Incontinence and Quality of Life in Children With Spina Bifida
NCT ID: NCT03410667
Last Updated: 2025-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
NA
67 participants
INTERVENTIONAL
2019-12-01
2026-03-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Use of a Diurnal Indwelling Urethral Catheter to Improve Quality of Life
NCT03573726
Micturition Reeducation in Children With Cerebral Palsy
NCT02364063
Nerve Rerouting Treatment for Neurogenic Bladder in Spina Bifida
NCT01096459
Pilot: Mind Over Matter: Healthy Bowels, Healthy Bladder
NCT02671747
Stem Cells Therapy for Fecal Incontinence in Children After Posterior Sagittal Ano-rectoplasty
NCT02161003
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Phase 2: In order to achieve a holistic and sustainable intervention, it is crucial that the investigators work with an interdisciplinary team that include designers, researchers, patients, family members, other caregivers, and health care providers in the process of creating the intervention. Therefore, the investigators will invite 8-10 of the dyads from Phase One to participate as members of the Co-Design Panel which will be brought together to participate in a 2-4 hour co-design session. During this session, designers will share the insights gained from Phase One work. Panel participants will be asked to help refine these insights to define domains of patient-centered urinary incontinence goals. From there, the Co-Design Panel will work to generate solutions for a tool to facilitate goal-setting and follow-up related to these domains (i.e., the tool, or app). This will be done through a series of generative, prototyping exercises with participants. For example, the group could work in small teams to generate ideas for their ideal goal-setting tool and then use sketches, storyboards, building materials like foam core, or verbal story-telling to prototype these ideas. The options for prototyping will be diverse to accommodate a spectrum of physical and cognitive abilities. These prototypes can then be used to generate discussion among the Co-Design Panel, which will further refine the ideal aspects of the app from the perspective of children and adolescents with SB and their caregivers.
The Physician Panel will then be invited to respond to a prototype of the app and give their input on how it can be improved to best fit into clinic workflow, address physician preferences, and work for a variety of patient-physician scenarios. These responses will be gathered through structured in-person interviews.
Phase 3: The investigators will ask patient/caregiver dyads with spina bifida (N=8), who were not part of the Co-Design Panel in Phase Two, to utilize the tool in conjunction with their pediatric urologist during a pediatric urology clinic visit at Riley Hospital. The investigators will comply with all IRB requirements at the study institution for the inclusion of patients in research, including obtaining the necessary consents/assents.
Testing Process. Following the clinic visit, the patient/caregiver will participate in Cognitive Interviews. They will be asked to describe their impressions of the prototype app through the use of scripted verbal probes ("What do you think is being represented here?" "Describe what you would do next.") and spontaneous probes ("What about this picture/sentence/etc., makes you feel that way?"), the investigators will determine if the prototype app is functioning as expected, or any key elements were missed. The investigators will also ask for feedback from the urologists on how well the tool functioned within the clinic setting to help in this iterative validation process. This will be accomplished by conducting interviews with approximately 6 physicians.
Phase 4: The investigators will recruit children and adolescents with SB (8-17 years old) who are followed at Riley Hospital Pediatric Urology Outpatient Clinic and their primary caregiver. The primary caregiver must be the patient's legal guardian. Well over 200 children and adolescents with SB are seen at this facility annually. Each week, a research assistant (RA) will be given a list of SB patients within the desired age range who have an upcoming appointment in two settings: the Pediatric Urology Clinic or the multidisciplinary Spina Bifida clinic. The RA will approach the patient and their primary caregiver upon arrival at the clinic appointment to gauge their interest in study participation. If the dyad indicates potential interest, the RA will take them to a private area to further discuss the details of the study, determine eligibility, and then obtain consent from the legal caregiver and assent from the patient wishing to enroll in the study. Over a 12-month period, the investigators will enroll 92 children and adolescents with SB and their primary caregivers. After enrollment in the study, the RA will administer the app, and collect baseline data regarding self-reported urinary and fecal incontinence and HRQOL. The patient and their caregiver will then meet with their urologist for the scheduled clinic appointment. After being enrolled at baseline, participants will continue with standard care for 12 months (while completing UI, HRQOL, and other questionnaires), at which point the app is introduced and the goal is set, and then they are followed for another 12 months. The urologist will be provided with the completed app and will utilize this tool to verify/discuss the goal selected, and then discuss plans for treatment in order to achieve this goal. Goal attainment, UI, and HRQOL will be assessed at 6 and 12 months after the app is introduced. Children with SB are typically seen in the outpatient clinic every 6-12 months. Therefore, these follow-up assessments will occur in-person at a clinic appointment, or, if not possible, investigators will contact the participant by telephone to notify them that an email link to a secure website to complete the necessary assessments will be sent. To minimize loss to follow-up, investigators will ask for 3 different phone numbers with at least one being a landline (if available). Investigators will also ask for two email addresses. Up to 3 attempts will be made to reach participants.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Standard Care
Standard of care arm
Phase One: Exploration
Spina Bifida patients from the pediatric urology clinic at Riley Hospital and their caregivers will participate in discussions of UI goals. These patients will self report their experiences and perspectives using a "Day in the Life" diary tool-kit.
