The prentif contraceptive cervical cap: Acceptability aspects and their implications for future cap design

CONTRACEPTION

THE PRENTIF ACCEPTABILITY

CONTRACEPTIVE

ASPECTS

AND THEIR

CERVICAL

CAP:

IMPLICATIONS

FOR

FUTURE CAP DESIGN* JAMES P. KOCH, M.D. Boston Hospital for Women (Division of Brigham and Women's Hospital) Boston, Massachusetts

Patients in a private gynecological practice were offered the Prentif contraceptive cervical cap. The first 413 acceptors were sent a questionnaire covering in detail many of the aspects of their experience. The 371 responses contained a wealth of information concerned with safety, Safety and effectiveness effectiveness and acceptability. are dealt with in the companion article preceding, while the less serious risk factors that reduce the acceptability of the Prentif cap are presented and discussed herein. In order of descending frequency, these factors include: odor; difficulty removing; discomfort to partner; difficulty inserting; dislike of spermicide; discomfort to self; urinary discomforts; vaginal infections; vaginal discharge; and vaginal itching. The most attractive features of the cap, as compared with the diaphragm, were: increased convenience; greater safety; less interference with spontaneity; increased frequency of intercourse; and increased libido. Despite multiple problems with Prentif caps, 67.4% of the cap recipients were still using their caps after one year. However, this was among a select group of highly motivated women of above-average intelligence. The causes of cap acceptability problems are discussed along with probable future improvements in cap design that may solve them.

* Presented in part at the Pan-American Conference on Fertility and Sterility, Aruba, March, 1979, and at the Meeting of Planned Parenthood Physicians, Washington, D.C., October, 1981. Correspondence

Address:

James P. Koch, M.D. 1037 Beacon Street Brookline, MA 02146

Submitted for publication May 29, 1981 Accepted for publication January 29, 1982

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1982 VOL. 25 NO. 2

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CONTRACEPTION INTRODUCTION

During the 143 years since the first formal description of a cervical cap (l), a number of reports have appeared in the literature (2-40) but only a few of them give detaiied information concerning the annoyances and less serious side Early effects that bear on the question of acceptability. in our experience it became clear that the Prentif cap had many problems. Since a plan to attempt to design new cervical caps with improved acceptability was under consideration, it seemed particularly important to learn the nature and extent of these Prentif cap problems. The present report will summarize and tabulate our findings. Additional background and introductory information is presented in the companion article preceding.

PATIENTS

- MATERIALS

- METHODS

Of the 371 patients who responded to the PATIENTS: questionnaire, 363 gave information concerning acceptability factors. The group was young, well educated and highly motivated and has been further characterized elsewhere (preceding article). Only Prentif SELECTION OF CAPS AND SPERMICIDES: Cavity-Rim Cervical Caps* were used in this study. These caps are cup-shaped and have a dome and a thickened rim. They come in four sizes designated 22, 25, 28 and 31 mm which are the measures of the inside diameters of their The rims are about 6 and the domes 1 mm in thickness. rims. The overall lengths of the caps are 34, 36, 38 and 40 mm, respectively. Delfen Cream** was the spermicide advised because it was thought to be most effective (40; preceding article). Each patient's cap fit FITTING AND TRAINING METHODS: was assessed according to criteria set forth in the preceding article which also describes the procedures used to train those patients who met the criteria. STANDARD INSTRUCTIONS FOR USE: These included filling the cap with Delfen Cream before placing on the cervix for a Further details maximum of seven days of continuous use. are included in the preceding article.

