Urethral Stricture After Transurethral Resection of the Prostate/Bladder: a Prospective Study of Risk Factors (STRICT-TURP)

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.

Study Overview

• Status: Recruiting
• Conditions: Fibrosis; Hormone Deficiency; Urethral Stricture, Male
• Intervention / Treatment: Procedure: Transurethral resection of the prostate or bladder

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 Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Ignacio Puche Sanz, MD PhD; Phone Number: 0034 958 020 145; Email: ignacio.puche.sspa@juuntadeandalucia.es

Study Locations

• Spain
  • Granada, Spain, 18003
    • Recruiting
    • Hospital Universitario Virgen de las Nieves
    • Contact: Ignacio Puche-Sanz, MD, PhD; Phone Number: 0034 958 020 145; Email: ignacio.puche.sspa@juntadeandalucia.es
    • Sub-Investigator: Almudena Sabio-Bonilla, MD
    • Sub-Investigator: Ana Cristina Jimenez-Dominguez, MD
    • Sub-Investigator: Laura Entrena-Ureña, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing transurethral resection of the prostate or bladder

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cases. Patients who develop urethral stricture; Patients who develop urethral stricture within 6 months after TUR P/B	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.
Controls. Patients who DO NOT develop urethral stricture; Patients who DO NOT develop urethral stricture within 6 months after TUR P/B	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Development of anatomic urethral stricture	It will be studied in all patients by flexible urethroscopy	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Development of functional urethral stricture	Studied by uroflowmetry and PROM questionnaries	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hormonal status	Determination of serum sexual hormones (Testosterone, estrogens, FSH, LH), TSH, T4 and PRL	Within 6 months after TUR P/B
Coagulation disorders	Comprehensive profile of procoagulation disorders determined in peripheral blood	The day before TUR P/B

Collaborators and Investigators

• Sponsor: University Hospital Virgen de las Nieves
• Collaborators: Instituto de Investigación Biosanitaria de Granada (ibs.Granada)
• Investigators: Principal Investigator: Ignacio Puche-Sanz, MD PhD, University Hospital Virgen de las Nieves

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2020
• Primary Completion (ANTICIPATED): September 1, 2021
• Study Completion (ANTICIPATED): September 1, 2022

Study Registration Dates

• First Submitted: March 9, 2021
• First Submitted That Met QC Criteria: March 11, 2021
• First Posted (ACTUAL): March 12, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 12, 2021
• Last Update Submitted That Met QC Criteria: March 11, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Pathological Conditions, Anatomical; Urethral Diseases; Urethral Obstruction; Constriction, Pathologic; Urethral Stricture
• Other Study ID Numbers: RTU_EstenosisUretra_2020_HUVN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No