BETHESDA, Maryland, Sept. 17, 2019 /PRNewswire-HISPANIC PR WIRE/ — Surgery for stress urinary incontinence (leaking that occurs with a cough or sneeze) improves symptoms of another form of incontinence, called urgency urinary incontinence, in women who have both types, according to a study supported by the National Institutes of Health. The findings challenge current treatment guidelines, which suggest that the surgery may worsen urgency urinary incontinence in women with both forms, also called mixed urinary incontinence. The study appears in the Journal of the American Medical Association. Funding was provided by NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and Office of Research on Women’s Health.

“Women with mixed urinary incontinence may have more bothersome symptoms than women with either stress or urgency urinary incontinence alone,” said Donna Mazloomdoost, M.D., study author and program director of the NICHD Pelvic Floor Disorders Network. “The findings show promise in treating a condition that can be hard to manage under existing practices.”

Roughly one-third to one-half of all women with urinary incontinence have mixed urinary incontinence. Urgency urinary incontinence results from the spontaneous contraction of bladder muscles, leading to a strong and sudden need to urinate. Stress urinary incontinence occurs when urine leaks out after abdominal pressure increases following a sneeze, cough, laugh or movement, which squeezes the bladder.

Standard treatment guidelines for mixed urinary incontinence often involve treating the two forms of incontinence independently. Urgency urinary incontinence often is first treated with behavioral techniques, such as trying to delay urinating for a brief period after feeling the urge, reducing liquid consumption, exercises to strengthen muscles around the bladder (involving pelvic floor physical therapy) and with medication. Surgery is not usually recommended early on. Stress incontinence also can be treated with exercises, and many women experience symptom improvement. However, in women who do not improve or opt out of the exercises, surgery may be offered.

The Effects of Surgical Treatment Enhanced with Exercise for Mixed Urinary Incontinence (ESTEEM) study is a randomized clinical trial that recruited 480 women with mixed urinary incontinence at centers across the United States. All participants underwent mid-urethral sling surgery, a well-established method that places a thin strip of mesh under the urethra; this helps prevent urine from leaking out during an exertion, such as a sneeze or cough. Participants were randomized to surgery alone or surgery with behavioral and pelvic floor muscle therapy, which included six visits with a trained health professional. They were followed for one year.

The women responded to a questionnaire, the urogenital distress inventory (UDI), which inquired about urinary symptoms. Symptoms are ranked from 0-300 points, depending on severity. They also responded to surveys on quality of life and perceptions of surgical success.

The study team found that both groups had significant improvements in their incontinence symptoms after surgery. The average UDI score for the surgery alone group was 176.8 before surgery and 40.3 a year after surgery; for the surgery and therapy combined group, the UDI score dropped from 178.0 to 33.8. According to the researchers, because the post-treatment UDI scores between the two groups did not differ greatly, adding behavioral and pelvic floor muscle therapy to the treatment may not result in better clinical outcomes.

However, the study team did find differences in other self-reported outcomes. The combined surgery and physical therapy group had fewer instances of incontinence a year after surgery and were less likely to receive additional treatment for urinary tract symptoms, suggesting they had more quality of life improvement than the surgery alone group.

“Current practice guidelines may be unnecessarily delaying surgery for women with mixed urinary incontinence,” said Vivian W. Sung, M.D., M.P.H., the study’s lead author and a professor at the Warren Alpert Medical School of Brown University in Providence, Rhode Island. “We hope these findings will improve how patients are counseled and treated.”

The researchers called for additional research to identify which patients with mixed urinary incontinence are at risk for continued symptoms after surgery and to identify effective treatments for them.

REFERENCE: 

Sung VW et al., Effect of behavioral and pelvic floor muscle therapy combined with surgery vs. surgery alone on incontinence symptoms among women with mixed urinary incontinence: the ESTEEM randomized clinical trial. Journal of the American Medical Association DOI: 10.1001/jama.2019.12467 (2019)

About the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): NICHD leads research and training to understand human development, improve reproductive health, enhance the lives of children and adolescents, and optimize abilities for all. For more information, visit http://www.nichd.nih.gov.

About the National Institutes of Health (NIH): NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.

