A study to assess the prevalence of chronic testicular pain in post-vasectomy men compared to non-vasectomised men.

OBJECTIVE: To assess the prevalence of chronic post-vasectomy testicular pain (CPTP) compared to the prevalence of chronic testicular pain in a control population of non-vasectomised men. METHODS: A retrospective postal study of 198 men who had a vasectomy more than 3 years previously at the Palatine Centre to determine the incidence of CPTP, of whom 101 (51%) replied (mean age 40.4 years, range 29-54 years, mean time since vasectomy 46.5 months). A control group of 102 men (mean age 40.2 years, range 28-55 years) who had not had a vasectomy were obtained via patients attending the community family planning clinics or associated general practitioner (GP) services in the same geographical area. RESULTS: Occasional non-troublesome discomfort was reported by 37/101 of the post-vasectomy men compared to 21/102 of the control group. Occasional discomfort which was a nuisance was felt by 10/101 of the post-vasectomy group compared with 3/102 of the control group, and 6/101 in the post-vasectomy group reported pain severe enough to seek medical advice compared to only 2/102 controls. None of the post-vasectomy men regretted having had the operation. CONCLUSIONS: Only 6% of cases (compared to 2% of controls) experienced pain severe enough to seek medical advice in the 3-4-year post-operative period. However, there was a significant difference in the prevalence of occasional testicular discomfort between post-vasectomy men and controls. Mostly these pains were not regarded as troublesome, however men attending for vasectomy counselling should be informed of the possibility of this morbidity.

Experience of the first pelvic examination.

OBJECTIVES: To analyze women's experiences of the first pelvic examination and identify positive and negative components. To learn lessons, and build on and incorporate the positive components into a model of good clinical practice. METHOD: The open, cross-sectional study was carried out in community family planning and young persons clinics. A self-administered questionnaire was offered to all women under 25 years of age who attended a family planning or young persons clinic during the study period. The questionnaire was constructed to determine how experience compared with expectations and which components showed a significant trend towards a positive or negative effect. It also aimed to find what women considered to be important aspects of an internal examination. RESULTS: A total of 167 evaluable questionnaires were completed in which experience of the first pelvic examination was reported from family planning clinics (41%), general practice (39%) and hospital/genitourinary medicine faculties (20%). These first pelvic examinations occurred at a mean age of 17.3 years (range 11-23 years). Significant trends of a positive experience were found when the examination was conducted by a female doctor (p = 0.02), when it was conducted in a family planning clinic as opposed to general practice (p = 0.04), after permission was sought (p = 0.001) and with increasing age at first examination (Mann-Whitney, p = 0.003). There were no significant differences in outcome with offer of, or presence of, a chaperone. CONCLUSIONS: A friendly, female doctor who seeks permission before the examination, which should be uninterrupted, were considered to be important aspects for an internal examination.

Prospective multicentre study comparing levonorgestrel implants with a combined contraceptive pill: final results.

Norplant is a hormonal, long term method of contraception requiring the sub-dermal placement of six flexible capsules containing levonorgestrel in the inner aspect of the upper non-dominant arm. This open, prospective, multicentre, parallel group study, comparing the acceptability of Norplant and a combined pill, was originally designed to follow 700 subjects for five years, but was discontinued early. The main outcome criteria were duration of use and reason for discontinuation if appropriate. This final analysis, concerning the 364 subjects who used the implant and 307 subjects who used a gestodene/ethinyloestradiol combined pill, shows a statistically significantly higher (p<0.001) continuation rate amongst the implant users at 83.4 per cent compared to the pill users at 64.4 per cent at one year and this difference decreased only slightly by two years. The most common reasons for discontinuation by the end of the study were adverse events in both groups (menstrual and then mood changes in the implant group and mood changes and then headaches in the pill group). From the whole cohort the proportion which were 'very satisfied' were higher in the implant group (28.5 per cent compared to 14.6 per cent). This study confirms, in the UK, a high continuation rate for implant users similar to other countries as reported in the literature. If acceptability and continuation rates are similar in the none study setting, then a substantial number of women will seek removal of the implant and possible reinsertion five years after the time of initial high popularity (ie 1999). Doctors need to be prepared for this possible high level of activity.

