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Clinical safety-in-use study of a new tampon design.

OBJECTIVE: To confirm the safety of a new experimental Tampax tampon and applicator compared with that of a currently marketed Tampax tampon and applicator using comprehensive gynecological and microbiological assessments. METHODS: A 2-month, single-blind, randomized, crossover study was conducted in which each subject served as her own control. Safety was evaluated by comparing potential product-related irritation (using colposcopic examination and subject diary data), assessment of vaginal discharge, vaginal pH, and effects on selected microorganisms (yeast, Escherichia coli, Staphylococcus aureus and group B streptococci) obtained by vaginal swab cultures after normal menstrual use in the experimental and control groups. RESULTS: In total, 110 women completed the study. There were no significant differences between the groups that used either the experimental or control tampon with regard to prevalence or mean cell density for the selected microorganisms. No differences were observed in the incidence or severity of erythema, in abrasion or ulceration of the cervix, vagina, introitus, vulva or perineum, or in mean vaginal pH and discharge assessments. There were equivalent low incidences of reported symptoms such as discomfort during insertion, wear or removal, and a similar low incidence of burning, stinging or itching during use of either the control or experimental tampon. There was a more favorable overall product rating for the experimental tampon (p = 0.003). CONCLUSIONS: This approach provides a combination of gynecological, microbiological and self-reported (diary recall) methodologies in order to assess tampon safety during use more thoroughly than has previously been reported, and it supports a comparable safety profile for the experimental tampon and a currently marketed tampon.

Adolescent↗

Selective quasispecies transmission after systemic or mucosal exposure of macaques to simian immunodeficiency virus.

Sexual transmission is the major cause of the AIDS epidemic. For the development of new antiviral and vaccine strategies, we therefore need to understand the mechanisms by which lentiviruses cross the mucosal barrier and the subsequent pathogenic consequences. For this purpose, experimental approaches are greatly facilitated by the development of relevant animal models. In this study, macaques were inoculated intravenously, intrarectally, or intravaginally with a pathogenic cell-free isolate of SIVmac251. Patterns of virological and immunological events significantly differed between vaginally (transient viremia, late seroconversion) and intravenously or intrarectally inoculated monkeys (persistent viremia and early seroconversion). Two weeks after infection, analysis of the env gene nucleotide sequences of proviruses recovered from PBMCs demonstrated that most of the differences were observed in the V1 loop. Three viral variants were specifically associated with vaginal transmission, whereas no such selection was evidenced after intravenous or intrarectal transmissions. These results are in favor of specific mechanisms associated with vaginal transmission, implicating viral envelope structure.

Amino Acid Sequence↗

An anatomical classification--a new paradigm for management of urinary dysfunction in the female.

A new classification specifies anatomical defects in the anterior, middle and posterior zones of the vagina as causing urinary dysfunction. An external musculoelastic mechanism stretches the vagina to open and close the outflow tract. The same pelvic floor muscles provide a peripheral control mechanism for micturition. The stretched vagina prevents the filling bladder from activating the stretch receptors. Vaginal laxity may weaken the transmission of muscle forces, interfering with the mechanical process of opening and closure. Laxity may also destabilize the peripheral control mechanism, a neurological process, causing bladder control to swing between the open and closed modes, i.e. bladder instability. Specific symptoms, signs and urodynamic tests were arranged into a pictorial algorithm as a practical guide for locating the three zones of anatomical defects. It was possible to reinterpret almost all the definitions and descriptions of the International Continence Society in terms of this classification, and to explain how vaginal laxity may cause premature activation of the micturition reflex (detrusor instability), stress incontinence and abnormal emptying (dribble, overflow). This convergence in anatomical and urodynamic (ICS) concepts explains many previously unexplained phenomena, and potentially opens up an entirely new approach to management, non-surgical strengthening of specific ligaments, or surgical reinforcement thereof with ambulatory 'keyhole' methods which do not require catheterization.

Algorithms↗

Elective delivery of infants with macrosomia in diabetic women: reduced shoulder dystocia versus increased cesarean deliveries.

