Predictors of Early Continence Recovery Following Radical Prostatectomy, Including Transperineal Ultrasound to Evaluate the Membranous Urethra Length (CHECK-MUL Study).

INTRODUCTION: To predict early continence recovery following radical prostatectomy (RP) using baseline demographic and clinical data, as well as dynamic transperineal ultrasound (TPUS) parameters of membranous urethral length (MUL). PATIENTS AND METHODS: A retrospective CHECK-MUL (check of membranous urethral length) study was conducted. We evaluated 154 patients who underwent RP between August 2018 and April 2023. All patients underwent pre- and postoperative dynamic TPUS to measure MUL. Urinary continence was defined as the use of one safety pad or less 3 months post surgery. The International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) was used to assess urinary incontinence (UI). We used logistic regression to assess the association between MUL and early continence recovery. A multivariable logistic regression model was then constructed for the prediction of early continence recovery based on the MUL. RESULTS: The median MUL observed pre- and postoperatively in this study were similar (14.6 mm and 12.9 mm). In the univariable logistic regression analysis, the pre- and postoperative MUL measured by TPUS (odds ratio (OR): 1.12; 95%-CI: 1.02-1.79; p = 0.05 and OR: 1.01; 95%-CI: 1.02-1.12; p < 0.01) directions were independent predictors of early continence recovery 3 months post surgery. In addition, age (OR: 1.23; 95%-CI: 1.11-1.42; p = 0.03), BMI (OR: 1.44; 95%-CI: 1.18-2.92; p = 0.05), and bilateral nerve sparing (OR: 1.24; 95%-CI: 1.02-1.9; p = 0.05) were independent predictors of urinary continence in univariable logistic regression models. Preoperative MUL >15 mm (95% CI 1.28-1.33; p = 0.03) and postoperative MUL >14 mm (95% CI 1.2-1.16; p = 0.05) were significantly associated with early continence recovery at 3 months post surgery. CONCLUSIONS: The likelihood of continence recovery increases with membranous urethral length and decreases with age, BMI, and lack of nerve sparing. Preoperative MUL >15 mm and postoperative MUL >14 mm were significantly associated with early continence recovery at 3 months post surgery.

[Urinary incontinence after radical prostatectomy for prostate cancer-data from 17,149 patients from 125 certified centers]. / Harninkontinenz nach radikaler Prostatektomie beim Prostatakarzinom ­ aktuelle Daten von 17.149 Patienten aus 125 zertifizierten Zentren.

BACKGROUND: In addition to erectile dysfunction, urinary incontinence is the most common functional limitation after radical prostatectomy (RPE) for prostate cancer (PCa). The German S3 guideline recommends informing patients about possible effects of the therapy options, including incontinence. However, only little data on continence from routine care in German-speaking countries after RPE are currently available, which makes it difficult to inform patients. OBJECTIVE: The aim of this work is to present data on the frequency and severity of urinary incontinence after RPE from routine care. MATERIALS AND METHODS: Information from the PCO (Prostate Cancer Outcomes) study is used, which was collected between 2016 and 2022 in 125 German Cancer Society (DKG)-certified prostate cancer centers in 17,149 patients using the Expanded Prostate Cancer Index Composite Short Form (EPIC-26). Changes in the "incontinence" score before (T0) and 12 months after RPE (T1) and the proportion of patients who used pads, stratified by age and risk group, are reported. RESULTS: The average score for urinary incontinence (value range: 0-worst possible to 100-best possible) was 93 points at T0 and 73 points 12 months later. At T0, 97% of the patients did not use a pad, compared to 56% at T1. 43% of the patients who did not use a pad before surgery used at least one pad a day 12 months later, while 13% use two or more. The proportion of patients using pads differs by age and risk classification. CONCLUSION: The results provide a comprehensive insight into functional outcome 12 months after RPE and can be taken into account when informing patients.

