Abstract
New female condom (FC) products, different in design and materials that have the potential to lower cost and improve acceptability are being developed. A pilot study of the Panty Condom was conducted among experienced FC users in Durban, South Africa. This pilot function trial enrolled 19 women who were asked to use five Panty Condoms each and collect information on use in a condom diary at home, followed by one follow-up interview. Primary endpoints were total clinical failure and total female condom failure. Non-inferiority of component modes, clinical breakage, non-clinical breakage, slippage, misdirection, and invagination were also determined. Frequencies and percentages were calculated for each failure mode. The mean age of the participants was 27.8 years (SD 4.9). Safety and acceptability data were also assessed. In 95 condom uses nine failure events occurred in eight condoms. Clinical breakage occurred in 8.4% (n = 8) of condoms and slippage in one condom. Total FC failure was 8.4% of all condom uses. Of the eight breakage events there were two reports of the condom ripping during sex and six reports of the condom detaching from the panty. Fifteen women either liked very much or liked somewhat using the Panty Condom. Total clinical failure was approximately twice that seen in other FC functionality studies.
Introduction
The female condom (FC) is key to increasing HIV and pregnancy protection options for women and men, and is the only female-initiated HIV prevention barrier method.1,2 The FC was identified by the Reproductive Health Supplies Coalition in 2011 as one of several under-used reproductive health technologies having the potential to expand choice in reproductive health and family planning programs, add value to the method mix, and respond to the needs of diverse types of clients. 3
The last decade has seen the emergence of new FC products, different in design and materials that have the potential to lower cost and improve acceptability. 4 There are challenges in developing these new FC products, regulatory issues being by far the greatest hurdle. However, in September 2018, The US Food and Drug Administration (FDA) issued a final order lowering the regulatory burden for device makers looking to market single-use female condoms by reclassifying the devices from Class III to Class II. 5 Several new designs are now available in different countries, having progressed through the final stages of regulatory approvals, where after they will potentially be available to country programmes. 6 The availability of new FC products, some of which may also be more acceptable and/or affordable, will increase options for couples who choose to use FCs as their prevention method against unintended pregnancy or infection. The Panty Condom, developed by the Innova Quality Company in Colombia, is registered by the Colombian National Institute of Food and Drug Monitoring (INVIMA). It additionally holds the CE mark in the European Union. In 2015, it was made available in Uganda and was given approval by the Uganda National Council for Science and Technology in 2018. 7 Early reports indicate its popularity and acceptability studies are underway. 7
Although The Panty Condom has been available for over a decade, there are no published data on its acceptability and functional performance. The primary objective of this study was to ascertain the functional performance of the Panty Condom. Secondary objectives included obtaining acceptability and safety data. We report on the findings of a pilot study of the Panty Condom in Durban, South Africa.
Methods
Study design
This pilot device function, safety and acceptability trial of the Panty Condom was conducted between June 14 and February 2015. The study design followed the guidelines of the ISO 29943–2 Condoms – Guidance on clinical studies – Part 2: Female condoms, clinical function studies based on self report. 9
Study population
The trial recruited experienced FC users who had completed another FC functionality trial at the same research site on the day of their final follow-up visit. 8 Women exiting the index trial were asked consecutively if they wished to take part in the Panty Condom pilot trial and enrolled if eligible until the sample size of 19 was reached. Potential participants had to be at least 18 years of age and no older than 45, with no known allergies to condoms, using a reliable, non-barrier method of contraception, and free of sexually transmitted infections, as determined by pelvic examination and use of a syndromic diagnostic tool. Pregnant women (according to urine pregnancy test) were excluded. Participants were required to be sexually active and monogamous. Since take-home condom diaries were used to gather data, participants were also required to be literate. Male partners were informed of the study by the participants through use of a fact sheet which explained the purpose of the study but they were not interviewed and all feedback came from the female participant.
Procedures
After completing a baseline demographic survey, participants were given training and education on the Panty Condom, and the fitting was demonstrated on a pelvic model. User instructions were provided in English and the local language Zulu and participants were asked to use five Panty Condoms and return for one follow-up exit visit approximately four to six weeks later. Participants were given a condom diary comprising questions on package opening, insertion technique, time of insertion related to sex, questions on each potential failure mode experienced, other problems and adverse events, to ensure consistency. An open-ended section of the diary allowed for additional descriptive information, e.g. circumstances of a condom breakage or other user issues. The condom diaries were reviewed by study staff and participants at the follow-up. Acceptability and safety data were also captured at follow-up.
