A randomized trial of colpopexy and urinary reduction efforts (CARE): design and methods

被引:83
作者
Brubaker, L
Cundiff, G
Fine, P
Nygaard, I
Richter, H
Visco, A
Zyczynski, H
Brown, MB
Weber, A
机构
[1] Loyola Univ, Med Ctr, Dept Obstet & Gynecol, Maywood, IL 60153 USA
[2] Johns Hopkins Univ, Dept Obstet & Gynecol, Baltimore, MD USA
[3] Baylor Coll Med, Dept Obstet & Gynecol, Houston, TX 77030 USA
[4] Univ Iowa, Dept Obstet & Gynecol, Iowa City, IA USA
[5] Univ Alabama, Dept Obstet & Gynecol, Birmingham, AL 35294 USA
[6] Univ N Carolina, Dept Obstet & Gynecol, Chapel Hill, NC USA
[7] Univ Pittsburgh, Dept Obstet & Gynecol, Pittsburgh, PA USA
[8] NICHHD, Bethesda, MD 20892 USA
来源
CONTROLLED CLINICAL TRIALS | 2003年 / 24卷 / 05期
关键词
pelvic organ prolapse; sacrocolpopexy; urinary incontinence; paravaginal defect repair; randomized surgical trial; urodynamics;
D O I
10.1016/S0197-2456(03)00073-4
中图分类号
R-3 [医学研究方法]; R3 [基础医学];
学科分类号
1001 ;
摘要
The primary aim of this randomized clinical trial is to evaluate whether a standardized modified Burch colposuspension, when added to planned abdominal sacrocolpopexy for the treatment of pelvic organ prolapse, improves the rate of urinary stress continence in subjects without preoperative symptoms of stress urinary incontinence. Secondary aims include comparison of immediate and short-term complications, overall urinary tract function, and other aspects of pelvic health between subjects with and without a concomitant Burch. The value of preoperative urodynamic testing with prolapse reduction will also be compared between subjects with and without a concomitant Burch. This trial is performed through the Pelvic Floor Disorders Network, which is funded by the National Institutes of Health-National Institute of Child Health and Human Development. Subjects will be enrolled at seven clinical centers across the United States and data will be analyzed by the central data coordinating center. Standardized questionnaires and physical observations and measurements will be obtained. The surgical team is masked to the preoperative urodynamic findings, and the patient and research coordinator are masked to treatment assignment. The primary outcome will be determined at 3 months after surgery. Stress continence is defined as absence of stress incontinence symptoms by questionnaire, a negative standardized stress test, and no treatment for stress incontinence other than the study intervention. Additional follow-up occurs at 6, 12; and 24 months. Accrual began in April 2002 and is projected to take 3 years. As of March 6, 2003, 91 patients have been randomized. This article highlights the scientific aspects of trial design for this pivotal clinical trial. The optimal approach to the urinary tract in women treated surgically for prolapse is not known. This trial is designed to provide pelvic surgeons and their patients with scientific data regarding the utility of urodynamics with and without prolapse reduction and the role of colposuspension with sacrocolpopexy. (C) 2003 Elsevier Inc. All rights reserved.
引用
收藏
页码:629 / 642
页数:14
相关论文
共 20 条
[1]   Psychometric evaluation of 2 comprehensive condition-specific quality of life instruments for women with pelvic floor disorders [J].
Barber, MD ;
Kuchibhatla, MN ;
Pieper, CF ;
Bump, RC .
AMERICAN JOURNAL OF OBSTETRICS AND GYNECOLOGY, 2001, 185 (06) :1388-1395
[2]  
Bennett KJ, 1996, QUALITY LIFE PHARMAC
[3]   3 SURGICAL-PROCEDURES FOR GENUINE STRESS-INCONTINENCE - 5-YEAR FOLLOW-UP OF A PROSPECTIVE RANDOMIZED STUDY [J].
BERGMAN, A ;
ELIA, G .
AMERICAN JOURNAL OF OBSTETRICS AND GYNECOLOGY, 1995, 173 (01) :66-71
[4]   The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction [J].
Bump, RC ;
Mattiasson, A ;
Bo, K ;
Brubaker, LP ;
DeLancey, JOL ;
Klarskov, P ;
Shull, BL ;
Smith, ARB .
AMERICAN JOURNAL OF OBSTETRICS AND GYNECOLOGY, 1996, 175 (01) :10-17
[5]   A randomized comparison of Burch colposuspension and abdominal paravaginal defect repair for female stress urinary incontinence [J].
Colombo, M ;
Milani, R ;
Vitobello, D ;
Maggioni, A .
AMERICAN JOURNAL OF OBSTETRICS AND GYNECOLOGY, 1996, 175 (01) :78-84
[6]  
DIOKNO AC, 1986, J UROLOGY, V136, P1022
[7]   Correlation of symptoms with location and severity of pelvic organ prolapse [J].
Ellerkmann, RM ;
Cundiff, GW ;
Melick, CF ;
Nihira, MA ;
Leffler, K ;
Bent, AE .
AMERICAN JOURNAL OF OBSTETRICS AND GYNECOLOGY, 2001, 185 (06) :1332-1337
[8]   A community-based epidemiological survey of female urinary incontinence: The Norwegian EPINCONT Study [J].
Hannestad, YS ;
Rortveit, G ;
Sandvik, H ;
Hunskaar, S .
JOURNAL OF CLINICAL EPIDEMIOLOGY, 2000, 53 (11) :1150-1157
[9]  
HERZOG AR, 1990, J GERONTOL, V45, P67
[10]   THE QUALITY-OF-LIFE IN WOMEN WITH URINARY-INCONTINENCE AS MEASURED BY THE SICKNESS IMPACT PROFILE [J].
HUNSKAAR, S ;
VINSNES, A .
JOURNAL OF THE AMERICAN GERIATRICS SOCIETY, 1991, 39 (04) :378-382