Prediction models of incontinence and sexual function one year after radical prostatectomy based on data from 20 164 prostate cancer patients.

BACKGROUND: Incontinence and sexual dysfunction are long-lasting side effects after surgical treatment (radical prostatectomy, RP) of prostate cancer (PC). For an informed treatment decision, physicians and patients should discuss expected impairments. Therefore, this paper firstly aims to develop and validate prognostic models that predict incontinence and sexual function of PC patients one year after RP and secondly to provide an online decision making tool. METHODS: Observational cohorts of PC patients treated between July 2016 and March 2021 in Germany were used. Models to predict functional outcomes one year after RP measured by the EPIC-26 questionnaire were developed using lasso regression, 80-20 splitting of the data set and 10-fold cross validation. To assess performance, R2, RMSE, analysis of residuals and calibration-in-the-large were applied. Final models were externally temporally validated. Additionally, percentages of functional impairment (pad use for incontinence and firmness of erection for sexual score) per score decile were calculated to be used together with the prediction models. RESULTS: For model development and internal as well as external validation, samples of 11 355 and 8 809 patients were analysed. Results from the internal validation (incontinence: R2 = 0.12, RMSE = 25.40, sexual function: R2 = 0.23, RMSE = 21.44) were comparable with those of the external validation. Residual analysis and calibration-in-the-large showed good results. The prediction tool is freely accessible: https://nora-tabea.shinyapps.io/EPIC-26-Prediction/. CONCLUSION: The final models showed appropriate predictive properties and can be used together with the calculated risks for specific functional impairments. Main strengths are the large study sample (> 20 000) and the inclusion of an external validation. The models incorporate meaningful and clinically available predictors ensuring an easy implementation. All predictions are displayed together with risks of frequent impairments such as pad use or erectile dysfunction such that the developed online tool provides a detailed and informative overview for clinicians as well as patients.

Diagnosis of female urethral diverticulum using pelvic floor ultrasound and comparison with voiding cystourethrogram (imaging study).

INTRODUCTION AND HYPOTHESIS: The purpose of this study was to evaluate the sensitivity and specificity of pelvic floor ultrasound (PFUS) in the diagnostic work-up of female urethral diverticulum (UD) and to compare results of PFUS with voiding cystourethrogram (VCUG). METHODS: We retrospectively reviewed our database of patients, who received VCUG and PFUS for the diagnosis of UD. A total of 196 consecutive female patients with a minimum of one symptom, such as a lower urinary tract symptom (LUTS), postmicturition dribble, dyspareunia and recurrent urinary tract infection (UTI) who underwent initial diagnostics with VCUG and PFUS were selected. Diagnostic performance of both procedures, which included size, complexity, echogenicity. and content were compared. RESULTS: Recurrent UTI and LUTS were the most common symptoms, which were present in 165 (84%) and 163 patients (83%) respectively. Final diagnosis of UD was based on PFUS and VCUG findings in 69 (35%) and 58 (30%) cases respectively. Based on our study cohort, the sensitivity of PFUS in detecting UD was significantly higher than that of VCUG: 94% (IQR: 89-97) versus 78% (IQR: 73-85, p<0.01), with a trend toward higher specificity: 100% (IQR: 94-100) versus 84% (IQR: 78-84, p=0.05). Enabling direct UD visualisation, PFUS was associated with a positive predictive value (PPV) of 100% (IQR: 97-100) and a negative predictive value (NPV) of 88% (IQR: 78-95), whereas VCUG had an inferior accuracy with a PPV of 84 (IQR: 80-84) and a NPV of 68 (IQR: 62-79). CONCLUSIONS: In clinical practice, VCUG has a lower sensitivity than PFUS. Based on these results, we recommend the usage of dynamic PFUS as part of a non-invasive work-up.

Correlation between symptoms and imaging findings including pelvic floor ultrasound to improve the symptom-based diagnosis of female urethral diverticulum (CHECK-UD study).

INTRODUCTION AND HYPOTHESIS: The objective was to establish a model to predict the presence of a female urethral diverticulum (UD) based on symptoms. METHODS: A prospective CHECK-UD study (check of female urethral diverticulum) was conducted. Female patients presenting with symptoms such as lower urinary tract symptoms (LUTS), postmicturition dribble or urinary incontinence (UI), dyspareunia or pain in the pelvic area, and recurrent urinary tract infection (UTI) treated between 2015 and 2020 were included. The association between each symptom variable and the positive finding of UD was evaluated by multivariate logistic regression adjusting for age, body mass index (BMI), vaginal deliveries, previous surgery for SUI, previous pelvic surgery, and microscopic hematuria. A predictive model for the presence of UD was then created. RESULTS: In total, 189 female patients with a minimum of one symptom were enrolled. Pelvic floor ultrasound revealed the presence of UD in 66 out of 189 (34.92%). Of the four symptoms, the combinations "LUTS + postmicturition dribble + UTI," "postmicturition dribble + LUTS," and "UTI + LUTS" were most significantly related to positive findings and had a higher positive prognostic value for the diagnosis of UD than each individual symptom alone (OR = 13.78 [95% CI: 6.95-16.35], p < 0.001; OR = 9.94 [95% CI: 4.60-12.2], p < 0.05; and OR = 5.78 [95% CI: 1.58-6.98] p = 0.05) respectively. CONCLUSION: Based on our model, the combination "LUTS + postmicturition dribble + UTI" seems to be the most sensitive combination of clinical symptoms predicting the positive finding of UD. This model could be used for patient counseling and for the identification of patients with UD.

Use of polyvinylidene fluoride in treatment of female stress urinary incontinence: Efficacy and safety of midurethral slings: 24-month follow-up results.

OBJECTIVE: To evaluate the safety and efficacy rate of polyvinylidene fluoride (PVDF) slings in the treatment of female stress urinary incontinence (SUI). MATERIAL AND METHODS: A prospective pilot study was conducted with women with SUI who underwent PVDF slings. Data regarding subjective (International Consultation on Incontinence Questionnaire - Urinary Incontinence [ICIQ-UI] and International Consultation on Incontinence Questionnaire - Overactive Bladder [ICIQ-OAB]) and objective (stress test and bladder diary) outcomes and complication rates were evaluated. Primary outcomes were objective (negative pad and stress test) and subjective (no leakage episodes) success after a median follow-up of 24 months. RESULTS: PVDF slings demonstrated a high level of satisfaction with objective cure (transobturator 90% compared with retropubic 100%, P = .90), urgency to urinate, frequency of de novo incontinence (transobturator 90% compared with retropubic 80%, P = .85), ability of physical and sexual activity (transobturator 90% compared with retropubic 100%, P = .90). The multivariate logistic regression model for satisfaction was associated with overall treatment success (odds ratio [OR] = 3.55, 95% confidence interval [CI] 2.32-6.1), greater reduction in ICIQ-UI (OR = 0.85; 95% CI 0.78-1.85) and ICIQ-OAB (OR =0.99; 95% CI 0.89-1.78). The total Female Sexual Function Index (FSFI) score for both groups was 19.3 ± 1.2 and 20.7 ± 1.8, statistically significant when compared with perioperative FSFI score 16.7 ± 1.1 and 17.6 ± 1.4 (P < .001). CONCLUSION: PVDF mid-urethral slings are safe with clinically efficacies at 3, 6, 12, and 24-month follow-up for the treatment of SUI. The high level of satisfaction seen after PVDF sling procedures is associated with objective improvement of SUI and fewer slings related complications. Further studies using larger sample sizes with longer and comparative clinical follow-up are required.

A systematic review and meta-analysis of clinical and functional outcomes of artificial urinary sphincter implantation in women with stress urinary incontinence.

