Urinary Incontinence (UI)NCT07887464
Clinical, Functional, and Therapeutic Characterization of Women With Urinary Incontinence and Analysis of Factors Associated With Treatment Response
An observational study of Urinary Incontinence (UI), run by Javier Pereira at 1 site in Spain.
Trial summary
The goal of this observational retrospective study is to characterize women with urinary incontinence and to identify factors associated with their response to treatment using artificial intelligence models. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Incontinence (UI)
- What is being tested?
- Artificial intelligence clinical decision support model
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2026to 30 Sep 2028
- How long will I take part?
- 12 Months
- Phase
- Observational
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women aged 18 years or older with a diagnosis of urinary incontinence who receive routine care at the Clínica Cobián. Participants will provide clinical, functional, therapeutic, questionnaire, and daily-life data, including information collected through wearable devices, for the development and evaluation of an artificial intelligence-based clinical decision support model.
Who may be able to join
- Women aged 18 years or older.
- Diagnosis of urinary incontinence (stress, urgency, or mixed urinary incontinence).
- Patients attending the Clínica Cobián.
- Willingness to participate in follow-up and complete the required patient-reported outcome measures (PROMs).
Who cannot join
- Inability to provide informed consent.
- Severe diseases or clinical conditions that, in the investigator's judgment, may interfere with participation in the study or interpretation of the results.
- Neurological Disorders (Causes of Neurogenic Bladder): Conditions affecting the central or peripheral nervous system can substantially alter bladder control; therefore, urinary incontinence may not be attributable to common mechanical or functional causes, such as stress or standard urgency incontinence.
- Multiple sclerosis (MS). Advanced Parkinson's disease or parkinsonian syndromes. Traumatic or medical spinal cord injuries (paraplegia or tetraplegia). Recent stroke or stroke with severe cognitive or motor sequelae. Severe diabetic autonomic neuropathy associated with detrusor hypotonia or urinary retention.
- Oncological Conditions and Previous Treatments: Pelvic cancer or its treatments may permanently alter pelvic anatomy and bladder tissue function.
- Active urinary tract or gynecological cancer (bladder, prostate, urethra, uterus, or cervix).
Show all 26Show fewer
- History of pelvic radiotherapy. Current chemotherapy, due to systemic effects and potential bladder toxicity (such as cyclophosphamide).
- Urological and Urogynecological Conditions: Local conditions that may confound the diagnosis of common urinary incontinence or require immediate surgical treatment.
- Severe pelvic organ prolapse (POP), stages III or IV according to the POP-Q classification, as it may cause obstruction or overflow incontinence.
- Urogenital fistulas (vesicovaginal or urethrovaginal), in which urine leakage is anatomical and continuous.
- Urethral diverticula or severe urethral stenosis. Active bladder stones or untreated low-compliance bladder.
- Severe or Unstable Systemic Diseases: Conditions that may pose a risk to the participant's health or adherence to the study, or that may produce symptoms that could be confused with urinary incontinence.
- Decompensated congestive heart failure (CHF), which may cause marked nocturnal polyuria and edema, interfering with voiding diaries and assessment of nocturia.
- Advanced chronic kidney disease (estimated glomerular filtration rate [eGFR] <30 mL/min/1.73 m² or requiring dialysis).
- Uncontrolled diabetes mellitus (HbA1c >8.5% or 9%), due to osmotic polyuria that may mask actual urinary frequency and urgency.
- Severe psychiatric disorders or moderate-to-severe cognitive impairment (e.g., Alzheimer's disease) that may prevent valid informed consent or accurate completion of assessment tools, including voiding diaries and quality-of-life questionnaires.
- Recent Pelvic Surgery
- Recent urogynecological or prostate surgery (generally within 6 or 12 months before screening), such as radical prostatectomy, total hysterectomy, or placement of pelvic mesh or slings, as the tissue may still be undergoing healing and remodeling.
- Conditions that may make adequate follow-up by the investigators difficult. Patients who have given birth within one year before study initiation, in order to avoid the influence of recent postpartum changes on pelvic floor musculature and urinary incontinence symptoms.
- Patients who underwent prepartum treatment within one year before study initiation.
- Concurrent participation in other clinical studies that may interfere with the objectives of the present study.
- Withdrawal Criteria
- Voluntary withdrawal of informed consent at any time, without the need to provide a reason.
- Failure to comply with study procedures to an extent that prevents adequate data collection.
- Occurrence of clinical or personal circumstances that, in the investigator's judgment, warrant withdrawal for safety or feasibility reasons.
- Decision by the principal investigator for justified reasons related to study conduct.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Clínica Cobian
A Coruña, La Coruña, 15009
Jorge R Rivadulla Brey, Computer Engenieering, 698176580, jorge.rivadulla@udc.es
About this study
Official title: Clinical, Functional, and Therapeutic Characterization of Women With Urinary Incontinence and Analysis of Factors Associated With Treatment Response: A Retrospective Observational Study in a Specialized Pelvic Floor Clinic
The goal of this observational retrospective study is to characterize women with urinary incontinence and to identify factors associated with their response to treatment using artificial intelligence models.
The main questions it aims to answer are:
Read more
What are the clinical, functional, and therapeutic characteristics of women with urinary incontinence? Which clinical, functional, and lifestyle factors are associated with response to treatment? Can artificial intelligence models identify patterns and factors associated with treatment response?
Researchers will analyze data from women with urinary incontinence collected during routine clinical care at a specialized pelvic floor clinic. The study will combine clinical information from medical records, measurements obtained from clinical assessment instruments, and daily-life data collected using wearable devices such as activity bracelets. Artificial intelligence and machine learning models will be applied to these data to characterize participants and identify factors associated with treatment response.
