Abraham N. Morse

Exclusion of elderly women from published randomized trials of stress incontinence surgery

OBJECTIVE: More than 20,000 women, aged 70 years or older, undergo surgery for stress urinary incontinence each year. Our objective was to review the published randomized trials of the surgical treatment of stress urinary incontinence and estimate the proportion of women 70 years or older enrolled in those trials. DATA SOURCES: MEDLINE and Cochrane Databases of Clinical Trials were searched from January 1966 through December 2003 with the terms “urinary incontinence,” “stress incontinence,” “urethropexy,” “needle suspension,” “pubovaginal sling,” “tension-free vaginal tape,” “urethral injection,” “collagen injection,” “anterior colporrhaphy,” and “clinical trial,” “controlled trial,” or “randomized trial” as both subject headings and words contained in article titles. We supplemented this search with manual searches of meta-analyses and review articles from 2000 to 2003. METHODS OF STUDY SELECTION: All studies that included at least one group undergoing an invasive treatment for stress incontinence (including urethral bulking injections) were reviewed. We excluded reports without sufficient data to estimate the number of women aged 70 and older who participated, those published only in abstract form, and those studies in languages other than English, French, German, Italian, or Spanish. Twenty studies met our inclusion criteria. TABULATION, INTEGRATION, AND RESULTS: The number of women aged 70 or older in each study was estimated using the demographic data provided. The median percentage of subjects aged 70 or older was 3.8% (interquartile range 0.37–15%). There was no significant difference in the proportion of subjects 70 years of age or older based on the year of publication. CONCLUSION: Our review of the published literature suggests that elderly women are underrepresented in clinical trials of stress incontinence surgery. Efforts should be made to include more elderly women in clinical trials of stress incontinence surgery.

Paper versus web-based administration of the Pelvic Floor Distress Inventory 20 and Pelvic Floor Impact Questionnaire 7

Web-based questionnaires are increasingly employed for clinical research. To investigate whether web-based and paper versions of the Pelvic Floor Distress Inventory 20 (PFDI-20) and Pelvic Floor Impact Questionnaire 7 (PFIQ-7) yield similar results, we compared results obtained with these two modes of administration. Women with pelvic floor disorders completed both versions of these questionnaires. Scores between modes of administration were compared using the paired t test and the intraclass correlation coefficient (ICC). Among the 52 participants, there were no significant differences in scores or scale scores between the web-based and paper questionnaires. The ICC was 0.91 for the PFDI-20 score and 0.81 for the PFIQ-7 score (p < 0.001 for each). The web-based format was preferred by 22 participants (53%), ten (24%) preferred the paper format, and nine (21%) had no preference. The acceptability and score equivalence recommend these web-based questionnaires as an alternative to paper questionnaires for clinical research.

Mesh extrusion through the internal cervical os: an unusual complication following laparoscopic sacrocervicopexy.

Mesh extrusion or exposure is a known complication of procedures using synthetic mesh for vaginal vault and pelvic organ suspension. Preservation of the uterine cervix is thought to be protective against such complications, as the well-vascularized in situ cervix provides an added barrier between the mesh and the colpotomy incision, limiting potential exposure to the vaginal flora. We describe a case of a 55-year-old multipara, who presented with vaginal discharge following a supracervical hysterectomy with sacrocervicopexy and was found to have a delayed mesh extrusion though the endocervical os.

It’s Not All About Birth: Biomechanics Applied to Pelvic Organ Prolapse Prevention

Pelvic organ prolapse is a common and costly womens health problem. Prevention of prolapse continues to play a role in the debate about the risks and benefits of elective cesarean section, making this an important topic for midwives to understand. While some women appear to be at higher risk for prolapse because of intrinsic anatomic and physiologic factors, others have modifiable risk factors that can be addressed by health care providers. This article discusses the current knowledge related to the etiology of prolapse and related components of pelvic anatomy. Biomechanical principles are then applied to enhance the understanding of prolapse development and prevention. Clinical recommendations are based on current evidence regarding topics such as physical activity during pregnancy, treatment of vaginal atrophy, and optimal pelvic floor muscle exercises.

Determining health-related quality of life and health state utility values of urinary incontinence in women.

Objectives: Health-related quality-of-life estimates currently available for urinary incontinence have largely been derived from population-based studies without physician confirmation of diagnosis. The purpose of this study was to compare the health state utility values for urinary incontinence in women derived from EQ-5D questionnaires and visual analog scale (VAS) with the economic gold standard method, the Standard Gamble (SG) interview. Methods: Subjects were approached for study participation after a diagnosis of stress or urge urinary incontinence was made by the attending urogynecologist. Twenty-eight patients completed the Sandvik Severity Index (SSI), EQ-5D, and VAS. They then participated in the SG conversation. Results: The median utility (interquartile range) for stress incontinence varied based on the methods: EQ-5D, 0.83 (0.23); VAS, 0.85 (0.15); and SG, 1.00 (0.01). There was a statistically significant difference between the SG assessment and the other 2 methods of assessing utility values, the EQ-5D and VAS in women with urodynamically demonstrated stress urinary incontinence (P = 0.0003 and P < 0.0001, respectively). In the combined group of women with urodynamically proven stress, urge, and mixed urinary incontinence, there was also a statistically significant difference between the SG and the generic methods of assessing utility values, the EQ-5D and VAS (P < 0.0001). Mean SSI scores were similar in women with stress incontinence (6.6 [23.5]) and in the combined group (7.9 [3.8]). Conclusions: Previous studies may have underestimated the health-related quality of life of urinary incontinence.

