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Biomedical subjects

Ingrid Nygaard

Publications and source records attributed to Ingrid Nygaard.

22 records · Page 2Linked to original sources

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

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.

Female↗

Proceedings of the National Institute of Diabetes and Digestive and Kidney Diseases International Symposium on Epidemiologic Issues in Urinary Incontinence in Women.

The Epidemiologic Issues in Urinary Incontinence: Current Databases and Future Collaborations Symposium included an international group of 29 investigators from 10 countries. The purpose of the symposium was to discuss the current understanding and knowledge gaps of prevalence, incidence, associated risk factors, and treatment outcomes for incontinence in women. During the symposium, investigators identified existing large databases and ongoing studies that provide substantive information on specific incontinence research questions. The investigators were able to form an international collaborative research working group and identify potential collaborative projects to further research on the epidemiology of urinary incontinence and bladder dysfunction.

Databases, Factual↗

Anorectal dysfunction after surgical treatment for cervical cancer.

BACKGROUND: Although bowel symptoms and complaints are common after radical hysterectomy, the effects of operation on anorectal function are incompletely understood. In this prospective pilot study we evaluated the incidence of bowel symptoms, changes in anorectal physiology, and quality of life after radical hysterectomy. STUDY DESIGN: Eleven women undergoing radical hysterectomy for early-stage cervical cancer completed bowel function symptom surveys and cancer-specific quality-of-life scales before operation and at 6 weeks and 6 months after operation. The bowel function symptom survey was also repeated at 18 months postoperation. Anorectal manometry, balloon defecation, and pudendal nerve latency tests were performed before the operation and 6 months postoperatively. RESULTS: The mean age was 45.3 years (range 34 to 56 years), and four of the patients were postmenopausal. Resting and squeeze sphincter pressures, volume of saline infused at first leak, total volume retained, and threshold volume for maximum tolerable volume were all decreased significantly (p < 0.05) after operation. Pudendal nerve terminal motor latency increased (p < 0.05) bilaterally. There were no significant differences in sensory thresholds. At 18 months, two women reported constipation, six reported flatus incontinence, and two reported fecal incontinence. The total quality-of-life score declined at 6 weeks but then improved significantly by 6 months (p = 0.02). CONCLUSIONS: Bowel dysfunction is common after radical hysterectomy. Many women exhibit manometric and subjective changes compatible with fecal incontinence.

Adult↗

Pelvic organ prolapse in the Women's Health Initiative: gravity and gravidity.

OBJECTIVE: The purpose of this study was to describe the prevalence of and correlates for pelvic organ prolapse. STUDY DESIGN: This was a cross-sectional analysis of women who enrolled in the Women's Health Initiative Hormone Replacement Therapy Clinical Trial (n = 27,342 women). Baseline questionnaires ascertained demographics and personal habits. A baseline pelvic examination assessed uterine prolapse, cystocele, and rectocele. Descriptive statistics and logistic regression models were used to investigate factors that were associated with pelvic organ prolapse. RESULTS: In the 16,616 women with a uterus, the rate of uterine prolapse was 14.2%; the rate of cystocele was 34.3%; and the rate of rectocele was 18.6%. For the 10,727 women who had undergone hysterectomy, the prevalence of cystocele was 32.9% and of rectocele was 18.3%. After controlling for age, body mass index, and other health/physical variables, African American women demonstrated the lowest risk for prolapse. Hispanic women had the highest risk for uterine prolapse. Parity and obesity were strongly associated with increased risk for uterine prolapse, cystocele, and rectocele. CONCLUSION: Pelvic organ prolapse is a common condition in older women. The risk for prolapse differs between ethnic groups, which suggests that the approaches to risk-factor modification and prevention may also differ. These data will help address the gynecologic needs of diverse populations.

Black or African American↗