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NCT Number: NCT06527638

PURI-PRO - 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.

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Key information

Conditions

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

Age range

40 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

ISPA-IU

Lisbon, Portugal

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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)

  2. 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.

  3. 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.

Secondary outcomes

  1. 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)

  2. 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).

  3. 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

  4. 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)

  5. 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.

  6. 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)

  7. 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

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Fundação para a Ciência e a Tecnologia

Registry information

Official study title

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

Acronym: PURI-PRO

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jul 30, 2024
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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