Study condoms
The Panty Condom is made of synthetic polyethylene resin condom, the same material used for the manufacturer’s male condoms (Figure 1).
Panty Condom. (a) Condom enclosed in membrane; (b) Condom removed from membrane; (c) Panty prior to insertion of adhesive membrane; (d) Panty with membrane inserted.
The length of the condom is 170 mm and is lubricated with pre-applied white vaseline. The shelf life of the Panty Condom is three years. The panty condom is compatible with all other lubricants; however, this information is not indicated on the packaging of the product. The condom is held in place by a reusable panty (100% nylon) via an adhesive membrane strip (similar to a panty liner). The panty comes in three different sizes (small, medium and large). The study participants received medium panties with the condoms. The panty holds the condom in place during intercourse and has the same function as the outer ring or frame of other FCs. The Panty Condom cannot be used without the panty. After use, the condom can be detached from the panty and disposed of. A new condom sheath can be inserted and secured into the panty prior to the next use (Figure 1(a)). The panty can be washed between uses. The Panty Condom does not have an insertion device like a ring or a sponge. Instead, once the panty is on, the condom sheath is pushed into the vagina using a finger or the penis.
In this study, participants were given instructions on use by the study nurse coordinator who demonstrated the Panty Condom on a pelvic model. Women were given five panties with condoms pre-inserted, and therefore were not required to reuse any panties. However, women were asked to remove the condom after use and wash the panties in the same way as they would normally wash their underwear at home and bring them back to the site for their follow-up visit. All used panties were inspected after washing to assess the condition of the opening through which the condom was attached during intercourse and compared directly to a new unused panty, with particular attention to the length of the opening, edges of material and any visible damage.
Sample size and analysis
The manufacturer made available 95 Panty Condoms for the study. As women were required to use five each, the total sample size was 19. The original sample size of 50 women planned for the study was reduced to 19 due to the manufacturer capacity at the time to produce all 275 required Panty Condoms.
Functional performance events were calculated and primary analyses centred on total clinical failure and total FC failure. Rates of clinical breakage, total breakage, slippage, misdirection, and invagination were calculated as well. Although the sample size was small, any problems with stability were to likely be identified at this point.
The following definitions of failure modes are internationally adopted by the WHO. 10 These definitions are used in the analysis of the FC function data. The functionality risk assessment identified that in the unique structure of the Panty Condom, the attachment of the condom to the panty acted in a similar way as a typical outer frame or ring to other FCs in that it stopped the condom from being pushed into the vagina. The definition of ‘clinical breakage’ includes breakage of any component of an FC, including any external or internal retention mechanism as well as the body of the condom. The Panty Condom does not have an external or internal ring as have other FCs as this condom is attached directly to the panty via the membrane. We therefore included full or partial detachment of the condom from the membrane or the membrane from the panty as an incident of clinical breakage. Each failure rate is calculated by dividing the number of FCs that experienced each particular failure by the number of FCs used during sexual intercourse.
While multiple failures may be experienced with a single condom within one sexual act, failures under this condition are counted as a single event for data analysis purposes. (Note: Male latex condom failures are counted in this manner.)
Clinical breakage is defined as breakage during sexual intercourse or during withdrawal of the FC from the vagina. Clinical breakage is breakage with potential adverse clinical consequences. Non-Clinical Breakage: Breakage noticed before intercourse (e.g. breakage on removal from packaging by fingernails or scissors) or occurring after withdrawal of the condom from the vagina. Non-clinical breakage is without potential adverse clinical consequences. Total breakage is defined as the sum of all FC breakages at any time before, during or after sexual intercourse. It includes both clinical breakages and non-clinical breakages. Slippage is defined as an instance when an FC slips completely out of the vagina during sexual intercourse. Misdirection is defined as vaginal penetration whereby the penis is inserted between the FC and the vaginal wall. Invagination is defined as an instance when the external retention feature of the FC is partially or fully pushed into the vagina during sexual intercourse. Total clinical failure is defined as the sum of FCs that clinically break or slip, or are associated with misdirection, invagination or any additional failure modes(s) identified in the risk assessment which results in the reduction of the FC protective function. The total clinical failure rate is calculated by dividing the number of FCs with a clinical failure by the number of FCs used during sexual intercourse. Total female condom failure is defined as an FC for which a non-clinical breakage, clinical breakage or slippage occurs, or is associated with misdirection, invagination or any additional failure modes(s) identified in the risk assessment. The female condom failure rate is calculated by dividing the number of FCs that fail by the number of FC packages opened.
