Effect of Glutamine on Urinary Incontinence

NCT ID: NCT03265509

Last Updated: 2019-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2018-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Urinary Incontinence

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Glutamine

30 g/day Glutamine supplementation for three months

Group Type ACTIVE_COMPARATOR

glutamine supplementation

Intervention Type DIETARY_SUPPLEMENT

30 g/day glutamine supplementation for three months

Fantomalt

30 g/day Fantomalt supplementation for three months

Group Type PLACEBO_COMPARATOR

fantomalt supplementation

Intervention Type DIETARY_SUPPLEMENT

30 g/day fantomalt supplementation for three months

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

glutamine supplementation

30 g/day glutamine supplementation for three months

Intervention Type DIETARY_SUPPLEMENT

fantomalt supplementation

30 g/day fantomalt supplementation for three months

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

45 Years

Maximum Eligible Age

100 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role collaborator

Istanbul University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Gulistan Bahat-Ozturk

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gulistan Bahat Ozturk, Ass. Prof.

Role: PRINCIPAL_INVESTIGATOR

Istanbul University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Istanbul University Istanbul Faculty of Medicine

Istanbul, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2014/1203

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.