eHealth intervention for menopausal women with urinary incontinence
PURI-PRO (Portuguese URinary Incontinence PROject) - Symptoms Impact and eHealth Intervention for Menopausal Women With Urinary Incontinence
NA · ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida · NCT06527638
This study tests if an online program that teaches pelvic floor exercises and healthy bladder habits can help women going through menopause with urinary incontinence feel better compared to just reading a health leaflet.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 40 Years to 65 Years |
| Sex | Female |
| Sponsor | ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida (other) |
| Locations | 1 site (Lisboa) |
| Trial ID | NCT06527638 on ClinicalTrials.gov |
What this trial studies
The PURI-PRO project focuses on addressing urinary incontinence (UI) in peri- and postmenopausal women through an 8-week eHealth cognitive-behavioral intervention. This randomized controlled trial compares the effectiveness of a multidisciplinary approach that includes pelvic floor muscle training and healthy bladder habits against a control group receiving a health literacy leaflet. The study evaluates various outcomes, including symptom severity, quality of life, and adherence to exercises, at multiple time points. The aim is to reduce the impact of UI on women's lives and improve their coping strategies.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 40-65 who experience urinary incontinence and have access to the internet.
Not a fit: Patients who are pregnant, have had recent UI-related surgery, or have certain medical conditions affecting bladder control may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the quality of life for menopausal women suffering from urinary incontinence.
How similar studies have performed: Previous studies have shown that eHealth interventions can be effective in managing urinary incontinence in women, suggesting a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Lisboa
- ISPA-IU — Lisboa, Portugal (RECRUITING)
Study contacts
- Principal investigator: Marta G Porto, Master's — ISPA-IU
- Study coordinator: Marta G Porto, Master´s
- Email: mporto@ispa.pt
- Phone: 910404417
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Urinary Incontinence, Menopause, Quality of life, Sexual Function, Beliefs and Coping Strategies, Social Isolation, Self Esteem, Pelvic Floor Muscle Training