Urethral Stricture After Transurethral Resection of the Prostate/Bladder: a Prospective Study of Risk Factors

• Conditions: Fibrosis; Urethral Stricture, Male; Hormone Deficiency
• Interventions: Procedure: Transurethral resection of the prostate or bladder

• Registration Number: NCT04795570
• Lead Sponsor: University Hospital Virgen de las Nieves

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.

Study Timeline

• Study Start: 2020-09-01
• Status Verified: 2021-03
• Study First Submitted: 2021-03-09
• Study First Submitted QC: 2021-03-11
• Last Update Submitted: 2021-03-11
• Study First Posted: 2021-03-12
• Last Update Posted: 2021-03-12
• Primary Completion: 2021-09-01
• Study Completion: 2022-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 300

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Controls. Patients who DO NOT develop urethral stricture	Transurethral resection of the prostate or bladder	Patients who DO NOT develop urethral stricture within 6 months after TUR P/B
Cases. Patients who develop urethral stricture	Transurethral resection of the prostate or bladder	Patients who develop urethral stricture within 6 months after TUR P/B

Primary Outcome Measures

Name	Time	Method
Development of anatomic urethral stricture	6 months	It will be studied in all patients by flexible urethroscopy

Secondary Outcome Measures

Name	Time	Method
Development of functional urethral stricture	6 months	Studied by uroflowmetry and PROM questionnaries

Trial Locations

Locations (1)

Hospital Universitario Virgen de las Nieves; 🇪🇸 Granada, Spain