Managing Impact-related Leakage During Exercise Using Intravaginal Support

NCT07103161 | Recruiting

• 1 other identifier: H-06-22-8153
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to evaluate the effectiveness of using a regular menstrual tampon or a Uresta pessary to reduce urine leakage associated with running-induced stress urinary incontinence (RI-SUI) in females aged 18 and older. Secondly, the study aims to assess whether either intervention mitigates transient changes in pelvic morphology that occur following a single running bout. Lastly, we aim to evaluate whether participants continue using either intervention during running over the 4-week period following their in-lab participation. The hypotheses are: Hypothesis 1: Among females with RI-SUI, both a tampon and pessary used during a single running bout will reduce urinary leakage symptoms, with greater symptom reduction observed when using the pessary. Hypothesis 2: Participants will report high satisfaction and perceived symptom improvement with both the tampon and pessary, with higher satisfaction and greater improvement reported for the pessary. Hypothesis 3: Both the tampon and pessary will reduce pelvic floor strain incurred by the end of the run, as evidenced by less bladder neck descent, levator plate lengthening, and levator hiatus area increasing relative to that observed when no tampon or pessary is used. Hypothesis 4: A greater proportion of participants will report continued use of the pessary compared to the tampon over the 4-week post-lab period, with higher frequency of use and fewer reported discontinuations. We will perform within-subject comparisons against baseline values to determine the effect of each intervention on RI-SUI symptoms and pelvic organ support. Participants will complete a baseline questionnaire to collect demographic information and assess incontinence severity. They will then attend three laboratory visits within a 10-day period. At each visit, bladder volume will be standardized to between 100 and 200mL, then the participant will undergo three-dimensional (3D) transperineal ultrasound imaging conducted in a standing position. Following imaging, participants will complete a treadmill protocol consisting of 25-minutes running at a moderately difficult pace (rated at 13 - 14 on the Borg Perceiver Rate of Exertion scale), followed by 5 minutes of running at a higher intensity pace. During the run, participants will be asked at 5 minute intervals whether they experienced any urine leakage and to report their perceived amount of leakage. The ultrasound image protocol will be repeated immediately after the run. Participants will be allowed to keep the pessary and will be contacted 4-weeks after the final visit to evaluate whether or not they continued use of a tampon or the pessary, and, if so, we will ask them to report their satisfaction with the intervention(s) they used.

Conditions

Stress Urinary Incontinence (SUI)

Keywords

stress urinary incontinence; conservative treatment; pelvic floor strain; pessary; bladder support device; urinary symptoms; tampon; urine leakage; urine leakage with exercise; urine leakage with running

Outcome Measures

Primary Outcomes (1)

• Urine leakage severity

  Self-reported urine leakage is evaluated as presence (yes/no) and amount (drops, squirts, gush) every 5 minutes during a 38-minute treadmill run. Leakage severity index is calculated as the proportion of 5-minute blocks with leakage times the median leakage amount per block.

  At Baseline (Visit 1), and at Visit 2 and Visit 3, which will occur within 10 days of Baseline.

Secondary Outcomes (5)

• Participant's perception of improvement

  At Visit 2 and Visit 3 only, which will occur within 10 days of Baseline (Visit 1).

• Change in levator plate length observed after an acute running bout

  At Baseline (Visit 1), Visit 2, and Visit 3 - each with pre- and post-running assessments, within 10 days of Baseline.

• Change in bladder neck height observed after an acute running bout

  At Baseline (Visit 1), Visit 2, and Visit 3 - each with pre- and post-running assessments, within 10 days of Baseline.

• Change in levator hiatus area observed after an acute running bout

  At Baseline (Visit 1), Visit 2, and Visit 3 - each with pre- and post-running assessments, within 10 days of Baseline.

• Use of tampon or pessary throughout the 4-week post-lab period

  At 4-week follow-up (4 weeks after Visit 3, approximately Day 38 post-Baseline).

Study Arms (2)

Tampon Visit: run with tampon

ACTIVE COMPARATOR

Device: Sportex regular tampon

Pessary Visit: run with pessary

ACTIVE COMPARATOR

Device: Uresta bladder support device

Interventions

Uresta bladder support device DEVICE

The Uresta bladder support device is an intravaginal device indicated for adult women over 18 years of age who experience stress urinary incontinence, including urine leakage during exercise and non-exercise activities such as coughing and laughing. The device is FDA-cleared and licensed by Health Canada. Participants receive the entire kit that includes the three most common sizes which fit 90% of women. Two additional sizes are available in the lab if needed. Participants will be instructed to self-insert the Uresta prior to running, following the manufacturer instructions with researcher guidance as needed. The device aims to provide mechanical support to the urethra and bladder neck to prevent urine leakage during activities that provoke leakage.

Also known as: Uresta pessary

Pessary Visit: run with pessary

Sportex regular tampon DEVICE

Participants will use a regular absorbency Sportex tampon as a conservative intravaginal support to potentially reduce stress urinary incontinence (SUI) symptoms during running. Participants will be instructed to insert the tampon prior to running into the mid-to-upper vaginal canal while standing or sitting.

Also known as: Menstrual tampon

Tampon Visit: run with tampon

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years of age
• Participate in any exercise or sport modality involving running or brisk walking
• Experiences urine leakage during running or brisk walking
• Speak and read English or French

You may not qualify if:

• No urine leakage in the first laboratory assessment (baseline / no intervention)
• Currently pregnant or have been pregnant in the previous 6 months
• Had or have had cardiac, pulmonary, metabolic and/or neurological conditions
• History of incontinence surgery
• Hysterectomy
• Symptoms consistent with urgency incontinence only
• Experience pain with tampon use or during gynecologic examinations

Sponsors & Collaborators

• University of Ottawa: lead

Study Sites (1)

University of Ottawa, Faculty of Health Sciences building, 200 Lees Avenue

Ottawa, Ontario, K1N 6N5, Canada

RECRUITING

Related Publications (22)

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MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

Menstrual Hygiene Products

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Feminine Hygiene Products; Equipment and Supplies

Study Officials

• Linda McLean, PhD.

  University of Ottawa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Grace Collins, BSc.

CONTACT

613-562-5800; gcollins@uottawa.ca

Anne-Marie Lake, MSc.

CONTACT

613-562-5800; alake@uottawa.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Model Details: This is an assessor blind randomized crossover study design in which all participants complete a baseline visit and are then repeat the protocol at two subsequent visits, one with the tampon and one with the pessary, with the order randomized.

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: August 5, 2025
• Study Start: September 13, 2022
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: August 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Information will be available beginning 1 month after publication with no end date.
• Access Criteria: No data sharing agreement necessary. Data will be made available to researchers wishing to perform secondary analyses or include the data in systematic reviews or meta-analyses.

Locations

CA (1)