SMAD2, SMAD3 AND TGF-β GENE EXPRESSION IN URGE URINARY INCONTINENCE
ARE SMAD2, SMAD3 AND TGF-β GENE EXPRESSION VALUABLE IN THE MANAGEMENT OF THE URGE URINARY INCONTINENCE?
1 other identifier
observational
24
1 country
1
Brief Summary
Urge urinary incontinence (UUI) is a common health problem. Changes in collagen metabolism in pelvic support organs, such as uterosacral ligaments (USLs), might be responsible for the complex pathophysiology of UUI. The TGF-β pathway is involved in collagen synthesis and degradation. The Transforming Growth Family- β (TGF-β) superfamily has essential intracellular signaling components, such as newly identified SMAD family members. We evaluated the changes in the levels of TGF-β and SMAD gene and protein expression in the USL of patients with concomitant pelvic organ prolapse (POP) and UUI.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2017
Typical duration for all trials
1 active site
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
November 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2020
CompletedFirst Submitted
Initial submission to the registry
August 20, 2020
CompletedFirst Posted
Study publicly available on registry
August 25, 2020
CompletedAugust 25, 2020
August 1, 2020
2.2 years
August 20, 2020
August 20, 2020
Conditions
Outcome Measures
Primary Outcomes (3)
SMAD2
tissue expression and protein level
intraoperative
SMAD3
tissue expression and protein level
intraoperative
TGF-ß1 mRNA Expression Levels
tissue expression and protein level
intraoperative
Study Arms (2)
Study group
wıth URGE INCONTINANCE
Control group
not urge incontinance
Interventions
a family of structurally related cytokines
Eligibility Criteria
patients who had been diagnosed with POP and UUI and asymptomatic women without complaints of POP and UUI
You may qualify if:
- patients who had been diagnosed with POP and UUI
- asymptomatic women without complaints of POP and UUI
You may not qualify if:
- Women who have SUI,
- a history of gynecologic malignancy,
- endometriosis,
- connective tissue disorders,
- asthma,
- previous pelvic inflammatory disease,
- pelvic radiation anamnesis,
- smoking,
- previous surgery for POP or UI,
- those on steroid therapy and hormone replacement therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mugla Sıtkı Kocman University Faculty of Medicine
Muğla, 48000, Turkey (Türkiye)
Related Publications (1)
Akin MN, Sivaslioglu AA, Edgunlu T, Kasap B, Celik SK. SMAD2, SMAD3 and TGF-beta GENE expressions in women suffering from urge urinary incontinence and pelvic organ prolapse. Mol Biol Rep. 2021 Feb;48(2):1401-1407. doi: 10.1007/s11033-021-06220-4. Epub 2021 Feb 18.
PMID: 33599951DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr Melike Nur Akın
Study Record Dates
First Submitted
August 20, 2020
First Posted
August 25, 2020
Study Start
November 1, 2017
Primary Completion
January 1, 2020
Study Completion
January 1, 2020
Last Updated
August 25, 2020
Record last verified: 2020-08