Phase Two: Creation
Patients, caregivers and providers will work to create a goal setting tool to help patients and physicians appropriately address the issue of UI in patients with spina bifida.
Phase Three: Reflection
This is a validation step to test whether the goal-setting tool is widely applicable and functional in a clinic setting. There will be cognitive interviews after the tool is completed to gather patient impressions.
Intervention Arm
Intervention arm
Aim 3
This will be a large scale validation of the app, with assignment to standard care for the first year of enrollment.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Phase One: Exploration
Spina Bifida patients from the pediatric urology clinic at Riley Hospital and their caregivers will participate in discussions of UI goals. These patients will self report their experiences and perspectives using a "Day in the Life" diary tool-kit.
Phase Two: Creation
Patients, caregivers and providers will work to create a goal setting tool to help patients and physicians appropriately address the issue of UI in patients with spina bifida.
Phase Three: Reflection
This is a validation step to test whether the goal-setting tool is widely applicable and functional in a clinic setting. There will be cognitive interviews after the tool is completed to gather patient impressions.
Aim 3
This will be a large scale validation of the app, with assignment to standard care for the first year of enrollment.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 8-17 years old
* Followed at Riley Hospital Pediatric Urology Outpatient Clinic
* Primary caregiver is patient's legal guardian
* Urinary incontinence in the past 4 weeks
* Fecal incontinence in the past 4 weeks
* Normal to mildly impaired cognitive development
* English language literacy
* Intent to receive care at the Riley Pediatric Urology Clinic for th extent of the study
The physician panel will be composed of pediatric urologists.
Exclusion Criteria
* Patients who underwent a genitourinary procedure or a bowel procedure in the past 4 weeks, since these patients are often temporarily catheterized and therefore not experiencing their typical level of urinary and fecal incontinence.
8 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Indiana University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Konrad Szymanski
Assistant Professor of Urology
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Riley Hospital for Children
Indianapolis, Indiana, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Szymanski KM, Cain MP, Hardacker TJ, Misseri R. How successful is the transition to adult urology care in spina bifida? A single center 7-year experience. J Pediatr Urol. 2017 Feb;13(1):40.e1-40.e6. doi: 10.1016/j.jpurol.2016.09.020. Epub 2016 Nov 9.
Roth JD, Misseri R, Cain MP, Szymanski KM. Mobility, hydrocephalus and quality of erections in men with spina bifida. J Pediatr Urol. 2017 Jun;13(3):264.e1-264.e6. doi: 10.1016/j.jpurol.2016.12.004. Epub 2017 Jan 11.
Szymanski KM, Misseri R, Whittam B, Large T, Cain MP. Current opinions regarding care of the mature pediatric urology patient. J Pediatr Urol. 2015 Oct;11(5):251.e1-4. doi: 10.1016/j.jpurol.2015.05.020. Epub 2015 Jun 21.
Strine AC, Misseri R, Szymanski KM, Kaefer M, Rhee AC, Hillier K, Rink RC, Cain MP. Assessing health related benefit after reconstruction for urinary and fecal incontinence in children: a parental perspective. J Urol. 2015 Jun;193(6):2073-8. doi: 10.1016/j.juro.2014.12.089. Epub 2015 Jan 3.
