Uretero-neocystostomy: a retrospective comparison of open, laparoscopic and robotic techniques.

BACKGROUND: Uretero-neocystostomy (UNC) is the gold-standard for distal-ureter repair. Whether the surgery should be conducted minimally invasive (laparoscopic (LAP), robotic RAL)) or open remains unanswered by the literature. METHODS: Retrospective analysis of surgical outcome of patients treated with UNC for distal ureteral stenosis (January 2012 - October 2021). Patient demographics, estimated blood loss (EBL), surgical technique, operative time, complications and length of hospital stay (LOS) were recorded. During the follow-up period, patient underwent renal ultrasound and kidney function tests. Success was defined as relieve of symptoms or no findings of obstruction needing urine drainage. RESULTS: 60 patients were included (9 RAL, 25 LAP, 26 open). The different cohorts were similar of age, gender, American Society of Anesthesiologists (ASA) score, body-mass index and history of prior treatment of the ureter. No intraoperative complications were detected in all groups. There was no conversion to open surgery in the RAL group, whereas one was found in the LAP arm. Six patients had a recurrent stricture, but with no significant difference between the cohorts. EBL was not different between the groups. LOS was significantly lower in the RAL + LAP group compared to open (7 vs. 13 days, p = 0.005) despite significantly longer operating times (186 vs. 125.5 min, p = 0.005). CONCLUSION: Minimal invasive UNC, especially RAL, is a feasible and safe surgical method and provides similar results in terms of success rates in comparison to open approach. A shorter LOS could be detected. Further prospective studies need to be done.

En bloc re-resection of high-risk NMIBC after en bloc resection: results of a multicenter observational study.

PURPOSE: To investigate the role of en bloc re-resection (EBRS) in patients who had undergone previous en bloc resection for high-risk non-muscle-invasive bladder cancer (NMIBC). METHODS: An international, multicenter, observational retrospective analysis of prospectively collected data. Patients with a high-risk NMIBC who had previously undergone en bloc resection were scheduled for EBRS of the resected area after 40 days. The primary outcome was the presence of residual tumor or recurrence-free survival. RESULTS: Overall, 78 patients underwent EBRS. Only five (6.41%) residual cancers were found: one patient had a pTa G3 (1.28%) cancer and four (5.13%) had a pTis. The detrusor muscle was preserved in all samples. Only one patient had a positive margin on EBRS. No procedure called for a conversion to traditional re-TURBT. No patient experienced bladder perforation or other intra-operative complications. The recurrence rate at the first follow-up cystoscopy (RRFF-C at 3 months) was 3.85% (three patients). The median follow-up period was 30.8 months (range 6.9-76.0 months). In univariate analysis, the only predictor of recurrence was grade. Overall we observed 11 recurrences. Only one tumor progressed to T2 MIBC. CONCLUSIONS: The low rates of residual tumor, recurrence, and progression seem to raise doubts about the efficacy of EBRS in patients who have previously undergone en bloc resection. EBRS appears to be a feasible and safe procedure with a low rate of complications. However, further data will be needed before EBRS can be used in clinical trials or recommended as a treatment modality.

LithoVue™ for renal stone therapy - a perfect fit for high volume academic centers; a retrospective evaluation of 108 cases.

BACKGROUND: Over the last few years the number of flexible ureterorenoscopies, used for renal stone treatment, has risen steadily. This was associated with an increase in costs for maintenance and repair of the fragile ureterorenoscopes used. To overcome this problem single-use devices have been introduced to the market. The aim of this study was to assess surgical outcome and workability for LithoVue™, a single-use flexible ureterorenoscope. METHODS: We retrospectively analyzed all flexible ureterorenoscopies performed at our department between January and October 2017. We included a total of 108 interventions for renal stone therapy, all performed using the single-use device LithoVue™. We assessed patients' characteristics including stone size, count and location. We evaluated the surgical outcome, analyzing stone-free rates, reintervention rates, complication rates, as well as surgery time. Learning curve for single-use ureterorenoscopes was evaluated by comparing the surgical outcome between residents and consultants. RESULTS: The average time needed per intervention was 52,31 min ± 28,11. In 77 out of 108 (71,30%) patients we were able to remove all stones by a single intervention. In 8 patients (7,41%) intra- or postoperative complications occurred, none of which was graded higher than Clavien-Dindo III B. We did not find any statistical differences comparing the surgical outcome between residents and consultants. No technical difficulties occurred during surgery. CONCLUSION: Single-use flexible ureterorenoscopes provide decent working properties resulting in good surgical outcome. Furthermore, they are proven to be easy to handle even for unexperienced surgeons, making them a feasible choice for high volume academic centers.

