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

NCT04795570 | Unknown

• 1 other identifier: RTU_EstenosisUretra_2020_HUVN
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Urethral Stricture, Male; Hormone Deficiency; Fibrosis

Outcome Measures

Primary Outcomes (1)

• Development of anatomic urethral stricture

  It will be studied in all patients by flexible urethroscopy

  6 months

Secondary Outcomes (1)

• Development of functional urethral stricture

  6 months

Other Outcomes (2)

• Hormonal status

  Within 6 months after TUR P/B

• Coagulation disorders

  The day before TUR P/B

Study Arms (2)

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

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

Interventions

Transurethral resection of the prostate or bladder PROCEDURE

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

Cases. Patients who develop urethral stricture; Controls. Patients who DO NOT develop urethral stricture

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing transurethral resection of the prostate or bladder

You may qualify if:

• Patients undergoing transurethral resection of the prostate or bladder (TUR P/B) at our department.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital Virgen de las Nieves: lead
• Instituto de Investigación Biosanitaria de Granada (ibs.Granada): collaborator

Study Sites (1)

Hospital Universitario Virgen de las Nieves

Granada, 18003, Spain

RECRUITING

MeSH Terms

Conditions

Urethral Stricture; Fibrosis

Interventions

Transurethral Resection of Prostate

Condition Hierarchy (Ancestors)

Urethral Obstruction; Urethral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostatectomy; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Ignacio Puche-Sanz, MD PhD

  University Hospital Virgen de las Nieves

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ignacio Puche Sanz, MD PhD

CONTACT

0034 958 020 145; ignacio.puche.sspa@juuntadeandalucia.es

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: March 12, 2021
• Study Start: September 1, 2020
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2022
• Last Updated: March 12, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)