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Purpose: The optimal harvesting site for oral grafting in patients with urethral strictures remain controversial, with no study investigating morbidity on large scale. We aimed to compare typical single cheek harvesting vs atypical lingual, labial or bilateral cheeks harvesting in terms of complications and patient-reported outcomes., Methods: Within 827 patients treated at our referral center with oral graft urethroplasty, we compared typical vs atypical harvesting techniques. A self-administered, semiquantitative, non-validated questionnaire assessed early (10 days) and late (4 months) postoperative complications and patient-reported outcomes. A semiquantitative score was calculated according to patient responses, and it was used to assess early (6 questions) and late (13 questions) patient dissatisfaction status. Patients were defined early and/or late dissatisfied when they scored ≥ 7 and ≥ 10 at the early or late questionnaires, respectively., Results: Between 1998 and 2019, our patients predominantly received typical single cheek harvesting (89% vs 11%), with + 1.5% increase rate per year (p < 0.001). Early and late dissatisfied patients were, respectively, 170 (23%) vs 39 (44%) and 59 (8%) vs 16 (18%) in the typical vs atypical groups. Atypical harvesting was associated with higher rates of early (Odds ratio [OR]: 2.34; 95% Confidence interval [CI] 1.44-3.75; p = 0.001) and late (OR: 2.37; 95%CI 1.22-4.42; p = 0.008) postoperative dissatisfaction., Conclusions: Typical single cheek harvesting was the preferred surgical option at our center and it was associated with negligible early and late rates of complications and patient's dissatisfaction. Conversely, atypical lingual, labial or bilateral cheeks harvesting was associated with higher complications and frequent patient dissatisfaction.

Purpose: This paper explores the feasibility of a new therapy for the treatment of hypospadias patients. Hypospadias is a very common congenital malformation of male genitals, with very high rate of recurrences after surgery. The field of regenerative medicine, which offers innovative solutions for many pathologies, still does not offer reliable solution for this pathology. Here, we propose quality, safety, and clinical feasibility assessment for an oral mucosa advanced therapy medicinal product (ATMP) grown on a biocompatible scaffold for a clinical study on urethral reconstruction of hypospadias patients., Methods: Urethral and oral mucosal epithelia from donor biopsies were cultivated between two fibrin layers, under clinical-grade conditions for cell and tissue characterization and comparison, aimed at tissue engineering. In addition, single-clone analyses were performed to analyze gene expression profiles of the two epithelia by microarray technology., Results: Oral mucosa appeared suitable for urethral reconstruction. The resulting ATMP was proven to maintain stem cells and regenerative potency. The preclinical safety studies were performed on human tissues to assess abnormalities and tumorigenicity, and confirmed the safety of the ATMP. Finally, the patient selection and the clinical protocol for the upcoming clinical trial were defined., Conclusions: Against this backdrop, in this paper, we are proposing a new reproducible and reliable ATMP for the treatment of hypospadias.

