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TRICKS OF THE TRADE
PRENTIF CERVICAL CAP


The information in this booklet has been compiled by Liz Summerhayes, RN,NP,CNM, a Nurse Practitioner in Women's Health since 1978.




She conducted a study for the Prentif Cavity-Rim Cervical Cap for 6 years prior to the FDA approval in 1988. She continues her private practice in California at this time, and trains clinicians nationwide in cervical cap fitting.

The information and comments in this booklet are those of Liz Summerhayes, based on her experience and communication with other clinicians since 1981. They should not in any way be construed as a substitution for the official FDA approved fitting instruction.

TRICKS OF THE TRADE

Here are some FACTS about the Prentif Cavity-Rim Cervical Cap
  • The cap was approved in 1988 based on the extensive data from an NIH funded clinical trial, conducted in Southern California by Gerald Bernstein MD. It was a randomized study with 580 women in each group, the Prentif Cavity-Rim cervical cap and the diaphragm. (Total number about 1200). The result of the study showed that there was little to no difference in the efficacy rate between the two devices and therefore it was concluded that the method effectiveness was equal (96.5 percent Prentif Cavity-Rim cervical cap, 97.2 percent diaphragm.) at the completion of the study after two years.

  • There were both nulliparous and multiparous women in the study. In both groups approximately 60% had previously been pregnant, however, only approximately 20 percent having had live births. There was no significant difference in method failure rates in either group at the two year exit study data, but initially at the six and twelve month questionnaire there were more multiparous than nulliparous women with both method and user failure rates. Many more nulliparous women stayed in the study to the 2 years conclusion. Many multiparous women are ideal candidates for the cervical cap and parity has not proven to be an issue.

  • Those in the study who exited because of dislike of their method were 4 times greater in the diaphragm group than the cap. (Reinforcing the fact that women with the cervical cap are much happier and therefore they USE their device).
  • >
  • At the three-month follow-up examination, there was a slight increase in abnormal Pap smears in those using the cervical cap (4 percent = 18/454), compared with those using the diaphragm. (1.7 percent =7/424 women). That is why the FDA recommended that there should be a Pap smear repeated at 3 months as indicated in the package insert and the fitting instructions. This recommendation still remains, although subsequent data submitted to the FDA in 1992 showed only 3.5 percent had an abnormal Pap smear in more than 2000 women using the cap, since 1988.

HERE ARE SOME REMINDERS ABOUT CAP USE & FITTING THE CAP

Have anxiety about cap fitting? Trained a long time ago and have not fitted for many years?
  • To get you back in the swing of things again, we have a video for clinicians. In just over 15 minutes it goes over all the steps of fitting and checking the fit. We also have a clinician handbook. Both a handbook and a video are also available for patients.

  • Consider, devoting a little extra time to confirming your technique and checking the fit after the cap has been on the cervix for 10 minutes. You should be able to see a raised ring around the cervix where the cells of the cervix have gone into the cavity-rim order to make the seal. If this is not there after 10 minutes you do not have a good fit. This "ring" may be felt and/or seen. It will disappear within about the same length of time that the cap is off the cervix.

  • Fit the cap MID-CYCLE whenever possible. This is when the cervix is smallest and firmest and the most critical time in the cycle for a good fit, at the time of ovulation.

  • Allow time for the patient to insert and remove the cap at the time of the fitting so that she is comfortable with the device before leaving your care. Preferably, have a small inventory of caps so that you can give her the cap at the time of the appointment. Talk to the patient about returning to the office for a three-month follow-up Pap smear.

  • Do a yearly check on the fit and replacement of the cervical cap as recommended by the FDA at the time of the approval in 1988. Also do a Pap smear annually. Recheck after childbirth, miscarriage or at any time dislodgment is reported.

  • When a condom is used with the cap, the condom MUST be lubricated to avoid the latex "grabbing" and causing dislodgment of the cap.

  • Over lubrication of the cap before insertion will make it too slippery to handle, especially when you have placed several fitting caps in the vagina.

  • Over filling the cap with spermicide may prevent a good seal and cause the cap to be dislodged. Avoid spermicide from getting into the cavity rim.

HERE ARE SOME OF THE MOST FREQUENTLY ASKED QUESTIONS & ANSWERS

  • WHO WILL WANT TO USE THE CERVICAL CAP?

