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Evaluation of the effects of a female condom on the female lower genital tract
CONTRACEPTION
Evaluation of the Effects of a Female Condom on the Female Lower Genital Tract
David E. Soper, MD Nancy J. Brockwell, RNC Harry P. Dalton, PhD Department of Obstetrics and Gynecology and Department of Pathology Medical College of Virginia Virginia Commonwealth University Richmond, Virginia
Abstract The purposes of this study were to determine if use of the female condom (RealityT”) was traumatic to the vaginal mucosa and/or vulvar skin and to determine its effect on resident vaginal bacterial flora. Thirty subjects were randomly assigned to utilize the female condom or diaphragm during the study period. Initially and during 3 follow-up visits, each subject underwent colposcopic examination of the vagina, cervix, and vulva with photographic record, and qualitative fungal, aerobic and anaerobic cultures of the vagina. The two groups were compared with respect to the frequency of abnormal physical findings determined by both macroscopic and colposcopic examination. Visits were compared within each contraceptive group with respect to changes in resident vaginal flora. There was no evidence of significant trauma associated with the use of either contraceptive device during the study period. The resident vaginal flora did not significantly change during the three follow-up visits in patients using the female condom. In diaphragm users, lactobacilli were less frequently isolated at the third (14/15 vs 6/15, P = 0.008) and fourth (14/15 vs 7/15, P = 0.039) follow-up visits when compared to the initial visit. In addition, aerobic gram-negative rods were more frequently isolated during the fourth visit (l/15 vs 9/15, P = 0.021) when compared to the first visit. We conclude that neither the female condom (Realitym) nor the diaphragm is associated with trauma to the lower genital tract. Subjects using the diaphragm undergo a significant change in vaginal bacterial flora, becoming more likely to be colonized with coliform microorganisms and less likely to maintain lactobacilli colonization. Submitted for publication February 21, 1991 Accepted for publication May 1, 1991
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Introduction In the United States, the number of acquired immunodeficiency syndrome (AIDS) cases reported in women has been steadily increasing. AIDS is expected to be among the five leading causes of death in reproductive age women by 1991.’ One of the HIVprevention strategies endorses the use of barrier contraception, specifically the condom, to prevent transmission of the virus during sexual intercourse. A new barrier contraceptive device, the female condom (RealityTM), is undergoing development in the United States. Initial studies have shown that the female condom is less likely to leak than a male In addition, this polyurethrane condom is impermeable to both HIV and condom.2 cytomegalovirus.3 Since the female condom may be worn for extended periods of time when used as a contraceptive device or for the prevention of sexually transmitted diseases,its effect upon the lower female genital tract requires more study. The purpose of this study was to determine if use of a female condom was traumatic to the vaginal mucosa and/or vulvar skin and to determine its effect on resident vaginal bacterial flora.
Methods and Material We hypothesized 1) that neither the female condom nor the diaphragm would have an effect on resident vaginal bacterial flora and 2) that neither the female condom nor the diaphragm would be traumatic to the vaginal mucosa. Thirty women were randomly assigned by drawing cards to utilize either the female condom (RealityTM, Wisconsin Pharmacal Co., Jackson, WI) or diaphragm (Wide-SealTM, Milex, Chicago, IL) during the study period. The size of the diaphragm used by the subjects was determined during the pelvic examination in the usual manner. Concomitant use of spermicides was not allowed. A lubricant was used for the insertion of both devices as needed. Patients had to be at least 18 years of age, sexually active, and using an alternative method of birth control. Patients were excluded from the study if they had a history of toxic shock syndrome, irregular menses, signs or symptoms of acute vaginitis, an allergy to latex or polyurethrane, and/or a Pap smear showing moderate dysplasia or greater. In addition, patients could not h&e used the diaphragm as a method of contraception in the past three months. At the initial visit (Visit #l), all patients responded to a questionnaire regarding demographic characteristics and a history of sexually transmitted diseases. A clean-catch urine specimen was obtained and sent for urinalysis and culture. In addition, an evaluation of the genital tract was performed in the following manner. The vulva, vagina, and cervix were inspected, both grossly and with colposcopy, and photographs taken of each anatomical site. Saline and potassium hydroxide preparations were obtained from the vaginal secretions. A Pap smear was performed. A culture of the endocervix was obtained for Neisseria gonmhoeae utilizing T-M Transgrow media (CamScarborough Microbiologicals, Inc., MD). A chlamydiazyme (Abbott Laboratories, IL) was also performed from an
22
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endocervical specimen. Swabs of the posterior vaginal fomix were cultured for aerobes, anaerobes, and Candida albicuns. A bimanual pelvic examination was then performed. A female condom or diaphragm was then placed into the vagina. Patients returned (Visit #2) after having worn the female condom or diaphragm for three hours following the completion of their initial examination. A clean-catch urine for urinalysis and culture was obtained. A repeat evaluation of the lower genital tract including photographs was performed looking for evidence of trauma due to the contraceptive device. Repeat cultures for aerobes, anaerobes, and Candida albicans were performed. On the evening of the first study day, patients used their respective contraceptive device and had sexual intercourse. They were instructed to leave the female condom or diaphragm in place until the following morning at which time it could be removed. Repeat evaluation the following morning (Visit #3) was identical to the evaluation described above on