Effect of Glutamine on Urinary Incontinence

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Assessment of the Effect of Glutamine Supplementation in Addition to Exercise on Pelvic Floor Muscle Strength and Clinical Parameters in Women With Urinary Incontinence or Pelvic Organ Prolapse

Conditions
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Urinary Incontinence

Intervention / Treatment
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* Dietary Supplement: glutamine supplementation
* Dietary Supplement: fantomalt supplementation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presence of urinary incontinence and/or pelvic prolapse and/or decreased vaginal muscle strength in gynaecological examination Exclusion Criteria: Uncontrolled diabetes Cognitive dysfunction hampering participation in exercise or assessment

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Glutamine<br>30 g/day Glutamine supplementation for three months | Dietary Supplement: glutamine supplementation<br>* 30 g/day glutamine supplementation for three months<br>|
| Placebo Comparator: Fantomalt<br>30 g/day Fantomalt supplementation for three months | Dietary Supplement: fantomalt supplementation<br>* 30 g/day fantomalt supplementation for three months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |