Papers by Michael Kennelly
A nonsurgical laser procedure is being developed for treatment of female stress urinary incontine... more A nonsurgical laser procedure is being developed for treatment of female stress urinary incontinence (SUI). Previous studies in porcine vaginal tissues, ex vivo, as well as computer simulations, showed the feasibility of using near-infrared laser energy delivered through a transvaginal contact cooling probe to thermally remodel endopelvic fascia, while preserving the vaginal wall from thermal damage. This study explores optical properties of vaginal tissue in cadavers as an intermediate step towards future pre-clinical and clinical studies. Optical clearing of tissue using glycerol resulted in a 15-17% increase in optical transmission after 11 min at room temperature (and a calculated 32.5% increase at body temperature). Subsurface thermal lesions were created using power of 4.6-6.4 W, 5.2-mm spot, and 30 s irradiation time, resulting in partial preservation of vaginal wall to 0.8-1.1 mm depth.
American Journal of Gastroenterology
Journal of Urology, 2020
INTRODUCTION AND OBJECTIVE:Urinary Incontinence (UI) is an involuntary loss or leakage of urine i... more INTRODUCTION AND OBJECTIVE:Urinary Incontinence (UI) is an involuntary loss or leakage of urine impacting quality of life, affecting physical, mental and sexual well-being. Single-center studies us...
Journal of Minimally Invasive Gynecology, 2016
Neurourology and Urodynamics, 2019
Spinal Cord Series and Cases, 2021
Study design Online survey distributed to healthcare professionals (HCPs) involved in care of spi... more Study design Online survey distributed to healthcare professionals (HCPs) involved in care of spinal cord injury (SCI) patients with neurogenic lower urinary tract dysfunction (NLUTD). Objectives Identify and bring awareness to the variation of neurogenic bladder management in around the world. Setting International online questionnaire. Methods A 32-question survey was drafted and circulated among a global network of SCI experts for review. The survey was disseminated to healthcare professionals involved in the care of NLUTD in SCI patients via social media, grassroots methods, and international societies. The survey was available for 6 weeks and respondents answered questions regarding SCI population demographics, access to care, common neurogenic bladder management, diagnostic and imaging methods, complications, and follow up. Results A total of 296 healthcare professionals, 132 from North America, 87 from Europe, 27 from Asia, 24 from Australia, 14 from South America, and 6 from Africa, responded to the survey. Global concurrence was noted among management method for patients without adequate hand function, first-line treatment for neurogenic detrusor overactivity, and common complications. Continents highly differed in responses regarding management method for patients with adequate hand function, frequency of patients reusing catheters, timing of urodynamics, and duration of antibiotic therapy for urinary tract infections. Conclusions The results of this international survey demonstrate the variability and uniqueness in neurogenic bladder management in SCI patients around the world. Increased international discourse and education will improve global communication and transparency with the efforts of reducing discrepancies in care.
International Journal of Gynecology & Obstetrics, 2012
Spinal Cord, Oct 28, 2008
Journal of Urology, 2005
Purpose: The feasibility of automatic event driven electrical stimulation of the dorsal penile/cl... more Purpose: The feasibility of automatic event driven electrical stimulation of the dorsal penile/clitoral nerve in treatment of neurogenic detrusor overactivity (NDO) was evaluated in individuals with spinal cord injury (SCI). Materials and Methods: The study included 2 women and 14 men with NDO, bladder capacities below 500 ml, age over 18 years and complete or incomplete suprasacral SCI. Detrusor pressure (P det) was recorded during an ordinary natural bladder filling. In a similar subsequent recording P det was used to trigger electrical stimulation when the pressure exceeded 10 cmH 2 O. Results: Of the 16 patients enrolled in this study 13 had an increased bladder capacity together with a storage pressure decrease as a result of automatic event driven electrical stimulation. In two patients the stimulation could not inhibit the first undesired contraction and leakage occurred and finally one patient could not tolerate the stimulation. During the stimulated filling P det never exceeded 55 cmH 2 O and the storage pressure is thus sufficiently low to prevent kidney damage. An average bladder capacity increase of 53% was obtained. Conclusions: This study demonstrates the feasibility of automatic event driven electrical stimulation in the treatment of NDO. Although the setup in this experiment is not suitable in a clinical setting, the treatment modality is promising and it warrants further investigation.
