Effect of Glutamine on Urinary Incontinence
Primary Purpose
Urinary Incontinence
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
glutamine supplementation
fantomalt supplementation
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence
Eligibility Criteria
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
Sites / Locations
- Istanbul University Istanbul Faculty of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Glutamine
Fantomalt
Arm Description
30 g/day Glutamine supplementation for three months
30 g/day Fantomalt supplementation for three months
Outcomes
Primary Outcome Measures
Pelvic floor muscle strength with dynamometer
vaginal dynamometer
Pelvic floor muscle strength with digital palpation
digital vaginal palpation method
Secondary Outcome Measures
body composition
muscle mass assessed by bioimpedance analysis
quality of life related prolapse
Prolapse quality of life (PQOL) questionnaire
general quality of life
King's Health Questionnaire (KHQ)
24 hour pad test
assessment of the severity of urinary incontinence as determined by the 24-hour pad weight
hand grip strength
Jamar hand dynamometer
urinary incontinence dairy
urinary incontinence dairy
degree of prolapse
systematic pelvic examination
Full Information
NCT ID
NCT03265509
First Posted
August 26, 2017
Last Updated
August 6, 2019
Sponsor
Istanbul University
Collaborators
Société des Produits Nestlé (SPN)
1. Study Identification
Unique Protocol Identification Number
NCT03265509
Brief Title
Effect of Glutamine on Urinary Incontinence
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
September 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University
Collaborators
Société des Produits Nestlé (SPN)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Glutamine
Arm Type
Active Comparator
Arm Description
30 g/day Glutamine supplementation for three months
Arm Title
Fantomalt
Arm Type
Placebo Comparator
Arm Description
30 g/day Fantomalt supplementation for three months
Intervention Type
Dietary Supplement
Intervention Name(s)
glutamine supplementation
Intervention Description
30 g/day glutamine supplementation for three months
Intervention Type
Dietary Supplement
Intervention Name(s)
fantomalt supplementation
Intervention Description
30 g/day fantomalt supplementation for three months
Primary Outcome Measure Information:
Title
Pelvic floor muscle strength with dynamometer
Description
vaginal dynamometer
Time Frame
3 months
Title
Pelvic floor muscle strength with digital palpation
Description
digital vaginal palpation method
Time Frame
3 months
Secondary Outcome Measure Information:
Title
body composition
Description
muscle mass assessed by bioimpedance analysis
Time Frame
3 months
Title
quality of life related prolapse
Description
Prolapse quality of life (PQOL) questionnaire
Time Frame
3 months
Title
general quality of life
Description
King's Health Questionnaire (KHQ)
Time Frame
3 months
Title
24 hour pad test
Description
assessment of the severity of urinary incontinence as determined by the 24-hour pad weight
Time Frame
3 months
Title
hand grip strength
Description
Jamar hand dynamometer
Time Frame
3 months
Title
urinary incontinence dairy
Description
urinary incontinence dairy
Time Frame
3 months
Title
degree of prolapse
Description
systematic pelvic examination
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gulistan Bahat Ozturk, Ass. Prof.
Organizational Affiliation
Istanbul University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul University Istanbul Faculty of Medicine
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Glutamine on Urinary Incontinence
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