Non-ischemic laparoscopic partial nephrectomy using 1318-nm diode laser for small exophytic renal tumors.

PURPOSE: Warm ischemia (WI) and bleeding constitute the main challenges for surgeons during laparoscopic partial nephrectomy (LPN). Current literature on the use of lasers for cutting and coagulation remains scarce and with small cohorts. We present the largest case series to date of non-ischemic LPN using a diode laser for small exophytic renal tumors. METHODS: We retrospectively evaluated 29 patients with clinically localized exophytic renal tumors who underwent non-ischemic laser-assisted LPN with a 1318-nm wavelength diode laser. We started applying the laser 5 mm beyond the visible tumor margin, 5 mm away from the tissue in a non-contact fashion for coagulation and in direct contact with the parenchymal tissue for cutting. RESULTS: The renal vessels were not clamped, resulting in a WIT (warm ischaemic time) of 0 min, except for one case that required warm ischemia for 12 min and parenchymal sutures. No transfusion was needed, with a mean Hemoglobin drop of 1,4 mg/dl and no postoperative complications. The eGFR did not significantly change by 6 months. Histologically, the majority of lesions (n = 22/29) were renal-cell carcinoma stage pT1a. The majority of malignant lesions (n = 13/22) had a negative margin. However, margin interpretation was difficult in 9 cases due to charring of the tumor base. A mean follow-up of 1.8 years revealed no tumor recurrence. The mean tumor diameter was 19.4 mm. CONCLUSION: The 1318-nm diode laser has the advantages of excellent cutting and sealing properties when applied to small vessels in the renal parenchyma, reducing the need for parenchymal sutures. However, excessive smoke, charring of the surgical margin, and inability to seal large blood vessels are encountered with this technique.

Update on the use of diode laser in the management of benign prostate obstruction in 2014.

AIM: To determine the status quo in respect of various diode lasers and present the techniques in use, their results and complications. We assess how these compare with transurethral resection of the prostate and other types of laser in randomized controlled trials (RCTs). When adequate RCTs were not available, case studies and reports were evaluated. MATERIALS AND METHODS: Laser for the treatment of benign prostatic hyperplasia (BPH) has aroused the interest and curiosity of urologists as well as patients. The patient associates the term laser with a successful and modern procedure. The journey that started with coagulative necrosis of prostatic adenoma based on neodymium: yttrium-aluminum-garnet (Nd:YAG) laser has culminated in endoscopic "enucleation" with holmium laser. Diode laser is being used in urology for about 10 years now. Various techniques have been employed to relieve bladder outlet obstruction due to BPH. RESULTS: The diode laser scenario is marked by a diversity of surgical techniques and wavelengths. We summarize the current published literature in respect of functional results and complications. CONCLUSION: More randomized controlled studies are needed to determine the position and the ideal technique of diode laser treatment for BPH.

[An incidental finding of retrocaval extraadrenal pheochromocytoma]. / Das retrocavale extraadrenale Phäochromozytom als Zufallsbefund.

As part of diagnostic work-up of a 71-year-old patient with resistant hypertension, an extraadrenal mass was found. After further imaging and biochemical evaluation an extraadrenal pheochromocytoma was diagnosed and after alpha-receptor blockade was removed via posterior approach laparoscopically in the course. The pheochromocytoma is a rare catecholamine-producing tumor with an incidence of 1-2 per 100 000. In about 1-25 % it is located extraadrenal. Establishing the diagnosis is dependent on the demonstration of significant catecholamine excess. Afterwards imaging with CT or MRI should be performed. After administration of alpha-blockers, the complete surgical resection is the treatment of choice.

From Interferon to Checkpoint Inhibition Therapy-A Systematic Review of New Immune-Modulating Agents in Bacillus Calmette-Guérin (BCG) Refractory Non-Muscle-Invasive Bladder Cancer (NMIBC).

BACKGROUND: In Bacillus Calmette-Guérin (BCG) refractory non-muscle-invasive bladder cancer (NMIBC), radical cystectomy is the gold standard. The advent of immune checkpoint inhibitors (CPIs) has permanently changed the therapy landscape of bladder cancer (BC). This article presents a systematic review of immune-modulating (IM) therapies (CPIs and others) in BCG-refractory NMIBC. METHODS: In total, 406 articles were identified through data bank research in PubMed/Medline, with data cutoff in October 2021. Four full-text articles and four additional congress abstracts were included in the review. RESULTS: Durvalumab plus Oportuzumab monatox, Pembrolizumab, and Nadofaragene firadenovec (NF) show complete response (CR) rates of 41.6%, 40.6%, and 59.6% after 3 months, with a long-lasting effect, especially for NF (12-month CR rate of 30.5%). Instillations with oncolytic viruses such as NF and CG0070 show good efficacy without triggering significant immune-mediated systemic adverse events. Recombinant BCG VPM1002BC could prove to be valid as an alternative to BCG in the future. The recombinant pox-viral vector vaccine PANVAC™ is not convincing in combination with BCG. Interleukin mediating therapies, such as ALT-803, are currently being studied. CONCLUSION: CPIs and other IM agents now offer an increasing opportunity for bladder-preserving strategies. Studies on different substances are ongoing and will yield new findings.

Lower ureteral compression through external vascular elongation in a cyclist: A case report.

INTRODUCTION AND IMPORTANCE: There is sparse literature about lower ureteric obstruction due to aberrant blood vessels. We report a case of a patient who was referred to our hospital due to left sided flank pain caused by external compression of the distal ureter. CASE PRESENTATION: A 47-year-old male patient presented with left sided flank pain. A computed tomography scan revealed external compression of the lower ureter. Hypertrophy of the psoas muscle due to extensive cycling for 20 years lead to concomitant kinking and elongation of the iliacal vessels which caused the distal ureteric obstruction. Robotic-assisted laparoscopic ureterocystoneostomy with psoas hitch technique was performed. CLINICAL DISCUSSION: Lower ureteric obstruction, mostly seen in children, is mostly caused by vascular anomalies such as a persistent umbilical artery. After literature review, we presume it to be the first reported case of distal ureteric obstruction caused by external vascular elongation. CONCLUSION: The external elongation of pelvic vessels due to excessive cycling and the concomitant extrinsic compression of the distal ureter should be considered as rare but possible cause of lower uretic obstructions.

Value of real-time elastography targeted biopsy for prostate cancer detection in men with prostate specific antigen 1.25 ng/ml or greater and 4.00 ng/ml or less.

PURPOSE: We assessed the prostate cancer detection rate of real-time elastography targeted biopsy in men with total prostate specific antigen 1.25 ng/ml or greater and 4.00 ng/ml or less. MATERIALS AND METHODS: Real-time elastography using an EUB 8500 Hitachi ultrasound system (Hitachi Medical, Tokyo, Japan) was done in 94 men with a mean age of 57.4 years (range 35 to 77) with increased prostate specific antigen between 1.25 ng/ml or greater and 4.00 ng/ml or less (mean 3.20, range 1.30 to 4.00) and a free-to-total prostate specific antigen ratio of less than 18%. Real-time elastography was done to evaluate peripheral zone tissue elasticity and hard areas were defined as suspicious. Targeted biopsies with a maximum of 5 cores were done in suspicious areas, followed by 10-core systematic biopsy. We analyzed the cancer detection rate of real-time elastography and systematic biopsy. RESULTS: Cancer was found in 27 of 94 patients (28.7%). Real-time elastography detected cancer in 20 patients (21.3%) and systematic biopsy detected it in 18 (19.1%). Positive cancer cores were found in real-time elastography targeted cores in 38 of 158 cases (24%) and in systematic cores in 38 of 752 (5.1%) (chi-square test p <0.0001). The cancer detection rate per core was 4.7-fold greater for targeted than for systematic biopsy. CONCLUSIONS: Real-time elastography targeted biopsy allows prostate cancer detection in men with prostate specific antigen 1.25 ng/ml or greater and 4 ng/ml or less with a decreased number of cores compared with that of systematic biopsy.

Dorsal urethroplasty with labia minora skin graft for female urethral strictures.

OBJECTIVE: to report a new dorsal labia minora skin-graft urethroplasty as a simple, safe and effective therapeutic alternative for female urethral strictures, as although distal urethral strictures can be treated by meatoplasty, proximal and mid-urethral strictures need appropriate urethroplasty. PATIENTS AND METHODS: eight women with a confirmed proximal or mid-urethral stricture had indications for urethroplasty with the use of a thin free labia minora skin graft using a dorsal (6 o'clock position) urethroplasty technique. Full informed consent was obtained. From the inner aspect of one labium minora a thin free skin flap was prepared. The strictured urethra and the anterior vaginal wall were transected and the graft sutured into the defect. All scar tissue was removed and the anterior vaginal wall closed in two layers over the area of the urethroplasty. Continence was evaluated by a stress test with a full bladder. RESULTS: all patients were operated on with no complications during or after surgery. After 1 and 2 years of follow-up seven and six of the eight patients had no recurrence of stricture disease. All patients remained continent. CONCLUSION: the urethroplasty using an inlay of free thin genital skin graft was safe, uncomplicated and effective.

The 1 year outcome of the transobturator retroluminal repositioning sling in the treatment of male stress urinary incontinence.

OBJECTIVE: To evaluate the efficacy and safety of a transobturator retroluminal repositioning sling suspension in the treatment of male stress urinary incontinence (SUI) after prostate surgery. PATIENTS AND METHODS: In 118 men with SUI after prostatic surgery, a transobturator retroluminal repositioning sling suspension was implanted. Patients were evaluated including: complete history and physical examination, 24-h pad test, a questionnaire (International Consultation on Incontinence Questionnaire, Short-Form), urodynamic evaluation and endoscopy. The surgical technique was described previously. The findings before and at 1 year after sling placement were compared. RESULTS: At the 12-month follow-up, 73.7% of the men were cured, 16.9% were improved, and 9.3% were still incontinent. After sling placement the daily pad use decreased significantly (P < 0.001), while the ICIQ-SF improved significantly (P < 0.01). The detrusor voiding pressure, postvoid residual urine volume and maximal flow rates remained unchanged, while the Valsalva leak-point pressure improved significantly (P < 0.01). In 19.5% of the men, there was transient scrotal pain or perineal discomfort. In 5.1% of the men, postoperative urinary retention occurred but resolved spontaneously after a few weeks of catheter placement. In 1.7% of the men adductor pain was reported, which resolved spontaneously. There were no major complications. CONCLUSION: The transobturator retroluminal repositioning sling suspension for the treatment of male SUI is effective and safe with a low complication rate after 1 year of follow-up.

Contrast-enhanced colour Doppler-targeted prostate biopsy: correlation of a subjective blood-flow rating scale with the histopathological outcome of the biopsy.

OBJECTIVE: To correlate a subjective blood-flow rating scale from contrast-enhanced colour Doppler (CECD) transrectal ultrasonography-targeted prostate biopsy with the histopathological outcome of the biopsy. PATIENTS AND METHODS: In all, 760 men with a serum total prostate-specific antigen (PSA) level of ≥ 1.25 ng/mL and a free-to-total PSA ratio of < 18% were included. CECD-targeted biopsies with five cores were taken only in hypervascular areas of the peripheral zone using a second-generation ultrasonography contrast agent, followed by a 10-core systematic biopsy. Prostate blood flow was scored using a subjective 5-point scale in which 1 indicated 'benign', 2 'probably benign', 3 'indeterminate', 4 'probably malignant' and 5 'malignant'. RESULTS: Overall 37% (283 of 760) patients had prostate cancer in the biopsy. All 100 patients with a score of 5 had cancer; 153 had a score of 4, of whom 130 (85%) had cancer and 23 had benign histology (15%); 131 had a score of 3, of whom 34 (26%) had cancer and 97 (74%) had benign histology; 284 had a score of 2, of whom 17 (6%) had cancer and 267 (94%) had benign histology; 92 had a score of 1, of whom two (2%) had cancer and 90 (98%) had benign tissue. Statistical evaluation showed that the subjective blood-flow rating scale correlated strongly and significantly (r = 0.75, P < 0.01) with the histopathological outcome of the biopsy. CONCLUSION: The present study shows that a subjective CECD blood-flow rating scale is a reliable tool to predict the pathological outcome of biopsy cores.

