Project description:ObjectiveTo report the first laparoscopic periprostatic implantation of an artificial urinary sphincter (AUS) after a transurethral resection of the prostate.BackgroundThe implantation of an AUS is a standard procedure for severe urinary incontinence. In men it is usually implanted through a perineal approach, with the cuff placed around the bulbous urethra, bladder neck, or even around the prostate.MethodWe report a laparoscopic periprostatic implantation of an AUS after a transurethral resection of a prostate in a 72-year-old-man with incontinence.ResultsThe operative duration was 180 min and the blood loss was 150 mL. There were no complications. After activating the AUS the patient was totally continent.ConclusionThe laparoscopic periprostatic implantation of an AUS is a safe, effective and considerably less invasive procedure.
Project description:The objective of this study is to present the outcomes of men undergoing implantation of artificial urinary sphincter, after treatment for prostate cancer and also to determine the effect of radiotherapy on continence outcomes after artificial urinary sphincter (AUS) implantation.A prospectively acquired database of all 184 patients having AUS insertion between 2002 and 2012 was reviewed, and demographic data, mode of prostate cancer treatment(s) before implantation, and outcome in terms of complete continence (pad free, leak free) were assessed. Statistical analysis was performed by Chi-squared and Fisher's exact tests.A total of 58 (32%) men had bulbar AUS for urodynamically proven stress urinary incontinence consequent to treatment for prostate cancer in this period. Median follow-up post-AUS activation was 19 months (1-119). Forty-eight (83%) men had primary AUS insertion. Twenty-one (36%) men had radiotherapy as part of or as their sole treatment. Success rates were significantly higher in nonirradiated men having primary sphincter (89%) than in irradiated men (56%). Success rates were worse for men having revision AUS (40%), especially in irradiated men (33%).Radiotherapy as a treatment for prostate cancer was associated with significantly lower complete continence rates following AUS implantation.
Project description:BACKGROUND:The injection of muscle precursor cells (MPC) into the external urinary sphincter muscle (EUS) is a promising therapeutic option for regenerative treatment of stress urinary incontinence (SUI). The objective of the present project was to conduct a pre-clinical trial to investigate the feasibility and accuracy of ultrasound (US) guided, transurethral injections into the EUS of female cadavers. METHODS:This is a prospective, anatomical, interventional and radiological cadaveric laboratory investigation. Two urologists performed transurethral US-guided injections to deliver nano-iron particles into the EUS. The intervention was performed in three unfixed, fresh female cadavers. Each cadaver received MRI before and CT as well as MRI of the pelvis after the injections. RESULTS:The precision and accumulation of nano-iron particles in the EUS was compared using a rating scale to evaluate left versus right and anterior versus posterior distribution in axial and sagittal orientation with US, MRI and CT. The accuracy of our US-guided injections into the anterior target region yielded 4 points on the rating scale. Adequate precision and accumulation of particles in the left versus right EUS were also demonstrated (3 vs. 3.33 points, respectively). Signal intensity in MRI revealed a mean ratio of 0.33 before and after injection. CT scans showed no relevant artefacts impairing the assessment. CONCLUSION:US-guided, transurethral injection into the EUS is feasible and imaging reveals a precise accumulation in the target region. Our method provides an appropriate approach to deliver MPC in the EUS muscle for a regenerative treatment of SUI in the near future.
Project description:OBJECTIVE:To determine whether postoperative oral antibiotics are associated with decreased risk of explantation following artificial urinary sphincter (AUS) or inflatable penile prosthesis (IPP) placement. Although frequently prescribed, the role of postoperative oral antibiotics in preventing AUS or IPP explantation is unknown. MATERIALS AND METHODS:We queried the MarketScan database to identify male patients undergoing AUS or IPP placement between 2003 and 2014. The primary end point was device explantation within 3 months of placement. Multivariate regression analysis controlling for clinical risk factors assessed the impact of postoperative oral antibiotic administration on explant rates. RESULTS:We identified 10,847 and 3594 men who underwent IPP and AUS placement, respectively, between 2003 and 2014. Postoperative oral antibiotics were prescribed to 60.6% of patients following IPP placement and 61.1% of patients following AUS placement. The most frequently prescribed antibiotics were fluoroquinolones (35.6%), cephalexin (17.7%), trimethoprim/sulfamethoxazole (7.0%), and amoxicillin-clavulanate (3.2%). Explant rates did not differ based upon receipt of oral antibiotics (antibiotics vs no antibiotics: IPP: 2.2% vs 1.9%, P?=?.18, AUS: 3.9% vs 4.0%, P?=?.94). On multivariate analysis, no individual class of antibiotic was associated with decreased odds of device explantation. CONCLUSION:Postoperative oral antibiotics are prescribed to nearly two-thirds of patients but are not associated with reduced odds of explant following IPP or AUS placement. Given the risks to individuals associated with use of antibiotics and increasing bacterial resistance, the role of oral antibiotics after prosthetic placement should be reconsidered and further studied in a prospective fashion.
