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

NCT06527638 | Active Not Recruiting

• 1 other identifier: D-022-11-2019
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence

Keywords

Urinary Incontinence; Menopause; Quality of life; Sexual Function; Beliefs and Coping Strategies; Social Isolation; Self Esteem; Pelvic Floor Muscle Training

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• UI-related Beliefs

  Evaluated by the Portuguese version of the "Brief Illness Perception Questionnaire" (IPQ-Brief). This instrument is based on the work of Figueiras and collaborators.

  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 (7)

• Urinary Incontinence symptom severity and impact

  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

• Self-reported Quality of Life

  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)

  Change from Baseline behavior to mid-intervention (1 month later), post-intervention (2 months later), and at a 3 month follow-up

• Self-esteem

  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

  Change from Baseline social isolation to mid-intervention (1 month later), post-intervention (2 months later), and at a 3 month follow-up

Study Arms (2)

eHealth intervention for UI symptoms improvement

EXPERIMENTAL

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.

Behavioral: Experimental Group: eHealth intervention for UI symptoms improvement

Control Group: Delivery of a Health Literacy single-leaflet

ACTIVE COMPARATOR

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

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

Interventions

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

A health literacy single-leaflet was delivered, by e-mail in the first week of the intervention. Beyond this, there was no further interaction with the group. All primary and secondary outcome measures were assessed at baseline, mid-intervention (one month later), post-intervention, and in a 3 month follow-up after the intervention.

Control Group: Delivery of a Health Literacy single-leaflet

Experimental Group: eHealth intervention for UI symptoms improvement BEHAVIORAL

The intervention was theoretically based on the HAPA model (including effective strategies in behaviour change, for example, action planning and coping with obstacles) and Common Sense Model of Self Regulation (beliefs, coping and appraisal), focusing on risk perception, planning, and self-efficacy. The intervention consisted of 8 sessions (90 minutes, once a week). All group intervention sessions, through the Zoom platform, were led by the psychologist responsible for the study, except the second session that was led by a physiotherapist. WhatsApp groups were created, to share experiences, knowledge, doubts and fears, and to create a sense of belonging, understanding and cohesion. All primary and secondary outcome measures were assessed at baseline, mid-intervention (one month later), post-intervention, and in a 3 month follow-up after the intervention.

eHealth intervention for UI symptoms improvement

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida: lead
• Fundação para a Ciência e a Tecnologia: collaborator

Study Sites (1)

ISPA-IU

Lisbon, Portugal

Location

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  BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence; Social Isolation

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Social Behavior; Behavior

Study Officials

• Marta G Porto, Master's

  ISPA-IU

  PRINCIPAL INVESTIGATOR

• Filipa F Pimenta, PhD

  ISPA-IU

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: July 30, 2024
• Study Start: April 22, 2025
• Primary Completion: December 18, 2025
• Study Completion: January 1, 2026
• Last Updated: December 15, 2025

Record last verified: 2025-12

Locations

PT (1)