Szymanski KM, Misseri R, Whittam B, Kaefer M, Rink RC, Cain MP. Quantity, Not Frequency, Predicts Bother with Urinary Incontinence and its Impact on Quality of Life in Adults with Spina Bifida. J Urol. 2016 Apr;195(4 Pt 2):1263-9. doi: 10.1016/j.juro.2015.07.108. Epub 2016 Feb 28.
Szymanski KM, Cain MP, Whittam B, Kaefer M, Rink RC, Misseri R. All Incontinence is Not Created Equal: Impact of Urinary and Fecal Incontinence on Quality of Life in Adults with Spina Bifida. J Urol. 2017 Mar;197(3 Pt 2):885-891. doi: 10.1016/j.juro.2016.08.117. Epub 2017 Jan 26.
Snow-Lisy DC, Yerkes EB, Cheng EY. Update on Urological Management of Spina Bifida from Prenatal Diagnosis to Adulthood. J Urol. 2015 Aug;194(2):288-96. doi: 10.1016/j.juro.2015.03.107. Epub 2015 Apr 1.
Metcalfe PD, Cain MP, Kaefer M, Gilley DA, Meldrum KK, Misseri R, King SJ, Casale AJ, Rink RC. What is the need for additional bladder surgery after bladder augmentation in childhood? J Urol. 2006 Oct;176(4 Pt 2):1801-5; discussion 1805. doi: 10.1016/j.juro.2006.03.126.
Salle JL, McLorie GA, Bagli DJ, Khoury AE. Urethral lengthening with anterior bladder wall flap (Pippi Salle procedure): modifications and extended indications of the technique. J Urol. 1997 Aug;158(2):585-90. doi: 10.1097/00005392-199708000-00092.
Murray CB, Holmbeck GN, Ros AM, Flores DM, Mir SA, Varni JW. A longitudinal examination of health-related quality of life in children and adolescents with spina bifida. J Pediatr Psychol. 2015 May;40(4):419-30. doi: 10.1093/jpepsy/jsu098. Epub 2014 Nov 29.
Sawin KJ, Bellin MH. Quality of life in individuals with spina bifida: a research update. Dev Disabil Res Rev. 2010;16(1):47-59. doi: 10.1002/ddrr.96.
Lloyd JC, Nseyo U, Madden-Fuentes RJ, Ross SS, Wiener JS, Routh JC. Reviewing definitions of urinary continence in the contemporary spina bifida literature: a call for clarity. J Pediatr Urol. 2013 Oct;9(5):567-74. doi: 10.1016/j.jpurol.2013.02.006. Epub 2013 Mar 16.
Kiresuk TJ, Sherman RE. Goal attainment scaling: A general method for evaluating comprehensive community mental health programs. Community Ment Health J. 1968 Dec;4(6):443-53. doi: 10.1007/BF01530764.
Hullfish KL, Bovbjerg VE, Gurka MJ, Steers WD. Surgical versus nonsurgical treatment of women with pelvic floor dysfunction: patient centered goals at 1 year. J Urol. 2008 Jun;179(6):2280-5; discussion 2285. doi: 10.1016/j.juro.2008.01.147. Epub 2008 Apr 18.
Anderson CB, Rapkin B, Reaves BC, Sun AJ, Morganstern B, Dalbagni G, Donat M, Herr HW, Laudone VP, Bochner BH. Idiographic quality of life assessment before radical cystectomy. Psychooncology. 2017 Feb;26(2):206-213. doi: 10.1002/pon.4025. Epub 2015 Nov 30.
Vroland-Nordstrand K, Eliasson AC, Jacobsson H, Johansson U, Krumlinde-Sundholm L. Can children identify and achieve goals for intervention? A randomized trial comparing two goal-setting approaches. Dev Med Child Neurol. 2016 Jun;58(6):589-96. doi: 10.1111/dmcn.12925. Epub 2015 Sep 16.
Missiuna C, DeMatteo C, Hanna S, Mandich A, Law M, Mahoney W, Scott L. Exploring the use of cognitive intervention for children with acquired brain injury. Phys Occup Ther Pediatr. 2010 Aug;30(3):205-19. doi: 10.3109/01942631003761554.
