Urethral Stricture, MaleSTRICT-TURPNCT04795570
Urethral Stricture After Transurethral Resection of the Prostate/Bladder: a Prospective Study of Risk Factors
An observational study of Urethral Stricture, Male and Hormone Deficiency, run by University Hospital Virgen de las Nieves at 1 site in Spain.
Trial summary
There is currently no prognostic or predictive risk marker for this urethral stricture disease. The most conservative standard treatment for urethral stricture (internal urethrotomy) has a very high recurrence rate (greater than 75%) and, on many occasions, reconstructive urologists have to choose within a great… Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Urethral Stricture, Male, Hormone Deficiency, Fibrosis
- What is being tested?
- Transurethral resection of the prostate or bladder
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2020to 1 Sep 2022
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing transurethral resection of the prostate or bladder
Who may be able to join
- Patients undergoing transurethral resection of the prostate or bladder (TUR P/B) at our department.
Who cannot join
- Patients not giving their informed consent
- Patients with urethral catheter at the moment of TUR P/B
- Patients with any type of urethral stricture at the moment of TUR P/B
- Patients under hormonal treatments (testosterone, thyroxine...) 1 year before the TUR P/B.
- Patients with already known coagulation disorders or undergoing anticoagulation treatments at the moment of the blood test.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Virgen de las Nieves
Granada, 18003
Ignacio Puche-Sanz, MD, PhD, 0034 958 020 145, ignacio.puche.sspa@juntadeandalucia.es
Almudena Sabio-Bonilla, MD
About this study
Official title: Hormonal Status and Coagulative Disorders as Risk Factors for Urethral Stricture After Transurethral Resection of the Prostate/Bladder: A Prospective Study
There is currently no prognostic or predictive risk marker for this urethral stricture disease.
The most conservative standard treatment for urethral stricture (internal urethrotomy) has a very high recurrence rate (greater than 75%) and, on many occasions, reconstructive urologists have to choose within a great variety of further complex interventions. Knowing risk and predictive markers of this disease could help to optimize both the need and the approach for these surgeries and may offer a more individualized management to patients.
Read the detailed description
The pathophysiological mechanisms that influence the development of urethral stricture are not established. In developed countries, the most common etiology of urethral stricture is idiopathic (41%) followed by iatrogenic (35%).
Serum testosterone is important in urethral development, in the integrity of the corpora cavernosa and has been shown to play a fundamental role in the development of genital structures. Recently, hypoandrogenism (HA) has been associated with a decrease in urethral androgen receptors and periurethral vascularization. Furthermore, low serum testosterone levels appear to be implicated in an increased risk of urethral atrophy.
In recent years it has been proven that coagulation, in addition to influencing the formation of the provisional matrix, participates in mechanisms of tissue injury through the activation of PARs. As a result, the coagulation cascade directly influences several key aspects of the wound healing response, from platelet aggregation and vasoconstriction, but also inflammation and scar formation. Although it is strictly regulated under normal conditions, an imbalance in favor of a procoagulant state as occurs in many pathologies of other organs (liver, lung, kidney) has the potential to deregulate inflammatory and tissue repair mechanisms and culminate in fibrosis.
In general, it is accepted that the probability of developing a urethral stricture after endoscopic treatment is around 2-10% of cases. However, this complication has never been studied in depth and the true incidence of urethral stricture, and its consequences in quality of life, after a transurethral procedure is unknown.
The aim of this study is to analyze the potential role of serum hormonal status and coagulation disorders as risk factors for the development of urethral stricture after transurethral surgery.
- Conditions
- Urethral Stricture, Male, Hormone Deficiency, Fibrosis
- Being tested
- Transurethral resection of the prostate or bladder
- Medical subject headings
- Urethral Stricture, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transurethral resection of the prostate or bladderProcedure or surgery
All patients undergoing TUR P/B will undergo a blood draw within 6 months after surgery to determine hormonal status and coagulation disorders.
