Ignite Creation Date:
2024-05-06 @ 3:30 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04650347
Status:
COMPLETED
Last Update Posted:
2021-03-02
First Post:
2020-11-24
Brief Title:
Holmium YAG Versus Cold Knife Internal Urethrotomy in Management of Short Urethral Strictures
Sponsor:
Ain Shams University
Organization:
Ain Shams University
Study Overview
Official Title:
Holmium YAG Versus Cold Knife Internal Urethrotomy in Management of Short Urethral Strictures A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 061-3 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 Sachses 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
Since 1974 Sachses 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None