Purpose: We investigated whether tissue engineered material may be adopted using standard techniques for anterior urethroplasty., Materials and Methods: We performed a retrospective multicenter study in patients with recurrent strictures, excluding those with failed hypospadias, lichen sclerosus, traumatic and posterior strictures. A 0.5 cm 2 oral mucosa biopsy was taken from the patient cheek and sent to the laboratory to manufacture the graft. After 3 weeks the tissue engineered oral mucosal MukoCell® graft was sent to the hospital for urethroplasty. Four techniques were used, including ventral onlay, dorsal onlay, dorsal inlay and a combined technique. Cystourethrography was performed 1 month postoperatively. Patients underwent clinical evaluation, uroflowmetry and post-void residual urine measurement every 6 months. When the patient showed obstructive symptoms, defined as maximum urine flow less than 12 ml per second, the urethrography was repeated. Patients who underwent further treatment for recurrent stricture were classified as having treatment failure., Results: Of the 38 patients with a median age of 57 years who were included in study the strictures were penile in 3 (7.9%), bulbar in 29 (76.3%) and penobulbar in 6 (15.8%). Median stricture length was 5 cm and median followup was 55 months. Treatment succeeded in 32 of the 38 patients (84.2%) and failed in 15.8%. Success was achieved in 85.7% of ventral onlay, 83.3% of dorsal onlay, 80% of dorsal inlay and 100% of combined technique cases. No local or systemic adverse reactions due to the engineered material were noted., Conclusions: Our findings show that a tissue engineered oral mucosa graft can be implanted using the same techniques suggested for anterior urethroplasty and native oral mucosa, and guaranteeing a similar success rate., (Copyright © 2018 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Background: Repair of penile urethral strictures is a challenging problem for which different techniques have been suggested., Objective: To describe a new surgical technique for one-stage penile urethroplasty using an oral graft and glue, and to assess its safety and efficacy., Design, Setting, and Participants: A retrospective review of medical records for patients who underwent one-stage penile urethroplasty using oral mucosa and glue from February 2013 to October 2014 was performed., Surgical Procedure: The penile urethra was opened and the urethral plate was incised to create a wide window within which the oral graft was pasted with glue. The urethra was sutured over the catheter., Outcome Measurements and Statistical Analysis: Clinical data were collected in a database. Intraoperative and postoperative complications and outcomes were assessed. A descriptive statistical analysis was performed., Results and Limitations: Fourteen patients were included in the study. Median operative time was 60min. The median postoperative stay was 3 d. Three intraoperative and one postoperative complication occurred. In all patients, voiding cystourethrography 2 wk after surgery failed to show urethral fistula or sacculation. No patients complained of penile chordee or sexual dysfunction after surgery. Median follow-up was 16 mo. Among the 14 patients, 12 (85.7%) procedures were successful and two (14.3%) were failures. Study limitations include the small sample size and short follow-up., Conclusions: An in vitro study and a one-stage reconstruction of penile urethral strictures with an oral mucosa graft and glue showed that the procedure is safe and efficient, but further studies including larger series of patients and longer follow-up are required., Patient Summary: We report on the repair of penile urethral stricture using one-stage urethroplasty with oral mucosa and glue. This new technique was safe and effective, with limited complications and satisfactory outcomes. We plan to increase the use of this technique in the future., (Copyright © 2016 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Objective: To describe a new technique for harvesting the long lingual mucosal graft (LMG) to repair the long-segment urethral strictures., Methods: We performed a retrospective observational study of patients from whom LMGs were harvested from the lateral lining of the tongue for the long-segment anterior urethral strictures repair from 2012 to 2014 at the Shanghai Sixth People's Hospital. Patients who had 12 months minimum follow-up were included. Patients with incomplete clinical records were excluded. The LMG was applied on the urethra according to the dorsal onlay technique., Results: The primary outcome of the study was the postoperative failure-free survival rate. The secondary outcome was the rate of early and late complications at the harvesting site. Success was defined as Qmax >12 ml/s and no postoperative procedures. One hundred and one patients were included. Median stricture length was 7.1 ± 3.6 cm; median LMG length was 7.2 ± 3.6 cm. The success rate was 81.2% with a median follow-up of 23 months. Complications at the donor site had occurred in 41 patients at 6-months follow-up, and persisted in 18 patients at the 12-months follow-up. A bilateral harvest and harvest length were the main factors influencing complication rate (P = .0038 for 6 months and P = .1112 for 12 months). Almost half of donor site complications subsided within 12 months (P = .0018)., Conclusion: In patients requiring long oral grafts >7 cm to repair anterior strictures, a valid option is to harvest the graft from the lateral lining of the tongue., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Urethral reconstruction has received much attention in recent years, due to pathologies such as recurrence of urethral strictures after treatments. Various surgical techniques have been developed to obtain the best risk-benefit ratio, such as autologous grafts taken from the oral cavity. Tissue engineering and stem cells, growing in a tissue from a small biopsies, can further improve surgery, reducing invasiveness and morbidity. To determine whether urethra or other epithelia can be equally useful for urethra engineering, a comparison of clonogenic ability, proliferative potential and stem cell markers should be obtained. In this study, 19 biopsies from urethra, and 21 from oral mucosa were obtained from patients, during reconstructive surgery. Urethral and oral tissues were removed from the same donor, to develop primary cultures and cell characterization. The long term regenerative properties of both tissues were investigated in vitro by life span, clonal analysis and markers of different clonal types. Results revealed the same high proliferative potential for urethra and oral mucosa cultures, but maintenance of specific markers. Karyotype and growth factor dependence confirmed the normal phenotype of cultured cells. Clonal analysis of the proliferative compartment highlighted a very different proportion of stem and transient amplifying cells, characterised by dissimilar cell size profile and marker expression. In conclusion, both tissues can be cultured and preserve their stem cells in vitro. Few differences appeared in oral mucosa vs urethra, suggesting that they can be equally useful for tissue engineering of the urethral tract.