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. ABBREVIATIONS: AMS: American Medical Systems; AUS: artificial urinary sphincter; EAU: European Association of Urology; LE: Level of Evidence; PRISMA: Preferred Reporting Items for Systematic Reviews and Meta-Analyses; QoL: quality of life; SHELTER: Services and Health for Elderly in Long TERm care (study); SUI: (stress) urinary incontinence.

Stem cell applications in regenerative medicine for stress urinary incontinence: A review of effectiveness based on clinical trials.

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; Qmax: maximum urinary flow; QOL: quality of life; RP: radical prostatectomy; TNC: total nucleated cell; (S)UI: (stress) urinary incontinence; UDSCs: urine-derived stem cells; UTUS: upper tract ultrasonography; VLPP: Valsalva leak-point pressure.

Functional MRI in patients with detrusor sphincter dyssynergia: Is the neural circuit affected?

AIMS: In recent years, the human brain-bladder control network has been visualized in different functional magnetic resonance imaging (fMRI) studies. The role of the brainstem and suprapontine regions has been elucidated. Especially the pontine region and the periaqueductal gray, as the central structures of the micturition circuit, were demonstrated. Detrusor sphincter dyssynergia (DSD) is a common problem in patients with neurological diseases. Residual urine and consecutive urinary tract infections with the risk of kidney damage remain a problem. In the present study, we used fMRI of the brain to compare the activation sites of patients with DSD with those of our previously published healthy controls with special emphasis on the brainstem region. METHODS: fMRI was performed in 11 patients with DSD who had an urge to void due to a filled bladder. In a nonvoiding model, they were instructed to contract or to relax the pelvic floor muscles repetitively. RESULTS: In patients with DSD, we could reproduce the activation sites found in healthy subjects, showing the regions in the brainstem as well as the other micturition-related areas. The activation of the pontine region was more rostral/dorsal compared with the healthy volunteers. CONCLUSION: Interestingly, we detected the well-known activation in the pontine region in the patients in the dorsal/rostral part compared with the more ventral activation in the healthy volunteers, suggesting that the L-region of the pontine micturition center is more prominent in cases of DSD.

Abdominal sacrocolpopexy with Pelvicol xenograft and concomitant Burch colposuspension.

PURPOSE: To evaluate the efficacy of Pelvicol xenograft use during abdominal sacrocolpopexy to repair pelvic organ prolapse (POP). PATIENTS AND METHODS: A total of 27 consecutive women with symptomatic POP were included in this study. A POP-quantification system and International Continence Society classification were used. Functional and anatomical outcomes were assessed. Subjective outcomes and physical activity after surgery were evaluated due to modified quality of life questionnaire. RESULTS: Median follow-up was 21 months (range: 16 to 41 months). Twenty-four (89%) patients were available for anatomical and subjective evaluation. Preoperative POP-quantification classification was: stage I: 11.1%, stage II: 25.9%, stage III: 48.2%, and stage IV: 14.8%. Overall, pad usage significantly decreased (mean 4.8 vs 1 pads, P=0.001). Stress urinary incontinence significantly improved after surgery in nine women (P=0.001). An additional five women were completely continent. No de-novo incontinence developed. Six women with preoperative urinary retention improved in the amount of residual urine postoperative (mean 35 vs 165 mL). Failure rate was 8.3% at 3 and 11 months after surgery, requiring a second reconstruction. There was no graft related complications or graft rejections necessitating removal occurring. Response rate of the questionnaire was 67%. Two women reported no interference in physical activity after 2 postoperative months, five women after 5 months, and five women 1 year later. Pelvic pain (vaginal pain) was partly improved in eight patients, postoperatively, and ten patients had complete resolution of pain after surgery. CONCLUSION: This study demonstrates that abdominal sacrocolpopexy is an effective surgical treatment in correcting POP. The use of Pelvicol is associated with a high recurrence rate and increased failure rate compared to traditional sacrocolpopexy with mesh. Larger clinical trials to evaluate the functional and anatomical outcomes are needed.

