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| Name | Class |
|---|---|
| Banner Health | OTHER |
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This study will assess the effectiveness of a new pelvic floor exercise device in strengthening pelvic floor muscles and treating urinary incontinence among women who are experiencing symptoms of pelvic floor weakness. The study will be conducted over 12 weeks and results will be collected through self-assessment questionnaires and clinical pelvic examination. Effectiveness outcomes will be tracked over the duration of the trial and measured against historical symptoms.
The objective of the study is to test the device with women who are experiencing symptoms of pelvic floor weakness, namely urinary incontinence, vaginal laxity and sexual sensation problems, to assess the changes in pelvic floor muscle strength, before and after the intervention.
The study device is a pelvic floor exercise device that provides biofeedback and exercise guidance.
Women who meet the inclusion criteria will be recruited from the regular patients at the investigation site and given the device to use at home daily for 12 weeks. Subjects will submit information regarding their experience with the device and self-assessed improvements in their symptoms. A pelvic examination will be conducted at the start and conclusion of the study to measure a pelvic floor muscle strength reading.
The research hypothesis is that strength level, subjective assessment of vaginal tightness and sexual sensations will be greater at the end of the study than at the baseline and the mean value of frequency and volume of bladder leaks will be less than at the baseline.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pelvic floor exercise | Experimental | Pelvic floor exerciser, daily use |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pelvic floor exerciser | Device | Daily exercise using the study device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in pelvic floor strength | Pelvic floor strength measured by a clinical perineometer in cm H2O. A baseline measurement of resting and peak muscle contraction values will be recorded at the start before the intervention and after the 12 weeks of treatment. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of bladder leaks. | Reporting of weekly incidence of bladder leaks. | 12 weeks |
| Volume of bladder leaks | Reporting of weekly average volume of bladder leaks.A subject assessment with very distinct category gradations. |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective assessment of vaginal tightness | Subjective assessment of increased vaginal tone. | 12 weeks |
| Subjective assessment of sexual sensations | Subjective assessment based on questions that rate this quality of life parameter. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Debra Wickman, MD | FACOG | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner University Medical Center | Phoenix | Arizona | 85006 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 30, 2018 | |
| Reset | Jul 25, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 30, 2018 | Jul 25, 2018 |
| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| D012735 | Sexual Dysfunction, Physiological |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| 12 weeks |
| 12 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 |
| D000091662 | Genital Diseases |