Finalising the use of tissue-engineered materials for urethral reconstruction still represents a difficult challenge. We must not deceive patients into thinking that this "quiet revolution" in urethral reconstruction will be available soon for all urethral conditions (congenital or acquired, simple vs complex) requiring surgery. This research and its clinical application require a prospective, multicentre, randomised, double-blind, and placebo-controlled/comparative phase 3 study for a large series of patients, and we are still far from this step., (Copyright © 2015 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Purpose: We investigated deterioration of the success rate of penile and bulbar substitution urethroplasty., Materials and Methods: We performed a retrospective descriptive analysis of patients who underwent substitution urethroplasty between July 1994 and September 2007. Inclusion criteria included 1-stage anterior urethroplasty using penile skin or oral mucosa with a minimum of 6 years followup. Patients with posterior urethral stricture, failed hypospadias or incomplete clinical records were excluded from analysis. The primary study outcome was postoperative failure-free survival and the secondary outcome was to identify significant predictors of treatment failure. The clinical outcome was considered a failure when any postoperative instrumentation was needed. Descriptive statistical analysis was done as well as Kaplan-Meier analysis, and univariable and multivariable Cox regression analysis., Results: A total of 359 patients were included in study. Median followup was 118 months. Of the procedures 265 (73.8%) were successful and 94 (26.2%) failed, including 91 (96.8%) within the first 5 years. Substitute tissue type (oral mucosa vs skin) was the only significant predictor on univariable analysis (HR 1.86, p = 0.005). This result was confirmed by multivariable analysis adjusting for age at surgery, stricture length and etiology, urethroplasty type and previous treatments (HR 2.26, p = 0.001)., Conclusions: Deterioration after anterior 1-stage substitution urethroplasty seems to develop within the first 5 years. Oral mucosa showed greater failure-free survival than penile skin and 1-stage penile urethroplasty showed the same success rate as bulbar urethroplasty., (Copyright © 2014 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Purpose: We investigated the early and late complications after oral mucosal graft harvesting, and reported the independent predictors of outcome via multivariable analysis., Materials and Methods: We performed a retrospective descriptive study of 553 patients from whom an oral mucosa graft was harvested for urethroplasty from single or bilateral cheeks. Patients who underwent oral mucosa harvesting from the lip, the tongue or from the cheek and lip at the same time were excluded from analysis. The oral graft was harvested in an ovoid shape with closure of the wound. Postoperative early and late complications were investigated using a self-administered, nonvalidated, semiquantitative questionnaire. There were 6 questions on early complications, and 13 questions investigated late complications and patient satisfaction., Results: Descriptive statistics of categorical variables focused on frequencies and proportions. Univariable and multivariable analyses were used to predict early and late dissatisfaction of patients. Bleeding was reported in 3.4% of patients. Overall 53.2% of patients did not report any pain and 36.3% reported no swelling. Late complications analysis showed that 95.5% of patients declared that the surgical closure of the wound did not cause any difficulty in opening the mouth or problems with smiling (98.2%) and/or dry mouth (95.8%). Overall 98.2% of patients were satisfied with the procedure. Univariable and multivariable analyses revealed that bilateral graft harvesting was the only significant predictor of patient dissatisfaction (OR 2.85, p = 0.01 and OR 2.72, p = 0.02; respectively)., Conclusions: Harvesting the oral mucosa ovoid graft from a single cheek with closure of the wound is a safe procedure with high rates of patient satisfaction., (Copyright © 2014 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Background: The ventral oral mucosal onlay graft is suggested in proximal bulbar strictures where the thick spongiosum provides excellent support to the graft. Some technical steps used in this technique are currently under debate in the literature., Objective: To describe the surgical steps of this urethroplasty and investigate predictive factors of success using a multivariable logistic regression analysis., Design, Setting, and Participants: This is a descriptive observational retrospective study of 214 patients who underwent urethroplasty for bulbar urethral strictures between May 1999 and November 2010 in a single high-volume center. Study inclusion criteria were patients presenting nontraumatic bulbar urethral strictures ranging from 1.3 cm to 6.8 cm in length. Exclusion criteria were traumatic strictures, panurethral strictures, lichen sclerosus, and failed hypospadias repair., Surgical Procedure: The oral graft was placed on the ventral bulbar urethral surface and pushed as proximally as possible using dedicated instruments and surgical techniques., Outcome Measurements and Statistical Analysis: The primary outcome measure was the objective result, defined as the absence of stricture recurrence at follow-up. The objective outcome was considered a failure when any postoperative instrumentation was needed. Multivariable logistic regression analysis was developed. All tests were two sided with a significance level set at 0.05., Results and Limitations: Median follow-up was 54 mo. Of the 214 patients, 183 (85.5%) were successful and 31 (14.5%) were failures. The preoperative maximum flow rate (Qmax) was a significant predictor of surgical outcome (odds ratio: 1.352; p = 0.001). Age, length, and type of stenosis, and previous treatment were not significant predictors of surgical outcome (all p > 0.05). The limitation of our survey is the absence of a subjective evaluation or the use of specific tools, such as a questionnaire., Conclusions: Ventral oral graft urethroplasty represents a valid option in nontraumatic bulbar strictures. Preoperative Qmax may be predictive of urethroplasty failure., (Copyright © 2013 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Background: The oral mucosa (OM) is a popular substitute for urethroplasty., Objective: The aim of this study was to investigate oral morbidity and patient satisfaction in a homogeneous group of patients who underwent OM harvesting., Design, Setting, and Participants: This study is a prospective analysis of 350 patients who underwent OM harvesting from a single cheek., Intervention: The graft was harvested in an ovoid shape with closure of the wound. Standard graft size was 4 cm in length and 2.5 cm in width., Measurements: Self-administered, nonvalidated semiquantitative (0, absence of complications or symptoms; 3, the worst complication or symptom) questionnaire consisting of six questions was used to investigate early complications, with 13 questions designed to investigate late complications and patient satisfaction., Results and Limitations: Early complications included bleeding, which occurred in 15 patients (4.3%); two patients required immediate surgical revision of the harvesting site. The majority of patients (85.2%) showed no pain, and only 3.7% of patients required use of anti-inflammatory drugs. The majority of patients (65.8%) showed slight or moderate swelling. With respect to late complications, most of the patients (73.4%) reported oral numbness for 1 wk, 22.9% for 1 mo, and 3.77% for 3 mo. Numbness resulting from scarring was absent or slight in most of patients. Changes in oral sensitivity occurred in 2.3% of patients. No difficulties opening the mouth or smiling was found in 98.3% and 99.7% of patients, respectively. Slight or moderate dry mouth was found in 97.1% of patients. In response to the question, "Would you undergo oral mucosa graft harvesting using this technique again," 343 patients (98%) replied "yes," and 7 patients (2%) replied "no.", Conclusions: The harvesting of an OM ovoid graft from a cheek with closure of the wound is a safe procedure with a high patient satisfaction rate., (Copyright 2010 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Objective: To investigate the feasibility, tolerability, safety and efficacy of using a new surgical technique for the repair of anterior urethral strictures to preserve vascular supply to the urethra and its entire muscular and neurogenic support., Patients and Methods: In all, 24 patients (mean age 46 years) underwent a new one-sided anterior dorsal oral mucosal graft urethroplasty while preserving the lateral vascular supply to the urethra, the central tendon of the perineum, the bulbospongiosum muscle and its perineal innervation. The cause of stricture was instrumentation in three cases (12%), unknown in five (21%), infection in four (17%), and lichen sclerosus in 12 (50%). The stricture site was bulbar in 12 cases (50%) and panurethral in 12 (50%). The mean stricture length was 4.2 cm in patients with bulbar strictures and 10 cm in patients with panurethral strictures. Of 24 patients, 20 patients (83%) had received previous treatments. Clinical outcome was considered a failure when any postoperative instrumentation was needed, including dilatation., Results: The overall mean (range) follow-up was 22 (12-55) months. Of the 24 patients, 22 (92%) had a successful outcome and two (8%) were failures. One failure was treated using definitive perineal urethrostomy and another failure underwent successful internal urethrotomy., Conclusions: The preservation of the one-sided vascular supply to the urethra and its entire muscular and neurogenic support should represent a slight but significant step toward perfecting the surgical technique of urethral reconstruction using a minimally invasive approach.

We critically reviewed recent reports of lingual mucosal grafts (LMGs) for substitution urethroplasty, to determine the efficacy and complications of this approach. Only a few centres have published the short or interim outcome of LMG urethroplasty. These studies dealt mainly with surgical techniques and harvesting LMGs, emphasizing the comparison of different intra-oral donor sites. The preliminary results seem to be encouraging for the safety and efficacy of LMG urethroplasty. When compared with other substitute materials, LMG give equally good results with much easier harvesting and minimal donor site morbidity. Thus, lingual mucosa is most likely to become an alternative to oral mucosa for substitution urethroplasty and longer term results of its use are awaited with interest.

Objectives: Investigate the tolerability, safety, and efficacy of using the lingual mucosal graft (LMG) for anterior urethroplasty., Methods: Ten patients (average age, 41 yr) underwent substitution urethroplasty LMG. Harvesting the graft from the tongue was performed by either the oral surgeon or the urologist. In five patients with penile urethral strictures, the grafts were placed on the dorsal urethral surface as a "dorsal inlay." In five patients with bulbar urethral strictures, the grafts were used as a "dorsal inlay" (3 cases) or "ventral onlay" (2 cases). The average follow-up was 5 mo (range: 3-12 mo)., Results: Nine cases (90%) were successful and one (10%) was a failure. Three patients who underwent bulbar urethroplasty showed prior failed repair using buccal mucosal grafts harvested from a single cheek (1 case), from both cheeks (1 case), or from the lip (1 case). The length of the lingual grafts was 4-6cm (mean: 4.5cm) with a width of 2.5cm. No patient developed early or late postoperative complications on the harvest site related to the tongue surgery. No difference was observed in patients in whom the graft harvesting was performed by the oral surgeon compared to the patients in whom the procedure was performed by the urologist., Conclusions: The surgical technique for harvesting a graft from the tongue is simple and safe. The tongue may be the best alternative donor site to the lip when a thin graft is required for urethroplasty or when the cheek harvesting is not possible.

