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NCT Number: NCT05678413

Role of Paclitaxel in Stricture Urethra

Stricture urethra is a common disease and has various causing factors. The most common performed procedure is direct visual internal urethrotomy (DVIU), but unfortunately has a high recurrence rates. Multiple trial were performed to improve the outcomes of DVIU. Various intralesional injections were used. in this trial we will evaluate intralesional paclitaxel injection following DVIU.

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Key information

Conditions

Stricture Urethra Constriction, Pathologic Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Urethral Diseases Urethral Obstruction Urethral Stricture Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Mohamed Fawzy Salman

Cairo, Egypt

Location status: Recruiting

Location contact

Aboelfotoh A Aboelfoth, MD

PRINCIPAL_INVESTIGATOR

Mohamed Fawzy Salman, MD

CONTACT

[email protected]

+201111788996

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Anterior urethral stricture
  • Short strictures (less than 2 cm)
  • International Prostate Symptom Score less than 11 and maximum flow rate < 15 ml per second.
  • No previous treatment for stricture disease

Exclusion criteria

  • Recurrent cases
  • Prior pelvic radiation
  • Associated other pathology or unresolved confounding etiologies (e.g. bladder neck contracture, neurogenic bladder, benign prostatic hyperplasia) were excluded.

Treatment and study plan

DVIU with paclitaxel injection

Procedure

Cystourethroscopy will be performed using a 22 Fr rigid cystoscope to allow for ureteric catheter 3F/a wire to be passed through the stricture and into the urinary bladder. DVIU will be performed by cold-knife incisions at the 12-, 3-, and 9 o'clock positions through the full thickness of the fibrosis to healthier appearing tissue. A 23 Fr Wolf (Vernon Hills, IL) injection scope and a standard injection needle was used to inject 30 mg/5mL of paclitaxel vial, 1.5 mL will be injected along the length of each incision into healthier appearing tissue for a total of 5 mL.

DVIU

Procedure

DVIU

Primary outcomes

  1. Success of treatment

    Time frame: 1 year

    Treatment free rates (Freedom from repeat intervention e.g., repeat dilation, DVIU or urethroplasty).

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed F Salman, MD

CONTACT

[email protected]

+201111788996

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

Role of Paclitaxel in Prevention of Stricture Recurrence After Direct Visual Internal Urethrotomy (DVIU); Prospective Clinical Trial

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jan 10, 2023
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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