Second-generation of temporary implantable nitinol device for the relief of lower urinary tract symptoms due to benign prostatic hyperplasia: results of a prospective, multicentre study at 1 year of follow-up.

Abstract:

OBJECTIVES:To report the clinical experience with a second-generation of temporary implantable nitinol device (iTIND; Medi-Tate Ltd, Or-Akiva, Israel) for the treatment of lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) after 1 year of follow-up. PATIENTS AND METHODS:In all, 81 patients with LUTS, International Prostate Symptom Score (IPSS) ≥10, maximum urinary flow rate (Qmax ) ≤12 mL/s, and prostate volume <75 mL, were enrolled in this prospective Research Ethics Committee-approved multicentre study. The main exclusion criteria were: haemostatic disorders, post-void residual urine volume (PVR) >250 mL, obstructive median lobe, and previous prostate surgery. The iTIND was implanted within the bladder neck and the prostatic urethra under light sedation, using a rigid cystoscope. The device was removed 5-7 days later in an outpatient setting. Demographics, perioperative results, complications (according to the Clavien-Dindo system), functional results and quality of life (QoL) were evaluated. Follow-up assessments were conducted at 1, 3, 6 and 12 months postoperatively. RESULTS:The mean (sd) patient age was 65 (8.9) years, prostate volume was 40.5 (12.25) mL, Qmax was 7.3 (2.6) mL/s, IPSS was 22.5 (5.6), and the median (interquartile range) IPSS QoL score was 4 (2-5). All the implantations were successful, with no intraoperative complications recorded; all patients were discharged on the same day of surgery. The devices were retrieved at a mean (SD) of 5.9 (1.1) days after implantation, typically under topical anaesthesia. No Clavien-Dindo Grade >II complications were recorded. The mean (SD) Qmax at the 1 month follow-up visit was 11.2 (5.7) mL/s and continued to improve thereafter, reaching 14.7 (8.1) mL/s at the 12-month follow-up visit (+100%). The mean (SD) IPSS urinary symptom scores were 11.7 (8.0) after 1 month and further improved to 8.8 (6.4) at the 12-month follow-up (-60%). In parallel, the mean (SD) IPSS QoL score drop reached 1.6 (1.3) by the end of the study. During the 12-month period, two patients (2.4%) required medical therapy for BPH, two patients (2.4%) required transurethral resection of the prostate, whilst 10 patients were lost to follow-up (12.3%). As compared to baseline, none of the 61 sexually active patients who completed the 12-month follow-up period reported sexual or ejaculatory dysfunction. CONCLUSION:iTIND implantation is feasible, safe and effective in providing relief of BPH-related symptoms, at least until 12 months postoperatively. Sexual and ejaculatory functions are fully preserved. Further studies with a longer follow-up period are needed to assess the durability of these results and to clearly define the indications for iTIND implantation.

journal_name

BJU Int

journal_title

BJU international

authors

Porpiglia F,Fiori C,Amparore D,Kadner G,Manit A,Valerio M,Nicolaas L,Ho BSH,Alonso S,Schulman C,Barber N

doi

10.1111/bju.14608

subject

Has Abstract

pub_date

2019-06-01 00:00:00

pages

1061-1069

issue

6

eissn

1464-4096

issn

1464-410X

journal_volume

123

pub_type

临床试验,杂志文章,多中心研究
  • Sexual function before and after various treatments for symptomatic benign prostatic hyperplasia.

    abstract:OBJECTIVE:To determine the effect of various treatments for benign prostatic hyperplasia (BPH) on sexual function. PATIENTS AND METHODS:In a longitudinal multicentre study carried out in the Netherlands, 670 consecutive patients with BPH (aged > or = 50 years) were examined at baseline and 9 months after inclusion. Al...

    journal_title:BJU international

    pub_type: 杂志文章,多中心研究

    doi:10.1046/j.1464-4096.2001.01817.x

    authors: Leliefeld HH,Stoevelaar HJ,McDonnell J

    更新日期:2002-02-01 00:00:00

  • The clinical utility of atypical cytology is significantly increased in both screening and monitoring for bladder cancer when indexed with nuclear matrix protein-22.

