Challenges of conducting multi-center, multi-disciplinary urinary incontinence clinical trials: experience of the urinary incontinence treatment network.

Abstract:

AIMS:The Urinary Incontinence Treatment Network (UITN) was established in 2000 as a multi-disciplinary, multi-institutional network by the National Institute for Diabetes, Digestive, and Kidney Diseases (NIDDK) to investigate treatments for urinary incontinence in women. METHODS:Over 8 years this network composed of urologists, urogynecologists, geriatricians, behavioral psychologists, physical therapists, nurses, epidemiologists, social scientists and statisticians from nine academic sites and a Data Coordinating Center has been effective in designing and completing prospective randomized clinical trials for treatments of urinary incontinence in women. RESULTS:Two major clinical trials have been completed and a third has completed recruitment. The focus of the completed trials was a comparison of surgical methods to treat stress urinary incontinence whereas the third examined the potential benefit of combined behavioral intervention and antimuscarinic drug therapy to eliminate the need for long-term use of drug therapy alone to manage urge urinary incontinence. The scientific output of the network measured by abstracts, original papers and presentations demonstrates the productivity of the network. CONCLUSIONS:Many unique challenges are posed by a multi-disciplinary team located at sites across the United States undertaking several clinical trials. This review presents some of the logistics, barriers, tactics, and strategies used to create this successful clinical trials network focused on urinary incontinence.

journal_name

Neurourol Urodyn

authors

Steers W,Richter H,Nyberg L,Kusek J,Kraus S,Dandreo K,Chai T,Brubaker L

doi

10.1002/nau.20653

subject

Has Abstract

pub_date

2009-01-01 00:00:00

pages

170-6

issue

3

eissn

0733-2467

issn

1520-6777

journal_volume

28

pub_type

杂志文章,评审
  • Nerve growth factor in bladder dysfunction: contributing factor, biomarker, and therapeutic target.

    abstract::In the last two decades, nerve growth factor (NGF), initially described as a prototypical trophic factor in the development of sensory and sympathetic innervation, has emerged as a complex regulator of neural plasticity along the micturition pathways. This review aims to summarize the current experimental and clinical...

    journal_title:Neurourology and urodynamics

    pub_type: 杂志文章,评审

    doi:10.1002/nau.21022

    authors: Ochodnický P,Cruz CD,Yoshimura N,Michel MC

    更新日期:2011-09-01 00:00:00

  • The role of transient receptor potential ankyrin 1 (TRPA1) channel in activation of single unit mechanosensitive bladder afferent activities in the rat.

    abstract:AIMS:We investigated the role of transient receptor potential ankyrin 1 (TRPA1) channel on the single unit mechanosensitive afferent activities (SAAs) primarily originating from the bladder in the rat. METHODS:Female Sprague-Dawley rats were used. Cystometry with continuous saline instillation was performed after intr...

    journal_title:Neurourology and urodynamics

    pub_type: 杂志文章

    doi:10.1002/nau.22449

    authors: Minagawa T,Aizawa N,Igawa Y,Wyndaele JJ

    更新日期:2014-06-01 00:00:00

  • Effect of partial urethral obstruction on force development of the guinea pig bladder.

    abstract::We created gradual partial urethral obstruction in 20 guinea pigs using silver jeweler's jump rings. After 4 or 8 weeks obstruction all animals underwent cystometry and were assigned to one of five urodynamic categories: normal, high pressure voiding, unstable, low compliance, or decompensated. After sacrifice, the co...

    journal_title:Neurourology and urodynamics

    pub_type: 杂志文章

    doi:10.1002/nau.1930120607

    authors: van Koeveringe GA,Mostwin JL,van Mastrigt R,van Koeveringe BJ

    更新日期:1993-01-01 00:00:00

  • Can we define and characterize the aging lower urinary tract?-ICI-RS 2015.

    abstract::The prevalence of lower urinary tract (LUT) symptoms increases with age but the etiology is unknown. This article aims to identify research directions that clarify the basis of this association. The initial question is whether biological age is the variable of interest or a time-dependent accumulation of factors that ...

    journal_title:Neurourology and urodynamics

    pub_type: 杂志文章,评审

    doi:10.1002/nau.23035

    authors: Vahabi B,Wagg AS,Rosier PFWM,Rademakers KLJ,Denys MA,Pontari M,Lovick T,Valentini FA,Nelson PP,Andersson KE,Fry CH