The failure rates or proportions of FC uses with clinical breakage, total breakage, slippage, misdirection, invagination, total clinical failure, and total FC failure were calculated according to endpoint definitions above.
Data were entered into Epidata v3.1 and exported into Stata IC v10 (College Station, Texas, USA) for analysis. Descriptive statistics were generated for demographic data, and the mean failure rate for each failure mode was calculated by dividing the number of specific failures by the total number of condom packages opened (N = 95).
Secondary study objectives
Secondary objectives were to evaluate the safety and acceptability of the Panty Condom. Safety was measured according to the proportion of participants with symptoms of genitourinary irritation during or immediately after any of the five separate uses. Medical and serious adverse events were classified by relatedness, expectedness and severity.
Acceptability endpoints included a range of product attributes including fit, comfort, appearance, colour, lubrication, length and ease of use. Women were also asked about scent (any noticeable smell) although the Panty Condom is not scented. Each attribute was assessed by ratings including ‘liked very much, liked somewhat, neither liked or disliked, disliked somewhat and disliked very much’. Women were also asked reasons for liking or disliking the product.
Ethics
The study was approved by the University of Witwatersrand Human Research Ethics Committee in South Africa (M130568), and local and provincial Departments of Health in KwaZulu-Natal. Written informed consent was obtained from all participants. Consents and interviews were conducted in Zulu or English according to participants’ language of choice.
Results
All 19 women enrolled completed their one follow-up visit, all returning within one calendar month of enrolment. Each woman used all five condoms resulting in a total of 95 condom uses. Women were of a mean age 27.8 years (SD 4.9), range 20–39 (Table 1). The majority (73.7%) had completed secondary school and half (52.6%) were unemployed. Half reported relationship duration between one and five years (47.4%) and most (84.2%, n = 16) were in non-marital and non-cohabiting relationships.
Socio-demographic information.
Almost half of the participants had one living child (42.1%). All participants reported having ever used a male condom (100%), one-fifth had ever used a tampon (21.1%) and most women currently used hormonal injectable contraception (89.5%).
Mean condom failure modes are reported in Table 2. In 95 condom uses, nine failure events occurred in eight condoms (one condom had two failure events). The condom reported to have two failures included a slippage and a detachment of the membrane from the panty which is classified as a clinical breakage. Clinical breakage occurred in 8.4% (n = 8) of condoms and slippage in one condom. There were no reports of non-clinical breakage, invagination or misdirection. Total FC failure was calculated at 8.4% of all condom uses. Of the eight clinical breakage events there were two reports of the condom ripping during sex and six reports of the condom detaching from the panty. The two participants reporting the condom had ripped could not confirm the location on the condom.
Panty condom functionality.
aN = 95 as each failure mode rate is calculated by dividing the number of that failure mode by the total number of condom packages opened.
bIncidences of condoms becoming detached (partially or fully) from the panty during sex were considered a clinical breakage.
cTotal female condom failure = 8, as multiple failure events in a single condom are counted as one total female condom failure.
Multiple adverse events were reported by one participant related to the tightness of the Panty. During sex, the back of the panty which is a ‘G’ string design (back of panty comprising a piece of elastic) rubbed the groin/vaginal area causing a burning that was painful and leaving a rash in some uses. Across the five condom uses, pain occurred in every condom use, burning in four, and rash in two uses. All adverse events resolved between one and a half and six and three quarter hours and without sequelae.
Acceptability data showed that the majority (79%) of the women liked using the Panty Condom. Most participants liked both the feel/sensation and ease of use (84.2%), the amount of lubrication (73.7%) as well as both the length and appearance (68.4%) of the Panty Condom (Table 3). Three women indicated in an open-ended question that their partner liked the Panty Condom as it was ‘sexy’ and because they did not have to wear the condom.
