Research Results

The CARE Study: Colpopexy and Urinary Reduction Efforts

1) L Brubaker, G Cundiff, P Fine, I Nygaard, H Richter, A Visco, H Zyczynski, MB Brown, A Weber, for the Pelvic Floor Disorders Network. A Randomized Trial of Colpopexy and Urinary Reduction Efforts (CARE): Design and Methods. Controlled Clinical Trials 2003; 24: 629-642.

Many women with pelvic prolapse also have trouble holding their urine. When prolapse and bladder problems occur, doctors can correct both problems at the same time. Some women who have surgery to correct prolapse and bladder problems will find that they leak urine even after the surgery. The goal of the CARE study is to find out the best way to avoid bladder problems in women who have prolapse surgery.

The CARE study will help answer these questions:

• How well does bladder testing before surgery predict future urine leakage?
• What are the benefits and risks of treating bladder problems during prolapse surgery?
  
  

2) L Brubaker, G Cundiff, P Fine, I Nygaard, HE Richter, A Visco, H Zyczynski, MB Brown, AM Weber for the Pelvic Floor Disorders Network. Abdominal Sacrocolpopexy With Burch Colposuspension to Reduce Urinary Stress Incontinence. New England Journal of Medicine 2006; 354: 1557-1566. Editorial 1627-1629.

Many women with pelvic prolapse also have trouble holding their urine. When prolapse and bladder problems occur, doctors can correct both problems at the same time. Some women who have surgery to correct prolapse and bladder problems will find that they leak urine even after the surgery. The goal of the CARE study is to find out the best way to avoid bladder problems in women who have prolapse surgery.

This first report of CARE study results showed that:

• Women who received the Burch had significantly less chance of bothersome stress incontinence after abdominal prolapse surgery.
• There were not more major problems in the women who had the extra (Burch) surgery.
  
  

3) IE Nygaard, R McCreery, L Brubaker, AM Connolly, G Cundiff, A Weber, and H Zyczynski. Abdominal sacrocolpopexy: A comprehensive review. Obstetrics and Gynecology 2004; 104: 805-823.

To prepare for the CARE study, the PFDN team reviewed what was known about abdominal sarcocolpopexy. This surgery is a common treatment for pelvic organ prolapse. The research team wanted to know about its impact on bladder, bowel and sexual function.

From this review, PFDN doctors learned that:

• The surgery relieves pelvic prolapse.
• Patients have a 20% chance of needing surgery again because prolapse, bladder control, or other problems remain.
• The most common problem was an erosion of the mesh used to hold the pelvic organs in place.
• More studies need to be done to find out the impact of the surgery on bladder, bowel, sexual function and quality of life.
• Studies need to follow women over longer periods of time. This will help learn how long the surgical repair will last.
  
  

4) CS Bradley, MB Brown, GW Cundiff, PS Goode, KS Kenton, IE Nygaard, WE Whitehead, PA Wren, and AM Weber for the Pelvic Floor Disorders Network. Bowel symptoms in women planning surgery for pelvic organ prolapse. American Journal of Obstetrics and Gynecology 2006; 195: 1814-9.

Bowel symptoms, such as constipation and fecal incontinence, are common in women and sometimes thought to result from pelvic organ prolapse. The goal of this study was to study the relationship between bowel symptoms and prolapse in women with moderate to severe prolapse who were enrolled in the CARE trial. Bowel symptoms, measured using a questionnaire, were compared to prolapse severity, measured using the Pelvic Organ Prolapse Quantitation (POP-Q) examination system.

The study found that bowel symptoms, including obstructive defecation, anal incontinence, and painful bowel symptoms, did not increase with the severity of prolapse. In other words, women with the most severe forms of prolapse did not have the most bowel symptoms. In fact, women with milder stages of prolapse had more obstructive bowel symptoms (straining to defecate, incomplete defecation, and needing to push around the vagina or anus to defecate) than women with greater degrees of prolapse. These results suggest that prolapse alone cannot explain the presence or absence of bowel symptoms. This study only included information obtained in the CARE trial before surgery was performed, so the results do not indicate whether bowel symptoms will improve or worsen after surgery for prolapse.

