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

Fibrosis Clinical Trial

— STRICT-TURP  

Official title:

Hormonal Status and Coagulative Disorders as Risk Factors for Urethral Stricture After Transurethral Resection of the Prostate/Bladder: A Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04795570
• Other study ID #: RTU_EstenosisUretra_2020_HUVN
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Constriction, Pathologic
• Fibrosis
• Hormone Deficiency
• Urethral Stricture
• Urethral Stricture, Male

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