    更新日期:2017-04-01 00:00:00

  • Bladder neck suspension for stress urinary incontinence: how does it work?

    abstract::The objective of this study was to compare urethral resistance as determined in pressure-flow studies before and after Burch retropubic urethropexy. Urethral resistance was retrospectively determined from pressure-flow studies in 178 patients before and 1 year after Burch retropubic urethropexy. Results of cotton swab...

    journal_title:Neurourology and urodynamics

    pub_type: 杂志文章

    doi:10.1002/(sici)1520-6777(1999)18:6<623::aid-nau12>3

    authors: Klutke JJ,Klutke CG,Bergman J,Elia G

    更新日期:1999-01-01 00:00:00

  • How to toilet train healthy children? A review of the literature.

    abstract:AIMS:To review the literature on toilet training (TT) in healthy children. METHODS:Through an extended literature search, all data on developmental signs of readiness for TT, TT methods, definitions of being toilet trained, TT problems, and predictive factors for success were reviewed. RESULTS:Specific studies on thi...

    journal_title:Neurourology and urodynamics

    pub_type: 杂志文章,评审

    doi:10.1002/nau.20490

    authors: Vermandel A,Van Kampen M,Van Gorp C,Wyndaele JJ

    更新日期:2008-01-01 00:00:00

  • Pelvic floor dysfunction negatively impacts general functional performance in patients with multiple sclerosis.

    abstract:BACKGROUND:There is a lack of evidence to assess whether gait functionality can be affected by the condition of the pelvic floor musculature in patients with multiple sclerosis (MS). OBJECTIVE:To evaluate the relationship between pelvic floor functionality and general functional performance, and also their relationshi...

    journal_title:Neurourology and urodynamics

    pub_type: 杂志文章

    doi:10.1002/nau.24314

    authors: Aguilar-Zafra S,Del Corral T,Vidal-Quevedo C,Rodríguez-Durán P,López-de-Uralde-Villanueva I

    更新日期:2020-03-01 00:00:00

  • Biochemical and morphological effects of bladder pumping on the urinary bladder in rats.

    abstract:AIMS:To study the influence of bladder pumping on the urinary bladder in 44 female rats. METHODS:Under halothane anesthesia, a urethral catheter was inserted into the bladder of 27 rats, and air (0.4-0.8 mL) was pumped in and out of the bladder at 0.5 cycles/second for a period of 5 minutes. Twenty-four hours after pu...

    journal_title:Neurourology and urodynamics

    pub_type: 杂志文章

    doi:10.1002/nau.10048

    authors: Sugaya K,Nishijima S,Hatano T,Ogawa Y,Kudo T,Nishizawa O

    更新日期:2002-01-01 00:00:00

  • Involvement of Rho-kinase in the contractile mechanism of human ureteral smooth muscle.

    abstract:AIM:Even though many agents have been implicated as modulators of ureteral contractile activity, the exact mechanisms that control human ureteral smooth muscle contractility have yet to be clearly defined. Recently, Rho-kinase has been reported to be involved in the contractile mechanism of smooth muscles in various or...

    journal_title:Neurourology and urodynamics

    pub_type: 杂志文章

    doi:10.1002/nau.20096

    authors: Hong SK,Kwak C,Chang Jeong B,Kim BS,Kim HH

    更新日期:2005-01-01 00:00:00

  • Mechanical failure rates of artificial urinary sphincter components: Is the 3.5-cm urethral cuff at higher risk?

    abstract:AIM:We report the rates of artificial urinary sphincter (AUS) mechanical failure in a contemporary cohort of patients stratified by component type and size to determine if the 3.5-cm cuff is at higher risk of failure. METHODS:From 2005-2016, a total of 486 male patients with stress incontinence underwent implantation ...

    journal_title:Neurourology and urodynamics

    pub_type: 杂志文章

    doi:10.1002/nau.23825

    authors: Loh-Doyle JC,Hartman N,Nazemi A,Wayne K,Doumanian LR,Ginsberg DA,Boyd SD

    更新日期:2019-01-01 00:00:00

  • Antidiuresis therapy: mechanism of action and clinical implications.

    abstract::Abnormalities of micturition occur in many different diseases, have a variety of causes and take several forms. This review will focus exclusively on those abnormalities in which antidiuretic therapy may be of benefit. These conditions are primarily characterized by an increase in the total amount of urine produced (p...

