BackgroundHarvest of oral mucosa for urethroplasty due to urethral stricture is associated with donor-site-morbidity. We assessed functionality and safety of an authorized tissue-engineered oral mucosa graft (TEOMG) under routine practice in stricture recurrences of any etiology, location, length and severity (real-world data).Methods99 patients from eight centers with heterogenous urethroplasty experience levels were included in this prospective, non-interventional observational study. Primary and secondary outcomes were success rate (SR) and safety at 12 and 24 months.FindingsAll but one patient had ≥ 1, 77.1% (64 of 83) ≥ 2 and 31.3% (26 of 83) ≥ 4 previous surgical treatments. Pre- and postoperative mean ± SD peak flow rate (Qmax) were 8.3 ± 4.7 mL/s (n = 57) and 25.4 ± 14.7 mL/s (n = 51). SR was 67.3% (95% CI 57.6–77.0) at 12 and 58.2% (95% CI 47.7–68.7) at 24 months (conservative Kaplan Meier assessment). SR ranged between 85.7% and 0% in case of high and low surgical experience. Simple proportions of 12-month and 24-month SR for evaluable patients in all centers were 70.8% (46 of 65) and 76.9% (30 of 39). Except for one patient, no oral adverse event was reported.InterpretationsTEOMG is safe and efficient in urethroplasty.

Objective To evaluate the current state, therapeutic benefit and safety of urethral injection of autologous stem cells for the treatment stress urinary incontinence (SUI). Materials and methods A selective database search of PubMed, the Excerpta Medica dataBASE (EMBASE), Cochrane Library and Google Scholar was conducted to validate the effectiveness of stem cell-based therapy. The search included clinical trials published up until 4 January 2020, written in English, and included cohorts of women and men who had received stem cell-based therapy for SUI. The search used the following keywords in various combinations: ‘stem cell therapy’, ‘cell-based therapy for SUI’, ‘regenerative medicine for SUI’, and ‘tissue engineering’. The success rates were assessed according to cough test, urodynamics, pad tests, and International Consultation on Incontinence Questionnaire-Urinary Incontinence. The primary endpoint was continence rate to measure objectively the effect of the treatment. Results We identified four clinical trials using local injections of adipose-derived stem cells (ADSCs), 11 trails with muscle-derived stem cells (MDSCs), and two trails with human umbilical cord blood stem cells (HUCBs) and total nucleated cells (TNCs). The median improvement rate of intrinsic sphincter deficiency after ADSCs, MDSCs, TNCs, HUCBs injections were 88%, 77%, 89%, 36% (improvement rate: 1–2 pads) at a mean (range) follow-up of 6 (1–72) months. The cell sources, methods of cell processing, cell number, and implantation techniques differed considerably between studies. Most of the periurethral injections were at the 3, 5, 7, and 9 o’clock positions and for submucosa were at the 4, 6, and 8 o’clock positions. No significant postoperative complications were reported. Conclusion Despite many challenges in stem cell-based therapy for treating SUI, it appears to provide, in both male and female patients, acceptable functional results with minimal side-effects and complications. In the future, more clinical trials should be funded in order to optimise stem cell-based therapy and evaluate long-term outcomes. Abbreviations ADSC: adipose-derived stem cell; BMSCs: bone marrow-derived mesenchymal stem cell; CLPP: cough leak-point pressure; FPL: functional profile length; HUCB: human umbilical cord blood stem cell; ICIQ-(QOL)(SF)(UI): International Consultation on Incontinence Questionnaire (Quality of life) (-Urinary incontinence Short Form) (-Urinary Incontinence); IIQ-7: Incontinence Impact Questionnaire-short form; I-QOL: Incontinence quality of life questionnaire; ISD: intrinsic urinary sphincter deficiency; MDSC: muscle-derived stem cell; MUCP: maximum urethral closure pressure; NR: not reported; Pdet-max: maximum detrusor pressure; PVR: post-void residual urine volume; Q max : maximum urinary flow; QOL: quality of life; RP: radical prostatectomy; TNC: total nu...

Objective: To evaluate the complications and results of artificial urinary sphincter (AUS) implantation in women with stress urinary incontinence (SUI). Methods: A selective database search using keywords (1990-2019) was conducted to validate the effectiveness of the AUS in women. Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were utilised. The meta-analysis included 964 women (15 studies) with persistent SUI. The Newcastle-Ottawa score was used to determine the quality of the evidence in each study. The success rate and complications associated with the AUS were analysed. Results: Meta-analysis of the published studies showed that complete continence was achieved at a mean rate of 79.6% (95% confidence interval [CI] 72.2-86.6%) and a significant improvement was achieved in 15% (95% CI 10-25%). The mean (range) follow-up was 22 (6-204) months. The mean number of patients per study was 68. The mean (range) explantation rate was 13 (0-44)%. Vaginal erosion occurred in a mean (range) of 9 (0-27)% and mechanical complications in 13 (0-47)%. Infections accounted for 7% of the complications. The total mean (range) revision rate of the implanted AUS was 15.42 (0-44)%. The mean (range) size of the cuff used was 6.7 (5-10) cm. Conclusion: Our present analysis showed that implantation of an AUS in women with severe UI is an effective treatment option after failure of first-line therapy. However, the currently available study population is too small to draw firm conclusions.

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