PIP: This is a multicenter comparative study on the acceptability of levonorgestrel implants (Norplant) and the ethinyl estradiol/gestodene combined pill (Femodene/Minulet) conducted in the UK, which was originally designed to follow 700 subjects for 5 years but was discontinued early. Norplant is a hormonal, long-term method of contraception requiring the subdermal placement of 6 flexible capsules containing levonorgestrel in the inner aspect of the upper nondominant arm. 364 subjects who used the implant and 307 subjects who used a combined pill were included in the final analysis, which showed a significantly greater (p 0.001) continuation rate among the implant users (83.4%) compared to the pill users (64.4%) at 1 year, with a slight decrease in difference at 2 years. The most common reasons for discontinuation were menstrual and mood changes in the implant group and mood changes and headaches in the pill group. A higher proportion of "very satisfied" users was noted in the implant group (28.5%) compared to the combined pill group (14.6%). The high continuation rate for implant users in this study is similar to the rate in the reported literature in other countries.

Initial UK experience of the levonorgestrel-releasing contraceptive intravaginal ring.

A study was performed to establish the tolerance, acceptability and associated efficacy of a levonorgestrel-releasing intravaginal ring (IVR) in a sample of British women requiring contraception. This was achieved with an open non-randomized prospective study of 1710 women aged 18-40 years, recruited in 75 centers geographically spread around the UK using an IVR designed to release 20 microg/day of levonorgestrel. Assessments were made at baseline, after 6 weeks, after 3 months and then 3-monthly. After initial insertion of the IVR, it was changed at 3-monthly intervals. A total of 1591 women were eligible for analysis, with 572 available after 12 months and 34 after 24 months of use. Life-table analysis revealed pregnancy rates of 5.1% and 6.5% at 12 months and 24 months, respectively. The IVR was rated as acceptable or very acceptable as a form of contraceptive by 60.7% of women at 12 months. The most common adverse events were menstrual disturbance, headache and vaginal discharge. No significant pattern of biochemical, hematological, microbiological or cytological abnormalities was found but vaginal erythematous lesions were noted at some centers. This IVR was found to be a generally well-accepted method of contraception with a failure rate comparable to some other progestogenonly methods. On this basis, further development of hormone-releasing intravaginal rings is justified.

Approaches for incorporating ovulation detection devices and home kits into learning NFP--implications for service delivery.

This paper presents demographic data about use of NFP in Europe and the factors which have been identified as influencing that very low use level. Experience with a new ovulation detection device in clinical trials and observations of its over-the-counter promotions is discussed in the context of what is already known about how to maximize uptake of contraception in main-stream service provision. Some suggestions are offered as to appropriate means of encouraging women who are using artificial methods or no method to understand enough about their natural fertile cycle to consider NFP as an acceptable option.

Profile of young people's advice clinic in reproductive health, 1988-93.

For an unprepared sexually active teenager the 1990s present a minefield of potential problems in addition to the most obvious problems of unplanned pregnancy and sexually transmitted disease. Promoting the importance of a healthy sexual and reproductive life to young people requires openness, better sex education, realistic discussion of related issues, and provision of contraception, as well as support if things go wrong. The Woodhouse Park Clinic in south Manchester opened in October 1988 with the aim of providing weekly advice sessions to young people up to the age of 18. Advice is given on topics such as substance misuse and smoking as well as on family planning. Attendance has steadily increased over the years; from April to June 1993 the average number of attenders per session was 39, one third of whom were young men.

PIP: Opened in October 1988, Woodhouse Park Clinic serves Wythenshawe, a large council housing estate in south Manchester. The district has a total population of 48,072, with an average conception rate over the period 1989-91 of 17.1/1000 among girls aged 11-15. The clinic was opened with the goal of providing weekly advice sessions to young people up to the age of 18 years, along with advice on topics such as substance misuse, smoking, and family planning. The authors describe how in 1986 family planning managers, school nurses, and the local midwife and parentcraft tutor planned the weekly clinic intended to lower the rates of teenage pregnancy in the area. One two-hour clinic session was held from 3:30 P.M. to 5:30 P.M. each Thursday in a multipurpose community health center, staffed by two female school nurses, the female midwife and parentcraft tutor, and one female family planning doctor. Program launching, facilities, consultation, pregnancy tests, clinic management, and attendances are described. Attendance increased steadily over the years, with an average of 39 attendees per session over the period April-June 1993; young men comprised one-third of those who attended.

Clinical comparison of two low-dose oral contraceptives, Minulet and Mercilon, in women over 30 years of age.

