The FemCap: a new contraceptive choice.

OBJECTIVE: To develop a female barrier to, first, prevent pregnancy and, second, protect against sexually transmitted diseases. DESIGN: The contraceptive is made of inert, soft material and is an anatomical design that utilizes the physiology of the vagina. It incorporates the use of microbicidal spermicide to kill sexually transmitted disease organisms. RESULTS: FemCap has been proven in clinical trials to be safe, and has no systemic or local side-effects, and does not increase the risk of urinary tract infections. Effectiveness in pregnancy prevention in 86.5% in typical use and 98% if used properly with emergency contraceptives as back-up. FemCap is highly acceptable to women and to their partners. CONCLUSIONS: A new method of birth control has arrived that is safe, effective, highly acceptable and may protect against sexually transmitted diseases of the upper female genital tract.

A comparison of the hydroxyl radical scavenging properties of the shark bile steroid 5 beta-scymnol and plant pycnogenols.

The hydroxyl radical (OH.) quenching abilities of the following compounds were compared in the deoxyribose degradation system (initiated by the ferrous-ascorbate Fenton reaction): (a) 5 beta-scymnol, the hepatoprotective shark bile sterol, and its mono- and di-sulfate esters; (b) three marketed pycnogenol preparations (syn: proanthocyanidin--natural plant-derived polyphenolic bioflavonoids) extracted from pine tree (Pinus maritima) bark and grape (Vitis vinifera) seeds; and (c) two known hydroxyl radical scavengers, dimethyl sulfoxide and mannitol, and the peroxyl radical scavenger Trolox (the alpha-tocopherol analogue). 5 beta-scymnol was a more potent OH. quencher than dimethyl sulfoxide, mannitol and Trolox, and markedly more potent than the pycnogenol preparations. Increased sulfation of 5 beta-scymnol progressively reduced its free radical scavenging activity, thus clearly attributing the potent OH. quenching properties to its novel tri-alcohol-substituted aliphatic side chain. The favourable interaction of these bile steroids with reactive oxygen species in an aqueous environment, makes them attractive candidates for evaluation as protective agents against disorders in which oxidative stress is implicated.

Hepatoprotective effects of the shark bile salt 5beta-scymnol on acetaminophen-induced liver damage in mice.

The hepatoprotective effect of the shark bile salt 5beta-scymnol has been studied in the model of acute hepatotoxicity induced by administration of acetaminophen (APAP, paracetamol). 5beta-Scymnol at doses of 20, 35, and 70 mg/kg intraperitoneally (ip) decreased significantly the serum activity of alanine aminotransferase, sorbitol dehydrogenase, and lactate dehydrogenase (p < 0.05) caused by APAP treatment (350 mg/kg ip) alone. The highest dose of 5beta-scymnol remained hepatoprotective when administered 4 hr after the APAP overdose. N-Acetylcysteine (NAC) is protective against APAP-induced hepatotoxicity at 250 and 500 mg/kg (ip) when administered up to 3 hr after APAP overdose, as shown by a significant reduction in serum enzyme activity. Coadministration of 5beta-scymnol (70 mg/kg) and NAC (250 mg/kg) also reduced serum enzyme levels and histopathological effects; however, a similar level of hepatoprotection was conferred by 5beta-scymnol treatment alone. In addition, 5beta-scymnol has potent hydroxyl radical quenching activity as it markedly inhibited deoxyribose degradation in a ferrous/ascorbate Fenton reaction system. These results indicate a possible role for the use of 5beta-scymnol, either alone or concomitant with NAC, in the prevention of hepatic necrosis following toxic doses of APAP.

Innovative technique for Norplant implants removal.

This study evaluates a unique and completely different approach from the original removal technique. The main objective of this technique is to facilitate removal of widely-spaced, deeply-positioned, and misplaced Norplant capsules. A local anesthetic is injected deep and perpendicular to the long axis of the Norplant rods. The hypodermic needle is left in place underneath the six silicone rods for the entire removal procedure. One or two 3-4mm vertical incisions were made between the capsules over the needle. The Norplant rods were dissected free from the fibrous tissue and the skin with a #11 blade. A curved mosquito forceps was inserted between the skin and the Norplant rod, to hook and deliver the capsule through the incision, from where it can be easily removed. This method resulted in far less time, effort, and skill from the health care provider, no damage to the capsules, and much less trauma to the clients.

