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

Completed

• Conditions: SMAD3; Pelvic Organ Prolapse; SMAD2; TGF-β; Urge Urinary Incontinence
• Interventions: Genetic: SMAD2

• Registration Number: NCT04525105
• Lead Sponsor: Muğla Sıtkı Koçman University

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.

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 Timeline

• Study Start: 2017-11-01
• Primary Completion: 2020-01-01
• Study Completion: 2020-01-01
• Status Verified: 2020-08
• Study First Submitted: 2020-08-20
• Study First Submitted QC: 2020-08-20
• Last Update Submitted: 2020-08-20
• Study First Posted: 2020-08-25
• Last Update Posted: 2020-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 24

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study group	SMAD2	wıth URGE INCONTINANCE
Control group	SMAD2	not urge incontinance

Primary Outcome Measures

Name	Time	Method
SMAD3	intraoperative	tissue expression and protein level
TGF-ß1 mRNA Expression Levels	intraoperative	tissue expression and protein level
SMAD2	intraoperative	tissue expression and protein level

Trial Locations

Locations (1)

Mugla Sıtkı Kocman University Faculty of Medicine; 🇹🇷 Mugla, Turkey