Proof Of Concept Menstrual Hygiene Product-Wondaleaf®
Condition: Other Menstruation Disorders
MeSH terms: Menstruation Disturbances
Study type: Interventional

Summary: 
      General objective:

      To assess the preference and performance in terms of satisfaction and acceptability as well
      as safety profile of a novel innovative design of menstrual hygiene device (Wondaleaf®)
      during the night for menstruating women by comparing it to prior experience of the usual
      hygienic product for menstrual control, i.e. sanitary pads.

      Specific objectives:

        -  To determine the preference of participants between Wondaleaf® and usual sanitary pads
           as a night use menstrual hygiene product.

        -  To determine the satisfaction of participants towards Wondaleaf® and usual sanitary pads
           as a night use menstrual hygiene product.

        -  To determine the acceptability of participants towards Wondaleaf® as a night use
           menstrual hygiene product.

        -  To determine the safety profile of the Wondaleaf®.
    

Detailed description: 
      This is a proof of concept study to assess preference, satisfaction and acceptability of
      Wondaleaf® versus prior experience of sanitary pads for night use among menstruating women.
      Community sampling will be done and 30 women within ages of 18 to 45 years old with regular
      menstrual cycles will be recruited. Potential participants will be screened based on the
      inclusion and exclusion criteria.

      During the Visit 1 after recruitment, participants will have to complete the Baseline
      Questionnaire (Refer to Appendix):

      Table 1 - Socio-demographic: age, race, education level, marital and personal / family income
      status.

      Table 2 - Usual menstrual characteristics for the past 1 year: age of menarche; most frequent
      length of menstrual cycle (days); most frequent duration of each menstrual bleeding (days);
      number of days with heavy bleeding; the usual (i.e. commonest types) of sanitary pads used at
      night (panty liner, ultra-thin, regular, maxi / super or night use); estimated number of
      times hygiene product changed at night with heavy bleeding; estimated number of times hygiene
      product changed at night with average menstrual flow and current menstrual problems if any.

      Table 3 - satisfaction of usual sanitary pads usage: product comfort; cleanliness; capacity;
      convenience; appearance and quality.

      Participants will receive instructions and demonstrations regarding the investigational
      device usage. Any update on the device will be informed by research officers through phone
      call. Each women subject is required to use the investigational device given for the
      subsequent menstrual cycle at night and record the day of the menstrual flow starts and ends
      with the frequency of the device changed for each night in the Wondaleaf® Menstrual Diary.
      The test materials that are used shall be discarded appropriately in the usual manner at
      home.

      A Home-based Questionnaire on the safety of the investigational device has to be completed by
      the participants at home within 24 hours of the last usage of Wondaleaf®.

      Satisfaction, acceptability and preference questionaire will be given at Visit 2 at the end
      of menstrual cycle within 7 days following the last use of Wondaleaf®. Any unused
      investigational devices will be returned for counting purposes.

      A final follow up by a phone call to each subject will be performed to enquire their general
      well-being after 3 months (+/- 7 days) of last Wondaleaf® usage.

      If the women were confirmed pregnant during study duration, the subject will be withdrawn
      from the study and referred for antenatal care of their choice. If any adverse event arises,
      subject will be advised to stop using the investigational device and will be referred for
      medical care in the Hospital by relevant specialist.
    

Intervention name(s): Wondaleaf®
Intervention type(s): Device
Intervention description(s): Use of Wondaleaf® during menstruation every night in one menstrual cycle.
Other intervention name(s): Female Barrier Film
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Menstruation, Female Barrier, Sanitary pads