A comparative study of two low-dose oral contraceptives, gestodene (GES) 75 mcg/ethinyl oestradiol (EE) 30 mcg and desogestrel (DES) 150 mcg/EE 20 mcg, was conducted in women over 30 years of age. This randomised, open-label study was organised in Denmark, Italy, New Zealand and United Kingdom. A total of 505 women received GES/EE and 501 received DES/EE for 6 consecutive menstrual cycles. The two groups were comparable in terms of demographic and gynaecologic characteristics at baseline. However, the menstrual flow length was slightly longer in the GES/EE group before the start of the treatment. The mean age (+/- SD) was 35 +/- 4 years in the GES/EE group and 35 +/- 5 years in the DES/EE group. The subjects in the GES/EE group contributed data for a total of 2800 cycles and those in the DES/EE group, data for 2796 cycles. There were no pregnancies on medication with either preparation. The results showed that there were significantly more normal cycles in the GES/EE group for cycles 1 to 6. Irregular bleeding between withdrawal bleeds occurred in 10% of GES/EE and 18.5% of DES/EE cycles. Absence of all bleeding was reported in 29 (1%) and 63 (2%) cycles, respectively. The incidence of missed pills was low in both groups (11% of cycles). No significant differences were observed in cycle length or withdrawal bleeding episode length. Withdrawal bleeding mean intensity was statistically significantly greater with GES/EE. However, for both preparations, the mean intensity was close to light bleeding. No clinically significant differences were noted in weight, blood pressure, Papanicolaou smears or laboratory data. Sixty-eight (13.5%) subjects in the GES/EE group and 64 (12.8%) in the DES/EE group discontinued before the end of the study. Among them, 37 (7%) and 40 (8%) in the respective groups withdrew because of adverse reactions. There was no difference between groups in terms of primary reasons for withdrawal. The most frequently reported complaints that led to discontinuation in both groups were headache, nausea and metrorrhagia. Breast tenderness led to the discontinuation of 1 subject in the GES/EE group and 3 in the DES/EE group. These results show excellent cycle control, efficacy and very low rate of side effects with both GES/EE and DES/EE. These low-dose oral contraceptives could be well suited to healthy nonsmoking women requiring contraception up to the age of menopause.

PIP: At 66 sites in Denmark, Italy, New Zealand, and the UK, clinicians randomly allocated 1006 women 30 years old, some of whom were in their early 50s, into 1 of 2 groups receiving a low-dose oral contraceptive (OC): Minulet containing 75 mcg gestodene (GES)/30 mcg ethinyl estradiol (EE) and Mercilon containing 150 mcg desogestrel (DES)/20 mcg EE. The study aimed to compare these 2 low-dose OCs to help physicians prescribe an OC that could be continued into later years. Before treatment, the 2 groups had similar demographic and gynecologic characteristics. The mean menstrual flow length in the GES/EE group was longer than that of the DES/EE group (4.7 days vs. 4.5 days; p = .035) though. None of the women during 2800 cycles of GES/EE use and 2796 cycles of DES/EE use conceived, even though women forgot to take at least 1 pill in 11% of cycles. The GES/EE OC had significantly better cycle control than did the DES/EE OC. For example, the GES/EE group was more likely to have normal cycles than the DES/EE group (84-93% vs. 73-83%; p .001). The DES/EE group experienced a significantly lower withdrawal bleeding mean intensity than the GES/EE group in all 6 cycles, but the bleeding for both groups was close to light bleeding. The 2 groups were similar in weight, blood pressure, Papanicolaou smears, and laboratory data. Discontinuation rates for the GES/EE and DES/EE groups were 13.5% and 12.8%, respectively. Adverse reactions accounted for discontinuation in 7% of the GES/EE group and 8% of the DES/EE group. The major complaints leading to discontinuation were headache, nausea, and breakthrough bleeding. Both GES/EE and DES/EE had very good cycle control and efficacy and a very low rate of side effects. These results suggest that both these low-dose OCs would be acceptable for healthy nonsmoking women needing contraception up to menopause.

A double-blind comparison of the efficacy and acceptability of Femodene and Microgynon-30.

The efficacy, cycle-control and tolerance of Microgynon-30, a widely prescribed levonorgestrel containing oral contraceptive, and Femodene, a new oral-contraceptive containing gestodene, were compared in a randomised, double-blind study involving 456 healthy women over a 6 month period. 229 women were allocated to receive Femodene and 227 received Microgynon-30. No differences between the groups in terms of obstetric and gynaecological history, previous contraceptive history, smoking habits, blood-pressure or body weight at admission were observed. No pregnancies were reported in either group, despite tablet-taking errors recorded in 6.3% of the Femodene group and 7.6% of the Microgynon-30 group. Both oral contraceptives were compared in terms of cycle length, intensity of the withdrawal bleed and side effects. Cycle-control was similar in the two groups. However, significantly fewer subjects reported breakthrough bleeding (with or without spotting) in the Femodene group (18% of patients) compared with the Microgynon-30 group (26% of patients). The incidence of absent withdrawal bleeds was 1% or less in both groups and no significant effects on body weight or blood pressure were observed.

Older women and family planning services.

