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Predictors of difficulty inserting the female condom.

This article describes the frequency of initial difficulty inserting the female condom and identifies predictors of insertion difficulty among women at risk of sexually transmitted diseases (STDs). Female STD clinic patients (n = 1144) were taught how to insert the female condom by using an anatomic model, then given an opportunity for self-insertion practice. Correct placement of the condom was verified by a nurse clinician, and the number of attempts required for correct insertion was recorded. Sociodemographic and psychosocial predictors of refusing the insertion practice and of difficulty inserting the female condom were evaluated using logistic regression. Only 5% of study participants refused the self-insertion practice. Women who never had a Papanicolaou smear test, did not use tampons, never used an inserted method of STD prevention/birth control, and disliked the insertion features of intravaginal barrier methods were more likely to refuse the self-insertion practice. Of those who attempted self-insertion, 25% were unable to insert the female condom correctly on the first attempt. Women who never expressed their sexual likes and were indifferent to the positive features of intravaginal contraceptive methods were more likely to experience difficulty their first insertion attempt. Other variables associated with insertion difficulty included longer fingernails. Insertion refusal and difficulty affect use of the female condom for a sizable proportion of women. Women in this study who refused the self-insertion practice had greater aversion to inserting intravaginal barrier methods. Women who had initial difficulty inserting the female condom had a different profile from those who refused and can benefit from intensive skills training that includes supervised self-insertion practice.

Acquired Immunodeficiency Syndrome↗

Evaluation of the effects of a female condom on the female lower genital tract.

The purposes of this study were to determine if use of the female condom (Reality) was traumatic to the vaginal mucosa and/or vulvar skin and to determine its effect on resident vaginal bacterial flora. Thirty subjects were randomly assigned to utilize the female condom or diaphragm during the study period. Initially and during 3 follow-up visits, each subject underwent colposcopic examination of the vagina, cervix, and vulva with photographic record, and qualitative fungal, aerobic and anaerobic cultures of the vagina. The two groups were compared with respect to the frequency of abnormal physical findings determined by both macroscopic and colposcopic examination. Visits were compared within each contraceptive group with respect to changes in resident vaginal flora. There was no evidence of significant trauma associated with the use of either contraceptive device during the study period. The resident vaginal flora did not significantly change during the three follow-up visits in patients using the female condom. In diaphragm users, lactobacilli were less frequently isolated at the third (14/15 vs 6/15, P = 0.008) and fourth (14/15 vs 7/15, P = 0.039) follow-up visits when compared to the initial visit. In addition, aerobic gram-negative rods were more frequently isolated during the fourth visit (1/15 vs 9/15, P = 0.021) when compared to the first visit. We conclude that neither the female condom (Reality) nor the diaphragm is associated with trauma to the lower genital tract. Subjects using the diaphragm undergo a significant change in vaginal bacterial flora, becoming more likely to be colonized with coliform microorganisms and less likely to maintain lactobacilli colonization.

Adult↗

Predictors of female condom use among women exchanging street sex in New York City.

BACKGROUND: Alternative female-initiated barrier methods, such as the female condom, are needed among women exchanging street sex to enhance their ability to protect themselves from HIV and STD infection. OBJECTIVE: To describe predictors of female condom use among 96 women exchanging sex for money and drugs on the streets of New York City. STUDY DESIGN: A total of 113 sex workers received a baseline interview, a demonstration on proper female condom use, and 10 female condoms. A total of 101 sex workers received a followed-up evaluation at 2 weeks, of which 96 were included in data analysis. Predictors of condom use were analyzed for (1) any type of use; and (2) use with commercial partners. RESULTS: The strongest predictors of female condom use among this sample of sex workers were (1) living with someone with a drug or alcohol problem; (2) having heard of the female condom; and (3) homelessness. Current physical or sexual abuse by a commercial partner and marriage decreased the probability of female condom use. CONCLUSIONS: Female condom distribution encouraged sex workers who may be most vulnerable or who reported characteristics or behaviors associated with the highest sexually transmitted disease and HIV risk to try female condoms with commercial partners. Implications for intervention development include the need to develop innovative programs provided on the street (e.g., through peers) that can access homeless, drug-using sex workers in the most at-risk environments.

