SMAD2, SMAD3 AND TGF-β GENE EXPRESSION IN URGE URINARY INCONTINENCE

NCT ID: NCT04525105

Last Updated: 2020-08-25

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

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Recruitment Status

COMPLETED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-01

Study Completion Date

2020-01-01

Brief Summary

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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.

Detailed Description

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This study included 10 patients who had been diagnosed with POP and UUI in the study group and 14 asymptomatic women without complaints of POP and UUI in the control group. Biopsy samples were collected from bilateral USL tissues during vaginal or abdominal hysterectomy. Total RNA was extracted from USL tissue and analyzed by qPCR. The protein expression levels were also analyzed with ELISA.

Conditions

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SMAD2 SMAD3 TGF-β Pelvic Organ Prolapse Urge Urinary Incontinence

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Study group

wıth URGE INCONTINANCE

SMAD2

Intervention Type GENETIC

a family of structurally related cytokines

Control group

not urge incontinance

SMAD2

Intervention Type GENETIC

a family of structurally related cytokines

Interventions

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SMAD2

a family of structurally related cytokines

Intervention Type GENETIC

Other Intervention Names

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SMAD3 TGF-β1

Eligibility Criteria

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Inclusion Criteria

* patients who had been diagnosed with POP and UUI
* asymptomatic women without complaints of POP and UUI

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Muğla Sıtkı Koçman University

OTHER

Sponsor Role lead

Responsible Party

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Melike Nur AKIN

Dr Melike Nur Akın

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mugla Sıtkı Kocman University Faculty of Medicine

Muğla, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 33599951 (View on PubMed)

Other Identifiers

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18/II/26.10.20

Identifier Type: -

Identifier Source: org_study_id

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