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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04525105

Enrollment

Registered

2020-08-25

Start date

2017-11-01

Completion date

2020-01-01

Last updated

2020-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Organ Prolapse, SMAD2, SMAD3, TGF-β, Urge Urinary Incontinence

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.

Interventions

GENETICSMAD2

a family of structurally related cytokines

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026