Postnatal Leaking, Exercise and Activity Shorts Evaluation (PLEASE) study

• Register: ISRCTN
• Last refreshed on: 17 October 2016
• Main ID: ISRCTN10972784
• Date of registration: 05/02/2015
• Prospective Registration: Yes
• Primary sponsor: Trinity College Dublin
• Public title: Postnatal Leaking, Exercise and Activity Shorts Evaluation (PLEASE) study
• Scientific title: Postnatal Leaking, Exercise and Activity Shorts Evaluation (PLEASE): a randomised cross over study
• Date of first enrolment: 16/02/2015
• Target sample size: 40
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN10972784
• Study type: Interventional
• Study design: Single centre randomised double-blind cross over trial (Prevention)

Countries of recruitment

Ireland

Contacts

• Name: Deirdre Daly

Key inclusion & exclusion criteria

Inclusion criteria: 1. Taking part in the MAMMI (Maternal health And Maternal Morbidity in Ireland, http://www.mammi.ie/) study
2. Gave consent to being contacted about taking part in future research related to the MAMMI study
3. Not pregnant or planning a pregnancy during the study
4. Baby's age is between 3 months and 12 months at study start
5. Do at least 30 minutes of vigorous exercise twice a week and are willing to continue doing this amount of exercise for at least 2 months during the study
Exclusion criteria: 1. Not taking part in the MAMMI study at the time of recruitment to the PLEASE study
2. Did not provide consent to take part in future research related to the MAMMI study
3. Pregnant or planning a pregnancy
4. Not exercising for at least 30 minutes, twice a week
5. Less than 3 months and more than 9 months postpartum
6. Ill

Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Urine leakage during exercising after giving birth
Pregnancy and Childbirth
Urine leakage

Intervention(s)

1. Women will be randomly allocated to either the intervention shorts or the other shorts group for 3 weeks.
2. At the end of the 3 weeks, women using the first type of shorts will be asked to document the exercise type and amounts and satisfaction with the product for that time using a standardised tested survey form.
3. Women will return their shorts and will be sent the other type of shorts to test similarly for a further 3 weeks. At the end of the second 3 weeks of using the second type of shorts, women will be asked to document the exercise type and amounts and satisfaction with the product for that time using the same standardised tested survey form.
4. Neither women nor researchers will be aware of which shorts have been sent until the coding is revealed at the end of the trial to avoid bias.
5. When women return the second pair of shorts, with their data, both pairs of shorts will be returned to them.

Primary Outcome(s)

Measured with a standardised tested survey form at the end of 3 weeks:
1. Security while wearing and exercising with sports shorts
2. Comfort while wearing and exercising with sports shorts
3. Confidence while wearing and exercising with sports shorts
4. Satisfaction with the product

Secondary Outcome(s)

Measured with a standardised tested survey form at baseline:
1. Characteristics of women (age and body-mass index [BMI]) and frequency and severity of urinary leakage
2. Type, frequency and severity of leakage (urge, stress or mixed)
3. Type of exercise taken

Secondary ID(s)

N/A

Source(s) of Monetary Support

Enterprise Ireland (UK)