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Urethral StrictureNCT03973619

Urethral Stricture: A Comparison Between Jugal or Labial Graft Urethroplasty

A study testing Labial Graft and Jugal Graft in people with Urethral Stricture, run by Hospital de Clinicas de Porto Alegre.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Buccal mucosa urethroplasty is a current fashion in urethral stricture management. In our university centre (Hospital de Clínicas de Porto Alegre) is a common surgical treatment choice. Read more about this study

Who is it for?
Any age, men only
Conditions the study is for
Urethral Stricture
What is being tested?
Labial Graft and Jugal Graft
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
77 participants
Where
No sites listed yet
Study dates
1 Oct 2016to 27 Nov 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Men only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Urethral Stricture Diagnosis
  • Indication for buccal mucosa graft urethroplasty
  • Accept the Informed Consent Term (patient or responsible)

Who cannot join

  • Severe urethral stricture which a two-staged procedure are required
  • Long strictures which need a both types of buccal mucosa graft due its length.
  • Refuse to ICT for the patient ou it responsible

About this study

Official title: Urethral Stricture Repair: A Prospective Randomized Analysis Between Jugal or Labial Graft in Buccal Mucosa Urethroplasty

Buccal mucosa urethroplasty is a current fashion in urethral stricture management. In our university centre (Hospital de Clínicas de Porto Alegre) is a common surgical treatment choice. This paper aims to evaluate the success rate of this treatment after randomized choice between labial and jugal (inner cheek) grafts during the past two years.

Read the detailed description

Free dorsal graft urethroplasty, first described by Barbagli et al, has been shown better results than ventral grafts. Fixed grafts on the corpora cavernosa results in a better mechanical support and vascular supply, with less chance to complications such as pseudodiverticula and sacculations either a better urethral phisiology.

This study aims to evaluate the current surgical management in our centre: buccal mucosa graft urethroplasty with jugal or labial replacement, comparing their group success rate and complications between the groups in patients led to surgery from October 2016 to June 2018.

Prospective analysis from urethral stricture surgical HCPA patient data by dorsal buccal mucosa graft urethroplasty. The graft choice were done by a software. Longer stricture with transoperative need for the two grafts use were excluded. Success rate were measured with a no stricture de novo or absence of complications in a six month interval.

Being tested
Labial Graft, Jugal Graft
Keywords
urethral stricture, mucosa graft, jugal graft,, labial graft, success rate
Medical subject headings
Urethral Stricture

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Labial GraftProcedure or surgery

    As replacement of the damaged urethral tissue, we used a buccal mucosa graft (labial graft).

  • Jugal GraftProcedure or surgery

    As replacement of the damaged urethral tissue, we used a buccal mucosa graft(inner cheek - jugal graft).

Study groups in NCT03973619
Study groupRoleWhat they receive
LabialActive comparatorPatients who received a labial graft as replacement of urethral tissue
Receives: Procedure: Labial Graft
JugalActive comparatorPatients who received a jugal (inner cheek) graft as replacement of urethral tissue
Receives: Procedure: Jugal Graft

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Success Rate

    Absence of surgical intervention after prior surgery

    Measured: 6 months

  2. Labial Group Success Rate

    Absence of surgical intervention after prior surgery on patients who received a labial graft.

    Measured: 6 months

  3. Jugal Group Success Rate

    Absence of surgical intervention after prior surgery on patients who received a inner cheek graft.

    Measured: 6 months

  4. Latex Catheter Success Rate

    Absence of surgical intervention on patients who used a latex catheter indwelling after prior surgery.

    Measured: 6 months

  5. Silicon Catheter Success Rate

    Absence of surgical intervention on patients who used a silicon catheter indwelling after prior surgery.

    Measured: 6 months

Secondary outcomes (4)

  1. Stricture Etiology

    Evaluation of the etiology of the stricture (trauma, other, infectious) on patients included on Labial and Jugal Groups

    Measured: 24 months

  2. Stricture Localization

    Evaluation of the stricture localization (penile, bulbar/bulbomembranous or combined) on patients included on Labial and Jugal Groups

    Measured: 24 months

  3. Stricture Size

    Evaluation of the stricture length (cm) on patients included on Labial and Jugal Groups

    Measured: 24 months

  4. Demographic Data

    Evaluation of the demographic data relationship with the results (age, cystotomy, cystostomy time, tobacco use, diabetes, balanitis xerotica, UTI infection, serum creatin levels) included on Labial and Jugal groups

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2019
  2. Study start1 Oct 2016
  3. Primary completion31 Jul 2018
  4. Study completion27 Nov 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
77 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03973619
Sponsor's protocol ID
170319
Status last verified
Aug 2020
First submitted
15 May 2019
Last updated
24 Aug 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Barbagli G, Palminteri E, Guazzoni G, Montorsi F, Turini D, Lazzeri M. Bulbar urethroplasty using buccal mucosa grafts placed on the ventral, dorsal or lateral surface of the urethra: are results affected by the surgical technique? J Urol. 2005 Sep;174(3):955-7; discussion 957-8. doi: 10.1097/01.ju.0000169422.46721.d7.