  • Women who choose the Prentif Cap are interested in finding a form of birth control which is safe, effective, easy to use and unintrusive. Those who have taken oral contraceptives and experience side effects or discontinue their use after extended periods of time, find it difficult to obtain a suitable alternative contraceptive. Many women are hesitant to use IUD'S, that have come under close medical scrutiny. Most women find that inserting diaphragms reduces spontaneity and additional insertions of spermicide are inconvenient and distasteful. Women show great enthusiasm when they learn about this method of birth control.

  • WHO SHOULD NOT USE THE CERVICAL CAP?

  • Most women are excellent candidates for wearing the cervical cap. Approximately 10 percent of patients should not use the cervical cap, including those who have:
    • An unusually long or short cervix.
    • A history of cervical lacerations or scarring.
    • Current cervicitis.
    • An unusually shaped or asymmetrical cervix.
    • Current vaginal infection.
    • Current abnormal Pap smear.

  • WHAT ARE THE ADVANTAGES OF THE CERVICAL CAP?
    • Can be left in place for up to 48 hours, allowing spontaneous "protected" sex.
    • Requires only one small application of spermicide inside the cap upon insertion, no need for additional vaginal spermicide.
    • Less messy than diaphragm, more aesthetic for the user.
    • Smaller than a diaphragm and less noticeable to either partner.
    • Good alternative for women who cannot use the diaphragm because of poor vaginal muscle tone.
    • Using the cervical cap may avoid urinary tract infections associated with diaphragm use.
    • Fewer and less serious side effects than the pill or IUD.
    • Rarely causes cramping or changes in menses.
    • Sturdier than a diaphragm, it can be used for long periods of time without deterioration.
    • FDA studies do not report any cases of toxic shock syndrome associated with cervical cap use.

  • HOW TO TELL THAT YOU HAVE A GOOD FIT?

  • When first fitting the cervical cap, the comfort and confidence level may be low and so it is important that this newly acquired skill is applied as quickly as possible. Sometimes if you trained a long time ago and you have not fitted for several years you may be anxious about the correct fit.

    At the time of examination of female patients ask for permission to put the cap on the cervix to assess the fit as often as possible no matter what their need for contraception. This gives you quick and easy experience. It will only take a moment of your time, and as you introduce the idea of this method the patient might possibly become interested in using the cervical cap then or at a later date.

    To get an outline of the fitting technique, review the video for clinicians. In just over 15 min it goes over all the steps of fitting and checking the fit. There is also a clinician handbook. Both a handbook and a video are also available for patients.

    Consider, devoting a little extra time to confirming your technique. There is one procedure to help confirm the correct fit of the cap. Leave the cap on the cervix for 10 minutes, remove it and visibly see the seal of the cavity-rim on the cervix by seeing a raised ring all the way around the cervix and not too close to the os. If the ring is not there at 10 minutes, it will never be there. It MAY increase in intensity from 10 to 20 minutes. Within 10 minutes of the cap being off the cervix the ring will disappear.

    This does not mean that every time you fit a cap you will need to leave it on for 10 minutes. It's best to do this either in the early days of your fitting or in such cases where there really is a questionable fit between two sizes. (Even today, after several thousand fits in my practice and in hands-on clinical training I still utilize this procedure).

    Confirming the fit can be done in several ways, but ultimately the best test for the fit is when the cap is used during intercourse, daily activities and exercise. By digital examination you can push, prod and try to dislodge the cap. However, at the time of coitus, there are changes to the vaginal cavity that may make the cap more precariously positioned.

    It is therefore important to advise your patients to use a backup method for the first menstrual cycle and check placement and fit before and after each act of intercourse.

  • WHAT TO DO IF THE CLIENT STATES HER PARTNER FEELS THE CAP?

  • A very small percentage of partners complain of discomfort during intercourse when the cap is on the cervix. The rim of the diaphragm is far more noticeable than the cervical cap. However there are ways to minimize any discomfort from the cap. The tab on the side of the cap is usually the culprit! This was designed as a locator, so that when the cap is placed on the cervix it can be rotated a quarter of a turn to increase the seal. (Like screwing a lid on a jar). If this tab is away from the probable point of contact with the penis there is less likelihood of the partner feeling discomfort.