Adult↗

Lea's Shield contraceptive device: pilot study of its short-term patient acceptability and aspects of use.

OBJECTIVE: To assess the short term patient acceptability and aspects of use of the Lea's Shield(R). DESIGN: Observational study. Ten women were each invited to use the Lea's Shield on 10 occasions and to report their observations and experiences on structured questionnaires after each use. Thus, data on a maximum of 100 uses would become available for analysis. Answers were recorded on numerical scales and in descriptive terms. On conclusion of their study participation, patients and their partners were required to document their overall experience with the product. SETTING AND SUBJECTS: Women aged 18 to 40 years, self-selected from clients attending the Margaret Pyke Family Planning Centre. They had to be in a stable monogamous relationship, gynaecologically healthy, and willing to continue their use of oral contraceptives, IUD, or injectable. MAIN OUTCOME MEASURE: Ability to use the method without formal teaching, assessed after vaginal examination by the investigator at end of first visit. User satisfaction, as expressed in structured questionnaires and by premature withdrawal from trial. RESULTS: Ten women used Lea's Shield on a total of 70 occasions, of which 46(66 per cent) were associated with sexual intercourse. Five subjects withdrew from the trial prematurely on account of discomfort to either or both partners (four), and recurrent cystitis (one). At the enrolment visit, all but one woman inserted the device correctly without formal teaching, but there was considerable inter-patient variation in their responses concerning ease of insertion/removal, and comfort during subsequent uses. CONCLUSIONS: These preliminary observations suggest that the Lea's Shield may be acceptable to a highly select minority of women. However, much more research is required to permit a reliable assessment of its acceptability to the wider public. The product's potential for causing pain and discomfort also needs further exploration.

Adolescent↗

The relationship of tubal infertility to barrier method and oral contraceptive use.

We studied past contraceptive use in 283 nulliparous infertile women who had a diagnosis of tubal adhesions or occlusion and in 3833 women admitted for delivery at seven collaborating hospitals from 1981 to 1983. The relative risk of tubal infertility associated with barrier contraceptive use or oral contraceptive use was calculated using multivariate logistic regression to control for confounding by region, age, religion, education, smoking, number of sexual partners, time since menarche, and use of other contraceptive methods. Women who had ever used barrier methods of contraception were at a significantly decreased risk of tubal infertility (relative risk = 0.6; 95% confidence limits, 0.5 and 0.8). When type of barrier method used for the longest time was evaluated, those who used the diaphragm or condoms plus spermicides were at lower risk than those who used condoms or spermicides alone. Overall, past use of oral contraceptives neither increased nor decreased a woman's risk of tubal infertility, but there was evidence that the association between oral contraceptives and tubal infertility may vary by the amount of estrogen and type of progestogen in the oral contraceptive used. We conclude that contraceptive users who use barrier methods that combine both a mechanical and chemical barrier, such as diaphragms, cervical caps, and condoms plus spermicides, have the clearest protection against tubal damage.

Adult↗

HIV prevention: the need for methods women can use.

Efforts to prevent heterosexual transmission of HIV (human immunodeficiency virus) infection have thus far focused on modifying sexual behaviors and the use of condoms. While the experience of family planners, particularly in those countries most threatened by heterosexual HIV transmission, has shown that the most effective measures of pregnancy prevention have relied on women, little attention has been given to barriers to HIV transmission that depend on the woman and are under her control. Tactics which interrupt transmission of the virus should be considered in their own right and separated from those that interrupt pregnancy, for insurance, the diaphragm. Greater emphasis is urged for research on preventive methods women could use, including the possibility of a topical virucide that might block transmission through the vaginal route.

Adult↗

Recruitment for complementary/alternative medicine trials: who participates after breast cancer.