Project description:Background:Many techniques in mitral valve repair (MVR) have been reported with successful long-term results. The aim of this study is to present our simplified technique in artificial chordae replacement for MVR, and reporting its short-term outcomes. Methods:We present a prospective single-surgeon experience. A new simplified artificial chordae implantation technique has been used to repair mitral valves. Postoperative echocardiography at 0, 6, then every 12 months is used to control the results. Endpoints involved freedom from mitral regurgitation (MR), reoperation and major adverse cardiac and cerebrovascular events (MACCE). Results:Between 01/2016 and 01/2018, 57 consecutive patients undergo MVR using this technique are evaluated. Mean age was 63.6±10.1 years and 68.4% were male. Mitral valve pathology was mainly degenerative (52, 91.2%) or healed endocarditis (5, 8.8%). Besides chordae replacement (3.6±1.1 per patient), annuloplasty was used in all patients to correct annulus dilation and stabilize the repair. Mean cross-clamping time was 53±13.4 minutes in isolated MVR and 69.4±31.1 minutes in concomitant procedures. Postoperative outcomes reported two mortalities. Discharge echocardiography reported mild MR in 4 patients and the rest of patients had non-to trace regurgitation. Follow-up results within a mean of 19.3±8.5 months reported no significant MR or need for reoperation and three more (non-valve related) mortalities. Conclusions:Our simplified technique allows to reduce the number of used chordae and re-correction if needed, which consequently reduces cross-clamping and bypass time especially in endoscopic MVR. Good intraoperative and short-term results are reported. These results are still under investigation to prove long-term stability of the repair.
Project description:IntroductionA prospective evaluation of outcomes in a series of patients with post-prostatectomy incontinence (PPI) treated with two different devices is presented.MethodsConsecutive patients with PPI underwent interventions with an adjustable transobturator male system (ATOMS) or artificial urinary sphincter (AUS). Decisions were based on patient preference after physician counselling. Patient characteristics and operative and postoperative parameters including dryness, satisfaction, complications, revision and device durability were evaluated.ResultsOne hundred twenty-nine patients were included: 102 (79.1%) received ATOMS and 27 (20.9%) AUS. Mean follow-up was 34.9 ± 15.9 months. No difference was observed between patient age (p = 0.56), ASA score (p = 0.13), Charlson index (p = 0.57) and radiation (p = 0.3). BMI was higher for AUS (27.1 vs. 29.7; p = 0.003) and also baseline incontinence severity (7.9% mild, 44.1% moderate and 48% severe for ATOMS vs. 11.1% moderate and 88.9% severe for AUS; p = 0.0007). Differential pad test was higher for AUS (- 470 vs. - 1000 ml; p < 0.0001) and so was ICIQ-SF (15.62 vs. 18.3; p < 0.001), but total dryness (76.5 vs. 66.7%; p = 0.33), social continence (90.2 vs. 85.2%; p = 0.49) and satisfaction (92.2 vs. 88.9%; p = 0.69) were equivalent. The postoperative complication rate was similar (22.6 vs. 29.6%; p = 0.4). The surgical revision rate was higher for AUS (6.9 vs. 22.2%; p = 0.029) and also the explant rate but did not reach statistical significance (4.9 vs. 14.8%; p = 0.09). Time to explant was shorter for AUS (log-rank p = 0.021). Regression analysis revealed radiation (p = 0.003) and incontinence severity (p = 0.029) predict total dryness, while complications (p < 0.005) and type of device (p = 0.039) independently predict surgical revision.ConclusionsBoth ATOMS and AUS are effective devices. Pad test change for AUS exceeds that of ATOMS. The revision rate is higher for AUS, and durability is superior for ATOMS. The satisfaction rate is equivalent. Larger series and longer follow-up are needed to compare both devices more appropriately. According to our experience, the AUS is not the only gold standard for PPI.
Project description:BackgroundIn an earlier pilot study with 10 women, we investigated a new approach for therapy of faecal incontinence (FI) due to obstetric trauma, involving ultrasound-guided injection of autologous skeletal muscle-derived cells (SMDC) into the external anal sphincter (EAS), and observed significant improvement. In the current study, we tested this therapeutic approach in an extended patient group: male and female patients suffering from FI due to EAS damage and/or atrophy. Furthermore, feasibility of lower cell counts and cryo-preserved SMDC was assessed.MethodsIn this single-centre, explorative, baseline-controlled clinical trial, each patient (n = 39; mean age 60.6 ± 13.81 years) received 79.4 ± 22.5 × 106 cryo-preserved autologous SMDC. Changes in FI parameters, Fecal Incontinence Quality of Life (FIQL), anorectal manometry and safety from baseline to 1, 6 and 12 months post implantation were evaluated.ResultsSMDC used in this trial contained a high percentage of myogenic-expressing (CD56+) and muscle stem cell marker-expressing (Pax7+, Myf5+) cells. Intervention was well tolerated without any serious adverse events. After 12 months, the number of weekly incontinence episodes (WIE, primary variable), FIQL and patient condition had improved significantly. In 80.6% of males and 78.4% of females, the WIE frequency decreased by at least 50%; Wexner scores and severity of FI complaints decreased significantly, independent of gender and cause of FI.ConclusionsInjection of SMDCs into the EAS effectively improved sphincter-related FI due to EAS damage and/or atrophy in males and females. When confirmed in a larger, placebo-controlled trial, this minimal invasive procedure has the potential to become first-line therapy for FI.Trial registrationEU Clinical Trials Register, EudraCT 2010-023826-19 (Date of registration: 08.11.2010).