OBJECTIVE: We sought to test the hypothesis that elective delivery of infants diagnosed with macrosomia by ultrasonographic studies in diabetic women will significantly reduce the rate of shoulder dystocia without significantly increasing cesarean section rate. STUDY DESIGN: In a prospective study diabetic women with ultrasonographic estimated fetal weight > or = 4250 gm underwent elective cesarean section; women with estimated fetal weight > or = 90th percentile but < 4250 gm underwent induction of labor. Maternal and neonatal outcomes were analyzed and compared for the periods before and after initiation of the protocol. RESULTS: A total of 2604 diabetic patients were included in this study. The rate of shoulder dystocia was significantly lower after instituting the protocol (2.4% vs 1.1%, odds ratio 2.2). The cesarean section rate increased significantly between the two periods (21.7% vs 25.1%, p < 0.04). Ultrasonography correctly identified the presence or absence of macrosomia in 87% of patients. Only 10.6% of diabetic patients at term required intervention under the protocol (6.8% labor induction, 3.8% elective cesarean section). The rate of shoulder dystocia was 7.4% in macrosomic infants delivered vaginally. CONCLUSION: An ultrasonographically estimated weight threshold as an indication for elective delivery in diabetic women reduces the rate of shoulder dystocia without a clinically meaningful increase in cesarean section rate. This practice, in conjunction with an intensified management approach to diabetes, improves the outcome of these high-risk women and their infants.

Adult↗

Fracture of the clavicle in the newborn following normal labor and delivery.

OBJECTIVE: Earlier works have associated neonatal clavicular fracture (0.2-3.5% of all deliveries) with a range of procedural, fetal and maternal risk factors; more recent studies, however, have failed to firmly identify any one or a combination of them. In the present work we sought to determine possible ante/intra-partum risk factors for this condition. STUDY DESIGN: Using a retrospective case-controlled approach, we examined a series of maternal, fetal and pregnancy or delivery-related variables in 87 cases (out of 403) of fractured clavicle of the newborn diagnosed in our department from 1986 to 1994. All infants were delivered vaginally (in the occipito-anterior position) at term by a specialist obstetrician and underwent peripartum sonographic fetal weight estimation. All variables were compared with those of an equal number of infants born immediately before or after each affected infant and delivered by the same obstetrical team. RESULTS: Fractured clavicles were found in 1.65% of the total number of deliveries during the study period. Neonatal clavicular fracture was significantly and directly related to the duration of the second stage of labor, peripartum sonographic fetal weight estimation, and neonatal length, and inversely related to maternal height; nevertheless, all values in both the study and control groups were within normal range. Logistic regression analysis showed that these antenatal variables significantly affect the chances of clavicular fracture, but due to the high false-positive rate they cannot serve clinically as a comprehensive antenatal prediction index. CONCLUSIONS: The majority of clavicular fractures occur in normal newborns following normal labor and delivery. The risk factors we identified statistically do not offer a method for clinical prenatal prediction. This work provides statistical evidence of the nature of this complication of early newborn life.

Adult↗

Acute viral hepatitis C-induced jaundice in pregnancy.

OBJECTIVE: Acute viral hepatitis C-induced jaundice in pregnancy is very rare and may be fatal. Here, we report a complicated case with acute hepatitis C-induced jaundice in pregnancy with successful management. CASE REPORT: A 27-year-old pregnant woman, gravida 2, para 1, with gestational age of 36 weeks and 5 days, was referred to our hospital due to jaundice and elevated liver enzymes of undetermined cause. She had been suffering from general weakness, diarrhea and vomiting for 1 week, and jaundice with tea-colored urine for 3 days. At our medical center, acute viral hepatitis C-induced jaundice was suspected. Since her general condition deteriorated at 36 weeks and 6 days of gestation, we decided to induce labor. A male baby was born smoothly via the vaginal route, with birth weight 2,857 g, birth length 48.6 cm, and 1- and 5-minute Apgar scores of 7 and 9, respectively. Maternal condition improved dramatically after delivery and her serum liver enzymes and bilirubin levels gradually approached normal ranges. CONCLUSION: Mothers and fetuses with acute viral hepatitis C-induced jaundice during pregnancy are at great risk of mortality and morbidity. Timely termination may be one of the choices of treatment when fetal maturity has been reached and the maternal condition has deteriorated.