- Conditions
- Urinary Incontinence (UI)
- Being tested
- Artificial intelligence clinical decision support model
- Keywords
- urinary incontinence, Artificial inteligence
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial intelligence clinical decision support modelOther
Development and evaluation of an artificial intelligence-based clinical decision support model for women with urinary incontinence. The model will integrate clinical data obtained during routine care, measurements from clinical assessment instruments, patient-reported information from questionnaires, and daily-life data collected through wearable devices. The model is intended to identify patterns and factors associated with treatment response and to provide information that may support clinicians in the assessment and management of women with urinary incontinence. The study does not assign or modify the treatment received by participants, which is provided as part of routine clinical care.
| Study group | Role | What they receive |
|---|---|---|
| Women with urinary incontinence | Women with urinary incontinence whose clinical, functional, therapeutic, and daily-life data are analyzed retrospectively. Data include information from medical records, clinical assessment instruments, and wearable devices such as activity bracelets. Artificial intelligence and machine learning models will be applied to these data to identify factors associated with treatment response. Receives: Other: Artificial intelligence clinical decision support model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of urinary incontinence (ICIQ-UI SF score)
Total score on the ICIQ-UI SF (International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form), range 0-21, with higher scores indicating greater severity. Treatment response will be defined as an improvement ≥2.52 points (MCID).
Measured: Baseline (V0) through 12 months (V0, V1 at 3 months, V2 at 6 months, V3 at 12 months)
Secondary outcomes (15)
Overactive bladder symptoms (ICIQ-OAB)
Score on the ICIQ-OAB questionnaire (8 items), range 0-16; higher scores indicate greater impairment.
Measured: V0(Day 1), V1 (3 months), V2 (6 months), V3 (12 months)
Incontinence severity - Sandvik Index (ISI)
Score on the Incontinence Severity Index (2 items), range 0-12, classified as mild/moderate/severe/very severe.
Measured: V0(Day 1) and V2 (6 months)
Lower urinary tract symptom-specific quality of life (ICIQ-LUTSqol)
Score on the ICIQ-LUTSqol questionnaire (19 items), range 19-76; higher scores indicate greater impairment in quality of life.
Measured: V0(Day 1), V1 (3 months), V2 (6 months), V3 (12 months)
Patient Global Impression of Severity (PGI-S)
Single-item scale (1-4) assessing the patient's global perception of symptom severity.
Measured: V0 (baseline)
Patient Global Impression of Improvement (PGI-I)
Single-item scale (1-7) assessing the patient's global perception of improvement relative to baseline.
Measured: V1 (3 months), V2 (6 months), V3 (12 months)
Sexual function (FSFI)
Female Sexual Function Index (19 items, 6 domains), range 2-36; a cutoff score ≤26.55 indicates female sexual dysfunction.
Measured: V0(Day 1), V1 (3 months), V2 (6 months), V3 (12 months)
Pelvic floor muscle function (Oxford Scale )
Pelvic floor muscle contraction strength will be assessed by vaginal palpation using the Oxford Scale, ranging from 0 (no contraction) to 5 (strong contraction). The outcome will be reported as the Oxford Scale score.
Measured: V0(Day 1) and V2 (6 months)
Amount of urine loss (1-hour Pad Test, ICS)
Standardized 1-hour pad test; objective quantification of urine loss in grams.
Measured: V0(Day 1) and V2 (6 months)
Voiding pattern (3-day Bladder Diary)
Voiding pattern and urinary symptoms will be assessed using a 3-day bladder diary. The recorded variables will include daytime and nighttime voiding frequency, urinary incontinence episodes per 24 hours, urgency episodes, voided urine volume, fluid intake, and pad use. Results will be reported for each recorded variable using the corresponding measurement unit.
Measured: V0(Day 1) and V2 (6 months)
Treatment satisfaction
Proportion of patients reporting satisfaction or high satisfaction with the treatment received, assessed via a satisfaction survey.
Measured: V1(3 months), V2(6 months), V3 (12 months)
Contextual physical activity variables (wearables)
physycal activity via a wearable device with local storage.
Measured: Continuous throughout the follow-up period (minimum 7 days)
Contextual sleep variables (wearables)
sleep duration via a wearable device with local storage.
Measured: Continuous throughout the follow-up period (minimum 7 days)
Contextual daily heart rate (wearables)
mean daily heart ratevia a wearable device with local storage.
Measured: Continuous throughout the follow-up period (minimum 7 days)
Pelvic floor muscle function (PERFECT protocol)
Pelvic floor muscle function will be assessed using the PERFECT protocol, including power, endurance, number of repetitions, number of fast contractions, co-contraction, and timing. Each component will be recorded according to the standardized PERFECT protocol.
Measured: Baseline (Day 1) and 6 months
Bladder symptoms assessed by the ICIQ-Bladder Diary (ICIQ-BD)
Bladder symptoms will be assessed using the International Consultation on Incontinence Questionnaire-Bladder Diary (ICIQ-BD). The outcome will be reported according to the scoring and variables specified by the ICIQ-BD instrument.
Measured: Baseline (Day 1) and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Incontinence (UI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Javier Pereira
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade da Coruña, Ministry of Work and Welfare - Xunta de Galicia
- Responsible party
- Sponsor-investigator, Javier Pereira, Universidade da Coruña
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07887464
- Sponsor's protocol ID
- 2026/271
- Status last verified
- Oct 2026
- First submitted
- 17 Sep 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No