SMAD2NCT04525105
SMAD2, SMAD3 AND TGF-β GENE EXPRESSION IN URGE URINARY INCONTINENCE
An observational study of SMAD2 and SMAD3, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- What is being tested?
- SMAD2
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2017to 1 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: patients who had been diagnosed with POP and UUI and asymptomatic women without complaints of POP and UUI
Who may be able to join
- patients who had been diagnosed with POP and UUI
- asymptomatic women without complaints of POP and UUI
Who cannot join
- Women who have SUI,
- a history of gynecologic malignancy,
- endometriosis,
- connective tissue disorders,
- asthma,
- previous pelvic inflammatory disease,
Show all 10Show fewer
- pelvic radiation anamnesis,
- smoking,
- previous surgery for POP or UI,
- those on steroid therapy and hormone replacement therapy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Mugla Sıtkı Kocman University Faculty of Medicine
Muğla, 48000
About this study
Official title: ARE SMAD2, SMAD3 AND TGF-β GENE EXPRESSION VALUABLE IN THE MANAGEMENT OF THE 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.
Read the 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.
- Conditions
- SMAD2, SMAD3, TGF-β, Pelvic Organ Prolapse, Urge Urinary Incontinence
- Being tested
- SMAD2
- Medical subject headings
- Pelvic Organ Prolapse, Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMAD2Genetic
Also called SMAD3, TGF-β1
a family of structurally related cytokines
| Study group | Role | What they receive |
|---|---|---|
| Study group | wıth URGE INCONTINANCE Receives: Genetic: SMAD2 | |
| Control group | not urge incontinance Receives: Genetic: SMAD2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
SMAD2
tissue expression and protein level
Measured: intraoperative
SMAD3
tissue expression and protein level
Measured: intraoperative
TGF-ß1 mRNA Expression Levels
tissue expression and protein level
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2020
- Study start1 Nov 2017
- Primary completion1 Jan 2020
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SMAD2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muğla Sıtkı Koçman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melike Nur AKIN, Muğla Sıtkı Koçman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04525105
- Sponsor's protocol ID
- 18/II/26.10.20
- Status last verified
- Aug 2020
- First submitted
- 20 Aug 2020
- Last updated
- 25 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If anyone demand the results of our study, we can share data with other researchers
Publications
Akin MN, Sivaslioglu AA, Edgunlu T, Kasap B, Celik SK. SMAD2, SMAD3 and TGF-beta GENE expressions in women suffering from urge urinary incontinence and pelvic organ prolapse. Mol Biol Rep. 2021 Feb;48(2):1401-1407. doi: 10.1007/s11033-021-06220-4. Epub 2021 Feb 18.
PubMed 33599951
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ARE SMAD2, SMAD3 AND TGF-β GENE EXPRESSION VALUABLE IN THE MANAGEMENT OF THE URGE URINARY INCONTINENCE?
- ClinicalTrials.gov ID
- NCT04525105
- Acronym / sponsor ID
- 18/II/26.10.20
- Conditions
- SMAD2, SMAD3, TGF-β, Pelvic Organ Prolapse, Urge Urinary Incontinence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 25 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Genetic: SMAD2wıth URGE INCONTINANCE |
| Control group | – | Genetic: SMAD2not urge incontinance |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who had been diagnosed with POP and UUI and asymptomatic women without complaints of POP and UUI
Key inclusion criteria (2 listed)
- patients who had been diagnosed with POP and UUI
- asymptomatic women without complaints of POP and UUI
Key exclusion criteria (10 listed)
- Women who have SUI,
- a history of gynecologic malignancy,
- endometriosis,
- connective tissue disorders,
- asthma,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMAD2Also: SMAD3, TGF-β1a family of structurally related cytokines | Genetic | Control group, Study group |
Primary outcome
SMAD2
Time frame: intraoperative
tissue expression and protein level
SMAD3
Time frame: intraoperative
tissue expression and protein level
TGF-ß1 mRNA Expression Levels
Time frame: intraoperative
tissue expression and protein level
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2020.
- Derived from this study: PubMed 33599951Akin MN, Sivaslioglu AA, Edgunlu T, Kasap B, Celik SK. SMAD2, SMAD3 and TGF-beta GENE expressions in women suffering from urge urinary incontinence and pelvic organ prolapse. Mol Biol Rep. 2021 Feb;48(2):1401-1407. doi: 10.1007/s11033-021-06220-4. Epub 2021 Feb 18.
- Individual participant dataSharing planned: Undecided. If anyone demand the results of our study, we can share data with other researchers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SMAD2 and SMAD3, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SMAD2 (time frame: intraoperative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04525105, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2020.