BACKGROUND: Despite the popularity and widespread practice of complementary/alternative medicine (CAM), researchers may face problems accruing patients to randomized clinical trials, considered the gold standard of biomedical research. Strict exclusion criteria and barriers to participation may limit accrual. Inadequate numbers of subjects decrease the ability of studies to detect an effect that exists and generalize their findings. This article describes the recruitment experience of a CAM trial, details reasons for non-participation, and contrasts participants and non-participants on demographic, clinical, and treatment-related variables. METHODS: Women who were Houston area residents and spoke English, had primary breast cancer (excluding Stage IV), and were 1 to 30 months posttreatment with no steroids, tamoxifen, substance abuse, psychiatric or heart disease, or immune deficiency were eligible. The enrollment process involved three contacts (i.e. introductory letter and brochure, telephone calls, and reminder post cards). Potential participants were told that the study would require blood samples (30 cc) to assess immune function; psychosocial measures to assess emotional well-being, quality-of-life, social support, and coping strategies; and possible assignment to six weekly support or imagery sessions. Factors influencing recruitment and reasons for non-participation were assessed by stratified analysis and multivariate logistic regression. RESULTS: Of 158 eligible participants, 30% (N = 47) consented to participate. Primary reasons for non-participation included work/childcare (33.3%), transportation/travel (30.6%), and lack of interest (24.3%). Participants were more likely to be 40-54 years of age versus younger or older, divorced/separated, and able to pay some/all medical expenses. Divorced or separated women appeared to be more likely to participate, regardless of financial status. CONCLUSIONS: Researchers must assess the impact of exclusion criteria on accrual and recognize the special needs of their target population. Although age, marital status, and pay status were the strongest predictors of participation, these factors are not amenable to intervention. Based on this study, researchers might boost accrual by providing interventions available during the day and evening to accommodate working women, child care services, transportation, or reimbursement for travel costs.

Adult↗

A randomized, controlled pilot study of the safety and efficacy of 4% icodextrin solution in the reduction of adhesions following laparoscopic gynaecological surgery.

BACKGROUND: Adhesion-related readmissions are frequent sequelae to gynaecological surgery. Attempts to prevent adhesions by separating healing peritoneal surfaces include site-specific barriers and hydroflotation by instilled solutions. Rapid absorption limits the effectiveness of solutions such as Ringer's lactated saline (RLS). This pilot study assessed the safety, tolerability and preliminary effectiveness of a non-viscous, iso-osmolar solution of 4% icodextrin, an alpha-1,4 glucose polymer with prolonged intraperitoneal residence, in reducing adhesions after laparoscopic gynaecological surgery. METHODS: Women aged > or = 18 years, requiring laparoscopic adnexal surgery (n = 62), were entered into a randomized, open-label, assessor-blinded, multicentre study to compare 4% icodextrin with RLS. Treatments were coded in blocks of four with equal randomization to each group, and pre-allocated to consecutively numbered patients. At least 100 ml per 30 min was used for intra-operative lavage, with 1 l instilled post-operatively. Per protocol analysis included all eligible patients (n = 53); reformation analysis required one or more baseline adhesion (n = 42). Incidence, extent and severity of post-operative adhesions were assessed at second-look laparoscopy after 6-12 weeks. Procedures were video-taped for third party, blinded assessment. RESULTS: Safety and tolerability (laboratory variables, adverse events, clinical follow-up) were good with no difference between treatments. A shift analysis of incidence-ranked adhesions (n = 53) showed apparent improvements in more patients with icodextrin than RLS (37 versus 15%; not significant). Adhesion score reduction (n = 42) was more frequent in icodextrin- than RLS-treated patients: incidence (52 versus 32%), extent (52 versus 47%), and severity (65 versus 37%). Despite greater baseline adhesions, median reformation was less after icodextrin (24%) than RLS (60%). The pilot study group sizes were not powered for statistical significance. CONCLUSIONS: In this preliminary study, 4% icodextrin lavage plus instillation was well tolerated and reduced adhesion formation and reformation following laparoscopic gynaecological surgery. A Phase III pivotal study is currently in progress.

Adult↗

The efficacy of telecolposcopy compared with traditional colposcopy.