BMC Urology, Apr 24, 2023
Background Overactive bladder (OAB) is defined as urinary urgency accompanied by frequency and no... more Background Overactive bladder (OAB) is defined as urinary urgency accompanied by frequency and nocturia, with or without urge urinary incontinence (UUI). Vibegron, a selective β 3-adrenergic receptor agonist approved in the US in December 2020, demonstrated efficacy in reducing symptoms of OAB and was safe and well tolerated in the 12-week EMPOWUR trial and its 40-week, double-blind extension trial. The goal of the COMPOSUR study is to evaluate vibegron in a real-world setting to assess patient treatment satisfaction, tolerability, safety, duration of treatment, and persistence. Methods This is a 12-month, prospective, observational, real-world study, with an optional 12-month extension to 24 months, in the US assessing adults ≥ 18 years old starting a new course of vibegron. Patients must be previously diagnosed with OAB with or without UUI, symptomatic for ≥ 3 months before enrollment, and receive prior treatment with an anticholinergic, with mirabegron, or with a combination of an anticholinergic and mirabegron. Enrollment is performed by the investigator following exclusion and inclusion criteria guided by US product labeling, reinforcing a real-world approach. Patients complete the OAB Satisfaction with Treatment Questionnaire (OAB-SAT-q) monthly and the OAB Questionnaire short form (OAB-q-SF) and Work Productivity and Activity Impairment Questionnaire (WPAI:US) at baseline and monthly for 12 months. Patients are followed up via phone call, in-person visits, or telehealth (ie, virtual) visits. The primary endpoint is patient treatment satisfaction as determined by the OAB-SAT-q satisfaction domain score. Secondary endpoints include percent positive responses to individual OAB-SAT-q questions, additional OAB-SAT-q domain scores, and safety. Exploratory endpoints include adherence and persistence. Discussion OAB leads to a significant decrease in quality of life, as well as impairment of work activities and productivity. Persistence with OAB treatments can be challenging, often due to lack of efficacy and adverse effects. COM-POSUR is the first study to provide long-term, prospective, pragmatic treatment data for vibegron in the US and the resultant effect on quality of life among patients with OAB in a real-world clinical setting.
The Journal of Urology, Nov 1, 2021
Purpose: The clinician treating patients with neurogenic lower urinary tract dysfunction (NLUTD) ... more Purpose: The clinician treating patients with neurogenic lower urinary tract dysfunction (NLUTD) needs to balance a variety of factors when making treatment decisions. In addition to the patient’s urologic symptoms and urodynamic findings, other issues that may influence management options of the lower urinary tract include cognition, hand function, type of neurologic disease, mobility, bowel function/management, and social and caregiver support. This Guideline allows the clinician to understand the options available to treat patients, understand the findings that can be seen in NLUTD, and appreciate which options are best for each individual patient. This allows for decisions to be made with the patient, in a shared decision-making manner, such that the patient’s quality of life can be optimized with respect to their bladder management. Materials and Methods: A comprehensive search for studies assessing patients undergoing evaluation, surveillance, management, or follow-up for NLUTD was conducted from January 2001 through October 2017 and was rerun in February 2021 to capture newer literature. The primary search returned 20,496 unique citations. Following a title and abstract screen, full texts were obtained for 3,036 studies. During full-text review, studies were primarily excluded for not meeting the PICO criteria. One hundred eight-four primary literature studies met the inclusion criteria and were included in the evidence base. Results: This guideline was developed to inform clinicians on the proper evaluation, diagnosis, and risk stratification of patients with NLUTD and the non-surgical and surgical treatment options available. Additional statements on urinary tract infection and autonomic dysreflexia were developed to guide the clinician. This Guideline is for adult patients with NLUTD and pediatric NLUTD will not be discussed. Conclusions: NLUTD patients should be risk-stratified as either low-, moderate-, high-, or unknown-risk. After diagnosis and stratification, patients should be monitored according to their level of risk at regular intervals. Patients who experience new or worsening signs and symptoms should be reevaluated and risk stratification should be repeated.
The Journal of Urology, Nov 1, 2021
Purpose: The clinician treating patients with neurogenic lower urinary tract dysfunction (NLUTD) ... more Purpose: The clinician treating patients with neurogenic lower urinary tract dysfunction (NLUTD) needs to balance a variety of factors when making treatment decisions. In addition to the patient’s urologic symptoms and urodynamic findings, other issues that may influence management options of the lower urinary tract include cognition, hand function, type of neurologic disease, mobility, bowel function/management, and social and caregiver support. This Guideline allows the clinician to understand the options available to treat patients, understand the findings that can be seen in NLUTD, and appreciate which options are best for each individual patient. This allows for decisions to be made with the patient, in a shared decision-making manner, such that the patient’s quality of life can be optimized with respect to their bladder management. Materials and Methods: A comprehensive search for studies assessing patients undergoing evaluation, surveillance, management, or follow-up for NLUTD was conducted from January 2001 through October 2017 and was rerun in February 2021 to capture newer literature. The primary search returned 20,496 unique citations. Following a title and abstract screen, full texts were obtained for 3,036 studies. During full-text review, studies were primarily excluded for not meeting the PICO criteria. One hundred eight-four primary literature studies met the inclusion criteria and were included in the evidence base. Results: This guideline was developed to inform clinicians on the proper evaluation, diagnosis, and risk stratification of patients with NLUTD and the non-surgical and surgical treatment options available. Additional statements on urinary tract infection and autonomic dysreflexia were developed to guide the clinician. This Guideline is for adult patients with NLUTD and pediatric NLUTD will not be discussed. Conclusions: NLUTD patients should be risk-stratified as either low-, moderate-, high-, or unknown-risk. After diagnosis and stratification, patients should be monitored according to their level of risk at regular intervals. Patients who experience new or worsening signs and symptoms should be reevaluated and risk stratification should be repeated.
The Journal of Spinal Cord Medicine, 2020
Objective: To provide an overview of clinical assessments and diagnostic tools, self-report measu... more Objective: To provide an overview of clinical assessments and diagnostic tools, self-report measures (SRMs) and data sets used in neurogenic bladder and bowel (NBB) dysfunction and recommendations for their use with persons with spinal cord injury /disease (SCI/D). Methods: Experts in SCI/D conducted literature reviews, compiled a list of NBB related assessments and measures, reviewed their psychometric properties, discussed their use in SCI/D and issued recommendations for the National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS) Common Data Elements (CDEs) guidelines. Results: Clinical assessments included 15 objective tests and diagnostic tools for neurogenic bladder and 12 for neurogenic bowel. Following a two-phase evaluation, eight SRMs were selected for final review with the Qualiveen and Short-Form (SF) Qualiveen and the Neurogenic Bowel Dysfunction Score (NBDS) being recommended as supplemental, highly-recommended due to their strong psychometrics and extensive use in SCI/D. Two datasets and other SRM measures were recommended as supplemental.