    journal_title:Neurourology and urodynamics

    pub_type: 杂志文章,评审

    doi:10.1002/nau.20437

    authors: Nørgaard JP,Hashim H,Malmberg L,Robinson D

    更新日期:2007-01-01 00:00:00

  • Retrospective clinic and urodynamic study in the neurogenic bladder dysfunction caused by human T cell lymphotrophic virus type 1 associated myelopathy/tropical spastic paraparesis (HAM/TSP).

    abstract:INTRODUCTION:HTLV-I associated tropical spastic paraparesis (TSP) and HTLV-I associated myelopathy (HAM) is an endemic disease in Caribbean Island. Bladder-sphincter dysfunctions are almost present. The objectives of the study are to describe clinic and urodynamic characteristics of voiding disorders in Martiniquan pop...

    journal_title:Neurourology and urodynamics

    pub_type: 杂志文章

    doi:10.1002/nau.22952

    authors: Troisgros O,Barnay JL,Darbon-Naghibzadeh F,Olive P,René-Corail P

    更新日期:2017-02-01 00:00:00

  • Precise injection of human mesenchymal stromal cells in the urethral sphincter complex of Göttingen minipigs without unspecific bulking effects.

    abstract:AIM:To investigate if injection of cells in the urethral sphincter complex causes unspecific bulking effects. METHODS:Human mesenchymal stromal cells were isolated, expanded, and characterized. For transurethral injection, cells were labeled with the fluorescent dye PKH26 and in magnetic resonance imaging associated e...

    journal_title:Neurourology and urodynamics

    pub_type: 杂志文章

    doi:10.1002/nau.23182

    authors: Amend B,Kelp A,Vaegler M,Klünder M,Frajs V,Klein G,Sievert KD,Sawodny O,Stenzl A,Aicher WK

    更新日期:2017-09-01 00:00:00

  • Autonomous contractile activity in the isolated rat bladder is modulated by a TRPV1 dependent mechanism.

    abstract:AIMS:Resiniferatoxin (RTX), a vanilloid compound and agonist of the transient receptor potential channel 1 (TRPV1), is known for its beneficial effects on neurogenic detrusor overactivity. The mainstream rationale for its use is the desensitization of TRPV1 on sensory bladder afferents. However, recent findings showed ...

    journal_title:Neurourology and urodynamics

    pub_type: 杂志文章

    doi:10.1002/nau.20313

    authors: Gevaert T,Vandepitte J,Ost D,Nilius B,De Ridder D

    更新日期:2007-01-01 00:00:00

  • Succinate decreases bladder function in a rat model associated with metabolic syndrome.

    abstract:AIMS:Succinate and its receptor, GPR91, have been implicated in different aspects of metabolic syndrome. As GPR91 is expressed in the urinary bladder, the aim of this study is to show the effect of chronically increased succinate levels on bladder function. MATERIALS AND METHODS:Healthy Sprague-Dawley (SD) rats and hy...

    journal_title:Neurourology and urodynamics

    pub_type: 杂志文章

    doi:10.1002/nau.23488

    authors: Velasquez Flores M,Mossa AH,Cammisotto P,Campeau L

    更新日期:2018-06-01 00:00:00

  • Long-term treatment of older patients with overactive bladder using a combination of mirabegron and solifenacin: a prespecified analysis from the randomized, phase III SYNERGY II study.

    abstract:AIMS:SYNERGY II was a 12-month phase III trial in patients with overactive bladder (OAB) symptoms that investigated the safety and efficacy of the combination of mirabegron and solifenacin in comparison with each monotherapy. This analysis evaluated the trial findings using four age subgroups (<65, ≥65, <75, and ≥75 ye...

    journal_title:Neurourology and urodynamics

    pub_type: 杂志文章,随机对照试验

    doi:10.1002/nau.23919

    authors: Mueller ER,van Maanen R,Chapple C,Abrams P,Herschorn S,Robinson D,Stoelzel M,Yoon SJ,Al-Shukri S,Rechberger T,Gratzke C

    更新日期:2019-02-01 00:00:00

  • Morphometric data of canine sacral nerve roots with reference to electrical sacral root stimulation.

    abstract::Experiments to investigate restoration of lower urinary tract control by electrical stimulation of the sacral nerve roots are mostly performed on dogs, yet little morphometric data (such as canine root and fiber diameter distributions) are available. The aim of this study was to acquire morphometric data of the intrad...

