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

December 6, 2025 updated by: Marta Monteiro da Silva Gonçalves Porto, ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida

PURI-PRO (Portuguese URinary Incontinence PROject) - Symptoms Impact and eHealth Intervention for Menopausal Women With Urinary Incontinence

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: eHealth intervention for UI symptoms improvement

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

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.
Active Comparator: Control Group: Delivery of a Health Literacy single-leaflet
The control group received a health literacy single-leaflet, delivered through email.
Behavioral: Control Group: Delivery of a Health Literacy single-leaflet

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brief Assessment of Urinary Incontinence symptoms and impact of Quality of Life
Time Frame: 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
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
Time Frame: 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
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
Time Frame: Change from Baseline UI-related beliefs to mid-intervention (1 month later), post-intervention (2 months later), and at a 3 month follow-up
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urinary Incontinence symptom severity and impact
Time Frame: 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
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
Pelvic Floor Muscle Exercises Adherence
Time Frame: 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
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
Self-reported Quality of Life
Time Frame: Change from Baseline quality of life to mid-intervention (1 month later), post-intervention (2 months later), and at a 3 month follow-up
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
Self-esteem
Time Frame: Change from Baseline self-esteem to mid-intervention (1 month later), post-intervention (2 months later), and at a 3 month follow-up
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
Time Frame: Change from Baseline social isolation to mid-intervention (1 month later), post-intervention (2 months later), and at a 3 month follow-up
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
Time Frame: 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
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
Behavior Change (HAPA)
Time Frame: Change from Baseline behavior to mid-intervention (1 month later), post-intervention (2 months later), and at a 3 month follow-up
Evaluated by the HAPA Questionnaire (tailored to Urinary Incontinence symptoms), based on Renner's and Schwarzer's RACK study
Change from Baseline behavior to mid-intervention (1 month later), post-intervention (2 months later), and at a 3 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Fundação para a Ciência e a Tecnologia

Investigators

  • Principal Investigator: Marta G Porto, Master's, ISPA-IU
  • Study Chair: Filipa F Pimenta, PhD, ISPA-IU

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 22, 2025

Primary Completion (Estimated)

December 18, 2025

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

July 17, 2024

First Submitted That Met QC Criteria

July 26, 2024

First Posted (Actual)

July 30, 2024

Study Record Updates

Last Update Posted (Actual)

December 15, 2025

Last Update Submitted That Met QC Criteria

December 6, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D-022-11-2019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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