Effectiveness of an 8-week Independent Cadence Retraining Program on Stress Urinary Incontinence in Parous Runners.

September 19, 2026 updated by: Nikki Ron, Mayo Clinic

Effectiveness of an 8-week Independent Cadence Retraining Program on Stress Urinary Incontinence in Parous Runners: A Randomized Controlled Trial.

The purpose of this research is to assess the impact of an eight-week home cadence training program on stress urinary incontinence symptoms in parous women.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
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.

Detailed Description

Following informed consent and completion of baseline study measures, participants will complete a home running-cadence assessment using their Garmin device. Participants will receive standardized written instructions through an electronic link, with verbal or technical assistance available from the research team as needed. Investigators will compare a cadence-increase intervention with a cadence-maintenance control condition. Both groups will complete 8 weeks of their typical at home running program. This study will be conducted entirely remotely, and no in-person study visits will be required. Participants assigned to the cadence-increase group will be instructed to continue their previously planned running program while increasing their running cadence by approximately 10% above their baseline cadence. Their Garmin watch will be programmed to provide an alert when cadence falls below or above the individualized target. Participants assigned to the cadence-maintenance control group will also continue their previously planning running program. Their Garmin watch will be programmed with cadence alerts intended to support maintenance of their baseline average cadence. The active intervention period will last eight weeks. Study measures will be collected at baseline, immediately following the eight-week intervention, and at six months. Electronic questionnaires will be used to assess urinary-incontinence symptoms and other relevant pelvic-floor symptoms.

The study is designed to determine whether a low-cost, fully remote, wearable-guided modification of running cadence can reduce SUI symptoms in parous runners.

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.
Interventional

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.
66

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

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

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Healthy
  • Nonpregnant
  • Female volunteers
  • Self-reported urinary incontinence during running with history of at least one prior delivery after 32 weeks gestation and who run 6 miles/week with a preferred cadence of less than or equal to 170 steps per minute determined via personal report from current Garmin watch data.
  • Participants must own their own or have access to a Garmin watch.
  • Participants must read, speak, and understand English sufficiently to provide informed consent and complete study procedures and questionnaires.

Exclusion Criteria:

  • Unwillingness to complete all components of the study
  • Urge only urinary incontinence
  • <3 months postpartum or current pregnancy
  • History of prolapse repair or incontinence surgery
  • Participants will also be excluded if they do not own or utilize a Garmin watch that provides cadence assessment and alarm.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Experimental: Cadence increase group

Participants will log running data and set cadence alarms to increase running cadence by 10%
Other: Cadence Increase

Utilizing cadence alarm on a garmin device, the intervention group will attempt to increase their running cadence by 10%.
Placebo Comparator: Cadence Maintenance Arm

Participants will log their running data and set cadence alarm to maintain cadence.
Other: Cadence Maintenance

Participants will use cadence alarms to maintain preferred running cadence.

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
Preferred Cadence
Time Frame: Baseline and 8 weeks

Participants will self-assess preferred running cadence using a garmin device during a 15 minute self-paced run.
Baseline and 8 weeks
The Pelvic Floor Distress Inventory-20 (PFDI-20)
Time Frame: Baseline, 8 weeks, and 6 month

questionnaire that assesses bowel, bladder, and pelvic symptoms and their impact on quality of life. Scores range from 0 to 300 with higher scores indicating greater pelvic floor distress and impact on quality of life.
Baseline, 8 weeks, and 6 month
Questionnaire for Female Urinary Incontinence Diagnosis (QUID)
Time Frame: Baseline, 8 weeks, and 6 months

6 item urinary incontinence questionnaire. A higher SUI score (range 0-15) suggests stress urinary incontinence is more likely.

A higher UUI score (range 0-15) suggests urge urinary incontinence is more likely.

The questionnaire is designed to help distinguish between these two main types of urinary incontinence in women.
Baseline, 8 weeks, and 6 months
International Consultation on Incontinence Questionnaire - Urinary Incontinence (ICIQ-UI)
Time Frame: Baseline, 8 weeks, and 6 months

The ICIQ-UI Short Form (ICIQ-UI SF) produces a single score from 0 to 21 by summing three scored items: leakage frequency, leakage amount, and impact on daily life. A higher score indicates increased severity of urinary incontinence symptoms.
Baseline, 8 weeks, and 6 months
Global Rating of Change (GROC)
Time Frame: 8 weeks and 6 months

Scale allowing patient to self-report perceived change of UI symptoms. This is an 11-point scale (-5 to +5) with a higher positive score indicating greater improvement in SUI symptoms and a lower negative score indicating worsening of SUI symptoms.
8 weeks 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.
Mayo Clinic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nicole Ron, PT, DPT, Mayo Clinic

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 (Actual)

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.
August 5, 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.
August 5, 2029

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.
August 5, 2029

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 15, 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.
September 15, 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.
September 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.
September 23, 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.
September 19, 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.
September 1, 2026

More Information

Terms related to this study

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.
  • 26-000371

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

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings