PURI-PRO - Symptoms Impact and eHealth Intervention for Menopausal Women With Urinary Incontinence

ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida

Status: Active, not recruiting

Conditions: Urinary Incontinence

Treatments: Behavioral: Control Group: Delivery of a Health Literacy single-leaflet; Behavioral: Experimental Group: eHealth intervention for UI symptoms improvement

Study type: Interventional

Funder types: Other

Identifiers

NCT06527638

D-022-11-2019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: Female

Ages: 40 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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80 participants in 2 patient groups

eHealth intervention for UI symptoms improvement

Experimental group

Description:

Participants in the Experimental Group were integrated into an eHealth 8-week group intervention, based on the Health Action Process Approach (HAPA). The eHealth (internet-based) cognitive-behavioural intervention developed to promote UI symptoms improvement consisted of: i) weekly group sessions (by Zoom platform), with a specific theme in each session, ii) weekly challenges, and iii) WhatsApp group interaction.

Treatment:

Behavioral: Experimental Group: eHealth intervention for UI symptoms improvement

Control Group: Delivery of a Health Literacy single-leaflet

Active Comparator group

Description:

The control group received a health literacy single-leaflet, delivered through email.

Treatment:

Behavioral: Control Group: Delivery of a Health Literacy single-leaflet