Effect of Glutamine on Urinary Incontinence

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

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.

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence
• Intervention / Treatment: Dietary supplement: glutamine supplementation; Dietary supplement: fantomalt supplementation

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34093
    • Istanbul University Istanbul Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Glutamine; 30 g/day Glutamine supplementation for three months	Dietary supplement: glutamine supplementation; 30 g/day glutamine supplementation for three months
Placebo Comparator: Fantomalt; 30 g/day Fantomalt supplementation for three months	Dietary supplement: fantomalt supplementation; 30 g/day fantomalt supplementation for three months

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Istanbul University
• Collaborators: Nestlé
• Investigators: Principal Investigator: Gulistan Bahat Ozturk, Ass. Prof., Istanbul University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): September 1, 2018
• Study Completion (Actual): September 1, 2018

Study Registration Dates

• First Submitted: August 26, 2017
• First Submitted That Met QC Criteria: August 26, 2017
• First Posted (Actual): August 29, 2017

Study Record Updates

• Last Update Posted (Actual): August 8, 2019
• Last Update Submitted That Met QC Criteria: August 6, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis
• Other Study ID Numbers: 2014/1203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No