visit #2. Repeat evaluation occurred on day seven of the study (Visit #4). The patient was required to have had a minimum of five sexual intercourses using their contraceptive device during the interim period. Evaluation at this visit was identical to the evaluation performed at the initial visit. The examiner (DES) was not blinded as to the device used. In addition, patients were asked to complete questionnaires regarding the acceptability of the technique of barrier contraception being utilized during the study. Microbiology. Rayon-tipped swabs were used to collect vaginal secretions from the posterior vaginal fornix. These swabs were transported to the laboratory in Stuart’s bacterial transport media (Culturette II, Becton Dickinson Microbiology Systems, MD). The swabs were then plated on blood agar and chocolate agar for the isolation of aerobic microorganisms. Aerobic plates were incubated at 35°C in a 5% CO, atmosphere. Additional rayon-tipped swabs from the vaginal fomix for anaerobic culture were transported to the laboratory in Carey-Blair transport media (Carr-Scarborough Microbiologic&, Inc., GA) They were then plated on prereduced blood agar, chocolate agar, and KV agar and were incubated in an anaerobic atmosphere at 35“C. All microrganisms were identified with standard methods as previously outlined.4 Bacterial isolates from the vagina were divided into the following groups of microorganisms: 1) aerobic gram-positive cocci; 2) aerobic gram-negative rods; 3) aerobic lactobacilli; 4) Candida; 5) anaerobic gram-positive cocci; 6) anaerobic gram-negative rods; and 7) no anaerobes grown. The frequency of isolation for each group of microorganisms was determined with respect to visit number. Statistics. The two contraceptive groups were compared with respect to the frequency of abnormal physical findings determined by both macroscopic and colposcopic examination. The frequency of bacterial and fungal isolates noted at the initial visit was
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compared to the frequency contraceptive group and Fisher’s exact test or the compared using the t-test.
of bacterial and fungal isolates noted at subsequent visits in each between groups. Significant differences were determined by a McNemar’s test where appropriate. Continuous variables were Significance was based on two-tailed tests with a p value 5 0.05.
Results The demography of the study population is presented in Table I. There were no significant differences between groups with respect to age, race, gravidity, level of education, history of a sexually transmitted disease, method of current contraception, or history of barrier contraceptive use. All subjects used their respective contraceptive device
Table I. Demography ________________________-_______-________________-_____----_______________________________ Variable
Female condom (N = 15)
Diaphragm (N = 15)
Age (years)
32.5 + 6.3
33.4 + 6.0
Race (No.) Black Caucasian Indian Gravidity
6 9 0
(No.)
1.0 + 1.0
5 9 1
1.5 + 1.3
Education (No.) High school College Graduate school
7 6 2
4 9 2
History of a STD* (No.)
2
2
11
13
12
9
1 2
0 6
History of barrier contraception Current
contraceptive method (No.) Oral contraceptive IUD Sterilization * sexually transmitted
24
disease
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CONTRACEPTION appropriately during the study period. All subjects complied with the directive to have a minimum of 5 episodes of coitus during the interim period. Subjects using the female condom had sexual intercourse a median of six times (range 5 to 9 times) and the subjects using the diaphragm had intercourse a median of six times (range 5 to 8 times). No subject discontinued use of the diaphragm or female condom due to discomfort, inconvienence, decreased sexual satisfaction, or partner dissatisfaction. There was no macroscopic or colposcopic evidence of trauma associated with either form of contraceptive device. The bimanual pelvic examination was normal in all subjects both at initiation and completion of the study. It wassurprising that despite daily sexual intercourse for most participants, no evidence of bruising, fissures, or tears were appreciated. In one subject using the female condom, colposcopic inspection at the 24-hour visit (visit #2) revealed two small superficial erythematous areas < 1 mm in diameter in the posterior fourchette at the vestibule. These areas were felt to be the result of pressure exerted on these areas during intercourse and not related specifically to the device. These areas were asymptomatic and resolved spontaneously despite continued sexual intercourse utilizing the female condom over the ensuing week. The groups of bacterial and fungal isolates were found with similar frequency at the initial visit in subjects using either the female condom or diaphragm with the exception of the aerobic gram-negative rods. Subjects randomized to the female condom group were more frequently colonized with aerobic gram-negative rods than patients in the diaphragm group but this difference did not reach statistical significance (P = 0.08). Aerobic gramnegative rods were more frequently isolated during visit #4 when compared with visit #l in subjects using the diaphragm. Lactobacilli were less frequently isolated at visits #3 and #4 when compared to visit #l in subjects using the diaphragm. These results are summarized in Tables II and III. There was no significant difference between groups with respect to the above noted changes in vaginal flora. All urinalyses performed were within normal limits with the exception of a single subject in the female condom group. This patient maintained a nitrite-positive urine in the absence of pyuria for the duration of the study. She was asymptomatic despite a concomitant urine culture growing > 1 million colonies of E. coli. This asymptomatic bacteriuria was not treated. There was no difference between contraceptive groups or among the four visits with respect to the frequency of E. coli bacteriuria. Three subjects in the female condom group and two women in the diaphragm group had positive urine cultures for > 100,000 colonies/ml of E. coli at their initial evaluation. At visit #4, two patients in the female condom group and four patients in the diaphragm group had positive cultures for > 100,000 colonies/ml of E. coli. All subjects with bacteriuria were asymptomatic.