Acute Disease↗

The evaluation and interpretation of cervical cytology: application of the likelihood ratio concept.

The Papanicolaou smear (Pap test), used for the detection and prevention of neoplastic lesions of the cervix, is known to have both false negative and false positive results. Proper handling of the diagnostic uncertainty resulting from these errors demands quantification of flaws. Traditionally, sensitivity, specificity and predictive values are used for that aim. In this study another approach is advocated, namely the use of the likelihood ratio. For cervical cytology this ratio is the quotient of the probability of a Pap class within the diseased population to the probability of that same Pap class within the non-diseased group. This approach enables the characterization of each Pap class separately, and is therefore much better for clinical interpretation of the result. It is also a superior approach for quality assessment.

Female↗

An assessment of smear taker training in the Northern & Yorkshire cervical screening programme.

OBJECTIVE: To assess the impact of a regional smear taker training scheme within the Northern and Yorkshire Cervical Screening Programme. DESIGN: An analysis of cervical screening KC activity returns to the Department of Health before and after the introduction of a structured training programme for smear takers. SETTING: Northern and Yorkshire Region of England. SUBJECTS: Women participating in cervical screening. RESULTS: The introduction of a region-wide smear taker training programme has resulted in fewer inadequate cervical smears, fewer opportunistic smears and fewer women aged below 20 having cervical smears. The training programme is cost effective. CONCLUSIONS: It is recommended that all cervical screening programmes consider the introduction of smear taker training. It is a cost-effective approach to running the cervical screening programme.

Adult↗

Techniques for eliciting mucosal immune response.

Development of techniques for eliciting an immune response on mucosal surfaces is a relatively new area of clinical research. With the recognition of the existence of secretory immunity, independent of the systemic system, there was renewed interest in re-examining the conventional approach for optimal immunization techniques. A large body of data indicate that the majority of the secretory immunoglobulins and antibody produced to antigenic stimulation of mucosal surfaces is locally produced. Thus, antibody to C. albicans in the cervical or vaginal mucus has been shown to be of local origin and it predominantly belongs to the secretory IgA immunoglobulin class. The mechanism of antigen processing by the secretory surface leading to antibody formation remains a mystery, but it might be determined by the selective localization of antigens in the reticuloendothelial cells of the lamina propria, bronchi or small intestine. Usually application of antigen topically to the mucosal surface elicits local antibody formation to a greater extent than does parenteral immunization. On the other hand, a more pronounced systemic immune response is seen when the antigen is administered systemically. However, a number of other factors determine the quality and quantity of the immune response, e.g., the physical state of the antigen, live vs killed vaccine, dose, adjuvant, previous exposure to similar or cross-reacting antigens, and site of application of the antigen. These factors are discussed in the review. Recent observations suggest that cell mediated immunity is a component of the secretory immune system, and like the humoral mechanism, also may be partially compartmentalized.

Animals↗

Comparison of genital examination techniques in prepubertal girls.

The results of three separate methods used to examine prepubertal girls are compared and a technique for measuring hymenal orifice diameters from colposcopic photographs is presented. A total of 172 girls who were examined by three techniques during their evaluation in a clinic for suspected child sexual abuse victims were studied. Their ages ranged from 10 months to 11 years with a mean of 5 years, 8 months. The examination techniques used were the supine position with labial separation, the supine position with labial traction, and the knee-chest position. The knee-chest position (98%) and the supine traction method (96%) proved to be superior to the supine separation technique (86%) in opening the vaginal introitus. The largest vertical transhymenal diameters were produced in the knee-chest position, whereas the greatest transverse horizontal spans were generated by the supine traction procedure. Other soft tissue changes were noted but not quantified. A multimethod approach to the examination of the sexually abused child is recommended to take advantage of the strengths of each technique.

Child↗

Vesicovaginal and ureterovaginal fistulas: a summary of 25 years of experience.