    abstract:OBJECTIVES:To assess atypical cytology as a positive bladder tumour marker and to determine if indexing atypical cytology to nuclear matrix protein-22 (NMP22) can decrease the false-positive results or increase the positive predictive value (PPV). PATIENTS AND METHODS:In all, 197 patients at risk of bladder cancer wer...

    journal_title:BJU international

    pub_type: 杂志文章

    doi:10.1111/j.1464-410X.2008.07789.x

    authors: Raina R,Pahlajani G,Ponsky LE,Agarwal A,Zippe CD

    更新日期:2008-08-01 00:00:00

  • Laparoscopic renal biopsy: a 9-year experience.

    abstract:OBJECTIVES:To present our experience and outcome of consecutive laparoscopic renal biopsy over a 9-year period, as renal biopsy remains an important diagnostic procedure for evaluating proteinuria, haematuria and renal failure, but when percutaneous biopsy is contraindicated, a laparoscopic biopsy is an attractive opti...

    journal_title:BJU international

    pub_type: 杂志文章

    doi:10.1046/j.1464-410x.2003.04243.x

    authors: Shetye KR,Kavoussi LR,Ramakumar S,Fugita OE,Jarrett TW

    更新日期:2003-06-01 00:00:00

  • Watchful waiting for localized prostate cancer in the PSA era: what have been the triggers for intervention?

    abstract:OBJECTIVE:• To report outcomes for patients with localized prostate cancer managed using a watchful waiting strategy at an American centre and to explore factors that have triggered intervention. PATIENTS AND METHODS:• From 1991 to 2005, 218 patients diagnosed with untreated localized prostate cancer were followed at ...

    journal_title:BJU international

    pub_type: 杂志文章

    doi:10.1111/j.1464-410X.2010.09652.x

    authors: Coen JJ,Feldman AS,Smith MR,Zietman AL

    更新日期:2011-05-01 00:00:00

  • Exploring pathways towards improving patient experience of robot-assisted radical prostatectomy (RARP): assessing patient satisfaction and attitudes.

    abstract:OBJECTIVE:To determine patient satisfaction and experience after robot-assisted radical prostatectomy (RARP) for prostate cancer, using a convergent mixed-method qualitative analysis approach. PATIENTS AND METHODS:412 patients who underwent RARP between January 2014 and June 2016 were mailed questionnaires and invited...

    journal_title:BJU international

    pub_type: 杂志文章

    doi:10.1111/bju.14226

    authors: Reynolds BR,Bulsara C,Zeps N,Codde J,Lawrentschuk N,Bolton D,Vivian J

    更新日期:2018-05-01 00:00:00

  • A prospective study of the short-term quality-of-life outcomes of patients undergoing transperineal prostate biopsy.

    abstract:OBJECTIVE:To investigate in a prospective, observational study whether transperineal prostate biopsy (TPbx) results in patient-reported quality-of-life (QoL) changes from baseline in the first 3-months after TPbx. PATIENTS AND METHODS:Consenting patients completed the 26-item Expanded Prostate cancer Index Composite (...

    journal_title:BJU international

    pub_type: 杂志文章

    doi:10.1111/bju.13413

    authors: Dowrick AS,Wootten AC,Howard N,Peters JS,Murphy DG

    更新日期:2016-07-01 00:00:00

  • Alendronate decreases the fracture risk in patients with prostate cancer on androgen-deprivation therapy and with severe osteopenia or osteoporosis.

    abstract:OBJECTIVE:To evaluate changes in bone mass and fracture risk in patients with prostate cancer on androgen-deprivation therapy (ADT) and with a basal T-score of >-2.0, who were treated with an oral bisphosphonate, as such patients treated with ADT are at increased risk of bone loss and bone fracture. PATIENTS AND METHO...

    journal_title:BJU international

    pub_type: 杂志文章

    doi:10.1111/j.1464-410X.2009.08622.x

    authors: Planas J,Trilla E,Raventós C,Cecchini L,Orsola A,Salvador C,Placer J,Encabo G,Morote J

