NCT07837167

Brief Summary

The effect of platelet rich plasma injection on post internal urethrotomy stricture recurrence

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 19, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 19, 2025

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2026

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 23, 2026

Completed
Last Updated

September 23, 2026

Status Verified

February 1, 2025

Enrollment Period

1 year

First QC Date

September 12, 2026

Last Update Submit

September 22, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Post-voiding residual urine volume (PVR)

    Post-voiding residual urine volume will be measured by ultrasonography , Unit of Measure : ml .

    2 weeks

  • Maximum urinary flow rate (Qmax)

    Maximum urinary flow rate will be assessed by uroflowmetry , Unit of Measure : ml/second

    2 weeks

Secondary Outcomes (1)

  • recurrence of stricture urethra

    2 years

Study Arms (2)

PRP in stricture urethra

ACTIVE COMPARATOR
Drug: PRP injection

viu in stricture urethra

PLACEBO COMPARATOR
Procedure: VIU

Interventions

The effect of platelet rich plasma injection on post internal urethrotomy stricture recurrence

PRP in stricture urethra
VIUPROCEDURE

VIU in stricture urethra

viu in stricture urethra

Eligibility Criteria

Age20 Years - 50 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • patients with symptomatic bulbar urethral stricture (diagnosed by retrograde urethrography) aged between 20 and 50 years.

You may not qualify if:

  • History or medical evidence of symptomatic benign prostatic enlargement.
  • documented or suspicious prostate cancer.
  • history of hypospadias, neurogenic disorders.
  • previous internal urethrotomy or urethral reconstruction.
  • strictures longer than 1.5 cm.
  • multiple strictures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mostafa Ali Mahmoud

Banhā, Qalyubia Governorate, 13111, Egypt

Location

MeSH Terms

Conditions

Urethral Stricture

Condition Hierarchy (Ancestors)

Urethral ObstructionUrethral DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
urology lecturer , urology department ,principal investigator ,benha university

Study Record Dates

First Submitted

September 12, 2026

First Posted

September 23, 2026

Study Start

February 19, 2024

Primary Completion

February 19, 2025

Study Completion

March 19, 2026

Last Updated

September 23, 2026

Record last verified: 2025-02

Locations