NCT03265509

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 26, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 29, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

August 8, 2019

Status Verified

August 1, 2019

Enrollment Period

2.7 years

First QC Date

August 26, 2017

Last Update Submit

August 6, 2019

Conditions

Urinary Incontinence

Outcome Measures

Primary Outcomes (2)

  • Pelvic floor muscle strength with dynamometer

    vaginal dynamometer

    3 months

  • Pelvic floor muscle strength with digital palpation

    digital vaginal palpation method

    3 months

Secondary Outcomes (7)

  • body composition

    3 months

  • quality of life related prolapse

    3 months

  • general quality of life

    3 months

  • 24 hour pad test

    3 months

  • hand grip strength

    3 months

  • +2 more secondary outcomes

Study Arms (2)

Glutamine

ACTIVE COMPARATOR

30 g/day Glutamine supplementation for three months

Dietary Supplement: glutamine supplementation

Fantomalt

PLACEBO COMPARATOR

30 g/day Fantomalt supplementation for three months

Dietary Supplement: fantomalt supplementation

Interventions

glutamine supplementationDIETARY_SUPPLEMENT

30 g/day glutamine supplementation for three months

Glutamine
fantomalt supplementationDIETARY_SUPPLEMENT

30 g/day fantomalt supplementation for three months

Fantomalt

Eligibility Criteria

Age45 Years - 100 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Presence of urinary incontinence and/or pelvic prolapse and/or decreased vaginal muscle strength in gynaecological examination

You may not qualify if:

  • Uncontrolled diabetes
  • Cognitive dysfunction hampering participation in exercise or assessment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University Istanbul Faculty of Medicine

Istanbul, 34093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gulistan Bahat Ozturk, Ass. Prof.

    Istanbul University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 26, 2017

First Posted

August 29, 2017

Study Start

January 1, 2016

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

August 8, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)