Stress Urinary IncontinenceNCT07829692
Effectiveness of an 8-week Independent Cadence Retraining Program on Stress Urinary Incontinence in Parous Runners.
A study testing Cadence Increase and Cadence Maintenance in people with Stress Urinary Incontinence, run by Mayo Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Cadence Increase and Cadence Maintenance
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2026to 5 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Sally Olmstead, 316-641-6192, olmstead.sally@mayo.edu
Nicole Ron, 505-480-4548, nicolejron@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Cadence Increase, Cadence Maintenance
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cadence IncreaseOther
Utilizing cadence alarm on a garmin device, the intervention group will attempt to increase their running cadence by 10%.
Cadence MaintenanceOther
Participants will use cadence alarms to maintain preferred running cadence.
| Study group | Role | What they receive |
|---|---|---|
| Cadence increase group | Experimental | Participants will log running data and set cadence alarms to increase running cadence by 10% Receives: Other: Cadence Increase |
| Cadence Maintenance Arm | Placebo comparator | Participants will log their running data and set cadence alarm to maintain cadence. Receives: Other: Cadence Maintenance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preferred Cadence
Participants will self-assess preferred running cadence using a garmin device during a 15 minute self-paced run.
Measured: Baseline and 8 weeks
The Pelvic Floor Distress Inventory-20 (PFDI-20)
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.
Measured: Baseline, 8 weeks, and 6 month
Questionnaire for Female Urinary Incontinence Diagnosis (QUID)
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.
Measured: Baseline, 8 weeks, and 6 months
International Consultation on Incontinence Questionnaire - Urinary Incontinence (ICIQ-UI)
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.
Measured: Baseline, 8 weeks, and 6 months
Global Rating of Change (GROC)
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.
Measured: 8 weeks and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start5 Aug 2026
- Primary completion5 Aug 2029 (estimated)
- Study completion5 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nikki Ron, Mayo Clinic
- Investigators
- Nicole Ron, PT, DPT, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07829692
- Sponsor's protocol ID
- 26-000371
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an 8-week Independent Cadence Retraining Program on Stress Urinary Incontinence in Parous Runners: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07829692
- Acronym / sponsor ID
- 26-000371
- Conditions
- Stress Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 5 Aug 2026 (actual)
- Primary completion
- 5 Aug 2029 (estimated)
- Study completion
- 5 Aug 2029 (estimated)
- First posted
- 21 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cadence increase group | Experimental | Other: Cadence IncreaseParticipants will log running data and set cadence alarms to increase running cadence by 10% |
| Cadence Maintenance Arm | Placebo comparator | Other: Cadence MaintenanceParticipants will log their running data and set cadence alarm to maintain cadence. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cadence IncreaseUtilizing cadence alarm on a garmin device, the intervention group will attempt to increase their running cadence by 10%. | Other | Cadence increase group |
| Cadence MaintenanceParticipants will use cadence alarms to maintain preferred running cadence. | Other | Cadence Maintenance Arm |
Primary outcome
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicole Ron, PT, DPT principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cadence Increase and Cadence Maintenance in people with Stress Urinary Incontinence, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sally Olmstead (316-641-6192, olmstead.sally@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preferred Cadence (time frame: Baseline and 8 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.