OBJECTIVE: Rural women have increased rates of cervical neoplasia, but colposcopic services are limited in rural clinics. The purpose of this study was to estimate the efficacy of telecolposcopy for women in rural health care sites. METHODS: Women with an indication for colposcopy were examined by local colposcopists at one of two rural clinics. Images of the colposcopic examination were transmitted to a tertiary care center for interpretation by an expert colposcopist. Another colposcopist (site expert) in attendance at the rural site also examined the same subjects, but did not share findings with the other colposcopists. Colposcopists independently determined the adequacy of the examination, colposcopic impression, biopsy intent and site, and management. Agreement between colposcopic impressions and cervical histology were assessed by using percent agreement, Cohen's kappa statistic, and McNemar's test with Bonferroni's adjustment. RESULTS: Teleconsultation was required for 36.2% of colposcopic examinations. A significantly lower percentage of satisfactory colposcopic examinations was noted by the distant colposcopists (60.0%) compared with the other colposcopists (P <.001). Colposcopic impression agreement with histology varied minimally, 59.7% (kappa = 0.31) for local colposcopists, 52.7% (kappa = 0.22) for site experts, 55.7% (kappa = 0.27) for distant experts who concurrently viewed the examination, and 49.7% (kappa = 0.16) for distant experts who viewed the examination on videotape at a later time. CONCLUSION: Teleconsultation was used for a substantial number of examinations. Diagnostic accuracy was maintained, but determination of colposcopic examination adequacy may be impaired by telecolposcopy. Telecolposcopy may help reduce barriers to medical access for women in rural areas.

Adolescent↗

A randomized trial of the impact of risk assessment and feedback on participation in mammography screening.

BACKGROUND: Although rates of mammography screening among women in the general population have been increasing they still fall short of national goals. This study evaluated the effects on rates of participation in mammography screening of obtaining risk factor information and providing general or personalized risk information through direct mailed correspondence. METHODS: Women enrollees in a health maintenance organization (N = 2,076), age 50 and above, were randomized to one of the following four groups: (a) no risk factor questionnaire + generic invitation, (b) no risk factor questionnaire + general risk invitation, (c) risk factor questionnaire + general risk invitation, and (d) risk factor questionnaire + personal risk invitation. Computerized visit records were monitored for 12 months following a mailed invitation to assess whether a mammogram had been obtained. RESULTS: Overall participation was 37.5% and the rate of participation did not differ significantly across groups (P = 0.26). Participation was related to age (P < 0.02), with rates highest for women ages 60-69 years (42.7%) compared with those for women ages 50-59 (35.5%) and those age 70+ (33.7%). Among women with a family history of breast cancer, the personalized risk invitation was associated with significantly higher participation compared with general risk invitation (66.7 versus 42.9%, respectively; P < 0.003). CONCLUSIONS: Women with a family history of breast cancer are more likely to obtain a mammogram if that fact is reinforced as a risk factor. Research on environmental barriers to mammography screening may suggest alternative strategies for increasing participation.

Adult↗

Depomedroxyprogesterone-induced hypoestrogenism and changes in vaginal flora and epithelium.

OBJECTIVE: To identify the effects of depomedroxyprogesterone acetate (DMPA) on vaginal microbial flora and epithelium. METHODS: Women who desired DMPA for contraception were evaluated before and at 3 and 6 months after initiation of 150-mg DMPA injections every 3 months. At each visit, we assessed genital symptoms, vaginal signs, vaginal microflora, and histopathology by vaginal biopsies. RESULTS: Among 38 women observed for 6 months, there was significant reduction in mean serum estradiol level (99.9 +/- 9.3 pg/mL to 26.6 +/- 1.6 pg/mL, P <.001). The number of subjects with any Lactobacillus did not change, but the number with hydrogen peroxide (H(2)O(2))-positive Lactobacillus decreased from 20% before to 12% after 6 months of DMPA (P =.005). The log concentration in colony-forming units per milliliter of vaginal fluid of H(2)O(2)-positive Lactobacillus decreased in a linear manner from 4. 0 +/- 0.6 at baseline to 2.5 +/- 0.6 after 6 months of DMPA use (P =. 006). The mean number of cell layers in the epithelium was reduced slightly from 28.1 +/- 0.7 to 25.9 +/- 0.9 (P =.05), epithelial thickness decreased from 1.02 +/- 0.04 mm to 0.89 +/- 0.05 mm (P =. 005), and the glycogen-positive thickness decreased from 0.81 +/- 0. 04 mm at baseline to 0.66 +/- 0.05 after 6 months of DMPA use (P =. 005). CONCLUSION: Depomedroxyprogesterone acetate produced a systemic hypoestrogenic state associated with decreased H(2)O(2)-positive Lactobacillus colonization and slight thinning of the glycogen vaginal epithelial layer. Such changes possibly compromise the vaginal barrier to infection.

Adolescent↗

Contraceptive choices among Nigerian women attending an antenatal clinic.

