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

August 20, 2020 updated by: Melike Nur AKIN, Muğla Sıtkı Koçman University

ARE SMAD2, SMAD3 AND TGF-β GENE EXPRESSION VALUABLE IN THE MANAGEMENT OF THE URGE URINARY INCONTINENCE?

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Mugla, Turkey, 48000
        • Mugla Sıtkı Kocman University Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study group
wıth URGE INCONTINANCE
Genetic: SMAD2
a family of structurally related cytokines
Other Names:
  • SMAD3
  • TGF-β1
Control group
not urge incontinance
Genetic: SMAD2
a family of structurally related cytokines
Other Names:
  • SMAD3
  • TGF-β1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SMAD2
Time Frame: intraoperative
tissue expression and protein level
intraoperative
SMAD3
Time Frame: intraoperative
tissue expression and protein level
intraoperative
TGF-ß1 mRNA Expression Levels
Time Frame: intraoperative
tissue expression and protein level
intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Muğla Sıtkı Koçman University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2017

Primary Completion (Actual)

January 1, 2020

Study Completion (Actual)

January 1, 2020

Study Registration Dates

First Submitted

August 20, 2020

First Submitted That Met QC Criteria

August 20, 2020

First Posted (Actual)

August 25, 2020

Study Record Updates

Last Update Posted (Actual)

August 25, 2020

Last Update Submitted That Met QC Criteria

August 20, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18/II/26.10.20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

If anyone demand the results of our study, we can share data with other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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