The difficult problem of a vesicovaginal fistula originally was cured surgically by Sims in 1849. During the last 25 years at UCLA and affiliated hospitals 68 patients have been treated by urologic surgeons for fistulas between the vagina and the urinary tract: 21 ureterovaginal and 47 vesicovaginal and urethrovaginal fistulas. The ureterovaginal fistulas often were complex and patients presented the most challenging diagnostic problem. However, they usually were repaired successfully by simple ureteroneocystostomy. Vesicovaginal and urethrovaginal fistulas were repaired transvaginally in 24 cases, with 70% success at the first attempt and 92% success with 2 attempts. Transabdominal or combined approaches were less successful. Only 58% of the cases were closed at first attempt. The transvaginal approach required less operating time, and resulted in less blood loss and shorter hospital stays than the transabdominal approach and will be described in detail.

Adult↗

[Vestibular approach in urinary incontinence in women. Original technic. Experience. Results].

Presentation of an original technique to treat S.U.I. in women. This technique contains in itself many others, both in terms of the conceptual anatomical base on which it is inspired, and in the possibilities of its surgical application. Lisfranc's approach, supra-meatic and infra-clitoridean, allows to section both the pubo-urethral ligament and Colles fascia thus reaching into the Retzius. It makes possible the use of solid anatomical elements (pelvian fascia, elevator, urethro-vaginal septum, etc...) thus allowing to suspend the pelvian base from fascia ligaments or from the abdominal wall muscles. Sixty patient who had simple S.U.I. received treatment, with a 95% efficacy index based on the evaluation of the urodynamic, bacteriological and clinical studies. We conclude with an evaluation on the validity of the results obtained by emphasizing the high efficacy index, simplicity, low morbidity and short hospital stay.

Female↗

[Vesicovaginal fistulae: review of our caseload].

Presentation of a review of vesico-vaginal fistulae diagnosed and treated in our Hospital between 1978-1992. There has been 20 cases. Etiology is varied, with predominance of cases due to gynaecological surgery. Considerations on diagnostic tests used in each case and the various therapeutical approaches applied, as well as on the results obtained. A revision is made of literature available on this condition.

Adult↗

Relative and seasonal incidences of the sexually transmitted diseases. A two-year statistical review.

In the United States statistics on sexually transmitted diseases (STDs), other than gonorrhoea and syphilis, are meagre. In this study the relative and seasonal incidences of most STDs in an American clinic where 34,938 patient visits were recorded over a two-year period (1975-76) are assessed. Gonorrhoea was the most common STD in male and female patients combined (18%), while nongonococcal urethritis (NGU) was most common in men (23%), and vaginitis (trichomonal 7.5%, yeast 7.1%, and non-specific 7.1%) was the most common in women. A significantly higher incidence of NGU occurred in Caucasian (63%) than in black (42%) men (P less than 0.005). No other STD was diagnosed in more than 5% of patients, and 31% had normal findings on clinical examination and investigation, and could be described as the 'worried well'. Two or more STDs co-existed in 4.2% of patients. In 1976 the incidence of genital herpes and scabies decreased in contrast to other STDs and total patient visits, which increased. A seasonal peak in late summer and early autumn was observed for most STDs. These observations indicate the importance of a comprehensive approach when attempting to compile accurate statistics on selected epidemiological aspects of sexually transmitted diseases.

Black or African American↗

Laparoscopic needle colposuspension for genuine stress incontinence.

Laparoscopic needle colposuspension offers a minimally invasive endosurgical treatment of genuine stress incontinence. With the patient in the low lithotomy position, three lower abdominal ports are inserted. Bilateral incisions are made in the peritoneum, and the retropubic space is dissected, leaving the urachus intact. A suprapubic incision is made down to rectus fascia only and a Stamey needle inserted into the retropubic space and passed into the vagina under vision. Using No. 1 Ethibond, a double bite of the vaginal wall is taken and the suture pulled into the suprapubic incision. The suture is tied over a silicone button with no slack and no tension. Seven women have been treated by this method, with all having control of their stress incontinence in the short term. The mean operative time was 112 minutes. The catheter was removed on the first postoperative day in six women and on the second day in one woman, with no voiding difficulties. The mean time to discharge was 3.3 days for all except one woman, who had a perforation of the bladder and remained for 12 days. The advantages of the laparoscopic approach are that it allows dissection of the retropubic space, direct examination of the bladder, and observation of the bladder neck during tying of the sutures, allowing them to be tied with no slack and no tension. As a consequence, there is a minimization of the duration of catheterization, voiding difficulties, hospital stay, and postoperative discomfort, with avoidance of scarring of the vaginal wall and urethra.

