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Urinary IncontinencePURI-PRONCT06527638

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

A study testing Experimental Group: eHealth intervention for UI symptoms improvement in people with Urinary Incontinence, run by ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida at 1 site in Portugal.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for
Urinary Incontinence
What is being tested?
Experimental Group: eHealth intervention for UI symptoms improvement
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 sitePortugal
Study dates
22 Apr 2025to Jan 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 65 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Portugal1 site

  • ISPA-IU

    Lisbon

Other trials in Portugal

About this study

Official title: 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.

Read the 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.

Being tested
Experimental Group: eHealth intervention for UI symptoms improvement, Control Group: Delivery of a Health Literacy single-leaflet
Keywords
Urinary Incontinence, Menopause, Quality of life, Sexual Function, Beliefs and Coping Strategies, Social Isolation, Self Esteem, Pelvic Floor Muscle Training
Medical subject headings
Urinary Incontinence, Social Isolation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Experimental Group: eHealth intervention for UI symptoms improvementBehavioural

    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-leafletBehavioural

    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.

Study groups in NCT06527638
Study groupRoleWhat they receive
eHealth intervention for UI symptoms improvementExperimentalParticipants 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.
Receives: Behavioral: Experimental Group: eHealth intervention for UI symptoms improvement
Control Group: Delivery of a Health Literacy single-leafletActive comparatorThe control group received a health literacy single-leaflet, delivered through email.
Receives: Behavioral: Control Group: Delivery of a Health Literacy single-leaflet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Brief Assessment of Urinary Incontinence symptoms and impact of Quality of Life

    Evaluated by "International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form" (ICIQ-UI SF)

    Measured: 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

  2. UI-related Coping Strategies

    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.

    Measured: 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

  3. UI-related Beliefs

    Evaluated by the Portuguese version of the "Brief Illness Perception Questionnaire" (IPQ-Brief). This instrument is based on the work of Figueiras and collaborators.

    Measured: 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 outcomes (7)

  1. Urinary Incontinence symptom severity and impact

    Evaluated by "King´s Health Questionnaire" (KHQ)

    Measured: 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

  2. Self-reported Quality of Life

    Evaluated by the Portuguese version of the "WHO Quality-of-Life-Bref" (WHOQOL-Bref).

    Measured: Change from Baseline quality of life to mid-intervention (1 month later), post-intervention (2 months later), and at a 3 month follow-up

  3. Behavior Change (HAPA)

    Evaluated by the HAPA Questionnaire (tailored to Urinary Incontinence symptoms), based on Renner's and Schwarzer's RACK study

    Measured: Change from Baseline behavior to mid-intervention (1 month later), post-intervention (2 months later), and at a 3 month follow-up

  4. Self-esteem

    Evaluated by the Rosenberg Self-Esteem Scale (RSS)

    Measured: Change from Baseline self-esteem to mid-intervention (1 month later), post-intervention (2 months later), and at a 3 month follow-up

  5. Social Isolation

    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.

    Measured: Change from Baseline social isolation to mid-intervention (1 month later), post-intervention (2 months later), and at a 3 month follow-up

  6. Pelvic Floor and UI Knowledge

    Evaluated by "Prolapse and Incontinence Knowledge Questionnaire" (PIKQ-UI)

    Measured: 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

  7. Pelvic Floor Muscle Exercises Adherence

    Evaluated by a checklist developed by Alewijnse and collaborators that includes items regarding the frequency, ease and satisfaction towards the pelvic floor muscle exercises

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2024
  2. Study start22 Apr 2025
  3. Primary completion18 Dec 2025 (estimated)
  4. Study completionJan 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06527638
Sponsor's protocol ID
D-022-11-2019
Acronym
PURI-PRO
Status last verified
Dec 2025
First submitted
17 Jul 2024
Last updated
15 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Schroe H, Van Dyck D, De Paepe A, Poppe L, Loh WW, Verloigne M, Loeys T, De Bourdeaudhuij I, Crombez G. Which behaviour change techniques are effective to promote physical activity and reduce sedentary behaviour in adults: a factorial randomized trial of an e- and m-health intervention. Int J Behav Nutr Phys Act. 2020 Oct 7;17(1):127. doi: 10.1186/s12966-020-01001-x.

    PubMed 33028335

  • Schwarzer R, Renner B. Social-cognitive predictors of health behavior: action self-efficacy and coping self-efficacy. Health Psychol. 2000 Sep;19(5):487-95.

    PubMed 11007157

  • Leventhal H, Phillips LA, Burns E. The Common-Sense Model of Self-Regulation (CSM): a dynamic framework for understanding illness self-management. J Behav Med. 2016 Dec;39(6):935-946. doi: 10.1007/s10865-016-9782-2. Epub 2016 Aug 11.

