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| Name | Class |
|---|---|
| Société des Produits Nestlé (SPN) | INDUSTRY |
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The objective of this study is to determine to effect of additional oral glutamine to Kegel exercises on pelvic floor strength and clinical parameters of urinary incontinence in females with either urinary incontinence (stress and/or urgency) and pelvic prolapse.
Urinary incontinence is a prevalent and costly condition that affects approximately 38% of older community-dwelling women (age>60 years). Incontinence predisposes patients to other health problems, contributes to depression and social isolation, is a significant source of dependency among the elderly, and is widely cited as a factor in nursing home admissions. Sarcopenia is age-related and is characterized by loss of muscle mass, strength and endurance. There is not only a decrease in the number of muscle fibers, but also atrophy in the remaining ones. Several studies indicate glutamine supplementations lead to better muscle performance by stimulate muscle producing in extremities. Similarly, we assume glutamine supplementation could increase pelvic muscle mass and improve the pelvic floor strength. From this point, using glutamine supplementation may effect positively on stress, urge or mixed incontinence, and pelvic prolapse.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glutamine | Active Comparator | 30 g/day Glutamine supplementation for three months |
|
| Fantomalt | Placebo Comparator | 30 g/day Fantomalt supplementation for three months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| glutamine supplementation | Dietary Supplement | 30 g/day glutamine supplementation for three months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pelvic floor muscle strength with dynamometer | vaginal dynamometer | 3 months |
| Pelvic floor muscle strength with digital palpation | digital vaginal palpation method | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| body composition | muscle mass assessed by bioimpedance analysis | 3 months |
| quality of life related prolapse | Prolapse quality of life (PQOL) questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gulistan Bahat Ozturk, Ass. Prof. | Istanbul University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul University Istanbul Faculty of Medicine | Istanbul | 34093 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| fantomalt supplementation | Dietary Supplement | 30 g/day fantomalt supplementation for three months |
|
| 3 months |
| general quality of life | King's Health Questionnaire (KHQ) | 3 months |
| 24 hour pad test | assessment of the severity of urinary incontinence as determined by the 24-hour pad weight | 3 months |
| hand grip strength | Jamar hand dynamometer | 3 months |
| urinary incontinence dairy | urinary incontinence dairy | 3 months |
| degree of prolapse | systematic pelvic examination | 3 months |
| 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 |