Clinical trial NCT06527638: PURI-PRO - Symptoms Impact and eHealth Intervention for Menopausal Women With Urinary Incontinence
Official title: PURI-PRO (Portuguese URinary Incontinence PROject) - Symptoms Impact and eHealth Intervention for Menopausal Women With Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Urinary Incontinence
Keywords: Urinary Incontinence
Menopause
Quality of life
Sexual Function
Beliefs and Coping Strategies
Social Isolation
Self Esteem
Pelvic Floor Muscle Training
Lead sponsor: ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida
Sponsor class: OTHER
Collaborators: name: Fundação para a Ciência e a Tecnologia
First posted: 2024-07-30
Enrollment: 80
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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 multidisciplinary intervention aimed at reducing UI symptoms' severity 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.

Detailed description: PURI-PRO's intervention followed an experimental design (randomised controlled trial) involving UI intervention (Experimental Group-EG) vs. Health Literacy single-leaflet (Control Group-CG), both delivered through the internet (eHealth). The study was comparative, since the sample was distributed in two groups (EG vs CG) through randomised distribution, and longitudinal, since all the outcome measures were evaluated at four different times.

Eligibility criteria: Inclusion Criteria:

* Age (40-65 years);
* Sex (women);
* The presence of UI (positive response to a question about experiencing involuntary urine loss during intra-abdominal pressure increment and/or when feeling an incontrollable urge to urinate, occasionally or frequently);
* Internet access.

Exclusion Criteria:

* Pregnancy or delivery in the past 6 months;
* Previous UI-related surgery;
* History of pelvic prolapse:
* Known malignancy in the lower abdomen;
* Neurological disease that could affect bladder control;
* Substance use disorder.

Primary outcomes:
measure: Brief Assessment of Urinary Incontinence symptoms and impact of Quality of Life
timeFrame: 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
measure: UI-related Coping Strategies
timeFrame: 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
measure: UI-related Beliefs
timeFrame: Change from Baseline UI-related beliefs to mid-intervention (1 month later), post-intervention (2 months later), and at a 3 month follow-up
Secondary outcomes:
measure: Urinary Incontinence symptom severity and impact
timeFrame: 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
measure: Self-reported Quality of Life
timeFrame: Change from Baseline quality of life to mid-intervention (1 month later), post-intervention (2 months later), and at a 3 month follow-up
measure: Behavior Change (HAPA)
timeFrame: Change from Baseline behavior to mid-intervention (1 month later), post-intervention (2 months later), and at a 3 month follow-up
measure: Self-esteem
timeFrame: Change from Baseline self-esteem to mid-intervention (1 month later), post-intervention (2 months later), and at a 3 month follow-up
measure: Social Isolation
timeFrame: Change from Baseline social isolation to mid-intervention (1 month later), post-intervention (2 months later), and at a 3 month follow-up
measure: Pelvic Floor and UI Knowledge
timeFrame: 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
measure: Pelvic Floor Muscle Exercises Adherence
timeFrame: 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
Other outcomes:
Locations:
city: Lisboa
country: Portugal
facility: ISPA-IU
Study officials:
affiliation: ISPA-IU
name: Marta G Porto, Master's
role: PRINCIPAL_INVESTIGATOR
affiliation: ISPA-IU
name: Filipa F Pimenta, PhD
role: STUDY_CHAIR
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