Liptak GS, Garver K, Dosa NP. Spina bifida grown up. J Dev Behav Pediatr. 2013 Apr;34(3):206-15. doi: 10.1097/DBP.0b013e31828c5f88.
Woodhouse CR, Neild GH, Yu RN, Bauer S. Adult care of children from pediatric urology. J Urol. 2012 Apr;187(4):1164-71. doi: 10.1016/j.juro.2011.12.011. Epub 2012 Feb 14.
Stohrer M, Blok B, Castro-Diaz D, Chartier-Kastler E, Del Popolo G, Kramer G, Pannek J, Radziszewski P, Wyndaele JJ. EAU guidelines on neurogenic lower urinary tract dysfunction. Eur Urol. 2009 Jul;56(1):81-8. doi: 10.1016/j.eururo.2009.04.028. Epub 2009 Apr 21.
Malone PS, Wheeler RA, Williams JE. Continence in patients with spina bifida: long term results. Arch Dis Child. 1994 Feb;70(2):107-10. doi: 10.1136/adc.70.2.107.
Whittam B, Szymanski K, Misseri R, Carroll A, Kaefer M, Rink R, Cain M. Long-term fate of the bladder after isolated bladder neck procedure. J Pediatr Urol. 2014 Oct;10(5):886-91. doi: 10.1016/j.jpurol.2013.12.022. Epub 2014 Jan 25.
Herndon CD, Rink RC, Shaw MB, Simmons GR, Cain MP, Kaefer M, Casale AJ. The Indiana experience with artificial urinary sphincters in children and young adults. J Urol. 2003 Feb;169(2):650-4; discussion 654. doi: 10.1097/01.ju.0000047320.28201.9d.
Tapia CI, Khalaf K, Berenson K, Globe D, Chancellor M, Carr LK. Health-related quality of life and economic impact of urinary incontinence due to detrusor overactivity associated with a neurologic condition: a systematic review. Health Qual Life Outcomes. 2013 Jan 31;11:13. doi: 10.1186/1477-7525-11-13.
Lemelle JL, Guillemin F, Aubert D, Guys JM, Lottmann H, Lortat-Jacob S, Mouriquand P, Ruffion A, Moscovici J, Schmitt M. Quality of life and continence in patients with spina bifida. Qual Life Res. 2006 Nov;15(9):1481-92. doi: 10.1007/s11136-006-0032-x. Epub 2006 Oct 11.
Vu Minh Arnell M, Seljee Svedberg K, Lindehall B, Moller A, Abrahamsson K. Health-related quality of life compared to life situation and incontinence in adults with myelomeningocele: is SF-36 a reliable tool? J Pediatr Urol. 2013 Oct;9(5):559-66. doi: 10.1016/j.jpurol.2013.05.005. Epub 2013 Jun 12.
Olesen JD, Kiddoo DA, Metcalfe PD. The association between urinary continence and quality of life in paediatric patients with spina bifida and tethered cord. Paediatr Child Health. 2013 Aug;18(7):e32-8.
MacNeily AE, Jafari S, Scott H, Dalgetty A, Afshar K. Health related quality of life in patients with spina bifida: a prospective assessment before and after lower urinary tract reconstruction. J Urol. 2009 Oct;182(4 Suppl):1984-91. doi: 10.1016/j.juro.2009.02.060. Epub 2009 Aug 20.
Ramachandra P, Palazzi KL, Skalsky AJ, Marietti S, Chiang G. Shunted hydrocephalus has a significant impact on quality of life in children with spina bifida. PM R. 2013 Oct;5(10):825-31. doi: 10.1016/j.pmrj.2013.05.011. Epub 2013 May 22.
Waters E, Davis E, Ronen GM, Rosenbaum P, Livingston M, Saigal S. Quality of life instruments for children and adolescents with neurodisabilities: how to choose the appropriate instrument. Dev Med Child Neurol. 2009 Aug;51(8):660-9. doi: 10.1111/j.1469-8749.2009.03324.x.