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Table II. Female Condom Users - Frequency of Bacterial Isolates by Group of Microorganism and Visit _______________________________~________________________________~~_____________~____ Group of Microorganism Visit #l Visit #2 Visit #3 Visit #4 Aerobic GPC
10 (67%)
12 (80%)
11 (73%)
13 (87%)
Aerobic GNR
6 (40%)
6 (40%)
7 (47%)
4 (27%)
Lactobacilli
12 (80%)
6 (40%)
8 (53%)
8 (53%)
Car&da
4 (27%)
4 (27%)
2 (13%)
4 (27%)
Anaerobic GPC
3 (20%)
2 (13%)
4 (27%)
3 (20%)
Anaerobic GNR
5 (33%)
4 (27%)
5 (33%)
2 (13%)
No anaerobes 6 (40%) 10 (67%) 8 (53%) 9 (60%) _~_________~___~____~~__~~____~___~~____~________~_____________________________~___ GPC = gram-positive cocci GNR = gram-negative rods
Table III. Diaphragm Users - Frequency of Bacterial Isolates by Group of Microorganism and Visit ~____~~___~_________~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~_~~~~~~~ Group of Microorganism Visit #l Visit #2 Visit #3 Visit #4 ~~__~~___~~____~____~__~~~___~~__~~~__~~___~~___~~____~___~~___~~___~~___~____~___ Aerobic GPC 11 (73%) 11 (73%) 11 (73%) 6 (40%) Aerobic GNR
1 (7%)#
4 (27%)
6 (40%)
9 (60%)’
Lactobacilli
14 (93%)5!
9 (60%)
6 (40%)’
7 (47%/o)!
Candida
2 (13%)
1 (7%)
3 (20%)
6 (40%)
Anaerobic GPC
4 (27%)
2 (13%)
7 (47%)
5 (33%)
Anaerobic GNR
5 (33%)
4 (27%)
3 (20%)
3 (20%)
No anaerobes 10 (67%) 7 (47%) 5 (33%) 8 (53%) _____~____________________________________________________~__~~~__~~~__~~~__~~~__~~ # = For visit #l versus visit #4, P = 0.021 $ = For visit #l versus visit #3, P = 0.008 ! = For visit #l versus visit #4, P = 0.039
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Initially, no subject had fungal elements seen during microscopy of the potassium hydroxide preparation of the vaginal secretions. Fungal elements were seen in six (40%) subjects using the female condom and in four (26.7%) patients using the diaphragm at visit #4. The initial fungal culture was positive for Candidu afbicans in four subjects utilizing the female condom and in two subjects utilizing the diaphragm. This frequency of isolation was not significantly different in subsequent visits in the group of women using the female condom. In the subjects using the diaphragm, six (40%) were culture-positive for Candida at visit #4 (P = 0.2). Two patients, one from each contraceptive group, complained of vulvar itching and vaginal discharge at the completion of the study and were treated for symptomatic vulvovaginal candidiasis. All other patients with either fungal elements noted during microscopy or a positive culture for yeast, including all other subjects cultured at visits #l and #4, were asymptomatic. All subjects had negative cultures for Neissetiu gonorrhoeae at the initiation and completion of the study. Two subjects had a positive chlamydiazyme during the study period. Both subjects were in the group of subjects using the female condom. The patient with a positive chlamydiazyme at the initiation of the study had a negative history for exposure to sexually transmitted diseases and a repeat test was negative. In addition, her aerobic culture of the vagina was positive for E. coli and it was felt that the initial test was a false-positive test due to cross-reaction with antigens associated with E. coli colonization. The second subject had a positive chlamydiazyme at the last visit. Again, no history of exposure to sexually transmitted diseases could be elicited and the female condom was used during each episode of sexual intercourse occurring between her initial negative test and her follow-up positive test one week later. A repeat chlamydiazyme was negative. It was felt that this, too, was a false-positive test. Both positive tests were associated with values near the manufacturer’s cutoff level for positivity.
