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

What this trial studies

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.

Conditions in scope

• Urinary Incontinence

Interventions

• 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…
• 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,…

Who can join

Women only · Ages 40 Years to 65 Years · 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.

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Active, not recruiting
• Study type: Interventional
• Phase: N/A
• Start date: 2025-04-22
• Primary completion: 2025-12-18
• Last update posted: 2025-12-15
• First posted: 2024-07-30

Sponsor & contact

Lead sponsor: ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida (Other)

Collaborators: Fundação para a Ciência e a Tecnologia

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Brief Assessment of Urinary Incontinence symptoms and impact of Quality of Life (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)
• UI-related Coping Strategies (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.
• UI-related Beliefs (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.

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.