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Original Research Article

Results of a User Satisfaction Study Carried Out in Women Using Uniplant Contraceptive Implant

Elsimar M. Coutinho,* Celia Athayde,* lone Barbosa,* Francisco Alvarez,t Vivian Brache,t Gu Zhi-Ping,f Edward E. Emuveyan,§ Adeyemi 0. Adekunle,# Luigi Devoto,**

Oscar Mateo de Acosta,tt Japheth Mati,tt and Oladapo A. Ladipo§§

A study of the acceptability of Uniplant, a 12-month single implant of nomegestrol acetate, included 819 women from Africa, Latin America-,-and China, participating in a clinical trial of Uniplant. A standard, pre-coded questionnaire was specially designed for this purpose and applied at the moment of removal of implant, either at the end of 12 months of use or at the time of discontinuation for whatever reason. The level of satisfaction proved high when users’ comparison with their previous contraceptive method, users’ recommendation of Uniplant to others, users’ intention to use the method in the future, and service satisfaction were taken into consideration. Uniplant was considered easy to use, safe (low risk of pregnancy), and also to cause fewer side effects than other methods. When asked about the least liked feature of Uniplant, almost half the respondents said that there was nothing that they disliked and about one-third mentioned the changes in their menstrual pattern. However, according to the clinical trial, over half of the Uniplant users have bleeding patterns similar to untreated cycles. The majority of respondents did not feel any discomfort during the procedure of insertion and removal of the implant. About 70% of patients in the study stated that they required contraception for more than one  year and most of these women said that they did not mind having to change the implant every year.  © 1996 by E.M. Coutinho et al. CONTRACEPTION 1996;54:313-317

*Maternidade Climerio de Oliveira, Federal University of Bahia, Salvador, Bahia, Brazil; Profamilia, Santo Domingo, Dominican Republic; Shanighal Institute of Materia Medics, Shanghai, China; §Depanment of Obstetrics and Gynecology, College of Medicine, University of Lagos, Lagos, Nigeria, ‘Department of Obstetrics and Gynecology,  University College Hospital, University of Ibadan, Ibadan, Nigeria; Department of Obstetrics and Gynecology, Faculty of Medicine, University of Chile, Santiago, Chile; trInstituto Nacional de Endocrinologia, Havana, Cuba; Kenya Medical Research Institute, Reproductive Health Research Unit, Nairobi, Kenya; and South-to-South Cooperation in Reproductive Health, Salvador, Bahia, Brazil

Name and address for correspondence: Elsimar M, Coutinho, M.D., Maternidade Climdrio be Oliveira, Rua do Limoeiro, No. 1, 40055-150 Salvador, Bahia, Brazil. Tel: (55-71) 243-0244; Fax: (55-71) 243-9153

Submitted for publication March 25, 1996

Revised August 12, 1996

Accepted for publication August 13, 1996

© 1996 by E.M Coutinho at al.

KEY WORDS: acceptability, Uniplant contraceptive implant, nomegestrol acetate


INTRODUCTION

Subdermal contraceptive implants have been the most important addition to contraceptive technology in the past two decades.¹⁻³ This new long-acting method involves the slow diffusion at a stable rate of a steroid progestin from polymer capsules or rods placed under the skin. The duration of contraceptive efficacy can vary from 1 to 5 years depending on the type of polymer, the number of capsules, and the specific progestin. Advantages of subdermal contraceptive implants are the high effectiveness of low-dose progestin without the use of estrogen, long duration of action, prompt reversibility, and the fact that implants do not depend on the user’s compliance. The levonorgestrel implant Norplant® system is the first of this new family of long-acting methods and the only one that has regulatory approval for distribution so far. The development of other implants aims to reduce the number of units, which greatly facilitates insertion and removal, and to introduce other progestins that may minimize side effects.⁴

This second generation of implants includes Uniplant, a single Silastic® implant of nomegestrol acetate which has been shown to provide contraceptive efficacy during 12 months of use.⁵ A multicenter clinical trial on Uniplant has been carried out in ten centers in nine countries with the participation of 1803 volunteers. The results of the first year of this multicenter study confirmed that Uniplant is an efficient, well-tolerated, 12-month contraceptive method.⁶ The overall acceptability of Uniplant by users was measured in this clinical trial by continuation rates and/or reasons for discontinuation. Although these two measures of acceptability can provide valuable information, questions directed to users regarding their experience may reflect considerations that have little to do with the intrinsic properties of the method under study.⁷ Safety, for example, is often perceived by users as something other than the simple absence of potentially adverse effects. In fact, women are concerned about how a contraceptive method might affect their overall health, including their interest in sex, their physical vitality, and emotional well-being, which are aspects of health that may not easily be measured in a clinical trial⁸. For this reason, during the course of this multicenter clinical trial, it was decided to design a questionnaire to determine the level of satisfaction of women using Uniplant, their future contraceptive plans, and to obtain their opinions about the removal procedure. This paper reports the users’ opinion about the method for subjects who completed one year of Uniplant use and for those who discontinued before completing 12 months.