    At the time the bimanual examination is performed, be aware of the position of the uterus and advise the patient of this position. If the uterus is anteverted/flexed the tab should be out of the way at 6 o'clock, the reverse for retroverted/flexed - at 12 o'clock. For the mid position uterus this is a 50/50 choice. At the digital examination you can assess whether there is likely to be an anterior or posterior cervical entry and advise accordingly. Remember too there is always a possibility that the partner may have an allergy to latex. Sometimes the actual rim of the cap and not only the tab causes the partner irritation.

    At different times in the cycle and positions during intercourse, the cervix and thus the cap will be more prominent. It is important to advise the client of this possibility and she can adjust accordingly, with more understanding of her anatomy.

  • WHAT TO DO WHEN A PATIENT STATES THAT SHE OR HER PARTNER MAY HAVE AN ALLERGY TO LATEX?

  • Decide upon another method of contraception. Milex has a silicone diaphragm. The Prentif Cavity-Rim Cervical Cap is made of latex. However, it is hopeful that this cap may soon be made from silicone.

  • WHAT TO DO WHEN A PATIENT STATES THAT SHE OR HER PARTNER MAY HAVE AN ALLERGY TO SPERMICIDE?

  • There is no published data to support the fact than not using spermicide is as effective as using it. However, if the cap is a very good fit and you have a careful and compliant couple, then you have a very effective method of contraception. Using spermicide just gives you a great back up should the cap be dislodged.

    Although I am not aware of any scientific studies, cervical cap users have suggested for decades that a natural spermicide is very effective as an alternative for some women. Use 3 drops of lemon juice in 1 tablespoon of Aloe Vera Gel mix and use, refrigerate excess and discard after 72 hours.

  • WHAT TO DO WHEN A PATIENT HAS HAD FREQUENT URINARY TRACT INFECTIONS?

  • Suggest the cervical cap! As the device does not touch the urethra or bladder wall, there is far less chance of recurring infections. In addition, there is no need for additional vaginal spermicide (just the spermicide inside the cap (1/3 of the dome) therefore the pH of the vagina is not affected

  • WHAT TO DO FOR MID-CYCLE SPOTTING WHEN A WOMAN FIRST BEGINS TO USE THE CAP?

  • I have learned to forewarn women at the time of the fitting. Mid-cycle is the optimum time for fitting. Spotting is a probable sign of ovulation. Many women may not have been quite so aware of spotting at this time, as the blood is now in a vessel and clearly visible, versus on a toilet tissue that may go unnoticed. In my experience, this spotting occurs only in 2 or 3 cycles, and a day or so at a time. If it is only spotting at this time of the cycle there is no cause for concern. Maybe the seal on the cervix draws some blood into the cap, generally this is not associated with awareness of the caps placement or discomfort. If a woman is advised that this may happen, she is not alarmed at the sight of blood. If she is not prepared she may feel there is a problem with her cervix/uterus caused by the fitting procedure and examination. Bleeding, however, is another matter and should be fully documented and treated.

  • WHAT TO DO FOR THOSE WOMEN WHO MAY BE DIFFICULT TO FIT?

  • Occasionally the patient may have a tight introitus or is very uncomfortable being examined. After completion of the pelvic exam and obtaining a Pap smear, "pop in" a cap that you think is the most likely size. Then leave the patient to remove and then reinsert this cap. Upon returning to evaluate the size, it is almost always easier to examine and fine-tune the fit as she has relaxed.

  • WHAT TO DO FOR THOSE WOMEN WHO HAVE DIFFICULTY REMOVING THE CAP?

  • Squatting and bearing down as if having a bowel movement, shortens the vagina and makes it easier for her to reach her cervix. If the vagina is deep and she has short fingers she may still have some difficulty. The index and middle finger should always be used together to increase the span. Her partner may be willing to remove the cap for her. Lastly, supplying her with the Ortho Universal Introducer as an extension of her fingers will allow her to "hook" the rim of the cap and bring the cap into the vagina thus allowing her to reach the cap more easily. Other brand introducers do not have the hook on one end and therefore are ineffective.

    This is a prescriptive device and can be obtained from the wholesale pharmacy supplier. The cost is about $5 at the time of this writing and the National Drug Code # is NDC-0062-3830-00.