Discussion Neither contraceptive device was associated with macroscopic or colposcopic evidence of trauma to the lower genital tract. Despite daily sexual intercourse, no evidence of bruising, fissures, or tears were appreciated. These observations not only confirm the safety of the female condom and the diaphragm, but they also represent normal findings in asymptomatic subjects having frequent sexual intercourse. These data further establish that findings of focal inflammatory lesions reportedly associated with the syndrome of focal vulvitis are not found in a study population of normal subjects.’ No qualitative changes in the microbial flora of the vagina could be appreciated in subjects using the female condom during the study period. However, subjects utilizing the diaphragm were more likely to develop vaginal colonization with aerobic Gram-negative rods and less likely to maintain colonization with lactobacilli. A previous report has documented the association between diaphragm use and urinary tract infection.6 In addition, a significantly greater frequency of colonization of the vagina with E. coli was noted.6 Our data confirm the association of diaphragm use and vaginal colonization with aerobic gram-negative microorganisms.7’8 Another report has suggested that the spermicide
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rather than the diaphragm may account for the increase in colonization of the vagina with E. coli.9 Since our subjects did not utilize spermicides during the study period, our data suggest that it is more likely that mechanisms of diaphragm use alone are responsible for the change in vaginal flora. Despite the significant changes in vaginal flora noted within the group of subjects utilizing the diaphragm, there were no significant differences noted between the groups when subjects utilizing either the female condom or the diaphragm were compared. However, the power of our study to detect these differences is low. Due to the small number of subjects, the power to detect a 50% difference in isolation rates between the two groups is only 67%. The replacement of the normal vaginal flora, consisting largely of lactobacilli, with aerobic gram-negative bacilli, precedes most episodes of urinary tract infection in women with recurrent infections.lO~” The frequency of asymptomatic bacteriuria due to E. coli doubled during the study period in patients using the diaphragm, however, no subjects developed a symptomatic urinary tract infection. The number of patients with visible fungal elements on microscopy of a potassium hydroxide slide of the vaginal secretions increased in both groups during the study period. The frequency of isolation of Candida by culture increased only in women using the diaphragm from 13.3% to 40% (P = 0.2). This increase in microscopically visible fungal elements and colonization was not associated with symptomatic infection. It is well known that lactobacilli play a role in colonization resistance, preventing overgrowth of potential pathogens in the vagina.‘* Our data suggest that the decrease in lactobacilli colonization in patients using the diaphragm may not only lead to an increase in colonization with bacterial isolates such as aerobic gram-negative microrganisms but yeast as well. Condoms have been used for many centuries and they have played an important role in the prevention of unwanted pregnancy and sexually transmitted diseases. Their safety and efficacy have been well studied. The female condom offers the same protection with several advantages including placement being under female control, less risk of rupture and less risk of pregnancy if it slips out of the vagina than if the male condom slips off the penis. In addition, it provides broader coverage than the male condom, covering the entrance of the vagina where STD lesions may be found and the urethra which may be an entrance to infection; and it covers the base of the penis during intercourse.13 Our study failed to show any evidence of trauma to the female lower genital tract during the study period. In addition, no changes in vaginal flora were noted with the use of the female condom. We conclude that the female condom (RealityTM) is a safe device and should continue to be studied as an alternative barrier method for the prevention of unwanted pregnancy and sexually transmitted diseases.
Acknowledzements: This study was supported Jackson, Wisconsin.
28
by a grant provided by Wisconsin
Pharmacal
Company,
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References 1. CDC: AIDS in women - United States. MMWR 1990;39:845-6. 2. Leeper MA, Conrady M: Preliminary evaluation of REALITY, a condom for women to wear. Adv Contracep 1989;5:229-35. 3. Drew WL, Blair M, Miner RC, Conant M: Evaluation of the virus permeability of a new condom for women. Sex Transm Dis 1990;17:110-2. 4. Lennette EH, Balows A, Hausler WJ, Shadomy HJ, eds. Manual of Clinical Microbiology. 4th ed. Washington, DC: American Society for Microbiology, 1985. 5. Peckham BM, Maki DG, Patterson JJ, Hafez G-R: Focal vulvitis: A characteristic syndrome and cause of dyspareunia. Am J Obstet Gynecol 1986;154:855-64. 6. Fihn SD, Latham RH, Roberts P, Running K, Stamm WE: Association between diaphragm use and urinary tract infection. JAMA 1985;254:240-5. 7. Watt B, Goldacre MJ, Loudon N, et al: Prevalence of bacteria in the vagina of normal
young women. Br J Obstet Gynaecol 1981;88:588-95. 8. Percival-Smith R, Barlett RI-I, Chow AW: Vaginal colonization of Escherichiu coli and its relation to contraceptive methods. Contraception 1983;27:497-504. 9. Hooton TM, Hillier S, Johnson C, Roberts PL, Stamm WE: Escherichia coli bacteriuria and contraceptive method. JAMA 1991;265:64-9. 10. Stamey TA, Sexton CS: The role of vaginal colonization with enterobacteriacieae recurrent urinary tract infections. J Urol 1975;113:214-19.
in
11. Marsch FR, Murray M, Panchamia P: The relationship between bacterial cultures of the vaginal introitus and urinary tract infection, In: Urinarv Tract Infection. Oxford, England: Oxford University Press, 1973. 12. Redondo-Lopez V, Cook RL, Sobel JD: Emerging role of lactobacilli in the control and maintenance of the vaginal bacterial microflora. Rev Inf Dis 1990;12:856-72. 13. Bounds W: Male and female condoms. Brit J Fam Plan 1989;15:14-7.