Szymanski KM, Wheeler DC, Mucci LA. Fish consumption and prostate cancer risk: a review and meta-analysis. Am J Clin Nutr. 2010 Nov;92(5):1223-33. doi: 10.3945/ajcn.2010.29530. Epub 2010 Sep 15.
Szymanski KM, Oliveira LM, Silva A, Retik AB, Nguyen HT. Analysis of indications for ureteral reimplantation in 3738 children with vesicoureteral reflux: a single institutional cohort. J Pediatr Urol. 2011 Dec;7(6):601-10. doi: 10.1016/j.jpurol.2011.06.002. Epub 2011 Jul 7.
Szymanski KM, Wei JT, Dunn RL, Sanda MG. Development and validation of an abbreviated version of the expanded prostate cancer index composite instrument for measuring health-related quality of life among prostate cancer survivors. Urology. 2010 Nov;76(5):1245-50. doi: 10.1016/j.urology.2010.01.027. Epub 2010 Mar 28.
Chang P, Szymanski KM, Dunn RL, Chipman JJ, Litwin MS, Nguyen PL, Sweeney CJ, Cook R, Wagner AA, DeWolf WC, Bubley GJ, Funches R, Aronovitz JA, Wei JT, Sanda MG. Expanded prostate cancer index composite for clinical practice: development and validation of a practical health related quality of life instrument for use in the routine clinical care of patients with prostate cancer. J Urol. 2011 Sep;186(3):865-72. doi: 10.1016/j.juro.2011.04.085. Epub 2011 Jul 23.
Szymanski KM, Bitzan M, Capolicchio JP. Is retroperitoneoscopy the gold standard for endoscopic nephrectomy in children on peritoneal dialysis? J Urol. 2010 Oct;184(4 Suppl):1631-7. doi: 10.1016/j.juro.2010.04.019. Epub 2010 Aug 21.
Szymanski KM, Al-Said AN, Pippi Salle JL, Capolicchio JP. Do infants with mild prenatal hydronephrosis benefit from screening for vesicoureteral reflux? J Urol. 2012 Aug;188(2):576-81. doi: 10.1016/j.juro.2012.04.017. Epub 2012 Jun 15.
Szymanski KM, St-Cyr D, Alam T, Kassouf W. External stoma and peristomal complications following radical cystectomy and ileal conduit diversion: a systematic review. Ostomy Wound Manage. 2010 Jan 1;56(1):28-35.
Wheeler DC, Szymanski KM, Black A, Nelson DE. Applying strategies from libertarian paternalism to decision making for prostate specific antigen (PSA) screening. BMC Cancer. 2011 Apr 21;11:148. doi: 10.1186/1471-2407-11-148.
Azhar RA, Szymanski KM, Lemercier E, Valenti D, Andonian S, Anidjar M. Visceral organ-to-percutaneous tract distance is shorter when patients are placed in the prone position on bolsters compared with the supine position. J Endourol. 2011 Apr;25(4):687-90. doi: 10.1089/end.2010.0547. Epub 2011 Mar 25.
Ghane Sharbaf F, Bitzan M, Szymanski KM, Bell LE, Gupta I, Tchervenkov J, Capolicchio JP. Native nephrectomy prior to pediatric kidney transplantation: biological and clinical aspects. Pediatr Nephrol. 2012 Jul;27(7):1179-88. doi: 10.1007/s00467-012-2115-y. Epub 2012 Feb 26.
Mansure JJ, Nassim R, Chevalier S, Szymanski K, Rocha J, Aldousari S, Kassouf W. A novel mechanism of PPAR gamma induction via EGFR signalling constitutes rational for combination therapy in bladder cancer. PLoS One. 2013;8(2):e55997. doi: 10.1371/journal.pone.0055997. Epub 2013 Feb 8.
Violette P, Abourbih S, Szymanski KM, Tanguay S, Aprikian A, Matthews K, Brimo F, Kassouf W. Solitary solid renal mass: can we predict malignancy? BJU Int. 2012 Dec;110(11 Pt B):E548-52. doi: 10.1111/j.1464-410X.2012.11245.x. Epub 2012 May 22.
Violette PD, Szymanski KM, Anidjar M, Andonian S. Factors determining fluoroscopy time during ureteroscopy. J Endourol. 2011 Dec;25(12):1837-40. doi: 10.1089/end.2011.0204. Epub 2011 Sep 9.
