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Trial · NCT07259148

Behavioral Interventions Versus Pelvic Floor Muscle Therapy as Adjuncts to Anticholinergic Pharmacotherapy for Urgency Urinary Incontinence: A Non-Inferiority Trial

NCT07259148, Not applicable, Active not recruiting, Emilio José Dávila Álvarez

3 sourcestrials-2026-11-12-0.4.0

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ConductScience Library. Behavioral Interventions Versus Pelvic Floor Muscle Therapy as Adjuncts to Anticholinergic Pharmacotherapy for Urgency Urinary Incontinence: A Non-Inferiority Trial. Trials, record NCT07259148. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07259148

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Behavioral Interventions Versus Pelvic Floor Muscle Therapy as Adjuncts to Anticholinergic Pharmacotherapy for Urgency Urinary Incontinence: A Non-Inferiority Trial
NCT number
NCT07259148
Status
Active not recruiting
Phases
Not applicable
Enrollment
80 participants, estimated
Lead sponsor
Emilio José Dávila Álvarez
Conditions
Urgency Urinary Incontinence
Interventions
Pelvic Floor Muscle Training (PFMT), Behavioral Bladder Training Program, Oxybutynin / Mirabegron (Standardized Pharmacotherapy)
First posted
2025-12-02
Last updated
2026-01-26

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryChange in ICIQ-SF Total Score from Baseline to Week 8Baseline and Week 8
This measure evaluates the change in the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) total score between baseline and week 8. The ICIQ-SF assesses frequency, severity, and impact of urinary incontinence on quality of life. Scores range from 0 to 21, with higher scores indicating greater severity.
SecondaryChange in ICIQ-LUTSqol Score from Baseline to Week 8Baseline and Week 8
This measure evaluates the change in the International Consultation on Incontinence Questionnaire-Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol) score between baseline and week 8. The questionnaire assesses the impact of urinary incontinence on daily activities, psychological well-being, and social functioning. Total scores range from 19 to 76, with higher scores indicating greater impairment.
SecondaryChange in Number of Urgency Urinary Incontinence Episodes per 24 HoursBaseline and Week 8Change in the frequency of urgency urinary incontinence episodes per 24 hours, based on a 3-day bladder diary completed at baseline and week 8.
SecondaryPatient Global Impression of Improvement (PGI-I) at Week 8Week 8
The PGI-I is a validated single-item global rating scale in which participants rate their improvement on a 7-point scale ranging from "very much better" to "very much worse." Lower scores indicate greater subjective improvement.
SecondaryChange in Number of Micturitions per 24 HoursBaseline and Week 8Change in the total number of micturitions per 24 hours, based on a 3-day bladder diary completed at baseline and week 8.
SecondaryChange in Number of Urgency Urinary Incontinence Episodes per 24 HoursBaseline and Week 8Change in the frequency of urgency urinary incontinence episodes per 24 hours, recorded in a 3-day bladder diary at baseline and week 8.
SecondaryChange in Number of Urgency Episodes per 24 HoursBaseline and Week 8Change in the number of urgency episodes per 24 hours, obtained from a 3-day bladder diary at baseline and week 8.
SecondaryChange in Number of Absorbent Pads Used per 24 HoursBaseline and Week 8Change in the total number of absorbent pads used per 24 hours, as documented in a 3-day bladder diary at baseline and week 8.
SecondaryAdherence to Assigned InterventionThroughout the 8-week intervention periodProportion of participants achieving ≥80% adherence to the assigned intervention protocol, monitored through weekly checklists and session attendance logs.

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT07259148

GET https://conductscience.org/api/trials/v1/NCT07259148/registered