A pilot study on the functional performance and acceptability of an innovative female condom (Wondaleaf^®) in Malaysia

Figures & data

Figure 1 Basic features of Wondaleaf.

Table 1 Participant demographics (n=31)

Background data	n	%
Age (mean)	34.61	7.6
Ethnicity
Chinese	9	29
Iban	7	23
Malay	5	16
Bidayuh	5	16
Others	2	6
Not reported	3	10
Highest education level
Primary school	4	13
PMR	2	6
SPM	9	29
STPM	1	3
University/diploma	11	36
Not reported	4	13
Occupation
Family planning officer	6	19
Administration officer	6	19
Nurse	5	17
Special needs teacher	1	3
Sex worker	8	26
Sales assistant	1	3
Field laborer	1	3
Not reported	3	10
Previous use of other FC	5	16
Previous use of WL	0	0

Note: PMR, SPM, and STPM are lower, middle, and upper secondary school respectively.

Abbreviations: FC, female condom; WL, Wondaleaf.

Table 2 Descriptive statistics on Part 1 and Part 2 survey items

Survey items		First use Mean (SD)	Second use Mean (SD)	Third use Mean (SD)	Fourth use Mean (SD)	Fifth use Mean (SD)
Part 1 items (n= 31)
1.	Easy to put on WL	2.39 (0.96)	2.58 (0.92)	2.97 (0.95)	3.32 (0.98)	3.39 (1.02)
2.	Easy to remove WL	3.35 (1.08)	3.45 (0.96)	3.65 (0.88)	3.87 (0.67)	3.97 (0.80)
3.	No breakage before use	4.26 (0.68)	4.26 (0.68)	4.39 (0.58)	4.42 (0.56)	4.52 (0.57)
4.	No breakage after use	4.03 (0.84)	4.03 (0.71)	4.19 (0.54)	4.26 (0.58)	4.35 (0.61)
5.	WL did not slip out during use	3.32 (1.22)	3.48 (1.09)	3.71 (1.04)	3.97 (0.88)	4.03 (0.88)
6.	Did not miss the direction of penis insertion	3.68 (0.98)	3.74 (0.89)	3.94 (0.77)	4.10 (0.70)	4.10 (0.75)
7.	WL did not get stuck in vagina after use	4.03 (0.48)	4.06 (0.51)	4.13 (0.43)	4.16 (0.52)	4.23 (0.50)
	Total	25. 06 (4.05)	25.61 (3.23)	26.97 (2.79)	28.10 (2.88)	28.58 (3.31)
			Max	Min	Mean	SD
Part 2 items (n= 31)
1.	Manual instruction is easy to follow		2	5	3.97	0.71
2.	Video instruction is easy to understand		3	5	4.42	0.72
3.	There is enough sensation when using this barrier film during intercourse		1	5	3.16	1.04
4.	I believe this barrier film could provide sufficient medical protection		2	5	4.29	0.78
5.	This female barrier film gives me a sense of mastery over my health		2	5	4.16	0.90
6.	This barrier film could assure my safety in sexual activities without worrying of infection		3	5	4.42	0.67
7.	My sexual partner could accept this barrier film		2	4	3.16	0.82
8.	I will continue to use this female barrier film		1	5	3.06	0.89
9.	I would recommend this barrier film to my friend		1	5	3.87	0.81
10.	I found this barrier film innovative		2	5	4.16	0.86
			Number of events per total WL used			%
Clinical failure modes (n=155)
1.	Clinical breakage		1/155			0.65
2.	Nonclinical breakage		0/155			0
3.	Clinical misdirectiona		1/155			0.65
4.	Nonclinical misdirectionb		2/155			1.30
5.	Invagination		0/155			0
6.	Partial slippagec		24/155			15.48
7.	Complete slippaged		2/155			1.30
8.	Total clinical failures		4/155			2.60

Notes: 1, extremely disagree; 2, disagree; 3, neutral; 4, agree; 5, highly agree.

a Incorrect vaginal penetration;

b difficulty in penetration;

c pouch sliding inside the vagina or partially moved outside of the vagina;

d the whole FC product detached from human body, either by will or by accident.

Abbreviations: FC, female condom; WL, Wondaleaf.

Table 3 Nonparametic correlations matrix between items of Part 1 (n=31)

Items	Item 1	Item 2	Item 3	Item 4	Item 5	Item 6	Item 7
1.	1.000	0.301	−0.087	0.109	0.548**	0.251	0.306
2.		1.000	−0.215	−0.026	−0.077	−0.059	0.396*
3.			1.000	0.671**	0.153	0.265	0.310
4.				1.000	0.246	0.006	0.399*
5.					1.000	0.487**	0.342
6.						1.000	0.221
7.							1.000

Notes:

* p<0.05 (two-tailed);

** p<0.01 (two-tailed).

Table 4 Nonparametic correlations matrix between items of Part 2 (n=31)

Items	Item 1	Item 2	Item 3	Item 4	Item 5	Item 6	Item 7	Item 8	Item 9	Item 10
1.	1.000	0.611**	−0.054	0.053	0.077	0.027	0.285	0.023	0.056	−0.064
2.		1.000	0.102	0.242	0.264	0.286	0.113	0.210	0.153	0.156
3.			1.000	0.185	0.247	0.357*	0.410*	0.695**	0.360*	0.425*
4.				1.000	0.727**	0.632**	−0.036	0.161	0.215	0.379*
5.					1.000	0.686**	0.100	0.275	0.219	0.309
6.						1.000	0.071	0.332	0.509**	0.628**
7.							1.000	0.639**	0.443**	0.413*
8.								1.000	0.624**	0.534**
9.									1.000	0.701**
10.										1.000

Notes:

* p<0.05 (two-tailed);

** p<0.01 (two-tailed).

Table 5 Thematic coding of written feedback toward WL (n=31)

Themes		n	%
Things the users like about WL
1.	Functions in protection and prevention	15	48
	• Hygienic, not dirty
	• Feeling safe
	• Providing full protection
	• No leaking
	• Prevention from getting STIs
	• Prevention from getting pregnant
2.	No opinion	6	19
3.	User-friendliness	4	13
	• Easy to put on
	• Female friendly
4.	Structural features and sensation	4	13
	• Very thin (“its thinness almost like a feather-light condom”)
	• Feeling soft
	• More sensation than condom
5.	More choices for women	2	6.5
	• Better choice of contraception (“do not need to take pill or injection to prevent from being pregnant”)
Areas for improvement in WL
1.	Structural improvements	11	35.5
	• Front size could be reduced
	• Retention unit—problems with tissue (e.g., “using WL with tissues that sticking together made me feel a little painful during intercourse”)
	• Improvement on design (more user-friendly, or “I would suggest WL can be created like panties so that it can be worn and can also prevent it from sticking on the surface of the skin”)
2.	No comment	10	32
3.	Felt very troublesome and inconvenient	4	13
4.	Embellishment on appearance and textual	3	10
	• Aesthetic appeal could be improved
	• Adding fragrance (“I hope WL can come with fruits fragrances”)
	• More polishing in texture (e.g., “if possible, please let WL smooth like male condom”)
5.	More marketing (“should introduce WL to other friends”)	2	6.5
6.	General improvements	1	3

Abbreviations: STI, sexually transmitted infection; WL, Wondaleaf.