Clinical trial NCT04795570: Urethral Stricture After Transurethral Resection of the Prostate/Bladder: a Prospective Study of Risk Factors
Official title: Hormonal Status and Coagulative Disorders as Risk Factors for Urethral Stricture After Transurethral Resection of the Prostate/Bladder: A Prospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Urethral Stricture, Male
Hormone Deficiency
Fibrosis
Lead sponsor: University Hospital Virgen de las Nieves
Sponsor class: OTHER
Collaborators: name: Instituto de Investigación Biosanitaria de Granada (ibs.Granada)
First posted: 2021-03-12
Enrollment: 300
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing transurethral resection of the prostate or bladder

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Development of anatomic urethral stricture
timeFrame: 6 months
Secondary outcomes:
measure: Development of functional urethral stricture
timeFrame: 6 months
Other outcomes:
measure: Hormonal status
timeFrame: Within 6 months after TUR P/B
measure: Coagulation disorders
timeFrame: The day before TUR P/B
Locations:
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
Study officials:
affiliation: University Hospital Virgen de las Nieves
name: Ignacio Puche-Sanz, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: