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OpenTrials
Completed

NCT Number: NCT03265509

Effect of Glutamine on Urinary Incontinence

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.

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Key information

Age range

45 year–100 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University Istanbul Faculty of Medicine

Istanbul, 34093, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

glutamine supplementation

Dietary Supplement

30 g/day glutamine supplementation for three months

fantomalt supplementation

Dietary Supplement

30 g/day fantomalt supplementation for three months

Primary outcomes

  1. Pelvic floor muscle strength with dynamometer

    Time frame: 3 months

    vaginal dynamometer

  2. Pelvic floor muscle strength with digital palpation

    Time frame: 3 months

    digital vaginal palpation method

Secondary outcomes

  1. body composition

    Time frame: 3 months

    muscle mass assessed by bioimpedance analysis

  2. quality of life related prolapse

    Time frame: 3 months

    Prolapse quality of life (PQOL) questionnaire

  3. general quality of life

    Time frame: 3 months

    King's Health Questionnaire (KHQ)

  4. 24 hour pad test

    Time frame: 3 months

    assessment of the severity of urinary incontinence as determined by the 24-hour pad weight

  5. hand grip strength

    Time frame: 3 months

    Jamar hand dynamometer

  6. urinary incontinence dairy

    Time frame: 3 months

    urinary incontinence dairy

  7. degree of prolapse

    Time frame: 3 months

    systematic pelvic examination

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Collaborators

  • Société des Produits Nestlé (SPN)

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 29, 2017
Registry last updated
Aug 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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