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Evaluation of the Effects of a Female Condom on the Female Lower Genital Tract
David E. Soper, MD Nancy J. Brockwell, RNC Harry P. Dalton, PhD Department of Obstetrics and Gynecology and Department of Pathology Medical College of Virginia Virginia Commonwealth University Richmond, Virginia
Abstract The purposes of this study were to determine if use of the female condom (RealityT”) was traumatic to the vaginal mucosa and/or vulvar skin and to determine its effect on resident vaginal bacterial flora. Thirty subjects were randomly assigned to utilize the female condom or diaphragm during the study period. Initially and during 3 follow-up visits, each subject underwent colposcopic examination of the vagina, cervix, and vulva with photographic record, and qualitative fungal, aerobic and anaerobic cultures of the vagina. The two groups were compared with respect to the frequency of abnormal physical findings determined by both macroscopic and colposcopic examination. Visits were compared within each contraceptive group with respect to changes in resident vaginal flora. There was no evidence of significant trauma associated with the use of either contraceptive device during the study period. The resident vaginal flora did not significantly change during the three follow-up visits in patients using the female condom. In diaphragm users, lactobacilli were less frequently isolated at the third (14/15 vs 6/15, P = 0.008) and fourth (14/15 vs 7/15, P = 0.039) follow-up visits when compared to the initial visit. In addition, aerobic gram-negative rods were more frequently isolated during the fourth visit (l/15 vs 9/15, P = 0.021) when compared to the first visit. We conclude that neither the female condom (Realitym) nor the diaphragm is associated with trauma to the lower genital tract. Subjects using the diaphragm undergo a significant change in vaginal bacterial flora, becoming more likely to be colonized with coliform microorganisms and less likely to maintain lactobacilli colonization. Submitted for publication February 21, 1991 Accepted for publication May 1, 1991
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21
CONTRACEPTION
Introduction In the United States, the number of acquired immunodeficiency syndrome (AIDS) cases reported in women has been steadily increasing. AIDS is expected to be among the five leading causes of death in reproductive age women by 1991.’ One of the HIVprevention strategies endorses the use of barrier contraception, specifically the condom, to prevent transmission of the virus during sexual intercourse. A new barrier contraceptive device, the female condom (RealityTM), is undergoing development in the United States. Initial studies have shown that the female condom is less likely to leak than a male In addition, this polyurethrane condom is impermeable to both HIV and condom.2 cytomegalovirus.3 Since the female condom may be worn for extended periods of time when used as a contraceptive device or for the prevention of sexually transmitted diseases,its effect upon the lower female genital tract requires more study. The purpose of this study was to determine if use of a female condom was traumatic to the vaginal mucosa and/or vulvar skin and to determine its effect on resident vaginal bacterial flora.
Methods and Material We hypothesized 1) that neither the female condom nor the diaphragm would have an effect on resident vaginal bacterial flora and 2) that neither the female condom nor the diaphragm would be traumatic to the vaginal mucosa. Thirty women were randomly assigned by drawing cards to utilize either the female condom (RealityTM, Wisconsin Pharmacal Co., Jackson, WI) or diaphragm (Wide-SealTM, Milex, Chicago, IL) during the study period. The size of the diaphragm used by the subjects was determined during the pelvic examination in the usual manner. Concomitant use of spermicides was not allowed. A lubricant was used for the insertion of both devices as needed. Patients had to be at least 18 years of age, sexually active, and using an alternative method of birth control. Patients were excluded from the study if they had a history of toxic shock syndrome, irregular menses, signs or symptoms of acute vaginitis, an allergy to latex or polyurethrane, and/or a Pap smear showing moderate dysplasia or greater. In addition, patients could not h&e used the diaphragm as a method of contraception in the past three months. At the initial visit (Visit #l), all patients responded to a questionnaire regarding demographic characteristics and a history of sexually transmitted diseases. A clean-catch urine specimen was obtained and sent for urinalysis and culture. In addition, an evaluation of the genital tract was performed in the following manner. The vulva, vagina, and cervix were inspected, both grossly and with colposcopy, and photographs taken of each anatomical site. Saline and potassium hydroxide preparations were obtained from the vaginal secretions. A Pap smear was performed. A culture of the endocervix was obtained for Neisseria gonmhoeae utilizing T-M Transgrow media (CamScarborough Microbiologicals, Inc., MD). A chlamydiazyme (Abbott Laboratories, IL) was also performed from an
22
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CONTRACEPTION
endocervical specimen. Swabs of the posterior vaginal fomix were cultured for aerobes, anaerobes, and Candida albicuns. A bimanual pelvic examination was then performed. A female condom or diaphragm was then placed into the vagina. Patients returned (Visit #2) after having worn the female condom or diaphragm for three hours following the completion of their initial examination. A clean-catch urine for urinalysis and culture was obtained. A repeat evaluation of the lower genital tract including photographs was performed looking for evidence of trauma due to the contraceptive device. Repeat cultures for aerobes, anaerobes, and Candida albicans were performed. On the evening of the first study day, patients used their respective contraceptive device and had sexual intercourse. They were instructed to leave the female condom or diaphragm in place until the following morning at which time it could be removed. Repeat evaluation the following morning (Visit #3) was identical to the evaluation described above on visit #2. Repeat evaluation occurred