PIP: Between September 1993 and June 1994, 4 physicians in California removed 22 Norplant implants using an innovative and simple removal technique designed to remove misplaced capsules. They all had had experience with the original removal technique. They inserted a 2 inch, 21 gauge hypodermic needle perpendicular to the long axis of the Norplant capsules and left it under the capsules during the entire procedure. This served to lift, stabilize, and make the rods easier to palpate and to dissect a tract underneath the rods. They injected 2-3 ml of 2% xylocaine with epinephrine as they slowly advanced the needle. The physicians made one or two 3-4 mm vertical incisions between capsules 2 and 3 and between capsules 4 and 5 over the needle. The 2nd incision reduced trauma and scarring as well as the time, effort, and skill needed from the provider. In about 46% of cases, they were able to remove the rods through a single incision. They used a 11 blade to dissect the rods free. They inserted a small curved mosquito forceps to deliver the rod through the incision. The tip was either facing downwards, then rotated 180 degrees to deliver the rod, or facing upwards to deliver it. Another forceps was used to dissect the rod free from fibrous tissue and to remove it. After removal of the 6th rod, they removed the needle and applied Steri-strips. About 70% of all rods were visible and palpable. About 14% were higher than the other rods. Two women had rods that crossed. It took, on average, 12 minutes to remove all 6 capsules. 77% of the women returned for the follow-up visit (3-4 days postremoval). The physicians followed up with the remaining women by telephone. 64% experienced a minor hemorrhagic spot over the procedure site. The Steri-strips caused a blister in 1 client. At the postremoval visit, no one had removal-site hematomas or infections. This removal technique may increase acceptability and use of Norplant and reduce its cost.

Acceptability of a new intravaginal barrier contraceptive device (Femcap).

A comprehensive questionnaire to assess acceptability was sent to 106 participants (and their partners) in a study on the safety and effectiveness of the Femcap. Participants were asked to rate their satisfaction with various aspects of the method, and were also asked about complaints such as vaginal infections, urinary tract infections, or other irritation. Eighty-one percent of the study sample either returned the mailed questionnaires or completed telephone interviews. Results were encouraging in that none of the study subjects or their partners reported any discomfort, trauma, or interference in sexual spontaneity with the cap. Vaginal irritation and infections were infrequently reported. The feature best liked by most participants was the absence of hormones associated with the method; the feature least liked was removal of the device. The Femcap may be an acceptable alternative to currently available barrier contraceptive devices.

PIP: 86 (81%) of 106 women participating in a study of the barrier contraceptive Femcap answered a mailed questionnaire or completed a telephone interview about acceptability of the device. The Femcap is a silicone rubber rim and brim that covers both the cervix and a portion of the vagina, which is used with spermicide, self-inserted, and worn for a minimum of 8 hours after intercourse, or a maximum of 48 hours. The study of subjects were 18-40 years old, and were self-selected in that they entered the study because they either had intolerable side effects from or were dissatisfied with other contraceptive methods, or could not be fitted with a Prentif cervical cap. For the study the women demonstrated proficiency in inserting the device, and were followed every 3 months. 57% of the women used the Femcap for 12 cycles or more. 74% continued using it after 1 year. Reasons for discontinuing this method included desire to conceive, loss of sexual partner, and dislike of insertion and removal. Total women-months accumulated were 1300. Only 3 complained of side effects such as urinary tract infections or vaginal problems. The most liked features of the Femcap were absence of hormones (80%), lack of side effects, perceived contraceptive effectiveness, and control by the woman. The most disliked features were difficulty in removing the Femcap, irritation from spermicide, and the mechanics of insertion and removal. The Femcap is an attractive alternative barrier method because of its ready fit, lack of urinary tract infection side effects, and user-friendly teaching booklet and videotape.

New female intravaginal barrier contraceptive device. Preliminary clinical trial.

The Fem Cap, a silicone rubber cervical cap, is shaped like a sailor's hat. While its dome covers the cervix, its rim fits snugly into the vaginal fornices, and its brim adheres and conforms to the vaginal walls. A spermicidal material is applied to the cap, then it is positioned over the cervix by hand or with a special applicator. The device is removed by hand up to 48 hours after insertion, but no sooner than eight hours after intercourse. Women chosen for the trial had contraindications to or were dissatisfied with the currently available contraceptive methods. Each woman was fitted with a cap of suitable size and instructed in its use. She was then asked to note any side effects and the dates of her menses in a diary. One-hundred-twenty-one women were enrolled in the study. Five became pregnant. Of those, two reported dislodgment of the cap during intercourse; the other three admitted to non-use of the cap on several occasions. This device has proven so far to be safe, effective and acceptable to women and men. It has several advantages over the currently available barrier contraceptive devices. The silicone rubber material from which it is made is non-allergenic, durable and easy to clean. Its design fits the anatomy and accommodates physiological changes. The Fem Cap is easy to insert and remove; an applicator facilitates insertion for some women. Instruction for use of the device requires short time from the health care provider.

Ureteric stone extraction by a new double-balloon catheter: an experimental study.

An atraumatic double-ballooned catheter was designed to extract endoscopically ureteral calculi of relatively large size (1 to 1.5 cm.) arrested at any level of the ureter. This reduces the need for ureterolithotomy, eliminates the problems of stone basket manipulations, and reduces the need for prolonged waiting for spontaneous migration of stones.