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

NCT ID: NCT04795570

Last Updated: 2021-03-12

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2022-09-01

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.

Conditions

Urethral Stricture, Male; Hormone Deficiency; Fibrosis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Cases. Patients who develop urethral stricture

Patients who develop urethral stricture within 6 months after TUR P/B

Transurethral resection of the prostate or bladder

Intervention Type: PROCEDURE

All patients undergoing TUR P/B will undergo a blood draw within 6 months after surgery to determine hormonal status and coagulation disorders.

Controls. Patients who DO NOT develop urethral stricture

Patients who DO NOT develop urethral stricture within 6 months after TUR P/B

Transurethral resection of the prostate or bladder

Intervention Type: PROCEDURE

All patients undergoing TUR P/B will undergo a blood draw within 6 months after surgery to determine hormonal status and coagulation disorders.

Interventions

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Instituto de Investigación Biosanitaria de Granada (ibs.Granada)

UNKNOWN

Sponsor Role: collaborator

University Hospital Virgen de las Nieves

OTHER

Sponsor Role: lead

Responsible Party

Ignacio Puche Sanz

MD PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ignacio Puche-Sanz, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Virgen de las Nieves

Locations

Hospital Universitario Virgen de las Nieves

Granada, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Ignacio Puche Sanz, MD PhD

Role: CONTACT

ignacio.puche.sspa@juuntadeandalucia.es

0034 958 020 145

Facility Contacts

Ignacio Puche-Sanz, MD, PhD

Role: primary

ignacio.puche.sspa@juntadeandalucia.es

0034 958 020 145

Other Identifiers

RTU_EstenosisUretra_2020_HUVN

Identifier Type: -

Identifier Source: org_study_id