    If a patient contacts you and is frustrated that she is unable to remove her cap, suggest that she try to relax and wait for a few hours before trying again. Taking a warm tub bath can often help to relax the muscles that have tightened after prolonged struggling. Emergency room clinicians have not reported seeing anyone for this reason!

  • HOW OFTEN SHOULD THE CERVICAL CAP BE REPLACED?

  • The FDA recommends annual replacement of the cap. This was recommended to coincide with the annual examination. Sometimes, women have had little use of their cap but there may still be deterioration of the latex over time. The cap should be kept away from heat, light and petroleum based products. Even if there has been little use, the cap should be inspected prior to each use and for "best" results, replaced each year. First signs of latex deterioration maybe "permanent" dimpling of the dome of the cap, also thinning or tearing. Damage by chemicals etc. often cause a mosaic pattern on the dome. The rim is very sturdy but it is possible that separation may occur. A sticky texture also denotes changes. Tiny holes may be checked for, by holding the cap up to the light. For longer life, the cap should be dusted lightly after drying, in cornstarch and kept in the original container. See care instructions on the back of the patient brochure as well as in the package insert.

  • ADDITIONAL SIZES IN THE PRENTIF CAVITY-RIM CERVICAL CAP

  • At this time the manufacturer has no plans to add sizes, although they are well aware of requests. As about 80 percent of women can be fit with the cap, even with more sizes not everyone would be able to be fitted with the Prentif cap because of their cervical anatomy, it is hard to justify more sizes for a possible 10 percent more caps fits. Clearly one smaller than the 22mm, and one between the 25mm and 28mm would be optimum.

  • CONTRACEPTIVE JELLIES AND CREAMS


  • Please be aware that Ortho Pharmaceuticals also have a 3 percent Nonoxynol 9 contraceptive jelly, GYNOL EXTRA. In some cases this concentrated amount can cause localized irritation, especially when left inside the cap for up to 48 hours. Using the standard 2 percent is less likely to be a problem. Contraceptive cream may be used; however, if left in the cap for extended period of time women have noted that the cream may have a rancid odor.

  • HOW TO OBTAIN A CERVICAL CAP

  • We sometimes receive phone calls from women who are wandering around trying to find a pharmacy to fill a prescription. Please remember that the caps are not stocked on pharmacy shelves or in their warehouses. It is possible however for you to make arrangements with a pharmacist in your neighborhood if you are not able to stock the cap for your patients.

    They can order them directly from our office 408-395-2100 As it is a prescriptive device, Cervical Cap Ltd. is not able to ship directly to the patient. We can accept payment by credit card (M/C or VISA) and ship the cap to the office of the provider who has written the prescription. Most insurance companies that cover birth control methods with their insurance plan will cover the cost of the cervical cap. This is a very inexpensive method of birth control. If you have difficulty with reimbursement from the insurance companies please contact CxC we will try to assist you.

    You can reach us in California at:
  • CLEANING OPTIONS FOR CERVICAL CAP FITTING DEVICES


  • It is important that the fitting cervical caps are scrubbed thoroughly in a liquid detergent and water prior to any of the next options. This will remove most of the bioburden. Immediately after fitting the patient, the caps should be immersed in a soapy solution so the debris does not dry on the device before cleansing.
    • AUTOCLAVE METHOD:
    • (1) Autoclave at 121 degrees C/15psi for 20 minutes unwrapped and 30 minutes wrapped.
      (2) Allow to air dry- do not put through "dry cycle".
      (3) Keep in container until ready to use.

    • CLOROX¨ METHOD:
    • (1) Soak in 1:10 dilution for 30 minutes.
      (2) Rinse thoroughly under running tap water.
      (3) Soak in 70% isopropyl (rubbing) alcohol for 15 minutes.
      (4) Rinse thoroughly under running tap water.
      (5) Allow to air dry and keep in container until ready to use.

    • CIDEX GLUTERALDEHYDE METHOD:
    • It is important to have adequate ventilation when using this method and running water.
      (1) Immerse in 2% Cidex solution for 20 minutes at room temperature.
      (2) Rinse and place in boiling water for 30 minutes.
      (3) Allow to air dry and then keep in container until ready to use.

      This method although effective, will cause deterioration of the latex and as the solution is caustic can be a hazardous substance to use in an office setting.

    Cervical Cap, Ltd. Products
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