MATERIALS AND METHODS

A standard, pre-coded form was specially designed for this purpose and the questionnaire was distributed to all centers of the South-to-South network participating in the multicenter trial, with instructions that it should be applied at the moment of removal of the implant, either at the end of the 12-month duration of the implant or at the time of the woman’s discontinuation from the study for whatever reason. Women were interviewed by trained personnel. All questionnaires were sent to the coordinating center for this study in Salvador, Brazil, where the data were entered into a data bank, using the EPI INFO program (Centers for Disease Control, Atlanta, GA, USA). Percentile distribution was calculated for each variable.

The questionnaire requested information on the following issues:

—The last contraceptive method used by the subject.

—How the subject compared Uniplant to that previous method (better, worse, or the same).

—What features subject most liked and disliked about Uniplant.

—Whether Uniplant had been noticed by other people.

—How much discomfort, if any, was felt during the insertion and removal procedure.

— Whether subjects would recommend this method to a friend or relative.

— Whether subjects think that the method is good for unmarried women under 20 years of age.

—Whether subjects required contraception for more than one year and, if so, if it upsets the

subject to have to change the implant every year.

—Whether subjects would prefer a longer-lasting single implant and what would be the ideal duration of contraceptive efficacy.

—How many implants subjects consider tolerable as a contraceptive.

—Whether they would request a second Uniplant if they still required birth control after the end of duration of action of the current one.

—Whether subjects felt that they had received sufficient information about the method.


RESULTS

A total of 819 subjects using Uniplant were interviewed. This study population represented 45% of subjects enrolled in the multicenter clinical trial. The questionnaires were applied immediately after implant removal, either at the end of the 12-month duration of action of the implant (86.2% of respondents) or at the time of discontinuation for whatever reason (13.8% of respondents). The distribution of respondents according to time of implant removal correlates well with that of subjects to whom the satisfaction questionnaire was not applied. Eighty percent of the women who were not interviewed also used Uniplant for the full 12-month period. Most women, either interviewed or not interviewed, used Uniplant until the end of its 12-month duration of contraceptive action. The principal reasons for implant removal in all participating centers were nonmedical. The analysis of reason versus time of discontinuation (month 1-12 of use) demonstrated that nonmedical reasons were more frequent than any other reasons for discontinuation except at months 5 and 11 for the interviewed group and at months 4,5,8,9, and 11 for the not-interviewed group. During those months the principal reason for implant removal in both groups was menstrual disturbances, which was, however, only slightly more frequent than nonmedical reasons. The geographical location of respondents is shown in Table 1. A significant proportion of respondents were from Africa and Latin America, only 7.1% being from the Chinese center. The characteristics of the interviewed subjects and those of the remaining subjects enrolled in the Uniplant multicenter trial who were not interviewed are provided in Table 2.

As can be seen from Table 3, almost 30% of respondents had never used a contraceptive method before entering the Uniplant study. Users of other contraceptives prior to Uniplant, however, compared both methods. Uniplant was considered better than the

previous method by 87.1% of the subjects; the same by 9.5%, and worse by 3.4%. The previous contraceptive method of the majority of respondents was either the pill or IUD.

As shown in Table 4, the subjects supplied information regarding what they most liked about Uniplant. Over half the respondents liked the fact that Uniplant is easy to use and that they do not have to remember anything. More than a quarter of the subjects said that they liked the low risk of pregnancy and about 13% responded that Uniplant caused fewer side effects than other methods

Table 5 indicates what subjects least liked about Uniplant. Alrhost half of the respondents (48.4%) said that there was nothing that they disliked. About one-third answered that they did not like the changes in their menstrual pattern. Some respondents (8.5%) mentioned side effects, especially weight gain (20 subjects), headache (13), and weight loss (7).