    更新日期:2009-12-01 00:00:00

  • The effect of fasting or desmopressin before treatment on the concentration of mitomycin C during intravesical administration.

    abstract:OBJECTIVE:To evaluate two methods of reducing the urine output during treatment (the most easily manipulated variable) in patients undergoing intravesical instillation with mitomycin C, where the concentration-time curve also depends upon dose, diluent volume, residual urine volume, and drug absorption and degradation....

    journal_title:BJU international

    pub_type: 杂志文章

    doi:10.1046/j.1464-410x.2000.00869.x

    authors: Cliff AM,Heatherwick B,Scoble J,Parr NJ

    更新日期:2000-10-01 00:00:00

  • Am I normal? A systematic review and construction of nomograms for flaccid and erect penis length and circumference in up to 15,521 men.

    abstract:OBJECTIVE:To systematically review and create nomograms of flaccid and erect penile size measurements. METHODS:Study key eligibility criteria: measurement of penis size by a health professional using a standard procedure; a minimum of 50 participants per sample. EXCLUSION CRITERIA:samples with a congenital or acquire...

    journal_title:BJU international

    pub_type: 杂志文章,评审

    doi:10.1111/bju.13010

    authors: Veale D,Miles S,Bramley S,Muir G,Hodsoll J

    更新日期:2015-06-01 00:00:00

  • Comparison of an adjustable anchored single-incision mini-sling, Ajust(®) , with a standard mid-urethral sling, TVT-O(TM) : a health economic evaluation.

    abstract:OBJECTIVES:To assess the cost, quality of life (QoL) and cost-effectiveness of a single-incision mini-sling (SIMS; Ajust(®) , C. R. Bard Inc., New Providence, NJ, USA) compared with a standard mid-urethral sling (SMUS; TVT-O™, Ethicon Inc., Somerville, NJ, USA) in the surgical management of female stress urinary incont...

    journal_title:BJU international

    pub_type: 杂志文章,随机对照试验

    doi:10.1111/bju.12388

    authors: Boyers D,Kilonzo M,Mostafa A,Abdel-Fattah M

    更新日期:2013-12-01 00:00:00

  • Evaluation of nuclear matrix protein 22 as a tumour marker in the detection of transitional cell carcinoma of the bladder.

    abstract:OBJECTIVES:To evaluate the sensitivity and specificity of urinary nuclear matrix protein-22 (NMP22) in detecting bladder cancer, to compare the diagnostic performance of NMP22 alone and when corrected by urinary creatinine level, and to correlate NMP22 level with the histological and clinical characteristics of bladder...

    journal_title:BJU international

    pub_type: 杂志文章

    doi:10.1046/j.1464-410x.1999.00254.x

    authors: Sánchez-Carbayo M,Herrero E,Megías J,Mira A,Soria F

    更新日期:1999-10-01 00:00:00

  • Biofeedback vs verbal feedback as learning tools for pelvic muscle exercises in the early management of urinary incontinence after radical prostatectomy.

    abstract:OBJECTIVE:To evaluate the comparative effectiveness of electromyographic (EMG) biofeedback with verbal instructions as learning tools of pelvic muscle exercises (PMEs) in the early management of urinary incontinence after radical prostatectomy. PATIENTS AND METHODS:Forty-two consecutive patients (mean age 64 years, sd...

    journal_title:BJU international

    pub_type: 临床试验,杂志文章,多中心研究,随机对照试验

    doi:10.1046/j.1464-410x.2002.02721.x

    authors: Floratos DL,Sonke GS,Rapidou CA,Alivizatos GJ,Deliveliotis C,Constantinides CA,Theodorou C

    更新日期:2002-05-01 00:00:00

  • Comparison of peri-operative outcomes of robot-assisted vs laparoscopic partial nephrectomy: a meta-analysis.

    abstract:OBJECTIVE:To conduct a meta-analysis of the literature on the peri-operative outcomes of both robot-assisted partial nephrectomy (RAPN) and laparoscopic partial nephrectomy (LPN). MATERIALS AND METHODS:An electronic database search of MEDLINE, EMBASE, Google Scholar and the Cochrane Library was performed for publicati...