Objective: To compare the results of a one-stage penile flap or graft urethroplasty., Patients and Methods: Sixty-three patients had a penile urethroplasty using one-stage techniques; 18 (29%) had a one-stage flap urethroplasty and 45 (71%) a one-stage urethroplasty using skin (23) or oral mucosal (22) grafts. The clinical outcome was considered a failure when any instrumentation was needed after surgery., Results: The mean follow-up was 55 months; of the 63 procedures, 48 (76%) were successful and 15 (24%) failures. Of 18 patients who had a one-stage flap urethroplasty, 12 (67%) were successful and six (33%) were failures; of the 45 who had one-stage graft urethroplasty, 36 (80%) were successful and nine (20%) were failures; of 23 penile skin grafts, 18 (78%) were successful and five (22%) were failures; and of 22 oral mucosal grafts, 18 (82%) were successful and four (18%) were failures., Conclusions: The use of grafts for one-stage penile urethroplasty gave a higher success rate (80%) than flaps (67%). The difference in the success rate between oral mucosal grafts (82%) and skin grafts (78%) was not clinically significant.

We performed an up-to-date review of the surgical techniques suggested for the treatment of anterior urethral strictures. References for this review were identified by searching PubMed and MEDLINE using the search terms "urethral stricture" or "urethroplasty" from 1995 to 2006. Descriptive statistics of the articles were provided. Meta-analyses or other multivariate designs were not employed. Out of 327 articles, 50 (15%) were determined to be germane to this review. Eight abstracts were referenced as the authors of this review attended the meetings where the abstract results were presented, thus it was possible to collect additional information on such abstracts. Urethrotomy continues to be the most commonly used technique, but it does have a high failure rate and many patients progress to surgical repair. Buccal mucosa has become the most popular substitute material in urethroplasty; however, the skin appears to have a longer follow-up. Free grafts have been making a comeback, with fewer surgeons using genital flaps. Short bulbar strictures are amenable using primary anastomosis, with a high success rate. Longer strictures are repaired using ventral or dorsal graft urethroplasty, with the same success rate. New tools such as fibrin glue or engineered material will become a standard in future treatment. In reconstructive urethral surgery, the superiority of one approach over another is not yet clearly defined. The surgeon must be competent in the use of various techniques to deal with any condition of the urethra presented at the time of surgery.

A one-stage onlay urethroplasty, using a buccal mucosa graft, is presented for patients with bulbous strictures in whom the urethral mucosa is seriously involved in the disease. Of 40 patients who underwent a dorsal buccal mucosa graft urethroplasty for bulbous urethral strictures, 5 required complete removal of the urethral mucosa and its replacement by a buccal mucosa graft. All these patients had undergone previous urethrotomy with a false passage inside the bulbous urethra and had a suprapubic tube in place. The goal of removal and replacement of the urethral mucosa in each case was to create a new, wide urethral mucosal bed to promote successful one-stage reconstruction. All patients voided spontaneously without problems after removal of the catheter. After 4 months, the mean peak flow was 21 mL/s. After 6 months, urethroscopy did not show any stricture recurrence. None of the patients required instrumentation or dilation. In patients with bulbous urethral strictures and false passage into the mucosa and spongiosum tissues, the complete removal and replacement of the urethral mucosa using a circumferential buccal mucosa graft promotes successful one-stage urethral reconstruction.

Dorsal onlay graft urethroplasty is a versatile procedure which may be combined with various substitute materials such as preputial skin, buccal mucosa grafts or pedicled flaps. Others substitute materials such as human urethral mucosa from corpses or collagen matrix will be possible in future. The long-term results of a wide series of patients showed a final success rate from 92% to 97%. Any kind of substitution urethroplasty deteriorate over time, and in our series of patients with an extended follow-up from 21.5 to 43 months the success rate of dorsal onlay graft urethroplasty decreased from 92% to 85%. With regard to substitute material concerns (buccal mucosa versus preputial skin) a long-term follow-up is mandatory to establish if buccal mucosa is superior to foreskin as urethral substitute material. At present, the authors currently use both according to patient preference, status of the genital tissues or strictures characteristics.