* Lambert's, Ltd., 200 Queensbridge Road, London E8 3LY, England. ** T.M., Ortho Pharmaceutical Corp., Raritan, N.J. 08869

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CONTRACEPTION

RESULTS

ACCEPTABILITY: The side effects of cap use which seemed likely to constitute annoyances to users, rather than threats to their life or health, are included in this section. The number of respondents is shown for each table and varies partly because all 363 respondents did not answer every question. Odor was by far the most common annoyance and affected two-thirds of our acceptors at least some of the tine. It was what 38% of our respondents disliked most about their caps and was also a leading cause of discontinuation, accounting for 21% of the acceptors who discontinued cap use for reasons other than pregnancy. In an effort to determine the cause of the odor, many patients troubled with this problem were examined for vaginal infections. Wet preps and cultures were nearly always negative, regardless of whether Delfen cream was present or had been absent for several When Delfen was present in the vagina at the time of days. examination, clinicians easily associated the odor The longer the cap had been in specifically with the cream. place, the more offensive the odor, especially immediately If spermicidal preparations other upon removing the cap. than Delfen were used or if, during interludes of abstinence, caps were used with no spermicide, there was seldom any troublesome odor. About 90% of those responding used their caps with Of the 77 respondents who noted Delfen cream as instructed. problems with Delfen Cream, 42, or 55%, complained of odor. As would be expected of most spermicides, Delfen Cream had problems associated with it apart from odor. Of 263 respondents, 77, or nearly 30%, had problems with Delfen. In Table I the first line shows the major complaints in descending order of frequency, and the second shows the percent of the above 77 respondents voicing a given complaint. TABLE I - Problems

Odor 55%

Irritation 28%

With Delfen Cream Availability 7%

(77 Respondents)

Taste 5%

Other 5%

In Table II a varied group of acceptability factors specifically related to cap use is summarized. Because of the nature of these factors, it seemed particularly important to learn not only whether, but also with what frequency, they occurred. Therefore, Table II shows the percent of respondents encountering each problem with any of five frequencies.

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CONTRACEPTION

TABLE II - Acceptability Factors: have you experienced:

"In your use of the cap No.

Always

Often --

Sometimes

%

%

%

Difficulty inserting?"

2

5

Difficulty removing?"

4

Discomfort to self durF intercourse?"

Seldom --

Never

of Respondents

%

%

13

42

38

270

10

20

33

33

271

1

0

5

19

75

270

Discomfort to self other than during intercourse?"

0

2

5

15

78

271

Discomfort to partner during intercourse?"

4

25

55

268

Cap coming off with intercourse?"

2

7

19

70

270

Cap coming off with bowel movements?"

1

4

6

17

72

267

Cap coming off spontaneously?"

1

1

4

8

86

269

28

16

23

2

11

272

Odor with cap in place?"

7

17

27

45

266

Increased vaginal itching or irritation?"

5

11

16

67

257

Odor on removing cap?"

164

10

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CONTRACEPTION

More acceptability factors are summarized below in Table III. Note that sex drive and frequency of intercourse were reported to have increased in a majority of respondents. The table next following (IV) tells what was disliked most, with the more frequent problems at the top. TABLE III - "Since you began using your cap have you had: Percent of Respondents Noting No. of

Increased

Decreased

Respondents

No Change

Vaginal discharge?"

19

13

68

248

Vaginal infections?"

14

15

71

231

Sex drive?"

19

4

77

256

Intercourse frequency?"

29

7

64

252

TABLE IV - "What did you dislike most about the cap?" Disliked Most

%* of 292 Respondents

Disliked Most

%* of 292 Respondents

Odor

37.7

Spermicide

9.6

Difficulty removing

18.5

Discomfort to self

7.5

Discomfort to partner

Cap design

6.5

11.3

Dislodgement

11.0

Urinary complaints

5.8

Inconvenience

3.7

Pregnancy

2.7

Miscellaneous

4.1

Unsure of effectiveness

11.0

Difficulty inserting

9.6

* Note that each respondent may cite more than one problem. Thus the percents total more than 100.

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CONTRACEPTION

Perhaps the most meaningful insight into acceptability factors is provided by the reasons given for stopping cap use given below (Table V) in decreasing order of frequency.

you TABLE V - "Why did Why Stopped

%* of 69 Respondents

Dislodgement

18.8

Pregnancy

la.8

Odor

17.4

Male discomfort Unsure of effectiveness Self discomfort Spermicide problems Desire pregnancy

Why Stopped

%* of 69 Respondents

Difficulty removing

4.3

Inconvenience

4.3

Increased vaginitis

4.3

Difficulty inserting

4.3

17.4

11.6 Increased UTIs

2.9

Irritation

1.4

Decreased sensation

1.4

a.7

5.8

5.8

Miscellaneous

10.1

There were also factors affecting acceptability as summarized in Table VI showing what 263 liked most about their caps.

