-bladder medication. Less-used conservative options include neuromodulation or continence pessaries. Although surgery is considered a last resort, approximately 1 in 5 women with urinary incontinence in the United States ultimately proceed to surgery by age 80 years.

Because surgery may worsen the urgency component of mixed incontinence, guidelines recommend treating urgency before surgery. No high-quality evidence exists on how to improve both components in women with mixed incontinence.

To compare behavioral and pelvic floor therapy after surgery with surgery alone, the researchers conducted a randomized controlled trial at nine high-volume surgical sites in the NIH-sponsored Pelvic Floor Disorders Network. The study took place from October 2013 to October 2017, and included women aged 21 years and older who suffered from moderate to severe mixed urinary incontinence for at least 3 months.

The analysis included 209 women randomly assigned to behavioral and pelvic floor muscle therapy with midurethral sling surgery and 207 women assigned to midurethral sling surgery alone. Participants had a mean age of 54 years, and were 78.5% white, 8.9% African American, and 22.9% Latina.

Behavioral and pelvic floor therapy consisted of one preoperative and five postoperative sessions up to 6 months after surgery. Sessions covered education, muscle training, bladder training, and strategies to control symptoms. Eighty-four percent (198/235) of the combined therapy + surgery group and 89% (204/229) of the surgery-only group completed assessment at 12 months.

Patients self-reported their outcomes on a variety of validated questionnaires designed specifically to assess incontinence symptoms.

The primary outcome was 12-month change in overall urogenital distress, as reported on the Urogenital Distress Inventory (UDI) long form — a validated symptom questionnaire that asks about irritative symptoms, stress incontinence, and obstructive symptoms. Scores range from 0 to 300 points with higher scores indicating worse symptoms. A difference of 35 points is considered minimally clinically important.

Researchers adjusted results for time since baseline, clinical site, severity of incontinence, and factors related to treatment and retreatment.

Overall symptoms improved in both groups.

The combined therapy + surgery group had an unadjusted UDI score that decreased from 178.0 points at baseline to 30.7 points at 12 months, with an adjusted mean change of −128.1 points (95% confidence interval [CI], −146.5 to −109.8).

The surgery-only group had an unadjusted UDI score that decreased from 176.8 points at baseline to 34.5 points at 12 months, with an adjusted mean change −114.7 points (95% CI, −133.3 to −96.2).

However, further analyses showed the difference between the two groups did not meet the minimal clinically important difference threshold (−13.4 points; 95% CI, −25.9 to −1.0; P = .04).

The two groups did not show clinically important differences in other outcomes, including irritative and stress scores on the UDI (model-estimated between-group difference −6.1 points; 95% CI, −12.1 to −0.2; P = .04; and −5.5 points; 95% CI, −11.5 to 0.6; P = .08, respectively).

However, the combined therapy + surgery group did have significantly fewer lower urinary tract symptoms at 12 months than the surgery-only group (8.5% vs 15.7%, respectively; adjusted odds ratio, 0.47; 95% CI, 0.26 - 0.85), and longer time to retreatment.

Serious adverse events occurred in 10.2% of total participants, with a smaller percentage in the combined therapy + surgery group (8.7% combined vs 11.8% surgery only).

"The ESTEEM trial was well done and robust and should be used to guide clinical care," writes Ingrid E. Nygaard, MD, from the University of Utah School of Medicine in Salt Lake City, in an accompanying editorial.

"The results are likely generalizable to women with mixed incontinence without pelvic organ prolapse," she adds.

She went on to note several clinical implications of this study. First, women with mixed incontinence who do not improve with conservative therapy can "reasonably" be offered midurethral sling surgery.  

Noting that about 85% of women in both groups "reported being much or very much improved," and that women reported a more than 80% decrease in symptoms after surgery, she writes:

"Most patients can expect marked reduction in both stress and urgency incontinence symptoms and high satisfaction at 1 year. These women can proceed with surgery alone because benefit was not shown for adding a behavioral therapy package."

Because a small percentage of women — about 15% — will not show much improvement after surgery, research is needed to help predict which women may and may not respond.

The authors mention several potential limitations. At the time of the study, thresholds for defining minimally clinically important differences for women with mixed incontinence had not been established. Also, participants were not masked.

The study was supported by the National Institute of Child Health and Human Development (NICHD) and the NIH Office of Research on Women's Health. Sung reported receiving grants from NICHD, National Institute on Aging (NIA), and Patient-Centered Outcomes Research Institute (PCORI). Study author Donna Mazloomdoost is an employee of NIH. One or more authors report grants, editorial fees, personal fees, travel reimbursement, and/or other support from one or more of the following: NICHD, NIA, PCORI, the National Institute of Diabetes and Digestive and Kidney Diseases, Digital Science Press, Brown University, Renovia, the National Institutes of Health, BlueWind Medical, UpToDate, Boston Scientific, Cogentix/Uroplasty, Axonics, US Department of Defense, Caldera, UroCure, Gray's Anatomy, Viveve, American College of Obstetricians and Gynecologists, American Board of Obstetrics and Gynecology, Coloplast Inc, and/or Ethicon Inc.

Nygaard served as a site principal investigator for the Pelvic Floor Disorders Network from 2001 to 2012 but was not involved in the ESTEEM trial.

JAMA. Published online September 17, 2019. Abstract, Editorial

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