The factors determining the choice of contraception were studied among 230 pregnant women attending the antenatal clinic at Nnewi, Nigeria. There were 174 (52.1%) choices for the natural methods of contraception, 86 (25.7%) for the traditional methods, and 74 (22.2%) for the artificial methods. The most commonly chosen contraceptive methods were rhythm, 95 (28.4%) and Billings, 79 (23.5%), while the least was surgical contraception, 4 (1.2%). The barrier method was not chosen at all. The most common reason given for choice of contraception was safety, 28.7%, followed by dislike of artificial methods, 25.2%; the no-response rate was 29.1%. Other reasons given were ease of use, 10%; husband's decision, 1.3%; fear of the complications of the artificial methods, 13%; dislike of foreign body, 2.6%; the method most understood, 24.8%; need for further counselling, 7%; and long-lasting, 2.6%. The most common reason given against the use of the artificial methods of contraception was fear of its complications, 31.9%, followed by preference for the natural methods, 22.3%. Condom use decreased with increasing age, being highest at 16-20 years, 37.5%, and lowest at 31-35 years, 5.9%. When compared with other parity groups, the grandmultipara group (> or = 5) used the IUD, 14.3%; injectable contraception, 4.8%; and other traditional methods (breastfeeding and abstinence), 28.5%, and did not use the rhythm method. Women of the lowest social class most commonly chose other traditional methods, 57.1%, and never chose the Billings method. Women who desired 1 to 3 children most commonly chose the pill, 23.5%, or withdrawal method, 23.5%, while women who desired 4 to 10 children most commonly chose the rhythm and Billings methods. There was no difference in choice of method of contraception for the various religious denominations, although the artificial methods were less commonly chosen by Catholics, 14.1%, compared with Anglicans, 33%, and other Christian denominations, 33.3%. The physician was the most common source of information for the choosers of the condom, 18.9%; surgical contraception, 2.7%; and the pill, 8.1%; the nurse for injectable contraception, 4.9%, while the commonest source of information among choosers of the rhythm method was the electronic media, 40.5%; print media, 34.9%; and peer group, 34.4%. Lecture/sex instruction was the commonest source of information among choosers of the Billings, 35.5%, and withdrawal, 22.6%, methods, while the no-response rate on source of information on contraception was highest among choosers of the Billings method. There is a need to bridge the gap in contraceptive information by redirecting counselling strategies and restructuring family planning programs to dispel negative perceptions and encourage informed choice of effective family planning methods.

Adolescent↗

Commentary: methods women can use that may prevent sexually transmitted disease, including HIV.

Although sexually transmitted diseases, including human immunodeficiency virus (HIV), are a major concern for women, few prevention messages are targeted specifically to women. Those that are generally stress abstaining, altering the number or selection of partners, and urging partners to use condoms. But these behaviors may be unrealistic for many women, particularly women who are at highest risk for sexually transmitted diseases, because they require significant changes in life-style or depend on male-controlled condom use. Recommendation of contraceptives for prevention of sexually transmitted diseases depends largely on how well specific methods perform under controlled conditions, either in the laboratory or in clinical trials. Observational studies, which better reflect day-to-day use, indicate that condoms, barriers, and spermicides, used properly and consistently, can provide substantial protection against various sexually transmitted diseases. Condoms can similarly help protect against HIV, but studies of barriers and spermicides are scant and currently inconclusive. Finally, those methods that are controlled by women are consistently more effective in preventing sexually transmitted diseases. Thus, although condoms used well are still the best choice, the imperative for female-controlled methods indicates that diaphragms and spermicides should receive greater emphasis in prevention messages.

Condoms↗

Breast conservation therapy in the United States following the 1990 National Institutes of Health Consensus Development Conference on the treatment of patients with early stage invasive breast carcinoma.

