Clinical, Functional, and Therapeutic Characterization of Women With Urinary Incontinence and Analysis of Factors Associated With Treatment Response

• Artificial intelligence clinical decision support model (Other): 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.

Primary outcomes

• Severity of urinary incontinence (ICIQ-UI SF score) [Baseline (V0) through 12 months (V0, V1 at 3 months, V2 at 6 months, V3 at 12 months)]: 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).

Secondary outcomes

• Overactive bladder symptoms (ICIQ-OAB) [V0(Day 1), V1 (3 months), V2 (6 months), V3 (12 months)]: Score on the ICIQ-OAB questionnaire (8 items), range 0-16; higher scores indicate greater impairment.
• Incontinence severity - Sandvik Index (ISI) [V0(Day 1) and V2 (6 months)]: Score on the Incontinence Severity Index (2 items), range 0-12, classified as mild/moderate/severe/very severe.
• Lower urinary tract symptom-specific quality of life (ICIQ-LUTSqol) [V0(Day 1), V1 (3 months), V2 (6 months), V3 (12 months)]: Score on the ICIQ-LUTSqol questionnaire (19 items), range 19-76; higher scores indicate greater impairment in quality of life.
• Patient Global Impression of Severity (PGI-S) [V0 (baseline)]: Single-item scale (1-4) assessing the patient's global perception of symptom severity.
• Patient Global Impression of Improvement (PGI-I) [V1 (3 months), V2 (6 months), V3 (12 months)]: Single-item scale (1-7) assessing the patient's global perception of improvement relative to baseline.
• Sexual function (FSFI) [V0(Day 1), V1 (3 months), V2 (6 months), V3 (12 months)]: Female Sexual Function Index (19 items, 6 domains), range 2-36; a cutoff score ≤26.55 indicates female sexual dysfunction.
• Pelvic floor muscle function (Oxford Scale ) [V0(Day 1) and V2 (6 months)]: 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.
• Amount of urine loss (1-hour Pad Test, ICS) [V0(Day 1) and V2 (6 months)]: Standardized 1-hour pad test; objective quantification of urine loss in grams.
• Voiding pattern (3-day Bladder Diary) [V0(Day 1) and V2 (6 months)]: 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.
• Treatment satisfaction [V1(3 months), V2(6 months), V3 (12 months)]: Proportion of patients reporting satisfaction or high satisfaction with the treatment received, assessed via a satisfaction survey.
• Contextual physical activity variables (wearables) [Continuous throughout the follow-up period (minimum 7 days)]: physycal activity via a wearable device with local storage.
• Contextual sleep variables (wearables) [Continuous throughout the follow-up period (minimum 7 days)]: sleep duration via a wearable device with local storage.
• Contextual daily heart rate (wearables) [Continuous throughout the follow-up period (minimum 7 days)]: mean daily heart ratevia a wearable device with local storage.
• Pelvic floor muscle function (PERFECT protocol) [Baseline (Day 1) and 6 months]: 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.
• Bladder symptoms assessed by the ICIQ-Bladder Diary (ICIQ-BD) [Baseline (Day 1) and 6 months]: 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.

Sex: Female, ages: 18 Years to any

Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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).

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.

• Study Protocol and Statistical Analysis Plan (PDF, 2026-07-10)