on day seven of the study (Visit #4). The patient was required to have had a minimum of five sexual intercourses using their contraceptive device during the interim period. Evaluation at this visit was identical to the evaluation performed at the initial visit. The examiner (DES) was not blinded as to the device used. In addition, patients were asked to complete questionnaires regarding the acceptability of the technique of barrier contraception being utilized during the study. Microbiology. Rayon-tipped swabs were used to collect vaginal secretions from the posterior vaginal fornix. These swabs were transported to the laboratory in Stuart’s bacterial transport media (Culturette II, Becton Dickinson Microbiology Systems, MD). The swabs were then plated on blood agar and chocolate agar for the isolation of aerobic microorganisms. Aerobic plates were incubated at 35°C in a 5% CO, atmosphere. Additional rayon-tipped swabs from the vaginal fomix for anaerobic culture were transported to the laboratory in Carey-Blair transport media (Carr-Scarborough Microbiologic&, Inc., GA) They were then plated on prereduced blood agar, chocolate agar, and KV agar and were incubated in an anaerobic atmosphere at 35“C. All microrganisms were identified with standard methods as previously outlined.4 Bacterial isolates from the vagina were divided into the following groups of microorganisms: 1) aerobic gram-positive cocci; 2) aerobic gram-negative rods; 3) aerobic lactobacilli; 4) Candida; 5) anaerobic gram-positive cocci; 6) anaerobic gram-negative rods; and 7) no anaerobes grown. The frequency of isolation for each group of microorganisms was determined with respect to visit number. Statistics. The two contraceptive groups were compared with respect to the frequency of abnormal physical findings determined by both macroscopic and colposcopic examination. The frequency of bacterial and fungal isolates noted at the initial visit was
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compared to the frequency contraceptive group and Fisher’s exact test or the compared using the t-test.
of bacterial and fungal isolates noted at subsequent visits in each between groups. Significant differences were determined by a McNemar’s test where appropriate. Continuous variables were Significance was based on two-tailed tests with a p value 5 0.05.
Results The demography of the study population is presented in Table I. There were no significant differences between groups with respect to age, race, gravidity, level of education, history of a sexually transmitted disease, method of current contraception, or history of barrier contraceptive use. All subjects used their respective contraceptive device
Table I. Demography ________________________-_______-________________-_____----_______________________________ Variable
Female condom (N = 15)
Diaphragm (N = 15)
Age (years)
32.5 + 6.3
33.4 + 6.0
Race (No.) Black Caucasian Indian Gravidity
6 9 0
(No.)
1.0 + 1.0
5 9 1
1.5 + 1.3
Education (No.) High school College Graduate school
7 6 2
4 9 2
History of a STD* (No.)
2
2
11
13
12
9
1 2
0 6
History of barrier contraception Current
contraceptive method (No.) Oral contraceptive IUD Sterilization * sexually transmitted
24
disease
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CONTRACEPTION appropriately during the study period. All subjects complied with the directive to have a minimum of 5 episodes of coitus during the interim period. Subjects using the female condom had sexual intercourse a median of six times (range 5 to 9 times) and the subjects using the diaphragm had intercourse a median of six times (range 5 to 8 times). No subject discontinued use of the diaphragm or female condom due to discomfort, inconvienence, decreased sexual satisfaction, or partner dissatisfaction. There was no macroscopic or colposcopic evidence of trauma associated with either form of contraceptive device. The bimanual pelvic examination was normal in all subjects both at initiation and completion of the study. It wassurprising that despite daily sexual intercourse for most participants, no evidence of bruising, fissures, or tears were appreciated. In one subject using the female condom, colposcopic inspection at the 24-hour visit (visit #2) revealed two small superficial erythematous areas < 1 mm in diameter in the posterior fourchette at the vestibule. These areas were felt to be the result of pressure exerted on these areas during intercourse and not related specifically to the device. These areas were asymptomatic and resolved spontaneously despite continued sexual intercourse utilizing the female condom over the ensuing week. The groups of bacterial and fungal isolates were found with similar frequency at the initial visit in subjects using either the female condom or diaphragm with the exception of the aerobic gram-negative rods. Subjects randomized to the female condom group were more frequently colonized with aerobic gram-negative rods than patients in the diaphragm group but this difference did not reach statistical significance (P = 0.08). Aerobic gramnegative rods were more frequently isolated during visit #4 when compared with visit #l in subjects using the diaphragm. Lactobacilli were less frequently isolated at visits #3 and #4 when compared to visit #l in subjects using the diaphragm. These results are summarized in Tables II and III. There was no significant difference between groups with respect to the above noted changes in vaginal flora. All urinalyses performed were within normal limits with the exception of a single subject in the female condom group. This patient maintained a nitrite-positive urine in the absence of pyuria for the duration of the study. She was asymptomatic despite a concomitant urine culture growing > 1 million colonies of E. coli. This asymptomatic bacteriuria was not treated. There was no difference between contraceptive groups or among the four visits with respect to the frequency of E. coli bacteriuria. Three subjects in the female condom group and two women in the diaphragm group had positive urine cultures for > 100,000 colonies/ml of E. coli at their initial evaluation. At visit #4, two patients in the female condom group and four patients in the diaphragm group had positive cultures for > 100,000 colonies/ml of E. coli. All subjects with bacteriuria were asymptomatic.
