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Principal investigator has decided not to continue her PhD studies.
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The overall purpose of this research is to determine the effect of ultrasound imaging biofeedback on urine leakage, pelvic floor muscle contractions, and quality of life in women with stress urinary incontinence. This study will include women 20 years or older with stress urinary incontinence.
The study will involve 2 groups: pelvic floor muscle (PFM) exercises with biofeedback using transabdominal Rehabilitative ultrasound imaging (RUSI) (Group A) and PFM exercises alone (Group B). The participants will perform 16 exercise sessions over a period of 8 weeks. Group A will perform 3 pelvic floor exercises using the transabdominal RUSI to provide biofeedback. Group B will perform the same 3 pelvic floor exercises without biofeedback.
All participants involved in the study will complete a general medical information questionnaire. In addition, all participants will have their PFM contraction assessed using an ultrasound machine placed over the lower abdomen, quality of life assessed with a written questionnaire, and given a 7-day bladder diary to complete prior to, at 4-weeks, and at completion of the study.
This study has been terminated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pelvic floor muscle exercises | Active Comparator | Three pelvic floor muscle exercises will be performed with verbal cueing from the instructor. |
|
| Pelvic floor exercises with biofeedback | Experimental | Pelvic floor exercises will be performed with biobeedback cueing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pelvic floor exercises with biofeedback | Other | Exercises will be performed with assistance of biofeedback cueing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the ability to contract the pelvic floor muscles from baseline to the midpoint and completion of the study | Pelvic floor muscle lift and length of pelvic floor muscle contraction will be measured using transabdominal ultrasound imaging. Ability to maintain continence during a cough will be measured by asking the participant to stand, contract the pelvic floor muscles, and cough. The participant will state whether or not they leaked urine. | baseline, 4 weeks, and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the number of incontinent episodes per week from baseline to the midpoint and conclusion of the study | Incidence of incontinent episodes will be measured using a 7-day bladder diary | Baseline, 4 weeks, and 8 weeks |
| Change in quality of life from the baseline to the midpoint and completion of the study |
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Inclusion Criteria:
Exclusion Criteria:
women with:
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| Name | Affiliation | Role |
|---|---|---|
| Elaine Trudell-Jackson, PT, PhD | Texas Woman's University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Woman's University | Dallas | Texas | 75235 | United States |
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| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D001676 | Biofeedback, Psychology |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D001521 | Behavior Therapy |
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| Pelvic floor muscle exercises | Other | Exercises will b performed with verbal cueing of investigator. |
|
Quality of life will be measured using the I-QOL questionnaire |
| Baseline, 4 weeks, and 8 weeks |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D011613 |
| Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D030141 | Feedback, Psychological |