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Holmium: YAG Versus Cold Knife Internal Urethrotomy in Management of Short Urethral Strictures

Primary Purpose

Urethral Stricture, Male

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
visualized internal urethrotomy
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urethral Stricture, Male

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • men with urethral stricture above the age of eighteen were included in our trial. the length of the urethral stricture was less than 1.5 cm.

Exclusion Criteria:

  • patient with complete urethral stricture with a suprapubic catheter in place.
  • patients whom internal urethrotomy is not applicable like multiple urethral strictures or balanitis xerotica obliterans.

Sites / Locations

  • Urology department - ain shams university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

internal urethrotomy using Holmium laser representing group

internal urethrotomy with Sachs cold knife

Arm Description

In group 1, a three hundred micron laser fiber was used to conduct the laser energy. holmium laser pulse energy of approximately 1 joule was used that was generated from a Holmium laser Quanta device and total power of 15 watts. the laser fiber was aimed directly to the midline at 12 o'clock position to start the procedure and cut the fibrous tissue till access to a wide lumen.

In group B, Sache cold knife internal urethrotomy was used with the same technique as Holmium laser internal urethrotomy at the same site to mechanically cut instead of the laser fiber.

Outcomes

Primary Outcome Measures

Maximum flow rate (ml/sec.)
maximum flow rate, uroflow finding (ml/sec.)
Maximum flow rate(ml/sec.)
maximum flow rate, uroflow finding (ml/sec.)

Secondary Outcome Measures

operation time in minutes
time of operation from cystoscopy till catheter insertion
number of patients with bleeding per urethra
postoperative bleeding around the catheter
number of patients with penile extravasation
penile swelling from fluid extravasation
number of patients with urinary tract infection
urinary tract infection from urine analysis and culture
number of patients with urethral stricture recurrence
recurrence of symptoms with urine outflow obstruction and difficult voiding as measured by uroflow

Full Information

First Posted
November 24, 2020
Last Updated
February 26, 2021
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT04650347
Brief Title
Holmium: YAG Versus Cold Knife Internal Urethrotomy in Management of Short Urethral Strictures
Official Title
Holmium: YAG Versus Cold Knife Internal Urethrotomy in Management of Short Urethral Strictures: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
March 1, 2018 (Actual)
Study Completion Date
March 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Urethral stricture disease is defined as narrowing of the urethral lumen because of fibrosis, which occurs in urethral mucosa and surrounding tissues. The etiology could be congenital, iatrogenic, infectious, or idiopathic. Several techniques are currently available for minimally invasive treatment of urethral strictures, including cold-knife incision, electrocautery, and various types of laser incisions. An incision with the cold knife does not cause any thermal effect on surrounding tissues but should create a mechanical injury that may lead to recurrence in long term. An incision with the electrocautery should cause a significant thermal effect on healthy surrounding tissues resulting in recurrent strictures during follow-up. Laser treatment modalities have gained popularity in the last two decades. the aim of this trial is to evaluate the safety and efficacy of endo-urethrotomy with Holmium laser and cold knife endo-urethrotomy
Detailed Description
Urethral stricture disease (USD) is the narrowing of the urethra from scar tissue, related to genitourinary tract infections, inflammatory skin conditions, traumatic urethral injury, pelvic radiation, and urinary tract instrumentation. It has an estimated prevalence rate of 0.6%.1-3 USD is a common and challenging problem for urologists. Multiple treatment modalities are available for the management of urethral strictures depending on the site and length of stricture, this includes simple urethral dilatation, urethral stenting, endoscopic visual internal urethrotomy (VIU), or open reconstruction. Since 1974, Sachse's internal urethrotomy has been considered the treatment of choice for USD which is fast and simple to carry out and is associated with a short recovery time. The success rates are 33%-60%. Bulow et al in 1979 introduced the laser for internal urethrotomy. The obvious dominance of Ho: YAG are clear vision, less bleeding, precise incision and ablation of scar tissue, and short hospital admission, however, most literature assessing the adequacy of the laser in contrast to cold-knife urethrotomy show no difference in final results. The aim of this trial is to assess the efficacy, safety, complications, and results of Holmium laser urethrotomy and cold knife internal urethrotomy for urethral stricture.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urethral Stricture, Male

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
the investigators planned to conduct a controlled trial with randomization in which eighty participants will be included with symptoms of outflow obstruction secondary to urethral stricture. this is between March 2017 and December 2019. those patients attended the outpatient clinic of our tertiary hospital of Ain Shams University. patients were allocated into 2 equal groups randomly. each group involved 40 patients. Group 1 will represent the holmium laser internal urethrotomy group while group 2 will represent the cold knife internal urethrotomy group.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
patients, data collector, and the statistician were blinded to the type of intervention. the assessment was done to group A and B
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
internal urethrotomy using Holmium laser representing group
Arm Type
Experimental
Arm Description
In group 1, a three hundred micron laser fiber was used to conduct the laser energy. holmium laser pulse energy of approximately 1 joule was used that was generated from a Holmium laser Quanta device and total power of 15 watts. the laser fiber was aimed directly to the midline at 12 o'clock position to start the procedure and cut the fibrous tissue till access to a wide lumen.
Arm Title
internal urethrotomy with Sachs cold knife
Arm Type
Active Comparator
Arm Description
In group B, Sache cold knife internal urethrotomy was used with the same technique as Holmium laser internal urethrotomy at the same site to mechanically cut instead of the laser fiber.
Intervention Type
Procedure
Intervention Name(s)
visualized internal urethrotomy
Intervention Description
incision of a urethral stricture to treat urinary obstruction using Quanta Holmium device or Sache cold knife, 18 Fr silicon catheter was kept for 7 days following the prodecure.
Primary Outcome Measure Information:
Title
Maximum flow rate (ml/sec.)
Description
maximum flow rate, uroflow finding (ml/sec.)
Time Frame
at 3 months
Title
Maximum flow rate(ml/sec.)
Description
maximum flow rate, uroflow finding (ml/sec.)
Time Frame
at 12 months
Secondary Outcome Measure Information:
Title
operation time in minutes
Description
time of operation from cystoscopy till catheter insertion
Time Frame
intraoperative finding
Title
number of patients with bleeding per urethra
Description
postoperative bleeding around the catheter
Time Frame
first day postoperative
Title
number of patients with penile extravasation
Description
penile swelling from fluid extravasation
Time Frame
first day postoperative
Title
number of patients with urinary tract infection
Description
urinary tract infection from urine analysis and culture
Time Frame
first month postoperative
Title
number of patients with urethral stricture recurrence
Description
recurrence of symptoms with urine outflow obstruction and difficult voiding as measured by uroflow
Time Frame
from catheter removal up to 1 year postoperative

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
surgical intervention of male urethra stricture
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: men with urethral stricture above the age of eighteen were included in our trial. the length of the urethral stricture was less than 1.5 cm. Exclusion Criteria: patient with complete urethral stricture with a suprapubic catheter in place. patients whom internal urethrotomy is not applicable like multiple urethral strictures or balanitis xerotica obliterans.
Facility Information:
Facility Name
Urology department - ain shams university
City
Cairo
ZIP/Postal Code
11361
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Holmium: YAG Versus Cold Knife Internal Urethrotomy in Management of Short Urethral Strictures

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