5) D Borello-France, MB Brown, V Handa, K Kreder, AM Weber, P Goode, K Kenton for the Pelvic Floor Disorders Network. Pelvic Floor Muscle Function in Women with Pelvic Organ Prolapse. Physical Therapy.

The Pelvic Floor Disorders Network (PFDN) investigators were interested to learn about pelvic floor muscle strength in women seeking surgery for prolapse. Specifically, they were interested to find out whether:

• severity of prolapse as measured by a physician or research nurse;
• self-reported severity of prolapse and urinary symptoms; and
• self-reported impact of prolapse on quality of life and sexual function;

were related to the strength of the woman’s pelvic muscles. 317 women with an average age of 62 years and about to undergo surgery for prolapse were studied. Investigators found that women with the best muscle strength had less severe prolapse and experienced less distress related to urinary symptoms than women who had the least muscle strength. Women reported similar quality of life and sexual function regardless of their pelvic floor muscle strength.

6) I Nygaard, V Handa, L Brubaker, D Borello-France, J Wei, E Wells, A Weber for the Pelvic Floor Disorders Network. Physical Activity in Women Planning Sacrocolpopexy. International Urogynecology Journal 2007; 18: 33-3.

Regular physical activity has many benefits. We know very little about whether women with pelvic organ prolapse (POP) decrease their physical activity. They might do this because of discomfort related to the prolapse, or in an attempt to keep the bulge from coming out. We analyzed the baseline data for women enrolled in the CARE study to describe physical activity before surgery in this population. We found that most women engaged in some type of activity: 76% in mild, 60% in moderate and 26% in strenuous exercise. Activity level did not decrease as prolapse increased. However, 27% of women reported that prolapse substantially interfered with exercise or recreation, while 19% found that prolapse interfered with their ability to do housework or yard work, and 8% reported that prolapse interfered with their ability to work outside the home. We will compare these results to those reported by women one year after surgery to see whether repairing the prolapse has an effect on physical activity.

7) AG Visco, JT Wei, LA McClure, VL Handa, ID Nygaard for the Pelvic Floor Disorders Network, Effects of examination technique modifications on pelvic organ prolapse quantification (POP-Q) results. International Urogynecology Journal 2003; 14: 136-140.

The Pelvic Organ Prolapse Quantification (POP-Q) system is used by doctors to measure prolapse in women during a physical exam. While all seven PFDN clinics used this system, each had a slightly different way of doing the POP-Q exam. This study looked at whether different styles of POP-Q exam affect prolapse measurement.

The study found that:

• The woman's position during her exam changed how her prolapse was measured by the doctor.
• When women stood up for the exam, the doctor could measure more of her prolapse. When women laid down for the exam, the doctor could see and measure less of the prolapse.
• When women tightened their pelvic floor muscles, the measurement of the vaginal opening was longer. When women tightened these muscles, the length of the tissue that separates the vagina from the rectum was longer.
• When women relaxed their pelvic floor muscles, both measures were smaller.
• As a result, doctors recommend taking POP-Q measures when women relax those muscles and also when they tighten them.
  
  

8) PA Wren, NK Janz, L Brubaker, MP Fitzgerald, AM Weber, FB LaPorte, and JT Wei for the Pelvic Floor Disorders Network. Reliability of health-related Quality of life measures one year following pelvic floor surgery. American Journal of Obstetrics and Gynecology 2005; 192:780-788.

Diseases and their treatments affect how patients function on a daily basis. There are several surveys designed to find out how prolapse, bladder, and bowel problems affect women's lives. These surveys ask questions about women's quality of life, whether they can perform their daily activities, and any symptoms or side effects. The PFDN team used these questions to learn more about the quality of life of women with pelvic floor problems.

In this study, women who had prolapse surgery were interviewed over the phone at two time periods about two weeks apart. They answered questions about quality of life and their pelvic floor symptoms. The results showed that the questions do a good job of describing what it is like to live with these problems. The questions were easy to answer and the women had no trouble with the interviews. This pilot study helped to test the questions the PFDN will use to understand women's quality of life in all of their studies.