    journal_title:BJU international

    pub_type: 杂志文章,meta分析,评审

    doi:10.1111/bju.12255

    authors: Zhang X,Shen Z,Zhong S,Zhu Z,Wang X,Xu T

    更新日期:2013-12-01 00:00:00

  • The prevalence of erectile dysfunction among Brazilian men screened for prostate cancer.

    abstract:OBJECTIVE:To determine the prevalence of erectile dysfunction (ED) in a large cohort of Brazilian men who were screened for prostate cancer, and to determine risk factors in this population, as there are large cultural differences among countries in reporting the frequency of ED, and it is likely that the prevalence of...

    journal_title:BJU international

    pub_type: 杂志文章

    doi:10.1111/j.1464-410X.2009.08562.x

    authors: Paranhos M,Antunes A,Andrade E,Freire G,Srougi M

    更新日期:2009-10-01 00:00:00

  • Effect of statin use on biochemical outcome following radical prostatectomy.

    abstract:OBJECTIVE:•To determine the relationship between statin use and biochemical recurrence (BCR) following radical prostatectomy (RP). PATIENTS AND METHODS:•A retrospective analysis was performed on 3198 RP patients between 1990 and 2008. •Exclusion criteria were neo-adjuvant or adjuvant therapy, follow-up <2 years, and i...

    journal_title:BJU international

    pub_type: 杂志文章

    doi:10.1111/j.1464-410X.2011.10159.x

    authors: Ritch CR,Hruby G,Badani KK,Benson MC,McKiernan JM

    更新日期:2011-10-01 00:00:00

  • Comparison of modified one- and two-layer microsurgical vasovasostomy.

    abstract:OBJECTIVE:To compare the outcome of a modified one-layer and two-layer vasovasotomy (VV) in two groups of similar men undergoing vasectomy reversal. PATIENTS AND METHODS:The charts and surgical records of all surgical procedures performed on men undergoing a modified one- or two-layer VV between June 1992 and July 199...

    journal_title:BJU international

    pub_type: 杂志文章

    doi:10.1046/j.1464-410x.2000.00668.x

    authors: Fischer MA,Grantmyre JE

    更新日期:2000-06-01 00:00:00

  • Native nephrectomy for autosomal dominant polycystic kidney disease: before or after kidney transplantation?

    abstract:UNLABELLED:Study Type - Therapy (case series). LEVEL OF EVIDENCE:4. What's known on the subject? and What does the study add? The indications and timing of native nephrectomy in patients with autosomal dominant polycystic kidney disease (ADPKD) is controversial, especially for those undergoing renal transplantation. P...

    journal_title:BJU international

    pub_type: 杂志文章

    doi:10.1111/j.1464-410X.2010.09938.x

    authors: Kirkman MA,van Dellen D,Mehra S,Campbell BA,Tavakoli A,Pararajasingam R,Parrott NR,Riad HN,McWilliam L,Augustine T

    更新日期:2011-08-01 00:00:00

  • Changes in patient characteristics and outcomes for radical cystectomy in England.

    abstract:OBJECTIVES:To describe temporal changes in patient characteristics and outcomes for radical cystectomy (RC) in England between 1995 and 2002, using routinely collected administrative data. PATIENTS AND METHODS:Data were extracted from the Hospital Episode Statistics database of the Department of Health in England, des...

    journal_title:BJU international

    pub_type: 杂志文章

    doi:10.1111/j.1464-410X.2005.05329.x

    authors: Nuttall MC,van der Meulen J,McIntosh G,Gillatt D,Emberton M

    更新日期:2005-03-01 00:00:00

  • Five-year data from the Oxford Laser Prostatectomy Trial.

    abstract:OBJECTIVE:To evaluate the natural history of a group of patients who underwent contact laser prostatectomy or transurethral resection of the prostate (TURP). PATIENTS AND METHODS:Patients were followed up at 5 years after enrolling in a prospective double-blind randomized controlled trial of TURP vs contact laser pros...

