PURI-PRO - Symptoms Impact and eHealth Intervention for Menopausal Women With Urinary Incontinence
NCT Number: NCT06527638
Acronym: PURI-PRO
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Urinary Incontinence
Interventions: BEHAVIORAL: Experimental Group: eHealth intervention for UI symptoms improvement|BEHAVIORAL: Control Group: Delivery of a Health Literacy single-leaflet
Sponsor: ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida
Collaborators: Fundação para a Ciência e a Tecnologia
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-03-06
Completion Date: 2024-10-12
Locations: ISPA-IU, Lisboa, Portugal

Summary:
Urinary Incontinence (UI) is a public health problem that disrupts the Quality of Life, Productivity, Social Isolation and Sexual Function; its prevalence in peri- and postmenopausal women is around 30-40%. UI remains underreported and undertreated. Previous eHealth interventions have been efficacious with women.

Thus, PURI-PRO (Portuguese Urinary Incontinence Project) (FCT Grant 2020.05710.BD) entailed a low-cost 8-week eHealth cognitive-behavioural intervention aimed at reducing symptoms through Pelvic Floor Muscle Training, development of healthy bladder habits, and promotion of adherence to exercises, realistic UI-beliefs, and functional coping strategies.

Urinary incontinence symptom severity, frequency and its impact on quality of life, beliefs and strategies regarding urinary incontinence, self-esteem, social isolation, and adherence to pelvic floor muscle excercises were evaluated.

Primary Outcome Measures: Urinary Incontinence symptom severity and impact, Evaluated by "King´s Health Questionnaire" (KHQ), Change from Baseline Urinary Incontinence symptom severity and impact to mid-intervention (1 month later), post-intervention (2 months later), and at a 3 month follow-up|Brief Assessment of Urinary Incontinence symptoms and impact of Quality of Life, Evaluated by "International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form" (ICIQ-UI SF), Change from Baseline urinary incontinence symptoms and impact on quality of life adherence to mid-intervention (1 month later), post-intervention (2 months later), and at a 3 month follow-up|Pelvic Floor Muscle Exercises Adherence, Evaluated by a checklist developed by Alewijnse and collaborators that includes items regarding the frequency, ease and satisfaction towards the pelvic floor muscle exercises, Change from Baseline pelvic floor muscle exercises adherence to mid-intervention (1 month later), post-intervention (2 months later), and at a 3 month follow-up
Secondary Outcome Measures: Self-reported Quality of Life, Evaluated by the Portuguese version of the "WHO Quality-of-Life-Bref" (WHOQOL-Bref)., Change from Baseline quality of life to mid-intervention (1 month later), post-intervention (2 months later), and at a 3 month follow-up|Behavior Change (HAPA), Evaluated by the HAPA Questionnaire (tailored to Urinary Incontinence symptoms), based on Godinho and collaborators' study, Change from Baseline behavior to mid-intervention (1 month later), post-intervention (2 months later), and at a 3 month follow-up|UI-related Beliefs, Evaluated by the Portuguese version of the "Brief Illness Perception Questionnaire" (IPQ-Brief) based on Figueiras and collaborators' study, Change from Baseline UI-related beliefs to mid-intervention (1 month later), post-intervention (2 months later), and at a 3 month follow-up|UI-related Coping Strategies, Evaluated by a bi-factorial instrument (hiding coping dimension and defensive coping dimension) developed by our team that entails a set of UI-related maladaptive coping strategies to manage immediate effects of UI. This instrument is based on the work of Diokno and collaborators., Change from Baseline UI-related coping strategies to mid-intervention (1 month later), post-intervention (2 months later), and at a 3 month follow-up|Self-esteem, Evaluated by the Rosenberg Self-Esteem Scale (RSS), Change from Baseline self-esteem to mid-intervention (1 month later), post-intervention (2 months later), and at a 3 month follow-up|Social Isolation, Evaluated by "Social Isolation Questionnaire" (tailored to Urinary Incontinence symptoms) (UI-SIQ). This questionnaire is still on the process of being published by our team., Change from Baseline social isolation to mid-intervention (1 month later), post-intervention (2 months later), and at a 3 month follow-up|Pelvic Floor and UI Knowledge, Evaluated by "Prolapse and Incontinence Knowledge Questionnaire" (PIKQ-UI), Change from Baseline pelvic floor and UI knowledge to mid-intervention (1 month later), post-intervention (2 months later), and at a 3 month follow-up