Effect of Glutamine on Urinary Incontinence

Urinary Incontinence Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03265509
• Other study ID #: 2014/1203
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: September 2018

Study information

• Verified date: August 2019
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence

Intervention

Dietary Supplement:
• glutamine supplementation
30 g/day glutamine supplementation for three months
• fantomalt supplementation
30 g/day fantomalt supplementation for three months

Locations

Country	Name	City	State
Turkey	Istanbul University Istanbul Faculty of Medicine	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Istanbul University	Nestlé

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pelvic floor muscle strength with dynamometer	vaginal dynamometer	3 months
Primary	Pelvic floor muscle strength with digital palpation	digital vaginal palpation method	3 months
Secondary	body composition	muscle mass assessed by bioimpedance analysis	3 months
Secondary	quality of life related prolapse	Prolapse quality of life (PQOL) questionnaire	3 months
Secondary	general quality of life	King's Health Questionnaire (KHQ)	3 months
Secondary	24 hour pad test	assessment of the severity of urinary incontinence as determined by the 24-hour pad weight	3 months
Secondary	hand grip strength	Jamar hand dynamometer	3 months
Secondary	urinary incontinence dairy	urinary incontinence dairy	3 months
Secondary	degree of prolapse	systematic pelvic examination	3 months