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

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:

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Urinary Incontinence (UI)
• Intervention / Treatment: Other: Artificial intelligence clinical decision support model

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Javier Pereira, computer science; Phone Number: +34 881 01 55 21; Email: javier.pereira@udc.es

Study Locations

• Spain
  • La Coruña
    • A Coruña, La Coruña, Spain, 15009
      • Clínica Cobian
      • Contact: Fernando Cobian Sanchez, Ginecologist; Phone Number: 981 14 29 29; Email: info@clinicacobian.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: COHORT
• Time Perspectives: PROSPECTIVE

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Other: Artificial intelligence clinical decision support model; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline (V0) through 12 months (V0, V1 at 3 months, V2 at 6 months, V3 at 12 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overactive bladder symptoms (ICIQ-OAB)	Score on the ICIQ-OAB questionnaire (8 items), range 0-16; higher scores indicate greater impairment.	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.	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.	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.	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.	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.	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.	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.	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.	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.	V1(3 months), V2(6 months), V3 (12 months)
Contextual physical activity variables (wearables)	physycal activity via a wearable device with local storage.	Continuous throughout the follow-up period (minimum 7 days)
Contextual sleep variables (wearables)	sleep duration via a wearable device with local storage.	Continuous throughout the follow-up period (minimum 7 days)
Contextual daily heart rate (wearables)	mean daily heart ratevia a wearable device with local storage.	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.	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.	Baseline (Day 1) and 6 months

Collaborators and Investigators

• Sponsor: Javier Pereira
• Collaborators: Universidade da Coruña; Ministry of Work and Welfare - Xunta de Galicia; Aldaba; Try New Roads; Clinica Cobian

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): September 30, 2028

Study Registration Dates

• First Submitted: September 17, 2026
• First Submitted That Met QC Criteria: October 14, 2026
• First Posted (Actual): October 21, 2026

Study Record Updates

• Last Update Posted (Actual): November 3, 2026
• Last Update Submitted That Met QC Criteria: October 29, 2026
• Last Verified: October 1, 2026

More Information

Terms related to this study

• Keywords: urinary incontinence; Artificial inteligence
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Urinary Incontinence
• Other Study ID Numbers: 2026/271

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No