Primary papers:
Paper 1 describes the design of the CARE study. Paper 2 presents the key results at the 3-month endpoint and Paper 3 presents the key results at the 12- and 24-month endpoints. Papers 4 and 5 describe results of other primary goals of the CARE study. Paper 6 is a comprehensive review paper of the abdominal sacrocolpopexy surgical procedure. Papers 7-18 present the results of ancillary analyses of the data.

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) L Brubaker,I Nygaard,HE Richter, A Visco, AM Weber, GW Cundiff, P Fine, C Ghetti, MB Brown for the Pelvic Floor Disorders Network. Two-year Outcomes Following Sacrocolpopexy With and Without Burch to Prevent Stress Urinary Incontinence. Obstetrics & Gynecology, 2008; 112:49-55. (PubMed#:18591307)

4) KL Burgio, IE Nygaard, HE Richter, L Brubaker, RE Gutman, W Leng, J Wei, AM Weber for the Pelvic Floor Disorders Network. Bladder Symptoms One Year after Abdominal Sacrocolpopexy with and without Burch Colposuspension in Women without Preoperative Stress Incontinence Symptoms. American Journal of Obstetrics and Gynecology, 2007; 197: 647.e1-e6. (PubMed#:18060965)

5) AG Visco, L Brubaker, G Cundiff, P Fine, I Nygaard, HE Richter, H Zyczynski, MB Brown, AM Weber for the Pelvic Floor Disorders Network. The Role of Pre-Operative Urodynamic Testing in Stress Continent Women. Undergoing Sacrocolpopexy: The Colpopexy and Urinary Reduction Efforts (CARE) Randomized Surgical Trial. International Urogynecology Journal, 2008; 19: 607-614. (PubMed#:18185903)

6) 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.

7) 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: 33-37. (PubMed#:16688397)

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.

8) CS Bradley, MB Brown, GW Cundiff, PS Goode, KS Kenton, IE Nygaard, WE Whitehead, PA Wren, 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: 1814-1819.

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.

9) D Borello-France, VL Handa, MB Brown, P Goode, K Kreder, LL Lcheufele, AM Weber, K Kenton for the Pelvic Floor Disorders Network. Pelvic Floor Muscle Function in Women with Pelvic Organ Prolapse. Physical Therapy 2007; 87: 399-407. (PubMed#:17341510)

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.

10) HE Richter, PS Goode, K Kenton, MB Brown, KL Burgio, K Kreder, P Moalli, EJ Wright, AM Weber for the Pelvic Floor Disorders Network. The Effect of Age on Short-Term outcomes After Abdominal Surgery For Pelvic Organ Prolapse. Journal of the American Geriatrics Society 2007; 55:857-863. (PubMed#:17537085)

11) MP Fitzgerald, N Janz, P Wren, J Wei, AM Weber, C Ghetti, G Cundiff for the Pelvic Floor Disorders Network. Prolapse Severity, Symptoms and Impact on Quality of Life Among Women Planning Sacrocolpopexy. International Journal of Gynecology and Obstetrics, 2007;98:24-28. (PubMed#:17477927)

12) WE Whitehead, CS Bradley, MB Brown, L Brubaker, RE Gutman, RE Varner, AG Visco, AM Weber, H Zyczynski for the Pelvic Floor Disorders Network. Gastrointestinal Complications Following Abdominal Sacrocolpopexy for Advanced Pelvic Organ Prolapse. American Journal of Obstetrics and Gynecology, 2007;197;78.e1-78.e7. (PubMed#:17618767)

13) VL Handa, HM Zyczynski, L Brubaker, I Nygaard, NK Janz, HE Richter, PA Wren, MB Brown, AM Weber for the Pelvic Floor Disorders Network. Sexual Function Before and After Sacrocolpopexy for Pelvic Organ Prolapse. American Journal of Obstetrics and Gynecology, 2007; 197: 629.e1-e6. (PubMed#:18060957)

14) CS Bradley, IE Nygaard, MB Brown, RE Gutman, KS Kenton, WE Whitehead, PS Goode, PA Wren, C Ghetti, AM Weber for the Pelvic Floor Disorders Network. Bowel Symptoms in Women One Year after Sacrocolpopexy. American Journal of Obstetrics and Gynecology, 2007; 197: 642.e1-e8. (PubMed#:18060963)

15) I Nygaard, VL Handa, L Brubaker, D Borello-France, J Wei, E Wells, P Goode for the Pelvic Floor Disorders Network. Changes in Physical Activity after Surgery for Advanced Pelvic Organ Prolapse. American Journal of Obstetrics and Gynecology, 2008; 198:570.e1-e5. (PubMed#:18455536)

16) PA Wren, NK Janz, MP FitzGerald, MD Barber, KL Burgio, GW Cundiff, IE Nygaard, HM Zyczynski, MB Brown, for the Pelvic Floor Disorders Network. Life Orientation and Optimism in Women Undergoing Abdominal Sacrocolpopexy for Pelvic Organ Prolapse. Journal of the American College of Surgeons, 2008; 207:240-245 (PubMed#:18656053)

17) PS Goode, MP FitzGerald, HE Richter, WE Whitehead, I Nygaard, PA Wren, HM Zyczynski, G Cundiff, S Menefee, JM Senka, X Gao, AM Weber for the Pelvic Floor Disorders Network. Enhancing Participation of Older Women in Surgical Trials. Journal of the American College of Surgeons, 2008; 207:303-311. (PubMed#:18722933)

18) CS Bradley, KS Kenton, HE Richter, X Gao, HM Zyczynski, AM Weber, IE Nygaard for the Pelvic Floor Disorders Network. Obesity and outcomes after sacrocolpopexy. American Journal of Obstetrics and Gynecology, 2008;199: 690.e1-690.e8. (PubMed#:18845288)