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Table II. Female Condom Users - Frequency of Bacterial Isolates by Group of Microorganism and Visit _______________________________~________________________________~~_____________~____ Group of Microorganism Visit #l Visit #2 Visit #3 Visit #4 Aerobic GPC
10 (67%)
12 (80%)
11 (73%)
13 (87%)
Aerobic GNR
6 (40%)
6 (40%)
7 (47%)
4 (27%)
Lactobacilli
12 (80%)
6 (40%)
8 (53%)
8 (53%)
Car&da
4 (27%)
4 (27%)
2 (13%)
4 (27%)
Anaerobic GPC
3 (20%)
2 (13%)
4 (27%)
3 (20%)
Anaerobic GNR
5 (33%)
4 (27%)
5 (33%)
2 (13%)
No anaerobes 6 (40%) 10 (67%) 8 (53%) 9 (60%) _~_________~___~____~~__~~____~___~~____~________~_____________________________~___ GPC = gram-positive cocci GNR = gram-negative rods
Table III. Diaphragm Users - Frequency of Bacterial Isolates by Group of Microorganism and Visit ~____~~___~_________~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~_~~~~~~~ Group of Microorganism Visit #l Visit #2 Visit #3 Visit #4 ~~__~~___~~____~____~__~~~___~~__~~~__~~___~~___~~____~___~~___~~___~~___~____~___ Aerobic GPC 11 (73%) 11 (73%) 11 (73%) 6 (40%) Aerobic GNR
1 (7%)#
4 (27%)
6 (40%)
9 (60%)’
Lactobacilli
14 (93%)5!
9 (60%)
6 (40%)’
7 (47%/o)!
Candida
2 (13%)
1 (7%)
3 (20%)
6 (40%)
Anaerobic GPC
4 (27%)
2 (13%)
7 (47%)
5 (33%)
Anaerobic GNR
5 (33%)
4 (27%)
3 (20%)
3 (20%)
No anaerobes 10 (67%) 7 (47%) 5 (33%) 8 (53%) _____~____________________________________________________~__~~~__~~~__~~~__~~~__~~ # = For visit #l versus visit #4, P = 0.021 $ = For visit #l versus visit #3, P = 0.008 ! = For visit #l versus visit #4, P = 0.039
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Initially, no subject had fungal elements seen during microscopy of the potassium hydroxide preparation of the vaginal secretions. Fungal elements were seen in six (40%) subjects using the female condom and in four (26.7%) patients using the diaphragm at visit #4. The initial fungal culture was positive for Candidu afbicans in four subjects utilizing the female condom and in two subjects utilizing the diaphragm. This frequency of isolation was not significantly different in subsequent visits in the group of women using the female condom. In the subjects using the diaphragm, six (40%) were culture-positive for Candida at visit #4 (P = 0.2). Two patients, one from each contraceptive group, complained of vulvar itching and vaginal discharge at the completion of the study and were treated for symptomatic vulvovaginal candidiasis. All other patients with either fungal elements noted during microscopy or a positive culture for yeast, including all other subjects cultured at visits #l and #4, were asymptomatic. All subjects had negative cultures for Neissetiu gonorrhoeae at the initiation and completion of the study. Two subjects had a positive chlamydiazyme during the study period. Both subjects were in the group of subjects using the female condom. The patient with a positive chlamydiazyme at the initiation of the study had a negative history for exposure to sexually transmitted diseases and a repeat test was negative. In addition, her aerobic culture of the vagina was positive for E. coli and it was felt that the initial test was a false-positive test due to cross-reaction with antigens associated with E. coli colonization. The second subject had a positive chlamydiazyme at the last visit. Again, no history of exposure to sexually transmitted diseases could be elicited and the female condom was used during each episode of sexual intercourse occurring between her initial negative test and her follow-up positive test one week later. A repeat chlamydiazyme was negative. It was felt that this, too, was a false-positive test. Both positive tests were associated with values near the manufacturer’s cutoff level for positivity.