Project description:Technological advancements in the medical field are often slow and expensive, sometimes due to complexities associated with pre-clinical testing of medical devices and implants. There is therefore a growing need for new test beds that can mimic more closely the in vivo environment of physiological systems. In the present study, a novel bladder model was designed and fabricated with the aim of providing a pre-clinical testing platform for urological stents and catheters. The model is collapsible, has a Young's modulus that is comparable to a biological bladder, and can be actuated on-demand to enable voiding. Moreover, the developed fabrication technique provides versatility to adjust the model's shape, size, and thickness, through a rapid and relatively inexpensive process. When compared to a biological bladder, there is a significant difference in compliance; however, the model exhibits cystometry profiles during priming and voiding that are qualitatively comparable to a biological bladder. The developed bladder model has therefore potential for future usage in urological device testing; however, improvements are required to more closely replicate the architecture and relevant flow metrics of a physiological bladder.
Project description:BackgroundStress urinary incontinence (SUI) is a frequent adverse effect for men undergoing prostate surgery. A large proportion (around 8% after radical prostatectomy and 2% after transurethral resection of prostate (TURP)) are left with severe disabling incontinence which adversely effects their quality of life and many are reliant on containment measures such as pads (27% and 6% respectively). Surgery is currently the only option for active management of the problem. The overwhelming majority of surgeries for persistent bothersome SUI involve artificial urinary sphincter (AUS) insertion. However, this is expensive, and necessitates manipulation of a pump to enable voiding. More recently, an alternative to AUS has been developed - a synthetic sling for men which elevates the urethra, thus treating SUI. This is thought, by some, to be less invasive, more acceptable and less expensive than AUS but clear evidence for this is lacking. The MASTER trial aims to determine whether the male synthetic sling is non-inferior to implantation of the AUS for men who have SUI after prostate surgery (for cancer or benign disease), judged primarily on clinical effectiveness but also considering relative harms and cost-effectiveness.Methods/designMen with urodynamic stress incontinence (USI) after prostate surgery, for whom surgery is judged appropriate, are the target population. We aim to recruit men from secondary care urological centres in the UK NHS who carry out surgery for post-prostatectomy incontinence. Outcomes will be assessed by participant-completed questionnaires and 3-day urinary bladder diaries at baseline, 6, 12 and 24 months. The 24-h urinary pad test will be used at baseline as an objective assessment of urine loss. Clinical data will be completed at the time of surgery to provide details of the operative procedures, complications and resource use in hospital. At 12 months, men will also have a clinical review to evaluate the results of surgery (including another 24-h pad test) and to identify problems or need for further treatment.DiscussionA robust examination of the comparative effectiveness of the male synthetic sling will provide high-quality evidence to determine whether or not it should be adopted widely in the NHS.Trial registrationInternational Standard Randomised Controlled Trial Registry: Number ISRCTN49212975 . Registered on 22 July 2013. First patient randomised on 29 January 2014.
Project description:PurposeThis study aimed to assess the feasibility of a rapid diffusion tensor imaging (DTI) for evaluation of the female urinary sphincter function based on differentiation between rest and muscle contraction.MethodsMagnetic resonance imaging (MRI) of the lower pelvis was performed at 3 Tesla in 10 healthy female volunteers (21-36 years; body mass index, 20.8±3.6 kg/m2) between June and July 2019. High-resolution T1- and T2-weighted images were acquired for anatomical reference, and following DTI performed in 4 experiment phases: twice during rest (denoted rest-1, rest-2) and contraction (contraction-1, contraction-2). Manual segmentation of the urinary sphincter and the levator ani muscles were performed by 2 independent readers. Mean diffusivity (MD) and fractional anisotropy (FA) values derived from DTI volumes were compared in search for significant differences between the experiment phases. Interreader agreement was assessed by intraclass correlation coefficient (ICC).ResultsKruskal-Wallis test showed significant differences between MD values among all the experiment phases, by both independent readers (1st: X2 [3,76]=17.16, P<0.001 and 2nd: X2 [3,76]=15.88, P<0.01). Post hoc analysis revealed differences in MD values by both readers between: rest-1 vs. contraction-1 (least P<0.05), rest-1 vs. contraction-2 (P<0.01), rest-2 vs. contraction-1 (P<0.03), rest-2 vs. contraction-2 (P=0.02) with overall mean 'rest' to 'contraction' ΔMD=20.6%. No MD or FA differences were found between rest-1 vs. rest-2 and contraction-1 vs. contraction-2 among all the experiment phases, and interreader agreement was ICC=0.85 (MD) and ICC=0.79 (FA).ConclusionRapid DTI might prospectively act as a supporting tool for the evaluation of female pelvic floor muscle function, and incontinence assessment.