Urinary IncontinenceNCT03265509
Effect of Glutamine on Urinary Incontinence
A study testing glutamine supplementation and fantomalt supplementation in people with Urinary Incontinence, run by Istanbul University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 45 to 100 years, women only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- glutamine supplementation and fantomalt supplementation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2016to Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of urinary incontinence and/or pelvic prolapse and/or decreased vaginal muscle strength in gynaecological examination
Who cannot join
- Uncontrolled diabetes
- Cognitive dysfunction hampering participation in exercise or assessment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Istanbul Faculty of Medicine
Istanbul, 34093
About this study
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
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.
Read the 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.
- Conditions
- Urinary Incontinence
- Being tested
- glutamine supplementation, fantomalt supplementation
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glutamine supplementationDietary supplement
30 g/day glutamine supplementation for three months
fantomalt supplementationDietary supplement
30 g/day fantomalt supplementation for three months
| Study group | Role | What they receive |
|---|---|---|
| Glutamine | Active comparator | 30 g/day Glutamine supplementation for three months Receives: Dietary Supplement: glutamine supplementation |
| Fantomalt | Placebo comparator | 30 g/day Fantomalt supplementation for three months Receives: Dietary Supplement: fantomalt supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic floor muscle strength with dynamometer
vaginal dynamometer
Measured: 3 months
Pelvic floor muscle strength with digital palpation
digital vaginal palpation method
Measured: 3 months
Secondary outcomes (7)
body composition
muscle mass assessed by bioimpedance analysis
Measured: 3 months
quality of life related prolapse
Prolapse quality of life (PQOL) questionnaire
Measured: 3 months
general quality of life
King's Health Questionnaire (KHQ)
Measured: 3 months
24 hour pad test
assessment of the severity of urinary incontinence as determined by the 24-hour pad weight
Measured: 3 months
hand grip strength
Jamar hand dynamometer
Measured: 3 months
urinary incontinence dairy
urinary incontinence dairy
Measured: 3 months
degree of prolapse
systematic pelvic examination
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study startJan 2016
- Primary completionSep 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Collaborators
- Société des Produits Nestlé (SPN)
- Responsible party
- Principal investigator, Gulistan Bahat-Ozturk, Istanbul University
- Investigators
- Gulistan Bahat Ozturk, Ass. Prof., Principal investigator, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03265509
- Sponsor's protocol ID
- 2014/1203
- Status last verified
- Aug 2019
- First submitted
- 26 Aug 2017
- Last updated
- 8 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03265509
- Acronym / sponsor ID
- 2014/1203
- Conditions
- Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Collaborators
- Société des Produits Nestlé (SPN)
- Study start
- Jan 2016 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 29 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glutamine | Active comparator | Dietary Supplement: glutamine supplementation30 g/day Glutamine supplementation for three months |
| Fantomalt | Placebo comparator | Dietary Supplement: fantomalt supplementation30 g/day Fantomalt supplementation for three months |
Who may qualify
- Ages
- 45 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Presence of urinary incontinence and/or pelvic prolapse and/or decreased vaginal muscle strength in gynaecological examination
Key exclusion criteria (2 listed)
- Uncontrolled diabetes
- Cognitive dysfunction hampering participation in exercise or assessment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| glutamine supplementation30 g/day glutamine supplementation for three months | Dietary supplement | Glutamine |
| fantomalt supplementation30 g/day fantomalt supplementation for three months | Dietary supplement | Fantomalt |
Primary outcome
Pelvic floor muscle strength with dynamometer
Time frame: 3 months
vaginal dynamometer
Pelvic floor muscle strength with digital palpation
Time frame: 3 months
digital vaginal palpation method
7 secondary outcomes
body composition
Time frame: 3 months
quality of life related prolapse
Time frame: 3 months
general quality of life
Time frame: 3 months
24 hour pad test
Time frame: 3 months
hand grip strength
Time frame: 3 months
urinary incontinence dairy
Time frame: 3 months
degree of prolapse
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gulistan Bahat Ozturk, Ass. Prof. principal investigator
Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing glutamine supplementation and fantomalt supplementation in people with Urinary Incontinence, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic floor muscle strength with dynamometer (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2019; AzTrials last refreshed its copy on 1 Nov 2026.