A Pilot Functional Performances Study of Two Synthetic Male Condom
Condition: Functional Performance; Synthetic Male Condom
Study type: Interventional

Summary: 
      Over the decades, male condoms had been widely commercialized and used to protect against
      unintended pregnancy and sexually transmitted infections (STI). While natural rubber latex
      (NRL) male condoms has majority proportion of male condoms in the market, synthetic male
      condoms (SMC) made from polyurethane or other synthetic materials remain new to the
      consumers. Notably, synthetic male condoms are found to be more durable, non-allergenic and
      have better compatibility with lubricants when compared to NRL male condoms. The SMCs that
      have FDA approval and commercially available are AvantiTM (polyisoprene condom), Trojan
      SupraTM (polyurethane condom) and eZ.onTM (polyurethane condom). Although the effectiveness
      of SMCs in the prevention of sexually transmitted infections has yet to be established, SMCs
      are believed to be comparable to NRL male condoms in both STI prevention and contraception
      protection. Notwithstanding, a recent literature had reported the shortfall on the quality of
      variant male condoms in the market, especially nonconforming volumetric capacity, burst
      pressure and freedom from holes. This warrant the current investigation, to evaluate the
      functional performances of two newly invented synthetic male condoms, branded as
      "WONDALEAF-CAP" (WLC) and "WONDALEAF-ON-MAN" (WLM). Apart from being made of polyurethane,
      the major feature of WLC and WLM are nonetheless their adhesive coating on the outer rim of
      the condom opening which by securely adhering to the foreskin, prevent slippage of condom and
      spillage of male ejaculate or secretions when the penis is flaccid, and thereby improve the
      user-friendliness of condom usage.
    


Intervention name(s): (1) WONDALEAF-CAP, (2) WONDALEAF-ON-MEN, (3) durex-TOGETHER (active comparator)
Intervention type(s): Device
Intervention description(s): WONDALEAF-ON-MEN (WLM) is a polyurethane pouch with outstretching adhesive shield. The pouch covers the penis in man user; while the adhesive shield covers the groin regions to provide extra protection for the couples. The pouch is equivalent to marketed polyurethane male; while the adhesive shield is equivalent to marketed polyurethane wound dressing. WLM integrally joined with an adhesive wound dressing, both made of the same polyurethane material.
WONDALEAF-CAP (WLC) is a miniature form of WLM: the pouch covers glans penis and the adhesive shield wraps around the shaft of the penis only, thereby emulating the configuration of a donned regular condom on the penis. Because of the adhesive coating, WLC overcomes the problems of slippage when the penis is flaccid.
The durex-TOGETHER serves as the active comparator in this study. It is a transparent natural rubber latex male condom which is commercially available.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Device Feasibility
Keywords: functional performance; synthetic male condom