See the unseen: Mesorectal lymph node metastases in prostate cancer.

BACKGROUND: Our study is the first evaluation of nodal metastatic prostate cancer (PCa) to mesorectal lymph nodes (MLN) detected by (68) Ga-PSMA-PET/CT. METHODS: We retrospectively analyzed 76 consecutive PCa patients who underwent (68) Ga-PSMA-PET/CT: 61 PCa patients with biochemical recurrence (BCR) after curative treatment and 15 high-risk PCa before primary therapy. We assessed PET-positive MLN, which are indicative for PCa. RESULTS: We detected PET-positive lesions for PCa in (68) Ga-PSMA-PET/CT in 66 of 76 (87%) patients. Nodal disease was imaged in 47 of 66 (71%) patients. Indicative mesorectal nodal lesions for PCa were detected in 12 of 76 (15.8%) patients. The median number of PET-positive MLN was one per patient. Seven of twelve patients had recurrent PCa after radical prostatectomy with a median PSA value of 1.84 ng/ml (range 0.31-13). Five of twelve patients had untreated first diagnosed high-risk PCa with median PSA value of 90 ng/ml (range 4.6-93) at PET/CT, respectively. For all PET positive MLN a morphological correlate was found in CT (shortest diameter median 4 mm [range 4-21]; longest diameter median 7.5 mm [range 5-25]). After PET/CT, four patients with recurrent PCa received hormonal therapy, one patient was treated with directed radiation therapy of MLN, one patient received chemotherapy, and one patient was treated with pelvic lymph node dissection. Three high-risk PCa patients received hormonal therapy, and two patients were treated with adjuvant hormonal therapy after radical prostatectomy. CONCLUSIONS: Detection and exact location of nodal metastasis for PCa is crucial for the choice of treatment and the patient's prognosis. (68) Ga-PSMA-PET/CT seems to improve the detection of nodal metastasis in PCa, especially concerning mesorectal lymph nodes.

Clinical significance of video-urodynamic in female recurrent urinary tract infections.

PURPOSE: We aimed to assess the value of video-urodynamic study (VUD) in the identification of lower urinary tract voiding dysfunction in female recurrent urinary tract infections (UTIs). PATIENTS AND METHODS: A total of 54 women with recurrent UTIs who underwent VUDs between 2013 and 2015 were analyzed. They were carefully evaluated by complete history, voiding diary, physical investigation, urosonography, and VUDs. RESULTS: Neurogenic and non-neurogenic voiding dysfunctions were found in 4% and 63% of women respectively. Detrusor sphincter dyssynergia, detrusor underactivity, and a combination of both were found in 17% (nine of 54), 22% (12 of 54), and 11% (six of 54) of women, respectively. Overactive bladder syndrome was determined in 28% (15 of 54) of women. Reduction in the maximal urinary flow rate to less than 15 mL/s and post-void residual volume were revealed in 63% (34 of 54) and 54% (29 of 54) of women, respectively. Stress urinary incontinence was noticed in 39% (21 of 54) of women with a median pad usage of three pads (range: 1-15) daily. Urgency and nocturia were complaints in 54% (29 of 54) and 43% (23 of 54) of women, respectively. The median voiding frequency and nocturia episodes were 7±4 (1-13) and 1±3 (0-12), respectively. CONCLUSION: Dysfunctional voiding can encourage the formation of recurrent UTIs in the female. The VUDs are the investigation of choice to diagnose voiding dysfunction.

Metal telescopic and Amplatz sheath dilation in nephrolithotomy.