Acceptability of different features of study FCs.
Two women complained about the size of the panty, reporting it was too tight. The ‘G string design’ of the panty and the lack of size choice for women in the study added to the discomfort and pain reported for one of these participants.
All participants reported washing the panty (hand-washing) and willingness to reuse, the majority (n = 15; 79%) using bar-soap and four (21.1)% using powder detergent. Inspection of the panties revealed general splaying of the opening, in most panties. The opening of the panty to push through the condom is approximately 10 cm. In 14 panties, the opening was extended. In 12 of the 14, the opening was extended by 0.5 cm to 2 cm in length. In two panties the opening exceeded 2 cm, and in one of these reached the panty seam.
Discussion
This is the first study to evaluate the function, safety and acceptability of the Panty Condom. Previous studies measuring the functionality of new FCs have shown total failure rates between 3.02 and 5.24%,8,10,11 while the Panty Condom total failure rate was 8.4%. The design of the Panty Condom renders the most common FC failures to be less prevalent compared to existing FC designs. This is because the condom is fixed to the external panty and it is less likely to be pushed inside the vagina (invagination), pulled out of the vagina (slippage) nor allow the penis to enter the vagina to the side of the condom (misdirection). This is borne out by the data where there were no reports of misdirection or invagination and only one occurrence (1%) of slippage in 95 uses. Slippage rates in other studies are usually between 0.9% and 2%.8,12
As participants were recruited after their participation in a larger clinical trial comparing the performance of three FCs, the low rates of failure modes may partly be a result of the practice effect from the aforementioned trial.8,13 However, the frequently reported failure mode of detachment of the condom from the panty in this study cannot be compared to other studies as the design of the Panty Condom is unique. The detachment is more likely to be related to the membrane adhesive properties as opposed to a user failure and therefore may not be subject to any practice effect. This is because the condom membrane was already inserted into the panty and therefore the user was not responsible for attaching it.
Although the sample size was small, the main problem related to condom function was identified. The clinical failure component was almost entirely comprised of a specific structural problem, i.e. the condom retention mechanism becoming detached from the panty during intercourse, and a possible cause for concern. This problem could be solved by making the adhesive strips wider on all four sides and/or improving the adhesion properties of the strips. This would have to be balanced against the removal of the condom membrane to not damage the panty if it is to be used again.
Acceptability of the Panty Condom was generally high. The Panty Condom comes in three sizes but unfortunately the study was only sent one size – medium. Although most women during enrolment felt the panty elastic was stretchy enough to accommodate them, some women complained of tightness of the Panty at the follow-up visit. Two women complained about the size of the panty being too small. There are two other sizes available (small and large) and had women been offered a choice this may have improved comfort.
Use of the Panty Condom after washing is advised with caution as the panty material appeared not to be sturdy enough for long-term use, unless there is a seam or reinforcement to the opening of the panty where the condom is inserted or the panty or is made of a better quality material. The extension of the opening of the panty through which the penis enters was noted in many observations after one use and wash of the panty. This may cause a problem with adhesion of the next condom as the adhesive strips may not adhere well if the nylon material is damaged or splayed.
Limitations
Due to a change in manufacturing plans, a smaller sample size (95 condoms) was made available compared to the original sample size of 275 condoms. Although the panty comes in three sizes – small, medium and large, only one size of panty was made available (medium) by the manufacturer.
Conclusion
Total clinical failure of the Panty Condom in this study was approximately twice that seen in FC2 and other FC functionality studies. Further investigation is needed to assess the Panty Condom retention mechanism and the adherence properties. Depending on the feature, acceptability ratings – ‘liked very much’/‘liked somewhat’ ranged from 63% to 84%.
Footnotes
Authors’ contribution
MB, JS and RG conceived the study and design; MB, JS, RG, VM and NM managed the undertaking of the pilot. RG and MB undertook the statistical analyses, and MB, RG and JS interpreted the data. MB, RG and JS drafted the article with input editing from VM. NM. All authors read and approved the final version for submission.
Acknowledgments
We thank all participants who gave their time to participate in the trial.
Declaration of conflicting interests
The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding
The authors disclosed receipt of the following financial support for the research, authorship and/or publication of this article: This pilot trial was funded by the Universal Access to Female Condoms (UAFC) Joint Programme.