Contrast-enhanced colour Doppler-targeted vs a 10-core systematic repeat biopsy strategy in patients with previous high-grade prostatic intraepithelial neoplasia.

OBJECTIVE: To compare the results of contrast-enhanced colour Doppler (CECD)-targeted prostate biopsy with a systematic 10-core grey-scale biopsy scheme in patients initially diagnosed with high-grade prostatic intraepithelial neoplasia (HGPIN), as although HGPIN is thought to be a precursor to invasive adenocarcinoma, its diagnosis is no longer considered an indication for repeat prostate biopsy and patients should be followed by prostate-specific antigen levels and a digital rectal examination. PATIENTS AND METHODS: In all, 104 patients (aged 45-78 years) diagnosed with HGPIN on initial prostate needle biopsy were referred for a repeat biopsy within 6 months. Two independent examiners evaluated each patient; one used CECD-targeted biopsy (up to five cores) into hypervascular regions in the peripheral zone only, and subsequently the second took a systematic 10-core grey-scale biopsy. Cancer detection rates of both techniques were compared. RESULTS: Overall, 26 of the 104 men (25%) had prostate cancer in the repeated biopsy. Using the CECD technique cancer was detected in 21% (22 of 104). The positive re-biopsy rate using the systematic technique was 9.6% (10 of 104; P < 0.001). The total incidence of HGPIN with no evidence of tumour on re-biopsy was 8.7% (nine of 104). The Gleason score in all 22 cancers detected with the CECD technique varied between 6 and 8. The systematic technique detected cancers with Gleason scores of 6 or 7. There were no adverse events or complications. CONCLUSION: CECD increased the detection rate of prostate cancer, and using fewer biopsy cores than the systematic biopsy technique in patients previously diagnosed with HGPIN.

Comparative efficiency of contrast-enhanced colour Doppler ultrasound targeted versus systematic biopsy for prostate cancer detection.

OBJECTIVE: To compare the efficiency of contrast-enhanced colour Doppler ultrasound (CECD-US) targeted biopsy versus systematic biopsy (SB) for PCa detection in 1,776 men. METHODS: Retrospective, single-centre, diagnostic accuracy study from 2002 until 2006 in 1,776 male volunteers with a serum total PSA of 1.25 ng/ml or greater. In each patient five CECD-US targeted biopsies were performed in hypervascular areas in the peripheral zone during intravenous injection of a second-generation microbubble US contrast agent. Subsequently, another examiner performed ten SBs. The PCa detection rates for the two techniques were compared. RESULTS: Of 1,776 patients, cancer was detected in 559 patients (31%), including 476 of the 1,776 patients (27%) with CECD-US and 410 (23%) with SB (p < 0.001). The detection rate for CECD-US targeted biopsy cores (10.8% or 961 of 8,880 cores) was significantly better than for SB cores (5.1% or 910 of 17,760 cores, p < 0.001). Among patients with a positive biopsy for PCa, cancer was detected by CECD-US alone in 149 patients (27%) and by SB alone in 83 (15%) (p < 0.001). CONCLUSION: This study represents the largest clinical trial to date, demonstrating a significant benefit of CECD-US targeted biopsy relative to SB.

Contrast-enhanced ultrasonography using cadence-contrast pulse sequencing technology for targeted biopsy of the prostate.

