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

Pelvic Organ Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04525105
• Other study ID #: 18/II/26.10.20
• Status: Completed
• Start date: November 1, 2017
• Est. completion date: January 1, 2020

Study information

• Verified date: August 2020
• Source: Mugla Sitki Koçman University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Pelvic Organ Prolapse
• Prolapse
• SMAD2
• SMAD3
• TGF-ß
• Urge Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Urge

Intervention

Genetic:
• SMAD2
a family of structurally related cytokines

Locations

Country	Name	City	State
Turkey	Mugla Sitki Kocman University Faculty of Medicine	Mugla

Sponsors (1)

Lead Sponsor	Collaborator
Mugla Sitki Koçman University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SMAD2	tissue expression and protein level	intraoperative
Primary	SMAD3	tissue expression and protein level	intraoperative
Primary	TGF-ß1 mRNA Expression Levels	tissue expression and protein level	intraoperative