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

• Sponsor: Muğla Sıtkı Koçman University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04525105
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Actual Duration (Months): 26
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
SMAD2; SMAD3; TGF-β; Pelvic Organ Prolapse; Urge Urinary Incontinence	Genetic: SMAD2

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 Design

• Study Type: Observational
• Actual Enrollment: 24 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: ARE SMAD2, SMAD3 AND TGF-β GENE EXPRESSION VALUABLE IN THE MANAGEMENT OF THE URGE URINARY INCONTINENCE?
• Actual Study Start Date: Nov 1, 2017
• Actual Primary Completion Date: Jan 1, 2020
• Actual Study Completion Date: Jan 1, 2020

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. SMAD2 [intraoperative]

   tissue expression and protein level

2. SMAD3 [intraoperative]

   tissue expression and protein level

3. TGF-ß1 mRNA Expression Levels [intraoperative]

   tissue expression and protein level

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mugla Sıtkı Kocman University Faculty of Medicine	Mugla		Turkey	48000

Sponsors and Collaborators

• Muğla Sıtkı Koçman University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Melike Nur AKIN, Dr Melike Nur Akın, Muğla Sıtkı Koçman University
• ClinicalTrials.gov Identifier: NCT04525105
• Other Study ID Numbers: 18/II/26.10.20
• First Posted: Aug 25, 2020
• Last Update Posted: Aug 25, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Urge; Prolapse; Pelvic Organ Prolapse

Study Results

No Results Posted as of Aug 25, 2020