TABLE VI - "What did you like most about your cap?" Liked Most

%* of 263 Respondents

Convenience

78.3

Effectiveness

18.6

Safety

41.1

Comfort

13.3

Spontaneity

23.6

Comfort partner

4.2

Ease of use

22.4 Other

3.8

Liked Most

%* of 263 Respondents

(self)

* Note that each respondent may make more than one response. Thus the percents total more than 100. FEBRUARY 1982 VOL. 25 NO. 2

CONTRACEPTION

As can be seen, many respondents found likeable aspects about their caps and, in spite of the many problems with caps, 91% of the 268 respondents were at least moderately, if not completely, satisfied with their caps, as shown below in Table VII. TABLE VII - "HOW satisfied Percent

are (were) you with your cap?"

of 268 Respondents:

Completely

Moderately

Not at all

56%

35%

9%

No. of Respondents 268

CONTINUATION RATES: Perhaps the ultimate test of acceptability for the individual method user is the decision to continue or discontinue using a method. This is expressed in the aggregate in the continuation rate described in the next section. These rates were also calculated by the Life Table method and can be derived from the data found in the They are calculated in a manner companion paper preceding. The continuation similar to that used for pregnancy rates. rate was first calculated individually for each month and from these rates the cumulative rates were calculated. Table VIII shows the continuation rates for every third The rate at 12 months was 0.674, meaning ordinal month. that after one year of experience, 67.4% continued and 32.6% had abandoned use of the cap. The rates at 18 and 21 months are based on much smaller numbers and are therefore subject to much greater statistical error.

TABLE VIII - CUMULATIVE

CONTINUATION

Month:

3

6

9

Rate:

0.854

0.752

0.728

12 0.674

RATES 15 0.652

18 0.604

21 0.462

A major purpose IMPROVEMENTS DESIRED FOR FUTURE CAPS: of the present study was to determine the problems of presently available caps and to identify the improvements With this in mind, the most important for new cap designs. questions shown in Tables IX through XI were asked.

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"IF NEW AND IMPROVED

CAPS WERE AVAILABLE:

IX - would you prefer one that could be left in place with safety, effectiveness and comfort for: TABLE

Percent One Week?"

of 268 Respondents

One Month?"

One Year?"

24

7

41

28

Indefinitely?"

TABLE X - Would it be important to you to have a device that would make it easier and quicker: Number of To remove your cap?" Respondents To insert your cap?" Yes

No -

Yes

No -

42%

58%

50%

50%

265

TABLE XI - Would a disposable cap with a slow-release contraceptive agent appeal to you: Number of Not at all?" Respondents Moderately?" Strongly?" 28%

45%

27%

269

DISCUSSION Many of the problems affecting ACCEPTABILITY: acceptability could be solved by cap design changes or by For example, the creation of compatible accessories. excessive amount of time required for training, as well as the difficulties too often encountered with insertion and removal, might all be reduced either with an inserter-remover device designed for conventional types of caps or by an entirely new type of cap equipped with an outflow valve designed to allow the cap to stay in place for months or years, including during bleeding episodes (43, 44). Odor was a major problem for many respondents in the present study and a major cause for discontinuing cap use. In contrast, in the Tietze, Lehfeldt, Liebmann study (311, none of the participants who discontinued cap use did so Since most spermicides are also because of odor. bactericides, they protect against venereal infections (42, Thus 43, 44) and should also work against bacterial odors. odor problems would not be expected to be severe if caps were used with spermicides.