Discussion Neither contraceptive device was associated with macroscopic or colposcopic evidence of trauma to the lower genital tract. Despite daily sexual intercourse, no evidence of bruising, fissures, or tears were appreciated. These observations not only confirm the safety of the female condom and the diaphragm, but they also represent normal findings in asymptomatic subjects having frequent sexual intercourse. These data further establish that findings of focal inflammatory lesions reportedly associated with the syndrome of focal vulvitis are not found in a study population of normal subjects.’ No qualitative changes in the microbial flora of the vagina could be appreciated in subjects using the female condom during the study period. However, subjects utilizing the diaphragm were more likely to develop vaginal colonization with aerobic Gram-negative rods and less likely to maintain colonization with lactobacilli. A previous report has documented the association between diaphragm use and urinary tract infection.6 In addition, a significantly greater frequency of colonization of the vagina with E. coli was noted.6 Our data confirm the association of diaphragm use and vaginal colonization with aerobic gram-negative microorganisms.7’8 Another report has suggested that the spermicide
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rather than the diaphragm may account for the increase in colonization of the vagina with E. coli.9 Since our subjects did not utilize spermicides during the study period, our data suggest that it is more likely that mechanisms of diaphragm use alone are responsible for the change in vaginal flora. Despite the significant changes in vaginal flora noted within the group of subjects utilizing the diaphragm, there were no significant differences noted between the groups when subjects utilizing either the female condom or the diaphragm were compared. However, the power of our study to detect these differences is low. Due to the small number of subjects, the power to detect a 50% difference in isolation rates between the two groups is only 67%. The replacement of the normal vaginal flora, consisting largely of lactobacilli, with aerobic gram-negative bacilli, precedes most episodes of urinary tract infection in women with recurrent infections.lO~” The frequency of asymptomatic bacteriuria due to E. coli doubled during the study period in patients using the diaphragm, however, no subjects developed a symptomatic urinary tract infection. The number of patients with visible fungal elements on microscopy of a potassium hydroxide slide of the vaginal secretions increased in both groups during the study period. The frequency of isolation of Candida by culture increased only in women using the diaphragm from 13.3% to 40% (P = 0.2). This increase in microscopically visible fungal elements and colonization was not associated with symptomatic infection. It is well known that lactobacilli play a role in colonization resistance, preventing overgrowth of potential pathogens in the vagina.‘* Our data suggest that the decrease in lactobacilli colonization in patients using the diaphragm may not only lead to an increase in colonization with bacterial isolates such as aerobic gram-negative microrganisms but yeast as well. Condoms have been used for many centuries and they have played an important role in the prevention of unwanted pregnancy and sexually transmitted diseases. Their safety and efficacy have been well studied. The female condom offers the same protection with several advantages including placement being under female control, less risk of rupture and less risk of pregnancy if it slips out of the vagina than if the male condom slips off the penis. In addition, it provides broader coverage than the male condom, covering the entrance of the vagina where STD lesions may be found and the urethra which may be an entrance to infection; and it covers the base of the penis during intercourse.13 Our study failed to show any evidence of trauma to the female lower genital tract during the study period. In addition, no changes in vaginal flora were noted with the use of the female condom. We conclude that the female condom (RealityTM) is a safe device and should continue to be studied as an alternative barrier method for the prevention of unwanted pregnancy and sexually transmitted diseases.
Acknowledzements: This study was supported Jackson, Wisconsin.
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by a grant provided by Wisconsin
Pharmacal
Company,
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References 1. CDC: AIDS in women - United States. MMWR 1990;39:845-6. 2. Leeper MA, Conrady M: Preliminary evaluation of REALITY, a condom for women to wear. Adv Contracep 1989;5:229-35. 3. Drew WL, Blair M, Miner RC, Conant M: Evaluation of the virus permeability of a new condom for women. Sex Transm Dis 1990;17:110-2. 4. Lennette EH, Balows A, Hausler WJ, Shadomy HJ, eds. Manual of Clinical Microbiology. 4th ed. Washington, DC: American Society for Microbiology, 1985. 5. Peckham BM, Maki DG, Patterson JJ, Hafez G-R: Focal vulvitis: A characteristic syndrome and cause of dyspareunia. Am J Obstet Gynecol 1986;154:855-64. 6. Fihn SD, Latham RH, Roberts P, Running K, Stamm WE: Association between diaphragm use and urinary tract infection. JAMA 1985;254:240-5. 7. Watt B, Goldacre MJ, Loudon N, et al: Prevalence of bacteria in the vagina of normal
young women. Br J Obstet Gynaecol 1981;88:588-95. 8. Percival-Smith R, Barlett RI-I, Chow AW: Vaginal colonization of Escherichiu coli and its relation to contraceptive methods. Contraception 1983;27:497-504. 9. Hooton TM, Hillier S, Johnson C, Roberts PL, Stamm WE: Escherichia coli bacteriuria and contraceptive method. JAMA 1991;265:64-9. 10. Stamey TA, Sexton CS: The role of vaginal colonization with enterobacteriacieae recurrent urinary tract infections. J Urol 1975;113:214-19.
in
11. Marsch FR, Murray M, Panchamia P: The relationship between bacterial cultures of the vaginal introitus and urinary tract infection, In: Urinarv Tract Infection. Oxford, England: Oxford University Press, 1973. 12. Redondo-Lopez V, Cook RL, Sobel JD: Emerging role of lactobacilli in the control and maintenance of the vaginal bacterial microflora. Rev Inf Dis 1990;12:856-72. 13. Bounds W: Male and female condoms. Brit J Fam Plan 1989;15:14-7.
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