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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04795570
Acronym
STRICT-TURP
Enrollment
300
Registered
2021-03-12
Start date
2020-09-01
Completion date
2022-09-01
Last updated
2021-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibrosis, Hormone Deficiency, Urethral Stricture, Male

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.

Interventions

PROCEDURETransurethral 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.

Sponsors

Instituto de Investigación Biosanitaria de Granada (ibs.Granada)
CollaboratorUNKNOWN
University Hospital Virgen de las Nieves
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Development of anatomic urethral stricture6 monthsIt will be studied in all patients by flexible urethroscopy

Secondary

MeasureTime frameDescription
Development of functional urethral stricture6 monthsStudied by uroflowmetry and PROM questionnaries

Other

MeasureTime frameDescription
Hormonal statusWithin 6 months after TUR P/BDetermination of serum sexual hormones (Testosterone, estrogens, FSH, LH), TSH, T4 and PRL
Coagulation disordersThe day before TUR P/BComprehensive profile of procoagulation disorders determined in peripheral blood

Countries

Spain

Contacts

Primary ContactIgnacio Puche Sanz, MD PhD
ignacio.puche.sspa@juuntadeandalucia.es0034 958 020 145

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026