Szymanski KM, Misseri R, Whittam B, Raposo SM, King SJ, Kaefer M, Rink RC, Cain MP. QUAlity of Life Assessment in Spina bifida for Adults (QUALAS-A): development and international validation of a novel health-related quality of life instrument. Qual Life Res. 2015 Oct;24(10):2355-64. doi: 10.1007/s11136-015-0988-5. Epub 2015 Apr 12.
Szymanski KM, Misseri R, Whittam B, Yang DY, Raposo SM, King SJ, Kaefer M, Rink RC, Cain MP. Quality of Life Assessment in Spina Bifida for Children (QUALAS-C): Development and Validation of a Novel Health-related Quality of Life Instrument. Urology. 2016 Jan;87:178-84. doi: 10.1016/j.urology.2015.09.027. Epub 2015 Oct 9.
Szymanski KM, Misseri R, Whittam B, Adams CM, Kirkegaard J, King S, Kaefer M, Rink RC, Cain MP. Mortality after bladder augmentation in children with spina bifida. J Urol. 2015 Feb;193(2):643-8. doi: 10.1016/j.juro.2014.07.101. Epub 2014 Jul 27.
Szymanski KM, Misseri R, Whittam B, Amstutz S, Kaefer M, Rink RC, Cain MP. Cutting for stone in augmented bladders-what is the risk of recurrence and is it impacted by treatment modality? J Urol. 2014 May;191(5):1375-80. doi: 10.1016/j.juro.2013.11.057. Epub 2013 Dec 5.
Szymanski KM, Keenan A, Cain MP, Waseem S, Kaefer M. A novel colonoscopic approach for the management of a Malone antegrade continence enema channel, which cannot be catheterized in the immediate postoperative period: a case report. Urology. 2014 Dec;84(6):1490-1. doi: 10.1016/j.urology.2014.07.047. Epub 2014 Oct 11.
Calaway AC, Whittam B, Szymanski KM, Misseri R, Kaefer M, Rink RC, Karymazn B, Cain MP. Multicystic dysplastic kidney: is an initial voiding cystourethrogram necessary? Can J Urol. 2014 Oct;21(5):7510-4.
Whittam BM, Calaway A, Szymanski KM, Carroll AE, Misseri R, Kaefer M, Rink RC, Karmazyn B, Cain MP. Ultrasound diagnosis of multicystic dysplastic kidney: is a confirmatory nuclear medicine scan necessary? J Pediatr Urol. 2014 Dec;10(6):1059-62. doi: 10.1016/j.jpurol.2014.03.011. Epub 2014 May 2.
Szymanski KM, Tabib CH, Idrees MT, Cain MP. Synchronous perivesical and renal malignant rhabdoid tumor in a 9-year-old boy: a case report and review of literature. Urology. 2013 Nov;82(5):1158-60. doi: 10.1016/j.urology.2013.04.050. Epub 2013 Jul 3.
Chan KH, Szymanski KM, Li X, Ofner S, Flack C, Judge B, Whittam B, Misseri R, Kaefer M, Rink RC, Cain MP. Effect of baseline obesity and postoperative weight gain on the risk of channel revision following continent catheterizable urinary channel surgery. J Pediatr Urol. 2016 Aug;12(4):249.e1-7. doi: 10.1016/j.jpurol.2016.05.021. Epub 2016 Jun 11.
Whittam BM, Szymanski KM, Flack C, Misseri R, Kaefer M, Rink RC, Cain MP. A comparison of the Monti and spiral Monti procedures: A long-term analysis. J Pediatr Urol. 2015 Jun;11(3):134.e1-6. doi: 10.1016/j.jpurol.2014.12.013. Epub 2015 Mar 25.
Szymanski KM, Whittam B, Misseri R, Flack CK, Hubert KC, Kaefer M, Rink RC, Cain MP. Long-term outcomes of catheterizable continent urinary channels: What do you use, where you put it, and does it matter? J Pediatr Urol. 2015 Aug;11(4):210.e1-7. doi: 10.1016/j.jpurol.2015.05.002. Epub 2015 May 30.