    PubMed 27515801

  • Imamura M, Abrams P, Bain C, Buckley B, Cardozo L, Cody J, Cook J, Eustice S, Glazener C, Grant A, Hay-Smith J, Hislop J, Jenkinson D, Kilonzo M, Nabi G, N'Dow J, Pickard R, Ternent L, Wallace S, Wardle J, Zhu S, Vale L. Systematic review and economic modelling of the effectiveness and cost-effectiveness of non-surgical treatments for women with stress urinary incontinence. Health Technol Assess. 2010 Aug;14(40):1-188, iii-iv. doi: 10.3310/hta14400.

    PubMed 20738930

  • Harper RC, Sheppard S, Stewart C, Clark CJ. Exploring Adherence to Pelvic Floor Muscle Training in Women Using Mobile Apps: Scoping Review. JMIR Mhealth Uhealth. 2023 Nov 30;11:e45947. doi: 10.2196/45947.

    PubMed 38032694

  • Dumoulin C, Hay-Smith J, Frawley H, McClurg D, Alewijnse D, Bo K, Burgio K, Chen SY, Chiarelli P, Dean S, Hagen S, Herbert J, Mahfooza A, Mair F, Stark D, Van Kampen M; International Continence Society. 2014 consensus statement on improving pelvic floor muscle training adherence: International Continence Society 2011 State-of-the-Science Seminar. Neurourol Urodyn. 2015 Sep;34(7):600-5. doi: 10.1002/nau.22796. Epub 2015 May 21.

    PubMed 25998603

  • Garley A, Unwin J. A case series to pilot cognitive behaviour therapy for women with urinary incontinence. Br J Health Psychol. 2006 Sep;11(Pt 3):373-86. doi: 10.1348/135910705X53876.

    PubMed 16870050

  • Funada S, Watanabe N, Goto T, Negoro H, Akamatsu S, Ueno K, Uozumi R, Ichioka K, Segawa T, Akechi T, Furukawa TA, Ogawa O. Cognitive behavioral therapy for overactive bladder in women: study protocol for a randomized controlled trial. BMC Urol. 2020 Aug 20;20(1):129. doi: 10.1186/s12894-020-00697-0.

    PubMed 32819331

  • Steenstrup B, Lopes F, Cornu JN, Gilliaux M. Cognitive-behavioral therapy and urge urinary incontinence in women. A systematic review. Int Urogynecol J. 2022 May;33(5):1091-1101. doi: 10.1007/s00192-021-04989-3. Epub 2021 Oct 30.

    PubMed 34716765

  • Dowd T, Kolcaba K, Steiner R. Using cognitive strategies to enhance bladder control and comfort. Holist Nurs Pract. 2000 Jan;14(2):91-103. doi: 10.1097/00004650-200001000-00013.

    PubMed 12119974

  • Dumoulin C, Alewijnse D, Bo K, Hagen S, Stark D, Van Kampen M, Herbert J, Hay-Smith J, Frawley H, McClurg D, Dean S. Pelvic-Floor-Muscle Training Adherence: Tools, Measurements and Strategies-2011 ICS State-of-the-Science Seminar Research Paper II of IV. Neurourol Urodyn. 2015 Sep;34(7):615-21. doi: 10.1002/nau.22794. Epub 2015 May 21.

    PubMed 25998493

  • Dumoulin C, Cacciari LP, Hay-Smith EJC. Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women. Cochrane Database Syst Rev. 2018 Oct 4;10(10):CD005654. doi: 10.1002/14651858.CD005654.pub4.

    PubMed 30288727

  • Bo K, Fernandes ACNL, Duarte TB, Brito LGO, Ferreira CHJ. Is pelvic floor muscle training effective for symptoms of overactive bladder in women? A systematic review. Physiotherapy. 2020 Mar;106:65-76. doi: 10.1016/j.physio.2019.08.011. Epub 2019 Aug 24.

    PubMed 32026847

  • Dowd T, Dowd ET. A cognitive therapy approach to promote continence. J Wound Ostomy Continence Nurs. 2006 Jan-Feb;33(1):63-8. doi: 10.1097/00152192-200601000-00010.

    PubMed 16444107

  • Kelleher CJ, Cardozo LD, Khullar V, Salvatore S. A new questionnaire to assess the quality of life of urinary incontinent women. Br J Obstet Gynaecol. 1997 Dec;104(12):1374-9. doi: 10.1111/j.1471-0528.1997.tb11006.x.

    PubMed 9422015

Questions about this trial

What is this clinical trial studying?

A study testing Experimental Group: eHealth intervention for UI symptoms improvement in people with Urinary Incontinence, run by ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida at 1 site in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06527638, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.

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