Effect of Glutamine on Urinary Incontinence

Not Applicable

Completed

• Conditions: Urinary Incontinence
• Interventions: Dietary Supplement: fantomalt supplementation; Dietary Supplement: glutamine supplementation

• Registration Number: NCT03265509
• Lead Sponsor: Istanbul University

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.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2017-08-26
• Study First Submitted QC: 2017-08-26
• Study First Posted: 2017-08-29
• Primary Completion: 2018-09
• Study Completion: 2018-09
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-06
• Last Update Posted: 2019-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fantomalt	fantomalt supplementation	30 g/day Fantomalt supplementation for three months
Glutamine	glutamine supplementation	30 g/day Glutamine supplementation for three months

Primary Outcome Measures

Name	Time	Method
Pelvic floor muscle strength with digital palpation	3 months	digital vaginal palpation method
Pelvic floor muscle strength with dynamometer	3 months	vaginal dynamometer

Secondary Outcome Measures

Name	Time	Method
general quality of life	3 months	King's Health Questionnaire (KHQ)
body composition	3 months	muscle mass assessed by bioimpedance analysis
24 hour pad test	3 months	assessment of the severity of urinary incontinence as determined by the 24-hour pad weight
degree of prolapse	3 months	systematic pelvic examination
quality of life related prolapse	3 months	Prolapse quality of life (PQOL) questionnaire
hand grip strength	3 months	Jamar hand dynamometer
urinary incontinence dairy	3 months	urinary incontinence dairy

Trial Locations

Locations (1)

Istanbul University Istanbul Faculty of Medicine; 🇹🇷 Istanbul, Turkey