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Completed

NCT Number: NCT04525105

SMAD2, SMAD3 AND TGF-β GENE EXPRESSION IN 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.

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Key information

Conditions

SMAD2 Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Organ Prolapse Prolapse SMAD3 Signs and Symptoms TGF-β Urge Urinary Incontinence Urinary Incontinence Urinary Incontinence, Urge Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Mugla Sıtkı Kocman University Faculty of Medicine

Muğla, 48000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SMAD2

Genetic

a family of structurally related cytokines

Other names: SMAD3, TGF-β1

Primary outcomes

  1. SMAD2

    Time frame: intraoperative

    tissue expression and protein level

  2. SMAD3

    Time frame: intraoperative

    tissue expression and protein level

  3. TGF-ß1 mRNA Expression Levels

    Time frame: intraoperative

    tissue expression and protein level

Sponsors and collaborators

Lead sponsor

Muğla Sıtkı Koçman University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Aug 25, 2020
Registry last updated
Aug 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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