| Study group | Role | What they receive |
|---|---|---|
| Cases. Patients who develop urethral stricture | Patients who develop urethral stricture within 6 months after TUR P/B Receives: Procedure: Transurethral resection of the prostate or bladder | |
| Controls. Patients who DO NOT develop urethral stricture | Patients who DO NOT develop urethral stricture within 6 months after TUR P/B Receives: Procedure: Transurethral resection of the prostate or bladder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of anatomic urethral stricture
It will be studied in all patients by flexible urethroscopy
Measured: 6 months
Secondary outcomes (1)
Development of functional urethral stricture
Studied by uroflowmetry and PROM questionnaries
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start1 Sep 2020
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urethral Stricture, MaleStudies 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Virgen de las Nieves
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Investigación Biosanitaria de Granada (ibs.Granada)
- Responsible party
- Principal investigator, Ignacio Puche Sanz, University Hospital Virgen de las Nieves
- Investigators
- Ignacio Puche-Sanz, MD PhD, Principal investigator, University Hospital Virgen de las Nieves
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04795570
- Sponsor's protocol ID
- RTU_EstenosisUretra_2020_HUVN
- Acronym
- STRICT-TURP
- Status last verified
- Mar 2021
- First submitted
- 9 Mar 2021
- Last updated
- 12 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hormonal Status and Coagulative Disorders as Risk Factors for Urethral Stricture After Transurethral Resection of the Prostate/Bladder: A Prospective Study
- ClinicalTrials.gov ID
- NCT04795570
- Acronym / sponsor ID
- STRICT-TURP / RTU_EstenosisUretra_2020_HUVN
- Conditions
- Urethral Stricture, Male, Hormone Deficiency, Fibrosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital Virgen de las NievesUniversity, hospital or other
- Collaborators
- Instituto de Investigación Biosanitaria de Granada (ibs.Granada)
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 12 Mar 2021 (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.
There is currently no prognostic or predictive risk marker for this urethral stricture disease.
The most conservative standard treatment for urethral stricture (internal urethrotomy) has a very high recurrence rate (greater than 75%) and, on many occasions, reconstructive urologists have to choose within a great variety of further complex interventions. Knowing risk and predictive markers of this disease could help to optimize both the need and the approach for these surgeries and may offer a more individualized management to patients.
Detailed description
The pathophysiological mechanisms that influence the development of urethral stricture are not established. In developed countries, the most common etiology of urethral stricture is idiopathic (41%) followed by iatrogenic (35%).
Serum testosterone is important in urethral development, in the integrity of the corpora cavernosa and has been shown to play a fundamental role in the development of genital structures. Recently, hypoandrogenism (HA) has been associated with a decrease in urethral androgen receptors and periurethral vascularization. Furthermore, low serum testosterone levels appear to be implicated in an increased risk of urethral atrophy.
In recent years it has been proven that coagulation, in addition to influencing the formation of the provisional matrix, participates in mechanisms of tissue injury through the activation of PARs. As a result, the coagulation cascade directly influences several key aspects of the wound healing response, from platelet aggregation and vasoconstriction, but also inflammation and scar formation. Although it is strictly regulated under normal conditions, an imbalance in favor of a procoagulant state as occurs in many pathologies of other organs (liver, lung, kidney) has the potential to deregulate inflammatory and tissue repair mechanisms and culminate in fibrosis.
In general, it is accepted that the probability of developing a urethral stricture after endoscopic treatment is around 2-10% of cases. However, this complication has never been studied in depth and the true incidence of urethral stricture, and its consequences in quality of life, after a transurethral procedure is unknown.
The aim of this study is to analyze the potential role of serum hormonal status and coagulation disorders as risk factors for the development of urethral stricture after transurethral surgery.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases. Patients who develop urethral stricture | – | Procedure: Transurethral resection of the prostate or bladderPatients who develop urethral stricture within 6 months after TUR P/B |
| Controls. Patients who DO NOT develop urethral stricture | – | Procedure: Transurethral resection of the prostate or bladderPatients who DO NOT develop urethral stricture within 6 months after TUR P/B |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing transurethral resection of the prostate or bladder
Key inclusion criteria (1 listed)
- Patients undergoing transurethral resection of the prostate or bladder (TUR P/B) at our department.
Key exclusion criteria (5 listed)
- Patients not giving their informed consent
- Patients with urethral catheter at the moment of TUR P/B
- Patients with any type of urethral stricture at the moment of TUR P/B
- Patients under hormonal treatments (testosterone, thyroxine...) 1 year before the TUR P/B.
- Patients with already known coagulation disorders or undergoing anticoagulation treatments at the moment of the blood test.
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 |
|---|---|---|
| Transurethral resection of the prostate or bladderAll patients undergoing TUR P/B will undergo a blood draw within 6 months after surgery to determine hormonal status and coagulation disorders. | Procedure or surgery | Cases. Patients who develop urethral stricture, Controls. Patients who DO NOT develop urethral stricture |
Primary outcome
Development of anatomic urethral stricture
Time frame: 6 months
It will be studied in all patients by flexible urethroscopy
1 secondary outcome
Development of functional urethral stricture
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2021.
- Individual participant dataSharing planned: No
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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.
Ignacio Puche-Sanz, MD PhD principal investigator
University Hospital Virgen de las Nieves
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 Urethral Stricture, Male and Hormone Deficiency, run by University Hospital Virgen de las Nieves at 1 site in Spain.
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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 12 Mar 2021. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ignacio Puche Sanz, MD PhD (0034 958 020 145, ignacio.puche.sspa@juuntadeandalucia.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of anatomic urethral stricture (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2021.