Clinical, Functional, and Therapeutic Characterization of Women With Urinary Incontinence and Analysis of Factors Associated With Treatment Response (XINE-IA)

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.

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.