    journal_title:Neurourology and urodynamics

    pub_type: 杂志文章

    doi:10.1002/(SICI)1520-6777(1996)15:3<235::AID-NAU8>3.

    authors: Rijkhoff NJ,Koldewijn EL,d'Hollosy W,Debruyne FM,Wijkstra H

    更新日期:1996-01-01 00:00:00

  • Comparison between urinary diaries completed with and without intensive patient instructions.

    abstract::The evaluation of the incontinent patient relies on accurate assessment of urinary symptoms. Although the 7 day urinary diary is a reproducible method of data collection, the optimal means of implementing this diary is unknown. The urinary diary is usually employed after the initial clinical pathophysiologic evaluatio...

    journal_title:Neurourology and urodynamics

    pub_type: 临床试验,杂志文章

    doi:10.1002/(SICI)1520-6777(1996)15:2<143::AID-NAU3>3.

    authors: Robinson D,McClish DK,Wyman JF,Bump RC,Fanti JA

    更新日期:1996-01-01 00:00:00

  • Association of index finger palpatory assessment of pubovisceral muscle body integrity with MRI-documented tear.

    abstract:AIMS:Pubovisceral (PV) muscle tears are associated with pelvic floor disorders. The goal of this study was to determine whether index finger palpatory assessment of PV muscle body integrity through the lateral vaginal wall is a reliable indicator of PV muscle tear severity diagnosed by magnetic resonance imaging (MRI)....

    journal_title:Neurourology and urodynamics

    pub_type: 杂志文章

    doi:10.1002/nau.23967

    authors: Sheng Y,Low LK,Liu X,Ashton-Miller JA,Miller JM

    更新日期:2019-04-01 00:00:00

  • Surgical anatomy of the dorsal nerve of the clitoris.

    abstract:AIMS:The purpose of this study was to describe the distal pathway of the dorsal nerve of the clitoris (DNC) from gross anatomical and histological studies of cadaver specimens. METHODS:We performed dissections on 14 intact adult cadaver vulva specimens using 2× loupe magnification and microscopy. The DNC was identifie...

    journal_title:Neurourology and urodynamics

    pub_type: 杂志文章

    doi:10.1002/nau.20996

    authors: Ginger VA,Cold CJ,Yang CC

    更新日期:2011-03-01 00:00:00

  • The relationship among flow index, uroflowmetry curve shape, and EMG lag time in children.

    abstract:PURPOSE:To determine the relationship among flow index (FI), uroflowmetry curve shape, and electromyography (EMG) lag time in children. MATERIALS AND METHODS:A total of 294 children with lower urinary tract symptoms were included. The overall relationship between lag time and FI was investigated with curve estimation ...

    journal_title:Neurourology and urodynamics

    pub_type: 杂志文章

    doi:10.1002/nau.24349

    authors: Ha JS,Lee YS,Han SW,Kim SW

    更新日期:2020-06-01 00:00:00

  • The effect of bladder sensation on uroflowmetry parameters in healthy young men.

    abstract:AIMS:To investigate the effect of the bladder sensation grade on uroflowmetry parameters. METHODS:Fifty healthy volunteering young men were enrolled in the present study. In total, three uroflowmetry evaluations were made. Qmax , Qave , VV, and PVR urine was obtained three times in three described bladder sensation gr...

    journal_title:Neurourology and urodynamics

    pub_type: 杂志文章

    doi:10.1002/nau.22762

    authors: Kaynar M,Kucur M,Kiliç O,Akand M,Gul M,Goktas S

    更新日期:2016-06-01 00:00:00

  • Levator plate descent correlates with levator ani muscle deficiency.

    abstract:AIMS:Measurements such as the minimal levator hiatus dimension, levator plate angle, iliococcygeal angle, and anorectal angle have been used for assessing the impact of levator damage on static and dynamic imaging features. The primary aim of this study was to investigate the association between levator ani muscle defi...

    journal_title:Neurourology and urodynamics

    pub_type: 杂志文章

    doi:10.1002/nau.22509

    authors: Rostaminia G,White DE,Quiroz LH,Shobeiri SA

    更新日期:2015-01-01 00:00:00

  • Results of surgical excision of urethral prolapse in symptomatic patients.