Over two-thirds of respondents stated that the implant had not been noticed by other people. Over 90% of the subjects would recommend the method to a friend or relative. The women interviewed gave their opinion on whether this contraceptive method is suitable for unmarried women under 20 years of age. Most of them {65.8%) thought that it was a good method for this age group, 23.8% were unsure, and 10.4% thought that it was not suitable. Among the respondents who did not approve of Uniplant use by this age group, the majority considered that contraception in this ease could lead to promiscuity and that sex should not be allowed for unmarried women. Moreover, some respondents fear side effects for young users, including weight gain or sterility. Only 2.0% of respondents felt considerable discomfort during insertion and only 3.8% at the removal of the implant. A little discomfort was felt by 30.1% of subjects at insertion and by 37.7% at removal. A significant proportion of respondents did not feel any discomfort during the insertion and the removal procedures (67.9% and 58.5%, respectively). Almost 70% of respondents stated that they required contraception for more than one year. Among these subjects, about 30% stated that it upset them to have to change the implant every year (principally because of fear of discomfort) and 13% were notsure. Two hundred thirty-six subjects who required contraception for more than one year and who did not like the implant replacement procedure or were unsure about it, answered the question regarding the ideal duration of a single contraceptive implant. Over half of these women (56.4%) would prefer a five-year implant.

All subjects answered the question on the number of implants they considered tolerable. Half of them considered a single implant ideal, while the remaining respondents would not mind using two to six implants.

Approximately 80% of subjects stated that they would use a second implant after the first had been removed and 94.1% felt that they had received enough information about the method. The participants in this study were then given the opportunity to make any additional comments regarding the study and the contraceptive implant. One hundred sixty-nine women (21% ) commented that they were completely satisfied with the use of Uniplant, 55 women (7%) felt that the implant should last longer, and 23 women (3%) complained about the changes to theirmenstrual pattern. Five hundred fourteen women (63%) made no additional comments.

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DISCUSSION

The fact that the decision to investigate the subjects’ opinion was made when the Uniplant multicenter trial was already in progress, limited the sample to 45% of the total number of participating women. This limited sample however, was still representative of the satisfaction level of Uniplant users, involving subjects of geographically and culturally diverse groups. Only Uniplant users from Indonesia and Egypt were not represented among the women interviewed. The group of subjects who were not interviewed was similar to the user satisfaction study population in age, parity, number of abortions, and also in duration of implant use and reasons for discontinuation. The majority of respondents demonstrated being very satisfied with the method. Most of them considered Uniplant to be a better method than the previous one they had used, would recommend the method to a friend or relative, and felt that they had received enough information from the research centers. When subjects were asked what they least liked about Uniplant, 48.4% found no problem to mention. Moreover, Uniplant was considered easy to use since the women do not have to remember anything, efficacious (low risk of pregnancy), and to cause fewer side effects than other methods. The majority of respondents considered the method suitable for unmarried women under 20 years of age.

According to 32.2% of respondents, the most important drawback of the method was the changes in the menstrual pattern. Menstrual pattern alterations are a common finding among users of progestogen-only methods. It is also unpredictable what characteristics would predispose a woman to suffer such changes during progestogen treatments. Over half of the Uniplant users, however, have bleeding patterns similar to untreated cycles throughout the 12-month action of the implant.⁶ The altered bleeding patterns are mostly represented by irregular or unpredictable bleeding, which was observed in approximately 22% of subjects in the multicenter trial. Amenorrhea and prolonged bleeding were less frequent findings in Uniplant users. Discomfort during the insertion and removal procedure was a minor problem, the majority of respondents feeling no discomfort. A little discomfort was felt by 30% of women during insertion and by approximately 40% during removal. Only a small group of women stated that they found the procedure really uncomfortable (2% of respondents reported noticeable discomfort during insertion and 3.8% reported noticeable discomfort during implant removal). However, when the sample is reduced to only 70% of the original study population in order to include only subjects who require contraception for more than one year, we observed that about 30% of these women would prefer a longer-lasting implant, thus avoiding the procedure of changing implants. Nevertheless, half of the total number of respondents indicated that a single implant is the ideal method when compared to the insertion of multiple capsules (two to.six). In studies carried out to assess the acceptability of

Norplant®, similar user satisfaction questionnaires obtained responses that are in general very similar to those reported in this Uniplant study. According to these results, women have been generally satisfied with Norplant®, the most-liked features being ease of use and low risk of pregnancy, while menstrual disturbance was the least-liked feature for the majority of users.⁹⁻¹³ Overall, the attitude of the subjects participating in this study toward Uniplant was positive, confirming the results previously reported.⁶

ACKNOWLEDGMENTS

This study was supported by a grant to South-to-South Cooperation in Reproductive Health by the Rockefeller Foundation. The authors would like to acknowledge the collaboration of Ms. Lesley Hanson de Moura in the linguistic revision of this manuscript and the participation of Mr. Dietmar Schuhman in the statistical analysis.

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