Active — Not RecruitingNot Applicable

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

Portugal80 participantsStarted 2025-04-22

Plain-language 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.

Who can participate

Age range

40 Years – 65 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

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

Trial details

NCT IDNCT06527638

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

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-18

View on ClinicalTrials.gov More Urinary Incontinence trials