INTRODUCTION: Comparison of Amplatz sheath percutaneous nephrolithotomy (Amplatz PCNL) and metal telescopic dilation PCNL (MTD PCNL) with respect to clinical outcomes and complications. MATERIALS AND METHODS: Single-institution retrospective chart review with 73 patients who underwent PCNL divided into two groups: Amplatz PCNL (n = 26) and MTD PCNL (n = 47). Efficacy (stone-free rate, residual stones, and surgical duration) and safety (transfusion rate and hemoglobin decrease) were evaluated. Complications were recorded and classified using the modified Clavien classification system. RESULTS: The two PCNL groups were similar regarding mean age, stone burden, side, stone location, and stone composition. There were no significant differences in surgery duration (101 ± 28 vs. 98 ± 30 min; P = 0.906), transfusion rate (3.9% vs. 4.3%; P = 0.382), and hemoglobin drop (0.9 ± 0.9 vs. 1 ± 0.7 g/dl; P = 0.424) for Amplatz and MTD PCNL, respectively. Stone-free rate (86% vs. 68%; P = 0.001) was significantly higher while residual fragments rate (37% vs. 60%; P = 0.001) was significantly lower in Amplatz PCNL compared to MTD PCNL. However, tube stay time (4.4 ± 1.8 vs. 5.8 ± 3.6 days; P = 0.005) and hospital time (8.6 ± 2.6 vs. 9.7 ± 5.5 days; P = 0.0001) were significantly longer in Amplatz PCNL compared to MTD PCNL. Clavien grading revealed a significantly higher rate of low-grade complications (I-III) for the MTD PCNL in comparison to Amplatz PCNL (10.6% vs. 3.9%, respectively; P = 0.011). There were no major complications and no tract dilation failure. CONCLUSION: The study demonstrates that Amplatz PCNL is a safe and effective procedure to remove large renal stones compared with MTD PCNL.

Biphasic 68Ga-PSMA-HBED-CC-PET/CT in patients with recurrent and high-risk prostate carcinoma.

PURPOSE: Binding of (68)Ga-PSMA-HBED-CC ((68)Ga-PSMA) at prostate cancer (PC) cells increases over time. A biphasic protocol may help separating benign from tumor lesions. The aim of this study was the retrospective evaluation of a diagnostic incremental value of a dual-time point (biphasic) (68)Ga-PSMA-PET/CT in patients with prostate cancer. METHODS: Retrospective analysis of 35 consecutive patients (49-78 years, median 71) with newly diagnosed PC (12/35) or recurrence of PC (23/35). PET/CT (Gemini TF16, Philips) was acquired 1 h and 3 h p. i. of 140-392 MBq (300 MBq median) (68)Ga-PSMA, followed by a diagnostic contrast CT. PET findings were correlated with histology or unequivocal CT findings. Semiquantitative PET data (SUVmax, SUV mean) were acquired and target-to-background-ratios (T/B-ratio) were calculated for benign and malign lesions for both time points. Size of lymph nodes (LN) on diagnostic CT was recorded. Statistical analysis was performed for assessment of significant changes of semiquantitative PET-parameters over time and for correlation of size and uptake of lymph nodes. RESULTS: One hundred and four lesions were evaluated. Sixty lesions were referenced by histology or unequivocal CT findings, including eight (13.3 %) histopathologically benign lymph nodes, 12 (20 %) histopathologically lymph node metastases, 12 (20 %) primary tumors, three (5 %) local recurrences, and 25 (41.7 %) bone metastases. Forty-four lesions were axillary LN with normal CT-appearance. Benign lesions had significantly lower SUVmax and T/B-ratios compared with malignant findings. Malign lesions showed a significant increase of both parameters over time compared to benign findings. There was no correlation between LN size and SUVmax. The sensitivity, specificity, the positive predictive value and negative predictive value of PET/CT regarding pelvic LN was 94 %, 99 %, 89 %, and 99.5 %, respectively. CONCLUSIONS: In contrast to benign tissues, the uptake of proven tumor lesions increases on (68)Ga-PSMA-PET/CT over time. A biphasic PET-study may lead to a better detection of tumor lesions in unequivocal findings.