    abstract:AIM:Here, we present the clinical presentation and surgical outcomes of women with symptomatic urethral prolapse presenting to our institution over 20 years, and seek to provide treatment recommendations for management of symptomatic urethral prolapse and caruncle. METHODS:A retrospective review of medical records fro...

    journal_title:Neurourology and urodynamics

    pub_type: 杂志文章

    doi:10.1002/nau.23232

    authors: Hall ME,Oyesanya T,Cameron AP

    更新日期:2017-11-01 00:00:00

  • Effect of anesthetics on reflex micturition in the chronic cannula-implanted rat.

    abstract::It is well known that urethane is a suitable anesthetic for acute studies and has been extensively recommended for investigations related to micturition physiology. This is mainly because of the capability of urethane anesthesia to spare reflex micturition as well as its easily established long-lasting and stable anes...

    journal_title:Neurourology and urodynamics

    pub_type: 杂志文章

    doi:10.1002/(sici)1520-6777(2000)19:1<87::aid-nau9>3.0

    authors: Matsuura S,Downie JW

    更新日期:2000-01-01 00:00:00

  • Comparison of voiding function and nociceptive behavior in two rat models of cystitis induced by cyclophosphamide or acetone.

    abstract:AIMS:Nociceptive behavior and its relationship with bladder dysfunction were investigated in two cystitis models, which were induced by intraperitoneal (i.p.) injection of cyclophosphamide (CYP) or intravesical instillation of acetone, using freely moving, non-catheterized conscious rats. METHODS:Female Sprague-Dawley...

    journal_title:Neurourology and urodynamics

    pub_type: 杂志文章

    doi:10.1002/nau.20777

    authors: Saitoh C,Yokoyama H,Chancellor MB,de Groat WC,Yoshimura N

    更新日期:2010-03-01 00:00:00

  • Stretch- and carbachol-induced ATP release from bladder wall preparations of young and aged mice.

    abstract:AIMS:Bladder wall stretch increases tissue tension and releases adenosine 5'-triphosphate (ATP) as part of a transduction process to sense bladder filling. Aging is associated with bladder fibrosis to produce a stiffer bladder wall: this may augment ATP release and contribute to age-dependent urgency. Muscarinic agonis...

    journal_title:Neurourology and urodynamics

    pub_type: 杂志文章

    doi:10.1002/nau.24426

    authors: Nishikawa N,Chakrabarty B,Kitney D,Jabr R,Kanai A,Fry C

    更新日期:2020-08-01 00:00:00

  • Reproducibility of urodynamic filling sensation at weekly interval in healthy volunteers and in women with detrusor overactivity.

    abstract:AIMS:To evaluate the reproducibility of bladder sensation during standardized filling cystometry in female volunteers and overactive bladder (OAB) patients, repeated with weekly interval. METHODS:We recruited 13 female nulliparous volunteers (age 21-47) and 17 female patients with OAB between (age 18-72). They partici...

    journal_title:Neurourology and urodynamics

    pub_type: 杂志文章

    doi:10.1002/nau.21100

    authors: Van Meel TD,Wyndaele JJ

    更新日期:2011-11-01 00:00:00

  • Urodynamics prior to treatment as an intervention: a pilot study.

    abstract:AIMS:To evaluate whether the treatment based on urodynamics (UDS) leads to better treatment response compared to where the treatment is based on symptoms alone. STUDY DESIGN, MATERIALS AND METHODS:All patients referred with lower urinary tract symptoms (LUTS) were offered the opportunity to participate in this patient...

    journal_title:Neurourology and urodynamics

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.1002/nau.20810

    authors: Majumdar A,Latthe P,Toozs-Hobson P

    更新日期:2010-04-01 00:00:00

  • Should we be revisiting LUT basic science and clinical measurement of LUT sensation to improve patient care? ICI-RS 2019.

    abstract:AIMS:This article reviews current knowledge of the underpinning mechanisms of how the bladder senses fullness locally and also revisits clinical measurements of lower urinary tract sensation. The former represents cellular sensing during bladder filling whereas the latter describes the sensations leading to conscious p...

    journal_title:Neurourology and urodynamics

    pub_type: 杂志文章,评审

    doi:10.1002/nau.24273

    authors: McCloskey KD,Wyndaele JJ,Speich JE,Birder L,Nelson PP

    更新日期:2020-07-01 00:00:00