Neurourology and Urodynamics, 2014
Kennelly M, Schulte-Baukloh H, Dmochowski R, Ethans K, Moore C, Zheng Y, Guard S, Jenkins B, Kars... more Kennelly M, Schulte-Baukloh H, Dmochowski R, Ethans K, Moore C, Zheng Y, Guard S, Jenkins B, Karsenty G 1. Carolinas Rehabilitation, Charlotte, NC, USA, 2. Hedwig-Krankenhaus, Berlin, Germany, 3. Vanderbilt University, Nashville, TN, USA, 4. University of Manitoba, Winnipeg, Manitoba, CA, 5. Cleveland Clinic, Cleveland, OH, USA, 6. Allergan, Inc., Bridgewater, NJ, USA, 7. Allergan, Inc, Marlow, UK, 8. Allergan, Inc, Irvine, CA, USA, 9. AixMarseille Universite, Marseille, France
Progrès en Urologie, 2014
Objectifs Suite a deux etudes internationales de phase 3 (randomisees, en double insu, comparativ... more Objectifs Suite a deux etudes internationales de phase 3 (randomisees, en double insu, comparatives avec placebo) evaluant le traitement par BOTOX ® de patients incontinents par hyperactivite du detrusor d’origine neurogene et refractaires au traitement par au moins 1 anti-cholinergique, les resultats finaux d’une etude multicentrique de suivi a long terme de patients ayant recu des injections repetees pendant une periode maximale de 4 annees sont presentes. Methodes Les patients SEP ou blesses medullaires ayant termine l’etude de phase 3 de 52 semaines, pouvaient integrer une etude de suivi a long terme de 3 ans avec traitements multiples (200 U ou 300 U). Les patients ont ete retraites a la demande avec des criteres de retraitement predefinis (3 mois de delais avec l’injection precedente et 1 fuite au moins sur le calendrier mictionnel des 3 jours. Criteres evalues : diminution des episodes quotidiens d’IU (critere principal), volume mictionnel, duree d’effet, evenements indesirables (EI) taux de recours a l’autosondage (ASIP). Resultats Au total, 388 patients ont recu des traitements successifs (4,2 avec BOTOX 200 U) jusqu’a 4 ans Le taux d’arret pour cause d’effets indesirables ou manque efficacite etait faible (3,1 %, 2,1 %), le taux global d’arret de 41,5 %. Des traitements repetes (jusqu’a 8) de BOTOX ® ont reduit de facon constante le nombre moyen d’episodes quotidiens d’IU versus la valeur de reference a semaine 6 (entre –3,2 et –4,1 avec 200 U). Le volume mictionnel augmentait de +166,1 ml (200 U)). La duree moyenne d’efficacite etait de 36,2 semaines (200 U). Les resultats avec 300 U etaient semblables. Les infections urinaires et la retention urinaire etaient les effets indesirables les plus communs. Les taux d’ASIP de novo avec 200U etaient de 29,5 %, 3,4 % et 6 % (cycles 1–3), puis 0 % (cycles 4–8). Conclusion Chez des patients souffrant d’HDN et dont l’incontinence n’est pas controlee par la prise d’au moins 1 anti-cholinergique, des injections repetees de BOTOX ® reduisent de facon significative les episodes quotidiens d’IU et ameliorent le volume mictionnel. Aucun nouveau signe d’intolerance sur une periode de suivi de quatre ans n’a ete detecte.
Journal of Clinical Medicine
Urinary tract infections (UTIs) are common and troublesome complications of clean intermittent ca... more Urinary tract infections (UTIs) are common and troublesome complications of clean intermittent catheterisation (CIC) in individuals suffering from incomplete bladder emptying, which may exacerbate the underlying disease and lead to hospitalisation. Aside from the design of the intermittent catheter and its handling, a recent review highlighted residual urine as one of several UTI risk factors. A new urinary intermittent catheter with multiple micro-holes has been developed for improved bladder emptying. In a controlled crossover study, adult male CIC users were randomised for a health care professional-led catheterisation with the new micro-hole zone catheter (MHZC) and a conventional eyelet catheter (CEC) in two individual test visits to compare the number of flow-stops and the residual urine at the first flow-stop as co-primary endpoints. In 42 male CIC users, the MHZC resulted in significantly fewer flow-stop episodes compared to the CEC (mean 0.17, 95% CI [0.06, 0.45] vs. mean 1...
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Papers by Michael Kennelly