Casey JT, Zhang M, Chan KH, Szymanski KM, Judge B, Whittam B, Kaefer M, Misseri R, Rink RC, Cain MP. Does endoscopy of difficult to catheterize channels spare some patients from formal open revision? J Pediatr Urol. 2016 Aug;12(4):248.e1-6. doi: 10.1016/j.jpurol.2016.04.030. Epub 2016 May 26.
Szymanski KM, Whittam B, Misseri R, Chan KH, Flack CK, Kaefer M, Rink RC, Cain MP. A case of base rate bias, or are adolescents at a higher risk of developing complications after catheterizable urinary channel surgery? J Pediatr Urol. 2017 Apr;13(2):184.e1-184.e6. doi: 10.1016/j.jpurol.2016.12.002. Epub 2017 Jan 11.
Large T, Szymanski KM, Whittam B, Misseri R, Chan KH, Kaefer M, Rink RC, Cain MP. Ambulatory patients with spina bifida are 50% more likely to be fecally continent than non-ambulatory patients, particularly after a MACE procedure. J Pediatr Urol. 2017 Feb;13(1):60.e1-60.e6. doi: 10.1016/j.jpurol.2016.06.019. Epub 2016 Aug 24.
Szymanski KM, Misseri R, Whittam B, Lingeman JE, Amstutz S, Ring JD, Kaefer M, Rink RC, Cain MP. Bladder stones after bladder augmentation are not what they seem. J Pediatr Urol. 2016 Apr;12(2):98.e1-6. doi: 10.1016/j.jpurol.2015.06.021. Epub 2015 Sep 25.
Hubert KC, Large T, Leiser J, Judge B, Szymanski K, Whittam B, Kaefer M, Misseri R, Rink R, Cain MP. Long-term renal functional outcomes after primary gastrocystoplasty. J Urol. 2015 Jun;193(6):2079-84. doi: 10.1016/j.juro.2014.12.088. Epub 2015 Jan 3.
Szymanski KM, Rink RC, Whittam B, Ring JD, Misseri R, Kaefer M, Cain MP. Long-term outcomes of the Kropp and Salle urethral lengthening bladder neck reconstruction procedures. J Pediatr Urol. 2016 Dec;12(6):403.e1-403.e7. doi: 10.1016/j.jpurol.2016.06.011. Epub 2016 Jul 26.
Speth L, Janssen-Potten Y, Rameckers E, Defesche A, Winkens B, Becher J, Smeets R, Vles H. Effects of botulinum toxin A and/or bimanual task-oriented therapy on upper extremity activities in unilateral Cerebral Palsy: a clinical trial. BMC Neurol. 2015 Aug 19;15:143. doi: 10.1186/s12883-015-0404-3.
Constand MK, MacDermid JC. Applications of the International Classification of Functioning, Disability and Health in goal-setting practices in healthcare. Disabil Rehabil. 2014;36(15):1305-14. doi: 10.3109/09638288.2013.845256. Epub 2013 Oct 23.
Pasch L, He SY, Huddleston H, Cedars MI, Beshay A, Zane LT, Shinkai K. Clinician vs Self-ratings of Hirsutism in Patients With Polycystic Ovarian Syndrome: Associations With Quality of Life and Depression. JAMA Dermatol. 2016 Jul 1;152(7):783-8. doi: 10.1001/jamadermatol.2016.0358.
Hinami K, Alkhalil A, Chouksey S, Chua J, Trick WE. Clinical significance of physical symptom severity in standardized assessments of patient reported outcomes. Qual Life Res. 2016 Sep;25(9):2239-43. doi: 10.1007/s11136-016-1261-2. Epub 2016 Mar 15.
Collins FS, Varmus H. A new initiative on precision medicine. N Engl J Med. 2015 Feb 26;372(9):793-5. doi: 10.1056/NEJMp1500523. Epub 2015 Jan 30.
Matheson GO, Pacione C, Shultz RK, Klugl M. Leveraging human-centered design in chronic disease prevention. Am J Prev Med. 2015 Apr;48(4):472-9. doi: 10.1016/j.amepre.2014.10.014. Epub 2015 Feb 18.