PIP: The characteristics of family planning services that make them acceptable to older women, and the specific contraceptive needs of older women, are discussed. As with other clients, older women are more likely to attend family planning clinics if they are advertised, if they have convenient hours, open appointments, proximity to other facilities, and lack of separate entrance for contraception clients only. Services are more acceptable if they are comprehensive, including breast exams, cervical smears, post-coital contraception, pregnancy tests, genetic counseling, rubella testing and vaccination. Services should be free, since the outcome of pregnancy in older women is poorer, it is cost- effective to provide contraception for all who need it in a country which pays for maternal-child medical care and welfare. Effective use of all methods is related to support and teaching. IUDs may be difficult to insert due to prior cervical surgery, but are best left in longer than usual if they are symptom free, even up to 1 year past the last menses.^ieng

The effect of deliberate omission of Trinordiol or Microgynon on the hypothalamo-pituitary-ovarian axis.

The effect of deliberate omission of a phased formulation pill, Trinordiol (ethinyl estradiol 30 micrograms + levonorgestrel 50 micrograms: 6 tablets; ethinyl estradiol 40 micrograms + levonorgestrel 75 micrograms: 5 tablets; ethinyl estradiol 30 micrograms + levonorgestrel 125 micrograms: 10 tablets) or a low-dose, combined, oral contraceptive pill, Microgynon (ethinyl estradiol 30 micrograms + levonorgestrel 150 micrograms: 21 tablets) on the hypothalamo-pituitary-ovarian axis were studied. Thirty-six women were recruited to the study and divided equally between the two types of pill. Medication was begun on the 8th pill-free day of the cycle and continued for 7 days (Group 1), 14 days (Group 2) or 21 days (Group 3). Levels of FSH, LH, estradiol (E2) and progesterone (P) were measured in plasma on alternate days during the final week of pill therapy, and daily for the 7 days after stopping the pill. For the first 2 weeks of pill therapy, follicular activity, as judged by plasma levels of E2, was greater in women taking Trinordiol than in those taking Microgynon, but was similar in both groups by the third week of pill treatment. Five women taking Trinordiol (2 in Group 1 and 3 in Group 2) had plasma levels of E2 in excess of 500 pmol/l whilst taking the pills, and only 1 patient achieved this degree of follicular activity after stopping the tablets. One woman who had taken 7 days of Trinordiol (Group 1) showed a rise of plasma levels of P to 6.8 nmol/l, but luteinization did not occur in any of the remaining 35 women who took Trinordiol or Microgynon. These findings suggest that follicular activity is less completely suppressed by Trinordiol than Microgynon, at least in the first 2 weeks of pill therapy, but that normal ovulation is still a rare event in the week after cessation of either of these pills, even if only 7 days of medication have been taken.

PIP: The effect of deliberate omission of a phased formulation pill, Trinordiol (ethinyl estradiol 30 microgram + levonorgestrel 50 microgram: 6 tablets; ethinyl estradiol 40 microgram + levonorgestrel 75 microgram: 5 tablets; ethinyl estradiol 30 microgram + levonorgestrel 125 microgram: 10 tablets) or a low-dose, combined, oral contraceptive pill, Microgynon (ethinyl estradiol 30 microgram + levonorgestrel 150 microgram: 21 tablets) on the hypothalamo-pituitary-ovarian axis were studied. 36 women were recruited to the study and divided equally between the 2 types of pill. Medication was begun on the 8th pill-free day of the cycle and continued for 7 days (Group 1), 14 days (Group 2) or 21 days (Group 3). Levels of FSH, LH, estradiol (E2) and progesterone (P) were measured in plasma on alternate days during the final week of pill therapy, and daily for the 7 days after stopping the pill. For the 1st 2 weeks of pill therapy, follicular activity, as judged by plasma levels of E2, was greater in women taking Trinordiol than in those taking Microgynon, but was similar in both groups by the 3rd week of pill treatment. 5 women taking Trinordiol (2 in Group 1 and 3 in Group 2) had plasma levels of E2 in excess of 500 pmol/l whilst taking the pills, but this level of follicular activity was maintained in only 3 of these women in the 7 "pill-free" days. None of the women taking Microgynon had levels of E2 above 500 pmol/l whilst taking the pills and only 1 patient achieved this degree of follicular activity after stopping the tablets. 1 woman who had taken 7 days of Trinordiol (Group 1) showed a rise of plasma levels of P to 6.8 nmol/l, but luteinization did not occur in any of the remaining 35 women who took Trinordiol or Microgynon. These findings suggest that follicular activity is less completely suppressed by Trinordiol than Microgynon, at least in the 1st 2 weeks of pill therapy, but that normal ovulation is still a rare event in the week after cessation of either of these pills, even if only 7 days of medication have been taken.