BACKGROUND: A National Institutes of Health (NIH) Consensus Development Conference on the treatment of patients with early stage invasive breast carcinoma, held in June 1990, recommended breast conservation therapy for the majority of women with Stage I or II breast carcinoma. The authors evaluated the national use of breast conservation therapy before and after the conference to determine whether the conference had had an impact on utilization. METHODS: Women with Stage I or II breast carcinoma (n = 109,880), diagnosed during the years 1983-1995, were identified via 9 population-based cancer registries of the Surveillance, Epidemiology, and End Results (SEER) program of the National Cancer Institute. The likelihood of breast conservation surgery versus mastectomy and, among women who underwent breast conservation surgery, the likelihood of postoperative radiation therapy versus none, were assessed for 3 time periods (January 1983 to April 1985, May 1985 to June 1990, and July 1990 to December 1995). Associations between the use of breast conservation surgery or postoperative radiotherapy according to patient stage, age, race, and region were compared among women diagnosed before and after the NIH Consensus Development Conference. RESULTS: From 1985 (the year that the U.S. randomized controlled trial demonstrating equivalent efficacy between breast conservation therapy and mastectomy was published) through 1989, approximately 35% of women with Stage I and 19% of women with Stage II breast carcinoma underwent breast conservation surgery; these percentages remained constant throughout this period. Beginning in 1990, the year of the NIH Consensus Development Conference, the use of breast conservation surgery increased in each subsequent year; by 1995, 60% of women with Stage I and 39% of women with Stage II breast carcinoma received such treatment. However, regional variation in use was observed (Stage I, range 41.4-71.4% for 1995) and no registry reported breast conservation therapy for the majority of women with Stage II disease (range, 23.8-48.0%). The use of postoperative radiotherapy for women who underwent breast conservation surgery was similar in the periods before and after the conference. CONCLUSIONS: Although breast conservation therapy was performed more frequently following the NIH Consensus Development Conference, variation in use by region of the U.S. suggests the continued presence of barriers to widespread adoption of the recommendations formulated at the conference.

Adult↗

Effect of distance and travel time on rural women's compliance with screening mammography: an UPRNet study. Upper Peninsula Research Network.

BACKGROUND: The purpose of this study was to determine whether the distance and time required for rural women to travel for a mammogram is associated with their compliance with screening mammography recommendations. METHODS: Women who were > or = 40 years old and visiting family physician offices for any reason were given a questionnaire regarding their frequency of mammography during the past 4 years, the distance and travel time from their homes to the nearest mammography unit, their attitudes and knowledge about mammography, and demographics. The study was conducted in the 12 family practices of the Upper Peninsula Research Network (UPRNet), a Michigan rural family practice research network. RESULTS: Eighty-eight percent (N = 416) of the women in the study had previously had mammography, but 41% were not compliant with American Cancer Society guidelines regarding mammography screening. After controlling for confounding, none of the measures of travel time or distance were associated with mammography compliance. CONCLUSIONS: In this rural population, mammography compliance is not affected by distance, travel time, or transportation. A population-based study in a more remote area is needed to further explore geographic barriers to mammography compliance among rural women.

Adult↗

The contraceptive practices of women seeking termination of pregnancy in an Auckland clinic.

AIM: The aim of the study was to assess the contraceptive knowledge and practices of women attending the abortion service at Epsom day unit, Green Lane Hospital. METHODS: Women attending the unit in December 1992 and January 1993 were asked to take part in the study. A questionnaire was administered to consenting women to assess demographic details and previous contraceptive education. If a contraceptive method was used the reason for failure was explored and if no method was used the reason for non use was explored. RESULTS: Sixty-one percent of women were using a contraceptive method in the month of conception. The condom was used by 48% and the pill by 42%. Eight percent of women had never used contraception and 30% were not using a method in the month of conception. Forty-three percent had a household income of less than $22,000 and financial barriers were the reason for non use in 32% of those not using a method. Of women who did not use contraception, only 11% used emergency contraception, whereas 78% of those surveyed said they knew about emergency contraception. Sixty-three percent of women said they had received enough contraceptive education to select and use a method effectively. Pacific Island women were least likely to have received adequate contraceptive education or to have been using a method of contraception. CONCLUSIONS: A number of technical problems were identified with condom use. These problems need to be emphasised by sexuality education programmes and contraceptive prescribers. Omitting pills, diarrhoea, vomiting and drug interactions were important causes of pill failure. The seven day rule needs more emphasis when teaching women how to take the pill and when antibiotics are prescribed. Costs were an important barrier to the use of contraception for a significant proportion of women. Section 99 approval should be utilised more readily and the provision of free contraception, especially to low income groups, needs to be urgently explored.

Abortion, Legal↗