    journal_title:BJU international

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.1046/j.1464-410x.2000.00778.x

    authors: Keoghane SR,Sullivan ME,Doll HA,Kourambas J,Cranston DW

    更新日期:2000-08-01 00:00:00

  • Contrast-enhanced ultrasonography with contrast-tuned imaging technology for the detection of prostate cancer: comparison with conventional ultrasonography.

    abstract:UNLABELLED:Study Type - Diagnostic (exploratory cohort) Level of Evidence 2b What's known on the subject? and What does the study add? The present study was to perform contrast-tuned imaging (CnTI) technology to detect prostate cancer and compare the use of CnTI technology for the detection of prostate cancer with conv...

    journal_title:BJU international

    pub_type: 杂志文章

    doi:10.1111/j.1464-410X.2011.10577.x

    authors: Xie SW,Li HL,Du J,Xia JG,Guo YF,Xin M,Li FH

    更新日期:2012-06-01 00:00:00

  • Incontinence aids in Sweden: users and costs.

    abstract:OBJECTIVE:To study age- and sex-specific use and costs of incontinence aids distributed free of charge in Sweden. SUBJECTS AND METHODS:The study was conducted in the county of Jämtland, Sweden (132,000 inhabitants). The use and cost of incontinence aids for people living in their homes and the total cost of incontinen...

    journal_title:BJU international

    pub_type: 杂志文章

    doi:10.1046/j.1464-4096.2001.01429.x

    authors: Samuelsson E,Månsson L,Milsom I

    更新日期:2001-12-01 00:00:00

  • Correlation between major histocompatibility complex class I molecules and CD8+ T lymphocytes in prostate, and quantification of CD8 and interferon-gamma mRNA in prostate tissue specimens.

    abstract:OBJECTIVE:To investigate the immunology of host-tumour interaction, critical for the development of immunotherapy against cancers, by assessing the major histocompatibility complex (MHC) class I expression in both benign and malignant prostate disease, and the relationship between their expression and degree of tumour-...

    journal_title:BJU international

    pub_type: 杂志文章

    doi:10.1046/j.1464-410x.2002.02993.x

    authors: Naoe M,Marumoto Y,Ishizaki R,Ogawa Y,Nakagami Y,Yoshida H

    更新日期:2002-11-01 00:00:00

  • Porcine small intestinal submucosa as a percutaneous mid-urethral sling: 2-year results.

    abstract:OBJECTIVE:To report the 2-year follow-up results on patients treated with a novel minimally invasive outpatient procedure for placing a mid-urethral sling, using porcine small intestinal submucosa (SIS). PATIENTS AND METHODS:Thirty-four women with urodynamic evidence of stress urinary incontinence (SUI, 19) or of SUI ...

    journal_title:BJU international

    pub_type: 杂志文章

    doi:10.1111/j.1464-410X.2005.05576.x

    authors: Jones JS,Rackley RR,Berglund R,Abdelmalak JB,DeOrco G,Vasavada SP

    更新日期:2005-07-01 00:00:00

  • Postoperative radiation therapy for patients at high-risk of recurrence after radical prostatectomy: does timing matter?

    abstract:OBJECTIVE:To evaluate among radical prostatectomy (RP) patients at high-risk of recurrence whether the timing of postoperative radiation therapy (RT) (adjuvant, early salvage with detectable post-RP prostate-specific antigen [PSA], or 'late' salvage with a PSA level of >1.0 ng/mL) is significantly associated with overa...

    journal_title:BJU international

    pub_type: 杂志文章

    doi:10.1111/bju.13043

    authors: Hsu CC,Paciorek AT,Cooperberg MR,Roach M 3rd,Hsu IC,Carroll PR

    更新日期:2015-11-01 00:00:00

  • The prevalence of loss of heterozygosity in chromosome 3, including FHIT, in bladder cancer, using the fluorescent multiplex polymerase chain reaction.

    abstract:OBJECTIVE:To determine some of the genetic alterations involved in the pathogenesis and progression of transitional cell carcinoma of the bladder. Materials and methods In a population-based study, freshly frozen tissue was collected from all patients newly diagnosed with urinary bladder cancer in the Stockholm region ...

