STUDY PERIOD | |||||||
---|---|---|---|---|---|---|---|
Enrolment | Allocation | Post-allocation intervention delivery and research follow-up | |||||
TIMEPOINT | -t1 | 0 m | 1-2 w | 1 m | 2 m | 3 m | 6 m |
ENROLMENT: | |||||||
Eligibility screening | X | ||||||
Informed consent | X | ||||||
Allocation | X | ||||||
INTERVENTIONS: | |||||||
The knack group | X | X | X | X | |||
PFMT group | X | X | X | X | |||
The Knack + PFMT group | X | X | X | X | |||
ASSESSMENTS: | |||||||
Basic socio-demographic data | X | ||||||
BMI | X | ||||||
General health status Medical history and medication | X | ||||||
Parity and obstetric history | X | ||||||
Type and duration of SUI | X | ||||||
3-day bladder diary | X | X | X | ||||
1-h pad test | X | X | X | ||||
ICIQ-SF | X | X | X | ||||
PERFECT scheme | X | X | X | ||||
Dynamometry | X | X | X | ||||
Vaginal squeeze pressure | X | X | X | ||||
I-QoL | X | X | X | ||||
Frequency of the outpatient sessions | X | X | X | X | |||
Adherence to the home exercises | X | X | X | X | |||
Self-efficacy and expectation | X | X | X | ||||
Subjective cure of SUI | X | X | |||||
Adverse events | X | X | X | X | X |