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Completed

NCT Number: NCT03118557

Pilates Pelvic Floor Strengthening Program to Improve Urinary Incontinence

Does a twice weekly, 12-week Pilates pelvic floor strengthening program improve short- and long-term measures of stress urinary incontinence symptoms in women ages 45-70 years of age?

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Key information

Conditions

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

Age range

45 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 45-70 years of age.
  • Able to provide informed consent.
  • Able to lower and rise from the floor safely and independently.
  • Anticipated to be able to attend at least 9 of the first 12 classes (75%) in weeks 1-6.
  • Anticipated to be able to attend at least 9 of the final 12 classes (75%) in weeks 7-12.
  • Score of 6+ on ICIQ-UI Short Form.

Exclusion criteria

  • Pregnancy
  • Unable to speak and comprehend English
  • Chronic neurologic condition (e.g., Parkinson's or Multiple Sclerosis) that impacts bladder function.

Treatment and study plan

Pilates pelvic floor strengthening

Other

Pilates pelvic floor strengthening.

Primary outcomes

  1. Change in score on International Consultation on Incontinence (ICIQ-UI Short Form)

    Time frame: Baseline, 12 weeks

    The ICIQ-UI Short Form consists of 3 questions. The ICIQ score is a sum of the responses to the 3 questions with a total possible range of 0 (none) to 21 (all the time/a great deal).

Secondary outcomes

  1. Change in score on Medical, Epidemiological, Social Aging (MESA) Urinary Incontinence Questionnaire

    Time frame: Baseline, 12 weeks

    The MESA Urinary Incontinence Questionnaire consists of 3 sections: General questions (unscored), Urge Incontinence (6 questions), and Stress Incontinence (9 questions). The scored questions can range from 0 (never) to 3 (often). The score for the Urge Incontinence is the sum of the responses/18, and the score for the Stress Incontinence section is the sum of the responses/27.

  2. Change in score on Linear Analogue Self Assessment (LASA)

    Time frame: Baseline, 12 weeks

    The LASA questionnaire consists of 6 questions, each ranging from 0 (as bad as it can be) to 10 (as good as it can be). Therefore, the total possible scores would range from 0 (as bad as it can be) to 60 (as good as it can be).

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

HLP-16-003H: Does a Twice Weekly, 12-week Pilates Pelvic Floor Strengthening Program Improve Short- and Long-term Measures of Stress Urinary Incontinence Symptoms in Women Ages 45-70 Years of Age.

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 18, 2017
Registry last updated
Mar 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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