SOURCE Eunice Kennedy Shriver National Institute of Child Health and Human Development

BETHESDA, Maryland, Sept. 17, 2019 /PRNewswire-HISPANIC PR WIRE/ — Two surgical procedures used to correct vaginal prolapse—one to remove the uterus and one that supports the uterus with mesh—have comparable three-year outcomes, according to a new study funded by the National Institutes of Health. To date, the randomized clinical trial provides the longest-term comparison of the procedures, and researchers will continue to follow the patients for a total of five years. The study appears in the Journal of the American Medical Association and was funded by NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and Office of Research on Women’s Health.

“These findings provide important information for women who have had these procedures and for the physicians entrusted with their care,” said Donna Mazloomdoost, M.D., one of the study authors and program director of the NICHD Pelvic Floor Disorders Network, which supported the work.

Vaginal prolapse is a pelvic floor disorder that occurs when support muscles weaken and pelvic organs press down on the vagina, sometimes forcing it to bulge or protrude from the vaginal opening. This condition is more likely to occur as a woman gets older.

Traditionally, surgeons treat vaginal prolapse by removing the uterus, thereby providing access to deep pelvic ligaments, such as the uterosacral ligaments. The top of the vagina can then be attached to those ligaments in a procedure known as uterosacral ligament suspension. Other procedures, such as mesh hysteropexy, do not require removal of the uterus and instead use mesh to suspend the uterus and pelvic organs so they no longer fall out of place. However, the U.S. Food and Drug Administration halted the sale and distribution of mesh kits for vaginal prolapse repair on April 16, 2019 for safety reasons, after the current study was completed.

The Study of Uterine Prolapse Procedures – Randomized Trial (SUPeR) is a randomized clinical trial that recruited 183 postmenopausal women at nine centers across the United States. Ninety-three women were randomized to mesh hysteropexy and 90 were randomized to hysterectomy with uterosacral ligament suspension.

The researchers compiled a failure rate for each procedure using a standard examination called the Pelvic Organ Prolapse Quantification System and whether women reported new symptoms of prolapse or needed retreatment for prolapse (i.e., another surgery or use of a supportive device called a pessary). The study team found that after three years, mesh hysteropexy had a 26% failure rate, while hysterectomy had a 38% failure rate. The difference in the two rates was not statistically significant, according to the authors.

“More long-term research is needed to determine if one procedure is better than the other,” said Charles W. Nager, the lead author of the study and chair of the Department of Obstetrics, Gynecology and Reproductive Sciences at UC San Diego Health. “After the five-year follow-up period, we’ll reanalyze the results.”

No differences were found in patient-reported outcomes on surgical pain, pelvic pain and body image. Similar proportions in each group reported “much better” or “very much better” improvements in their symptoms (90% of respondents for mesh hysteropexy, 89% for hysterectomy) when queried at three years. Both groups also reported improvements in sexual function and lower incidence of painful sex (dyspareunia).

The study team also found no significant differences in adverse events, such as urinary tract infections and incontinence, between the two groups. The mesh hysteropexy group had an 8% mesh exposure rate, meaning the mesh became visible through the vaginal wall. For some women, this causes no symptoms, but for others, it may cause pain, bleeding or other problems. None of the women in this study required surgery for their mesh-related complications. The study team also did not observe any significant problems with uterine tissue in the mesh group during the three years of follow-up. Surgery for mesh hysteropexy was shorter than hysterectomy by about 45 minutes (average of 111.5 minutes compared to 156.7 minutes).

REFERENCE: 

Nager CW et al., Effect of vaginal mesh hysteropexy vs vaginal hysterectomy with uterosacral ligament suspension on treatment failure in women with uterovaginal prolapse: a randomized clinical trial. Journal of the American Medical Association DOI: 10.1001/jama.2019.12812  (2019)

About the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): NICHD leads research and training to understand human development, improve reproductive health, enhance the lives of children and adolescents, and optimize abilities for all. For more information, visit http://www.nichd.nih.gov.

About the National Institutes of Health (NIH): NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov. 

SOURCE Eunice Kennedy Shriver National Institute of Child Health and Human Development