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Delfen Cream, however, has a unique problem. It contains 5% nonoxynol-9 as the active ingredient in an oil-in-water base. It was formulated for use as a vaginal spermicide to be used independently and was never intended for prolonged use or for use in conjunction with diaphragms or caps. No other spermicidal preparation on the U.S. market shares Delfen's oil-in-water base. It seems probable that certain conditions, within the normal range of the vaginal environment (perhaps certain normal flora alone or in combination with certain pH ranges), may cause the oils in the Delfen vehicle to turn rancid, thus producing the offensive odors. This hypothesis is, at least, consistent with the observations described. In any event, it appears that, in the present study, the problem of odor is unfortunately so intertwined with the use of Delfen cream that the data shed only limited light on the general problem. A cap designed to fit the cervix exactly might eliminate the space in which odor-generating secretions could accumulate. Thus, it would seem that, one way or another, odor need not be a difficult problem. Discomfort to nartners and selves was cited as a maior reason for discontinuing‘cap use by an aggregate of 26.i% (17.4 and 8.7%. Table VI. Most of this discomfort could probably be eliminated if caps were made softer, shorter, and less bulky than Prentif caps. The two most popular attributes of the cap were the convenience of prolonged wearing which avoided the necessity and awkwardness of the methods having to be dealt with at the time of need, and the lack of messiness afforded by the requirement for less spermicide and by its being sealed more tightly in place. In summary it is, perhaps, not quite so much a compliment to the cap as it is a reflection on alternative methods that 67.4% of the respondents were still using their caps after one year in spite of the problems. Thus, the cap is relatively acceptable to the majority of users. FUTURE CAPS: The Prentif cap was designed in the 1930's and was based on the Pro-race cap of Dr. Marie Stopes which was designed in about 1918 (11). It would be no reflection on these designs if substantial improvements could now be made. At least two new kinds of caps with some of the following characteristics are likely. The first would be a custom-fitted contact cap that would have to be individually made and probably inserted by professionals but could stay in place indefinitely because it would have a menstrual outlet valve. It would not require chemical spermicides because it would be sperm tight or have other intrinsic sperm inactivating properties (43, 44). The second would be a small, thin, non-contact cap that would be prefabricated in a set of properly assorted sizes FEBRUARY 1982 VOL. 25 NO. 2

CONTRACEPTION

and shapes sufficiently varied and flexible so as to conform securely to the cervix of almost any woman. It would contain an amount of safe, effective, timed-release spermicide sufficient to last for several weeks. Finally, it would be compatible with a simple device which would allow the owner to place the cap on and remove it from the cervix with ease, speed and accuracy.

ACKNOWLEDGEMENTS

First of all, I would like to dedicate this report to my patients whose active and enthusiastic participation in this and related projects has been a never ending source of encouragement. They have taught me much of what I know about cerivcal caps. A special vote of thanks is due to those who responded so painstakingly to the lengthy questionnaire. Several members of the office staff have made special contributions to this undertaking. Patricia Canavan, C.N.S., fitted many of the cervical caps and also edited this manuscript. Deborah Kattenbach, P.A., oversaw the initial coding of the questionnaire. Kate Matson solved a myriad of difficult phone and schedule problems and translated ancient German manuscripts. Paula von Lichtenberg kept everything and everyone going. I could never have completed this study without the constant support of my family, especially my wife, Harriet, who took time from her own professional responsibilities to help with long series of calculations and endless rereading of the manuscript. The frequent fruitful discussions and the incisive editorial advice provided by Dr. Phillip Stubblefield were extremely valuable and deeply appreciated. Ever since our first meeting, Dr. Hans Lehfeldt has been His for me an unusually cordial and enthusiastic teacher. keen mind and extensive experience have contributed much of our published knowledge about cervical caps (31-33, 40) and there is promise of still more to come. Dr. Raymond Neff, Peggy Morrision and Elizabeth Allred, all from the Computing Center of the Harvard School of Public Health, contributed importantly to questionnaire design and data analysis. Frances Flynn and Anne Alach of the Countway Library Medical Bibliographic Service were indispensible in securing copies of the most obscure original references. Finally, I am grateful to Mr. John Rogers and the Ortho Pharmaceutical Corporation for furnishing Delfen Cream and for helping to defray a portion of the out-of-pocket costs of the study.

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