NCT07829692

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
35mo left

Started Aug 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress5%
Aug 2026Aug 2029

Study Start

First participant enrolled

August 5, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 15, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 21, 2026

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2029

Last Updated

September 23, 2026

Status Verified

September 1, 2026

Enrollment Period

3 years

First QC Date

September 15, 2026

Last Update Submit

September 19, 2026

Conditions

Outcome Measures

Primary Outcomes (5)

  • Preferred Cadence

    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)

    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)

    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)

    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)

    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

Study Arms (2)

Cadence increase group

EXPERIMENTAL

Participants will log running data and set cadence alarms to increase running cadence by 10%

Other: Cadence Increase

Cadence Maintenance Arm

PLACEBO COMPARATOR

Participants will log their running data and set cadence alarm to maintain cadence.

Other: Cadence Maintenance

Interventions

Utilizing cadence alarm on a garmin device, the intervention group will attempt to increase their running cadence by 10%.

Cadence increase group

Participants will use cadence alarms to maintain preferred running cadence.

Cadence Maintenance Arm

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nicole Ron, PT, DPT

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 15, 2026

First Posted

September 21, 2026

Study Start

August 5, 2026

Primary Completion (Estimated)

August 5, 2029

Study Completion (Estimated)

August 5, 2029

Last Updated

September 23, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations