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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04795570
Other study ID # RTU_EstenosisUretra_2020_HUVN
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2020
Est. completion date September 1, 2022

Study information

Verified date March 2021
Source University Hospital Virgen de las Nieves
Contact Ignacio Puche Sanz, MD PhD
Phone 0034 958 020 145
Email ignacio.puche.sspa@juuntadeandalucia.es
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date September 1, 2022
Est. primary completion date September 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients undergoing transurethral resection of the prostate or bladder (TUR P/B) at our department. Exclusion Criteria: - 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.

Study Design


Intervention

Procedure:
Transurethral resection of the prostate or bladder
All patients undergoing TUR P/B will undergo a blood draw within 6 months after surgery to determine hormonal status and coagulation disorders.

Locations

Country Name City State
Spain Hospital Universitario Virgen de las Nieves Granada

Sponsors (2)

Lead Sponsor Collaborator
University Hospital Virgen de las Nieves Instituto de Investigación Biosanitaria de Granada (ibs.Granada)

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Other Hormonal status Determination of serum sexual hormones (Testosterone, estrogens, FSH, LH), TSH, T4 and PRL Within 6 months after TUR P/B
Other Coagulation disorders Comprehensive profile of procoagulation disorders determined in peripheral blood The day before TUR P/B
Primary Development of anatomic urethral stricture It will be studied in all patients by flexible urethroscopy 6 months
Secondary Development of functional urethral stricture Studied by uroflowmetry and PROM questionnaries 6 months
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