    PubMed 16094007

  • Bracka A. A versatile two-stage hypospadias repair. Br J Plast Surg. 1995 Sep;48(6):345-52. doi: 10.1016/s0007-1226(95)90023-3.

    PubMed 7551506

  • Morey AF, McAninch JW. When and how to use buccal mucosal grafts in adult bulbar urethroplasty. Urology. 1996 Aug;48(2):194-8. doi: 10.1016/S0090-4295(96)00154-9.

    PubMed 8753728

  • Palminteri E, Lumen N, Berdondini E, Di Pierro GB, Cucchiarale G, Tenti G, De Nunzio C. Two-sided dorsal plus ventral oral graft bulbar urethroplasty: long-term results and predictive factors. Urology. 2015 Apr;85(4):942-7. doi: 10.1016/j.urology.2015.01.013.

    PubMed 25817122

  • Pansadoro V, Emiliozzi P, Gaffi M, Scarpone P, DePaula F, Pizzo M. Buccal mucosa urethroplasty in the treatment of bulbar urethral strictures. Urology. 2003 May;61(5):1008-10. doi: 10.1016/s0090-4295(02)02585-2.

    PubMed 12736025

  • Sharma AK, Chandrashekar R, Keshavamurthy R, Nelvigi GG, Kamath AJ, Sharma S, Venkatesh GK. Lingual versus buccal mucosa graft urethroplasty for anterior urethral stricture: a prospective comparative analysis. Int J Urol. 2013 Dec;20(12):1199-203. doi: 10.1111/iju.12158. Epub 2013 Apr 21.

    PubMed 23601029

  • Barbagli G, Palminteri E, Lazzeri M, Guazzoni G, Turini D. Long-term outcome of urethroplasty after failed urethrotomy versus primary repair. J Urol. 2001 Jun;165(6 Pt 1):1918-9. doi: 10.1097/00005392-200106000-00018.

    PubMed 11371881

  • Martinez-Pineiro JA, Martinez-Pineiro L, Tabernero A. [Substitution urethroplasties with free graft buccal mucosa]. Arch Esp Urol. 1998 Sep;51(7):645-59. Spanish.

    PubMed 9807890

  • Barbagli G, Pellegrini G, Corradini F, Montorsi F, Sansalone S, Butnaru D, Lazzeri M. One-stage Penile Urethroplasty Using Oral Mucosal Graft and Glue. Eur Urol. 2016 Dec;70(6):1069-1075. doi: 10.1016/j.eururo.2016.04.025. Epub 2016 May 6.

    PubMed 27160949

  • Aldaqadossi H, El Gamal S, El-Nadey M, El Gamal O, Radwan M, Gaber M. Dorsal onlay (Barbagli technique) versus dorsal inlay (Asopa technique) buccal mucosal graft urethroplasty for anterior urethral stricture: a prospective randomized study. Int J Urol. 2014 Feb;21(2):185-8. doi: 10.1111/iju.12235. Epub 2013 Aug 12.

    PubMed 23931150

  • Fichtner J, Filipas D, Fisch M, Hohenfellner R, Thuroff JW. Long-term outcome of ventral buccal mucosa onlay graft urethroplasty for urethral stricture repair. Urology. 2004 Oct;64(4):648-50. doi: 10.1016/j.urology.2004.05.011.

    PubMed 15491691

  • Asopa HS, Garg M, Singhal GG, Singh L, Asopa J, Nischal A. Dorsal free graft urethroplasty for urethral stricture by ventral sagittal urethrotomy approach. Urology. 2001 Nov;58(5):657-9. doi: 10.1016/s0090-4295(01)01377-2.

    PubMed 11711331

  • Akyuz M, Gunes M, Koca O, Sertkaya Z, Kanberoglu H, Karaman MI. Evaluation of intraoral complications of buccal mucosa graft in augmentation urethroplasty. Turk J Urol. 2014 Sep;40(3):156-60. doi: 10.5152/tud.2014.46343.

    PubMed 26328170

  • Barbagli G, Vallasciani S, Romano G, Fabbri F, Guazzoni G, Lazzeri M. Morbidity of oral mucosa graft harvesting from a single cheek. Eur Urol. 2010 Jul;58(1):33-41. doi: 10.1016/j.eururo.2010.01.012. Epub 2010 Jan 19.

    PubMed 20106587

  • Elbaz J, Le Long E, Dugardin F, Sibert L, Peron JM. [Buccal mucosal graft for the treatment of urethral stricture]. Ann Chir Plast Esthet. 2012 Dec;57(6):626-9. doi: 10.1016/j.anplas.2010.09.008. Epub 2010 Oct 14. French.

    PubMed 20950921

Questions about this trial

What is this clinical trial studying?

A study testing Labial Graft and Jugal Graft in people with Urethral Stricture, run by Hospital de Clinicas de Porto Alegre.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Success Rate (time frame: 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03973619, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2020.

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