    journal_title:BJU international

    pub_type: 杂志文章

    doi:10.1046/j.1464-410x.2001.02212.x

    authors: Wada T,Louhelainen J,Hemminki K,Adolfsson J,Wijkström H,Norming U,Borgström E,Hansson J,Steineck G

    更新日期:2001-06-01 00:00:00

  • Is magnetic resonance imaging-targeted biopsy a useful addition to systematic confirmatory biopsy in men on active surveillance for low-risk prostate cancer? A systematic review and meta-analysis.

    abstract:OBJECTIVE:To systematically review and meta-analyse evidence regarding the additional value of magnetic resonance imaging (MRI) and MRI-targeted biopsies to confirmatory systematic biopsies in identifying high-grade prostate cancer in men with low-risk disease on transrectal ultrasonography (TRUS) biopsy, as active sur...

    journal_title:BJU international

    pub_type: 杂志文章,meta分析

    doi:10.1111/bju.14358

    authors: Schoots IG,Nieboer D,Giganti F,Moore CM,Bangma CH,Roobol MJ

    更新日期:2018-12-01 00:00:00

  • The ageing male and erectile dysfunction.

    abstract::Erectile dysfunction is common in the ageing man and reliable therapies are needed. The pathophysiology of erectile dysfunction in this group mainly includes chronic ischaemia, which triggers the deterioration of cavernosal smooth muscle and the development of corporeal fibrosis. Assessing the ageing man with erectile...

    journal_title:BJU international

    pub_type: 杂志文章,评审

    doi:10.1046/j.1464-410x.2003.04378.x

    authors: Montorsi F,Briganti A,Salonia A,Deho' F,Zanni G,Cestari A,Guazzoni G,Rigatti P,Stief C

    更新日期:2003-09-01 00:00:00

  • Chemopreventive effects of cyclooxygenase-2 inhibitor and epidermal growth factor-receptor kinase inhibitor on rat urinary bladder carcinogenesis.

    abstract:OBJECTIVE:To examine the chemopreventive effects of a selective cyclooxygenase (COX)-2 inhibitor, meloxicam, and a selective epidermal growth factor (EGF)-receptor tyrosine kinase inhibitor, gefitinib (as a single agent) on a carcinogen-induced rodent bladder carcinogenesis model. MATERIALS AND METHODS:The study compr...

    journal_title:BJU international

    pub_type: 杂志文章

    doi:10.1111/j.1464-410X.2006.06053.x

    authors: Hattori K,Iida K,Joraku A,Tsukamoto S,Akaza H,Oyasu R

    更新日期:2006-03-01 00:00:00

  • Long-term follow-up of treatment of erectile dysfunction after radical prostatectomy using nerve grafts and end-to-side somatic-autonomic neurorraphy: a new technique.

    abstract:OBJECTIVE:To study a novel penile reinnervation technique using four sural nerve grafts and end-to-side neurorraphies connecting bilaterally the femoral nerve and the cavernous corpus and the femoral nerve and the dorsal penile nerves. PATIENTS AND METHODS:Ten patients (mean [± sd; range] age 60.3 [± 4.8; 54-68] years...

    journal_title:BJU international

    pub_type: 杂志文章

    doi:10.1111/bju.13772

    authors: Souza Trindade JC,Viterbo F,Petean Trindade A,Fávaro WJ,Trindade-Filho JCS

    更新日期:2017-06-01 00:00:00

  • Damage to the bladder neck alters autonomous activity and its sensitivity to cholinergic agonists.

    abstract:OBJECTIVE:To identify and describe changes to the motor component of the motor/sensory system, which contributes to sensation during the filling phase of the micturition cycle, as a result of surgically induced bladder pathology, i.e. damage to the bladder neck and outlet obstruction. MATERIALS AND METHODS:Adult male ...

    journal_title:BJU international

    pub_type: 杂志文章

    doi:10.1111/j.1464-410X.2007.07129.x

    authors: de Jongh R,van Koeveringe GA,van Kerrebroeck PE,Markerink-van Ittersum M,de Vente J,Gillespie JI

    更新日期:2007-10-01 00:00:00