Searl MM, Borgi L, Chemali Z. It is time to talk about people: a human-centered healthcare system. Health Res Policy Syst. 2010 Nov 26;8:35. doi: 10.1186/1478-4505-8-35.
Domecq JP, Prutsky G, Elraiyah T, Wang Z, Nabhan M, Shippee N, Brito JP, Boehmer K, Hasan R, Firwana B, Erwin P, Eton D, Sloan J, Montori V, Asi N, Dabrh AM, Murad MH. Patient engagement in research: a systematic review. BMC Health Serv Res. 2014 Feb 26;14:89. doi: 10.1186/1472-6963-14-89.
Ravens-Sieberer U, Auquier P, Erhart M, Gosch A, Rajmil L, Bruil J, Power M, Duer W, Cloetta B, Czemy L, Mazur J, Czimbalmos A, Tountas Y, Hagquist C, Kilroe J; European KIDSCREEN Group. The KIDSCREEN-27 quality of life measure for children and adolescents: psychometric results from a cross-cultural survey in 13 European countries. Qual Life Res. 2007 Oct;16(8):1347-56. doi: 10.1007/s11136-007-9240-2. Epub 2007 Aug 1.
Muthen B, Shedden K. Finite mixture modeling with mixture outcomes using the EM algorithm. Biometrics. 1999 Jun;55(2):463-9. doi: 10.1111/j.0006-341x.1999.00463.x.
Proust C, Jacqmin-Gadda H. Estimation of linear mixed models with a mixture of distribution for the random effects. Comput Methods Programs Biomed. 2005 May;78(2):165-73. doi: 10.1016/j.cmpb.2004.12.004.
National Kidney Foundation. K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Am J Kidney Dis. 2002 Feb;39(2 Suppl 1):S1-266. No abstract available.
Zappitelli M, Parvex P, Joseph L, Paradis G, Grey V, Lau S, Bell L. Derivation and validation of cystatin C-based prediction equations for GFR in children. Am J Kidney Dis. 2006 Aug;48(2):221-30. doi: 10.1053/j.ajkd.2006.04.085.
Schwartz GJ, Munoz A, Schneider MF, Mak RH, Kaskel F, Warady BA, Furth SL. New equations to estimate GFR in children with CKD. J Am Soc Nephrol. 2009 Mar;20(3):629-37. doi: 10.1681/ASN.2008030287. Epub 2009 Jan 21.
Boulet SL, Yang Q, Mai C, Kirby RS, Collins JS, Robbins JM, Meyer R, Canfield MA, Mulinare J; National Birth Defects Prevention Network. Trends in the postfortification prevalence of spina bifida and anencephaly in the United States. Birth Defects Res A Clin Mol Teratol. 2008 Jul;82(7):527-32. doi: 10.1002/bdra.20468.
Elkoshy M, Szymanski KM, Morehouse D, Anidjar M, Andonian S. Shock-wave lithotripsy retreatment rates among three different lithotripters. UroToday Int. June 2012 2012;5(3):18.
Giacomin J. What Is Human Centred Design? The Design Journal. 2014/12/01 2014;17(4):606-623.
Sanematsu H, Wiehe S. Learning to look: Design in health services research. Touchpoint. 2014;July:TP06-02P82.
Jones JHC, Thornley DG. Conference on Design Methods. Oxford, New York,: Pergamon Press; 1963.
Sanematsu H, Wiehe S. How do you do? Design research methods and the
Sanematsu H. 53. Fun with Facebook: The Impact of Focus Groups on the Development of Awareness Campaigns for Adolescent Health. Journal of Adolescent Health. January 2011 2011;48(2):S44-S45.
Nielsen J. Estimating the number of subjects needed for a thinking aloud test. Int J Human-Computer Studies. 1994;41:385-397.
Stickdorn M, Schneider J. This is Service Design Thinking. Basics - Tools - Cases. Amsterdam: BIS Publishers; 2011.
Singer JD, Willett JB. Applied longitudinal data analysis : modeling change and event occurrence. Oxford ; New York: Oxford University Press; 2003.
Related Links
Access external resources that provide additional context or updates about the study.
Hasso Plattner Institute of Design. bootcamp bootleg Accessed March 24, 2015.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1707207063
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.