Development of a core set of outcome measures for OAB treatment

Introduction and hypothesisStandardized measures enable the comparison of outcomes across providers and treatments giving valuable information for improving care quality and efficacy. The aim of this project was to define a minimum standard set of outcome measures and case-mix factors for evaluating the care of patients with overactive bladder (OAB).MethodsThe International Consortium for Health Outcomes Measurement (ICHOM) convened an international working group (WG) of leading clinicians and patients to engage in a structured method for developing a core outcome set. Consensus was determined by a modified Delphi process, and discussions were supported by both literature review and patient input.ResultsThe standard set measures outcomes of care for adults seeking treatment for OAB, excluding residents of long-term care facilities. The WG focused on treatment outcomes identified as most important key outcome domains to patients: symptom burden and bother, physical functioning, emotional health, impact of symptoms and treatment on quality of life, and success of treatment. Demographic information and case-mix factors that may affect these outcomes were also included.ConclusionsThe standardized outcome set for evaluating clinical care is appropriate for use by all health providers caring for patients with OAB, regardless of specialty or geographic location, and provides key data for quality improvement activities and research.

Patient and Physician Attitudes Toward Low-Value Diagnostic Tests

LESS IS MORE Patient and Physician Attitudes Toward Low-Value Diagnostic Tests Many American physicians think unnecessary tests and procedures are a serious problem facing our health care system, but 53% order unnecessary tests if requested by patients.1 This discrepancy between appropriate and actual care suggests that patients’ perceptions of good care are not aligned with physicians’ commitment to care that optimizes quality while reducing unnecessary interventions. We assessed patients’ and physicians’ perceptions of high-value care.

Infection of ectocervical tissue and universal targeting of T-cells mediated by primary non-macrophage-tropic and highly macrophage-tropic HIV-1 R5 envelopes

BackgroundHIV-1 variants carrying non-macrophage-tropic HIV-1 R5 envelopes (Envs) are predominantly transmitted and persist in immune tissue even in AIDS patients who have highly macrophage-tropic variants in the brain. Non-macrophage-tropic R5 Envs require high levels of CD4 for infection contrasting with macrophage-tropic Envs, which can efficiently mediate infection of cells via low CD4. Here, we investigated whether non-macrophage-tropic R5 Envs from the acute stage of infection (including transmitted/founder Env) mediated more efficient infection of ectocervical explant cultures compared to non-macrophage-tropic and highly macrophage-tropic R5 Envs from late disease.ResultsWe used Env+ pseudovirions that carried a GFP reporter gene to measure infection of the first cells targeted in ectocervical explant cultures. In straight titrations of Env+ pseudovirus supernatants, mac-tropic R5 Envs from late disease mediated slightly higher infectivities for ectocervical explants although this was not significant. Surprisingly, explant infection by several T/F/acute Envs was lower than for Envs from late disease. However, when infectivity for explants was corrected to account for differences in the overall infectivity of each Env+ pseudovirus (measured on highly permissive HeLa TZM-bl cells), non-mac-tropic early and late disease Env+ pseudoviruses mediated significantly higher infection. This observation suggests that cervical tissue preferentially supports non-mac-tropic Env+ viruses compared to mac-tropic viruses. Finally, we show that T-cells were the main targets for infection regardless of whether explants were stimulated with T-cell or monocyte/macrophage cytokines. There was no evidence of macrophage infection even for pseudovirions carrying highly mac-tropic Envs from brain tissue or for the highly mac-tropic, laboratory strain, BaL, which targeted T-cells in the explant tissue.ConclusionsOur data support ectocervical tissue as a favorable environment for non-mac-tropic HIV-1 R5 variants and emphasize the role of T-cells as initial targets for infection even for highly mac-tropic variants.

Laparoscopic repair of vesicouterine fistula.

Background Vesicouterine fistulae are the least common type of urogenital fistulae found in women and are often the result of inadvertent bladder injury at the time of cesarean delivery. Few case reports exist on the management and repair of these fistulae. Case A 41-year-old woman with a history of three cesarean deliveries with persistent urinary incontinence who underwent laparoscopic repair of a vesicouterine fistula. Conclusion Whereas in the past, these fistulae were predominantly repaired via a transvaginal or abdominal approach, vesicouterine fistulae can be successfully repaired endoscopically.

Overactive bladder and stress urinary incontinence: From diagnosis to treatment

Urinary incontinence is not a natural consequence of aging, though many patients believe it is. A focused evaluation and equally focused treatment plan can not only relieve a womans symptoms but significantly improve her quality of life.