OBJECTIVE: To evaluate contrast-enhanced ultrasonography (US) using cadence-contrast pulse sequencing (CPS) technology, compared with systematic biopsy for detecting prostate cancer, as grey-scale US has low sensitivity and specificity for detecting prostate cancer. PATIENTS AND METHODS: In all, 44 men with suspicious prostate-specific antigen (PSA) levels and CPS findings were assessed; all had CPS-targeted and systematic biopsy. Transrectal CPS images were taken with a low mechanical index (0.14). A microbubble contrast agent (SonoVue, Bracco International BV, Amsterdam, the Netherlands) was administered as a bolus, with a maximum dose of 4.8 mL. CPS was used to assess prostatic vascularity. Areas with a rapid and increased contrast enhancement within the peripheral zone were defined as suspicious for prostate cancer. Up to five CPS targeted biopsies were taken and subsequently a 10-core systematic biopsy was taken. Cancer detection rates for the two techniques were compared. RESULTS: Overall, cancer was detected in 35 of 44 patients (80%), with a mean PSA level of 3.8 ng/mL. Lesions suspicious on CPS showed cancer in 35 of 44 patients (80%) and systematic biopsy detected cancer in 15 of 44 patients (34%). CPS-targeted cores were positive in 105 of 220 cores (47.7%) and in 41 of 440 systematic biopsy cores (9.3%) (P < 0.001). Lesions suspicious on CPS were false-positive in nine of 44 patients (20%). The mean Gleason score for systematic biopsy was 6.7 and for CPS-targeted biopsy 6.8 (P > 0.05). The sensitivity of CPS for detecting cancer was 100% (confidence interval, 95%). However, limitations in the series included that only CPS-positive cases were investigated, and CPS-targeted biopsy should be evaluated in a more extended biopsy scheme. CONCLUSIONS: Contrast-enhanced US using CPS enables excellent visualization of the microvasculature associated with prostate cancer, and can improve the detection of prostate cancer compared with systematic biopsy.

Sonographic detection of renal and ureteral stones. Value of the twinkling sign.

PURPOSE: To compare the detection of urinary stones using standard gray scale ultrasound for diagnostic accuracy using the color Doppler "twinkling sign". MATERIALS AND METHODS: Our study population consisted of forty-one patients who demonstrated at least one urinary stone on unenhanced CT evaluation of the kidneys or ureters. Each patient was evaluated using gray scale ultrasound and color Doppler imaging by an observer who was blinded to the CT results. RESULTS: Seventy-seven stones were present in 41 patients, including 47 intrarenal stones, 5 stones in the renal pelvis, 8 stones at the ureteropelvic junction, 5 ureteral stones and 12 stones at the ureterovesical junction. Based upon gray scale sonography the diagnosis of stone was made with confidence in 66% (51/77) of locations. Based upon Doppler sonography using the twinkling sign, the diagnosis of stone was made with confidence in 97% (75/77) of locations. Clustered ROC analysis demonstrated that the Doppler twinkling sign (Az = 0.99) was significantly better than conventional gray scale criteria (Az = 0.95) for the diagnosis of urinary stones (p = 0.005, two-sided test). CONCLUSIONS: The color Doppler twinkling sign improves the detection, confidence and overall accuracy of diagnosis for renal and ureteral stones with minimal loss of specificity.

Sporadic renal hemangioblastoma: A case report of a rare benign renal tumor.

In renal tumors, suspicious for renal cell carcinoma, where there is any doubt and discrepancy between morphology and immune profile, we recommend performing further immunohistochemical staining for pan-cytokeratin, S100, NSE, and inhibin-alpha. Thus, follow-up overtreatment can be avoided in cases of benign kidney tumors.

Real-World Evidence Data on Metastatic Renal-Cell Carcinoma Treatment in Austria: The RELACS Study.

BACKGROUND: Treatment decisions in routine clinical practice are based on reports of clinical trials, which represent highly selected populations. Limited studies reported real-world evidences representing routine clinical practices in patients with renal-cell carcinoma (RCC) in Europe. The aim of this retrospective, noninterventional chart review was to collect data on the treatment landscape for patients with advanced/metastatic RCC in routine clinical practice in a broader patient population in Austria. PATIENTS AND METHODS: Patients with advanced/metastatic RCC receiving systemic treatment between June 2010 and June 2016 across 12 centers in Austria were included. Parameters were entered into an electronic case report form from the participating sites via the application Hermesoft electronic data capture system. Progression-free survival (PFS) and overall survival (OS) were the 2 primary end points. RESULTS: The median PFS and OS were 12 months and 44 months, respectively (first-line PFS was 14 months for pazopanib and 13 months for sunitinib; first-line OS was 44 months for pazopanib and 48 months for sunitinib). Factors influencing the OS were sex, with female patients at a significantly higher risk than male patients (hazard ratio = 1.719), Eastern Cooperative Oncology Group performance status > 0 increased the risk twice (hazard ratio = 2.048), and number of metastases > 3 before the first line doubled the risk compared to metastases (hazard ratio = 2.064). CONCLUSION: OS in this retrospective chart review was considerably longer than the previous reports in real-world patients, underlining the benefit of current RCC treatment options in routine clinical practice.

