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

October 29, 2026 updated by: Javier Pereira

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Spain
    • La Coruña
      • A Coruña, La Coruña, Spain, 15009
        • Clínica Cobian
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: COHORT
  • Time Perspectives: PROSPECTIVE

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Severity of urinary incontinence (ICIQ-UI SF score)
Time Frame: 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).
Baseline (V0) through 12 months (V0, V1 at 3 months, V2 at 6 months, V3 at 12 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overactive bladder symptoms (ICIQ-OAB)
Time Frame: 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.
V0(Day 1), V1 (3 months), V2 (6 months), V3 (12 months)
Incontinence severity - Sandvik Index (ISI)
Time Frame: 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.
V0(Day 1) and V2 (6 months)
Lower urinary tract symptom-specific quality of life (ICIQ-LUTSqol)
Time Frame: 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.
V0(Day 1), V1 (3 months), V2 (6 months), V3 (12 months)
Patient Global Impression of Severity (PGI-S)
Time Frame: V0 (baseline)

Single-item scale (1-4) assessing the patient's global perception of symptom severity.
V0 (baseline)
Patient Global Impression of Improvement (PGI-I)
Time Frame: 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.
V1 (3 months), V2 (6 months), V3 (12 months)
Sexual function (FSFI)
Time Frame: 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.
V0(Day 1), V1 (3 months), V2 (6 months), V3 (12 months)
Pelvic floor muscle function (Oxford Scale )
Time Frame: 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.
V0(Day 1) and V2 (6 months)
Amount of urine loss (1-hour Pad Test, ICS)
Time Frame: V0(Day 1) and V2 (6 months)

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)
Time Frame: 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.
V0(Day 1) and V2 (6 months)
Treatment satisfaction
Time Frame: 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.
V1(3 months), V2(6 months), V3 (12 months)
Contextual physical activity variables (wearables)
Time Frame: Continuous throughout the follow-up period (minimum 7 days)

physycal activity via a wearable device with local storage.
Continuous throughout the follow-up period (minimum 7 days)
Contextual sleep variables (wearables)
Time Frame: Continuous throughout the follow-up period (minimum 7 days)

sleep duration via a wearable device with local storage.
Continuous throughout the follow-up period (minimum 7 days)
Contextual daily heart rate (wearables)
Time Frame: Continuous throughout the follow-up period (minimum 7 days)

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)
Time Frame: 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.
Baseline (Day 1) and 6 months
Bladder symptoms assessed by the ICIQ-Bladder Diary (ICIQ-BD)
Time Frame: 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.
Baseline (Day 1) and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Javier Pereira

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Universidade da Coruña
Ministry of Work and Welfare - Xunta de Galicia
Aldaba
Try New Roads
Clinica Cobian

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 17, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 21, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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