Clinical use of the FemAssist device in female urinary incontinence.

OBJECTIVE: We sought to determine the safety and effectiveness of a new, simple noninvasive device, "FemAssist" for women suffering from urinary incontinence. METHODS: The "FemAssist" is a dome-shaped medical grade silicon device intended to be worn over the external urethral meatus and held in place by suction and an adhesive gel. Thirty eight women with varying degrees of genuine stress urinary incontinence (GSUI) or mixed incontinence on multichannel urodynamic testing were fitted with one of two sizes of "FemAssist" with regard to their anatomy and dexterity. RESULTS: Thus far, of the 38 women who have completed the study, there have been no reported significant increases in bacteriuria or urinary tract infection rates. Over half of the women reported an improvement in the quality of life including comfort, convenience, and overall satisfaction. The device was worn for a total of 886 days by the group; 82% of these were dry days. CONCLUSION: Our preliminary study suggests that the "FemAssist" device is safe and effective for some women with urinary incontinence.

A computerized voiding diary.

OBJECTIVE: To examine a group of subject and control patient's preferences and compliance with regard to the Compu-Void (CV) electronic voiding diary as compared to the written diary (WD) and to compare the two methods with respect to the type of information obtained and whether the order of use of each method influenced results in the subject group. STUDY DESIGN: Thirty-six women between the ages of 20 and 84 with bladder symptoms were compared to a group of 36 age-matched women. RESULTS: In 100% of subjects and 95% of control patients, CV entries exceeded the number made with the WD in voiding events and, in subjects, in incontinence episodes recorded (P < .005 and P < .005, respectively). Over 98% of subjects and over 80% of controls preferred the CV (P < .0005). The order of use of each method in subjects made no significant difference with regard to the volume of information obtained (P < .407), number of leakage events recorded (P < .494) or fluid intake patterns (P < .410). Patients' compliance with each method was not affected by the order of use. CONCLUSION: Our results suggest an increased volume of data and greater patient compliance in reporting bladder symptoms and events using the CV and that the order of use is not important.

"Compu-Void II": the computerized voiding diary.

OBJECTIVE: We have previously described an electronic voiding diary, "Compu-Void" (Copyright, 1990) developed to automate recording of bladder symptoms (Rabin et al., 1993). Our objectives in this, the second phase of this study, were to examine a group of subject and control patients' preference and compliance with regard to the "Compu-Void" (CV) compared to the standard written voiding diary (WD), to compare the two methods with respect to the amount and type of information obtained and to determine whether or not the order of use of each recording method influenced results in the subject group. METHODS: Thirty-six women between the ages of 20 and 84 with bladder symptomatology were compared to a group 36 age-matched women. RESULTS: In 100% of subjects and 95% of control patients, CV entries exceeded the number made with the WD in voiding events and in subjects, in incontinent episodes recorded (P < 0.0005 and P < 0.005, respectively). Over 98% of subjects and over 80% of control patients preferred CV over the WD (p < 0.0005). The order of use of each recording method in subjects made no significant difference with regard to the volume of information obtained (p < 0.407), number of urinary leakage events recorded (p < 0.494), and fluid intake patterns (p < 0.410). Patient impressions of, and compliance with each method were not affected by order of use. The only difference regarding order of use was that most subjects who used the CV first also found the WD to be tedious (61% vs 14%). CONCLUSIONS: Our results suggest increased volume of data and of patient compliance in reporting bladder symptoms and events using CV, and that order of use is not an important factor in determining patient impressions of the two methods. The majority of subject and control patients preferred CV over traditional methods. An updated version of the software and hardware is also included.

An estrogen receptor genetic polymorphism and a history of spontaneous abortion--correlation in women with estrogen receptor positive breast cancer but not in women with estrogen receptor negative breast cancer or in women without cancer.