Autologous myoblasts and fibroblasts versus collagen for treatment of stress urinary incontinence in women: a randomised controlled trial.

BACKGROUND: Preclinical studies have suggested that transurethral injections of autologous myoblasts can aid in regeneration of the rhabdosphincter, and fibroblasts in reconstruction of the urethral submucosa. We aimed to compare the effectiveness and tolerability of ultrasonography-guided injections of autologous cells with those of endoscopic injections of collagen for stress incontinence. METHODS: Between 2002 and 2004, we recruited 63 eligible women with urinary stress incontinence. 42 of these women were randomly assigned to receive transurethral ultrasonography-guided injections of autologous myoblasts and fibroblasts, and 21 to receive conventional endoscopic injections of collagen. The first primary outcome measure was an incontinence score (range 0-6) based on a 24-hour voiding diary, a 24-hour pad test, and a patient questionnaire. The other primary outcome measures were contractility of the rhabdosphincter and thickness of both the urethra and rhabdosphincter. Analysis was by intention to treat. This trial is registered with Controlled-Trials.com, number CCT-NAPN-16630. FINDINGS: At 12-months' follow-up, 38 of the 42 women injected with autologous cells were completely continent, compared with two of the 21 patients given conventional treatment with collagen. The median incontinence score decreased from a baseline of 6.0 (IQR 6.0-6.0; where 6 represents complete incontinence), to 0 (0-0) for patients treated with autologous cells, and 6.0 (3.5-6.0) for patients treated with collagen (p<0.0001). Ultrasonographic measurements showed that the mean thickness of the rhabdosphincter increased from a baseline of 2.13 mm (SD 0.39) for all patients to 3.38 mm (0.26) for patients treated with autologous cells and 2.32 mm (0.44) for patients treated with collagen (p<0.0001). Contractility of the rhabdosphincter increased from a baseline of 0.58 mm (SD 0.32) to 1.56 mm (0.28) for patients treated with autologous cells and 0.67 mm (0.51) for controls (p<0.0001). The change in the thickness of the urethra after treatment was not significantly different between treatment groups. No adverse effects were recorded in any of the 63 patients. INTERPRETATION: Long-term postoperative results and data from multicentre trials with larger numbers of patients are needed to assess whether injection of autologous cells into the rhabdosphincter and the urethra could become a standard treatment for urinary incontinence.

Myoblast and fibroblast therapy for post-prostatectomy urinary incontinence: 1-year followup of 63 patients.

PURPOSE: We assessed the efficacy and safety of the application of autologous fibroblasts and myoblasts for treatment in post-prostatectomy urinary incontinence after a minimal followup of 1 year. MATERIALS AND METHODS: Sixty-three patients with stress urinary incontinence after radical prostatectomy were treated with transurethral ultrasound guided injections of autologous fibroblasts and myoblasts obtained from skeletal muscle biopsies. All subjects were evaluated preoperatively and 12 months postoperatively in terms of incontinence and Quality of Life Instrument scores, urodynamic parameters, and morphology and function of the urethra and rhabdosphincter. RESULTS: Of the 63 patients 41 were continent 12 months after implantation of cells, 17 showed improvement and 5 did not show any improvement. Incontinence and Quality of Life Instrument scores as well as thickness and contractility of the rhabdosphincter were significantly improved postoperatively. CONCLUSIONS: The use of myoblast and fibroblast therapy represents a minimally invasive, safe and effective treatment for post-prostatectomy incontinence after a followup of 1 year.