Adult↗

Repair of vesico-vaginal fistula.

One hundred and thirteen patients with vesico-vaginal fistula were seen at the University of California Hospital from 1932 through 1959. The most common cause of fistula was trauma associated with pelvic operation, and the operation most often involved was total abdominal hysterectomy. Malignant disease of the pelvic organs was the second most common cause, while radiation therapy and obstetrical causes were next in the order of frequency. Three fistulas healed spontaneously. Twelve bladder by-pass operations were done and 54 repairs were carried out in 46 patients. Thirty-eight patients (82.6 per cent) were cured after one or more repair operations. A variety of operative approaches were used, selected in accordance with the needs of the individual case. Bladder distention postoperatively, due to a plugged catheter, was held responsible for failure of the repair in three cases, and this complication was considered preventable. Close attention to surgical technique, the recognition of bladder injury, and proper repair at the time of operation are prime factors in the prevention of vesico-vaginal fistula.

Adult↗

Female sexual arousal: a behavioral analysis.

OBJECTIVE: This study was designed to assess female sexual arousal by using a combination of physiologic measures and self-reported level of arousal. DESIGN: Twenty subjects viewed a 23-minute sequence of randomly ordered relaxation and erotic tapes, both with and without auditory stimulus. The physiologic parameters of vaginal blood flow, galvanic skin resistance, respiration, pulse, and blood pressure, as well as self-reported level of arousal, were simultaneously recorded and correlated with video segments. SETTING: An academic teaching hospital. PATIENT(S): The 20 subjects (mean age +/- SD: 24.9 +/- 3.0 years) included Caucasian (10), Hispanic (2), Asian-American (4), and African-American (4) women. All women were screened for normal sexual function with the Female Sexual Function Index (FSFI) and with the Beck Anxiety Inventory and Beck Depression Inventory. INTERVENTION(S): Randomly ordered sequences of erotic and relaxation tapes with and without sound. MAIN OUTCOME MEASURE(S): Physiologic and behavioral data, as well as subjective arousal rating, were acquired. The resulting set of multichannel data was correlated with erotic segments and analyzed for sound vs. no sound and time to maximal physiologic arousal. RESULT(S): Four independent variables were found to have beta values that were significantly different from 0: respiration (mean = -0.239, SD = 0.177, range = -0.55-0.09, t = -6.04), VPP (mean = 0.158, SD = 0.37, range = -0.48-0.80, t = 1.91), rVPP (mean = 0.161, SD = 0.35, range = -0.537-0.686, t = 2.075), and erotic marker (mean = 0.582, SD = 0.191, range = 0.16-0.85, t = 13.6). Neither heart rate nor galvanic skin resistance beta values approached significance. Respiration period was correlated negatively with arousal rating, indicating that subjects breathed faster when aroused. Auditory stimuli during erotic segments did not increase subjective arousal, and for both subjective arousal rating as well as VPP measurement, maximal response occurred within 2 minutes. CONCLUSION(S): Simultaneous measurement of vaginal blood flow, respiration, pulse, and a variable accounting for the onset and offset of erotic video segments accounts for approximately 50% of the variance in predicting subjective female arousal. Regardless of the presence or absence of audio input, 2 minutes was the average minimum time required to reach maximal arousal in young, sexually functional women.

Arousal↗

Operative culdolaparoscopy: a new approach combining operative culdoscopy and minilaparoscopy.

The tendency is to use small cannulas for operative laparoscopy; however, working with these cannulas may have technical limitations. We developed a technique for performing appendectomy combining culdoscopy and minilaparoscopy. It uses 3- or 5-mm abdominal cannulas, and the large 10- or 12-mm cannula is inserted into the posterior vaginal fornix under laparoscopic surveillance. The vaginal port is used to introduce operative instruments and extract specimens, and for vision. Culdolaparoscopy avoids additional or large abdominal ports, thus overcoming limitations of small cannulas.

Adult↗