We previously identified a polymorphism in the human estrogen receptor gene. In a preliminary study on women with estrogen receptor positive (ER+) breast tumors, we found that the presence of the rarer of the two alleles, the B' allele, is correlated with a history of spontaneous abortion. Because that study evaluated only women with estrogen receptor positive (ER+) breast cancer, it was unknown whether the observed correlation was restricted to the cancer group or was independent of breast cancer. We have now extended our analysis to include not only additional women with ER+ breast cancer, but also those with estrogen receptor negative (ER-) breast cancer and women without cancer. Results of the current study continue to show an association between the B' allele and a history of spontaneous abortion in the ER+ breast cancer group. There was no such correlation either in the ER- breast cancer group or in the group without cancer. Also, we continue to observe, in the ER+ breast cancer group, a significantly higher concentration of ER protein in tumors from homozygous wild type women (genotype BB), than in the tumors from women who are heterozygous for the rarer allele (genotype BB'). We conclude that the combination of spontaneous abortion and the BB' ER genotype may be a marker for breast cancer susceptibility.

Computerized voiding diary.

An electronic, computerized voiding diary, "Compu-Void" (patent pending) was developed in order to simplify, augment, and automate patients' recording of bladder symptomatology. A voiding diary as a tool has the potential to provide essential information for a more complete diagnostic and therefore therapeutic picture for each patient. Two major problems with the standard written voiding diary have been a lack of patient compliance and the limited amount of information it garners. Twenty-five women with various types of voiding dysfunctions were compared to twenty-five age and parity-matched control women in order to determine patient preferences of the Compu-Void when compared to the standard written voiding diary, compliance with each method, and amount and quality of information obtained with each method. Over 90% of subjects and over 70% of control group patients preferred the Compu-Void over the written diary (P < 0.005). The amount and quality of information obtained with Compu-Void exceeded that obtained with the written method.

Type IX Ehlers-Danlos syndrome: bladder diverticula with transitional cell carcinoma.

Patients with type IX Ehlers-Danlos syndrome have a tendency for development of diverticulae of the urinary bladder, and these often recur after surgical excision. We report on a patient with this syndrome in whom an extensively infiltrating transitional cell carcinoma developed in a diverticulum. To our knowledge, this is the first reported case of malignancy developing in a patient with type IX Ehlers-Danlos syndrome. The highly aggressive nature of the neoplasm is discussed in relation to the dampened desmoplastic response to the tumor, observed in this patient.

The long term benefits of a comprehensive teenage pregnancy program.

A comprehensive program was founded in 1982 to provide adolescents with prenatal and family planning care. The program's impact through its first five years of operation on medical aspects of pregnancy course and fetal outcome will be the subject of a separate report. This study examines subsequent maternal and infant health of the patients attending the program compared to a control group. Four hundred ninety-eight adolescents and their newborns attending the program's mother-baby family planning clinic from 1982 to 1989 (subject group) were compared to ninety-one adolescents and their newborns receiving postpartum family planning and pediatrics clinics from 1980 through 1989 (control group). Seventy-five percent of the subject group regularly attended mother-baby clinic, compared to 18% of the control group attending family planning and pediatric clinics (P less than or equal to .0001). The subject group experienced less maternal and infant morbidity, greater school attendance, graduation, employment, and contraceptive use than the control group (P less than or equal to .0001). Many parameters improved with each program year indicating continued wide acceptance of our program by area adolescents.

Topical anesthesia for gynecologic procedures.

Topical benzocaine 20% gel was evaluated for its ability to reduce pain associated with several common gynecologic procedures. In the first phase of the investigation, designed to determine the efficacy of the gel, 40 women received it before one or more of five procedures (cervical biopsy, intrauterine device insertion, endocervical curettage, paracervical block, and tenaculum placement). These women reported significantly less pain than 42 control subjects (P less than .05 to P less than .0005). In the second phase of the study, a placebo gel was compared in a blind fashion with 20% benzocaine gel in 63 study subjects and 64 control women undergoing procedures similar to those in the first part of the study. The modal pain rating by both physician and patient was "none" in the study group for all procedures except endocervical curettage, for which the rating was "mild"; ratings were "mild" or "moderate" in the control group. Compliance with respect to keeping follow-up visits was significantly greater in the study group. These data indicate that benzocaine 20% significantly reduces the pain experienced by patients after many gynecologic procedures performed vaginally.