Outcomes Primary Outcomes Secondary Outcomes Tertiary Outcomes

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1 Urology David Joseph, MD, Chair Hadley Wood, MD Elizabeth Yerkes, MD Dominic Frimberger, MD Michelle Baum, MD Rose Khavari, MD Rosalie Misseri, MD Stacey Tanaka, MD Sharon Baillie, RN

2 Outcomes Primary Outcomes Maintain normal renal function throughout the lifespan Achieve urinary continence as early as socially acceptable for specific individual Maximize urologic independence Secondary Outcomes Eliminate hostile bladder dynamics through medical management Reduce/eliminate operative reconstruction of the bladder Identify utilization needs of available resources Maximize renal outcome while minimizing expense of studies Timing-frequency of studies urodynamic testing, upper tract imaging, lab studies Reduce impact of UTIs and antibiotic overuse Establish a care program that allows for urologic independence/self CIC Tertiary Outcomes Minimize occurrence of urolithiasis Determine long effectiveness of surgical intervention (or lack of)

3 Prenatal/Infancy (through age 1 year) Clinical Questions 1. How do you define a symptomatic urinary tract infection and what is its long term sequela? 2. What has worked to predict/prevent adverse change (UDS, Imaging?) 3. Is proactive management better to maintain normal upper tract? 4. What is proactive management?

4 Prenatal/Infancy (through age 1 year) Guidelines Attachment A&B 1. UTI defined by a positive UA, cath UC and fever (100.4), < one month failure to thrive\dehydration\increasing spasticity 2. Obtain baseline: Renal Ultrasound Urodynamic testing Serum creatinine 3. Initiate CIC and antimuscarinic therapy when indicated based on above results.

5 Toddler (1-3 years) Clinical Questions 1 How do you account for neurologic bladder changes due to growth and/or tethering? 2. What diagnostic tools are reliable for assessing renal function? Once upper tract changes occur are they reversible? 3. UTI: a. How do we define symptomatic UTI? b. What is the sequela of symptomatic UTI? c. What is the optimal upper/lower urinary tract surveillance? 4. Proactive CIC/antimuscarinics --does this help to maintain a normal upper tract?

6 Toddler (1-3 years) Guidelines Attachment A, C, and D 1. Obtain Renal\Bladder ultrasound every 6 months under the age of 2 then yearly if stable. 2. Obtain Urodynamic testing yearly through the age of 3 then if upper tract changes noted or recurrent UTI s 3. Obtain a serum creatinine if change in upper tract noted. 4. UTI defined by a positive UA, cath UC and fever (100.4) (+ UA = >10 WBCs/hpf, uncentrifuged specimen > 5 WBCs/hpf, centrifuged specimen, > trace nitrite OR leukocyte esterase on dip UA) (+UC = >50,000 CFU per ml (cath or suprapubic) >100,000 CFU per ml clean voided specimen) 5. Initiate CIC and antimuscarinic therapy when indicated.

7 Preschool (3-5 years) Clinical Questions 1. Inclusive of all of the above 2. Compliance with CIC? Who participates?

8 Preschool (3-5 years) Guidelines Attachment E 1. Obtain Renal\Bladder Ultrasound yearly 2. Obtain Urodynamic testing only if upper tract changes occur, recurrent UTI s or interest in a continence program 3. If on CIC begin teaching self catheterization 4. Obtain a serum creatinine if change in upper tract noted. 5. UTI defined by a positive UA, cath UC and fever (100.4) (+ UA = >10 WBCs/hpf, uncentrifuged specimen > 5 WBCs/hpf, centrifuged specimen, > trace nitrite OR leukocyte esterase on dip UA) (+UC = >50,000 CFU per ml (cath or suprapubic) >100,000 CFU per ml clean voided specimen) 6. Initiate CIC and antimuscarinic therapy when indicated.

9 School Age Clinical Questions 1. What are the social/environmental/economic limitations/hurdles to achieve continence? 2. What is worse: stool or urinary incontinence? 3. How we define urologic continence? Are the definitions of continence congruent between patient/family/physician perspective?

10 School Age Guidelines Attachment F & G 1. Obtain Renal\Bladder Ultrasound yearly 2. Obtain Urodynamic testing to initiate a urinary continence program or if upper tract changes or UTI s occur 3. Obtain a serum renal panel on anyone who has had urinary reconstruction. 4. Initiate a urinary continence program 5. Initiate a bowel management program

11 Teenage Clinical Questions 1. How is continence affected by shift in responsibility to self care? 2. How is maintaining a normal upper tract effected by shift in responsibility to self care? 3. What is optimal surveillance of the upper and lower urinary tract? 4. If surgery occurred- would you do it again? / If no surgery occurred do you wish you had?

12 Teenage Guidelines Attachment E, H 1. Obtain a Renal Bladder Ultrasound yearly 2. Obtain a serum renal panel/b12 on anyone who has had urinary reconstruction. 3. Transition CIC to self management 4. Transition bowel program to self management

13 Adult Clinical Questions 1. What is optimal surveillance of the upper and lower urinary tract? (What cancer screening is needed)? 2. How do we define UTI in the adult and when do we treat? 3. How do we minimize sequelae of secondary incontinence in adulthood? 4. What is the pregnancy outcome in women who have had urinary tract reconstruction? (If not covered by women s health)

14 Adult Guidelines Attachment A, I, J 1. Obtain a Renal Bladder Ultrasound yearly 2. Obtain a serum renal panel/b12 on anyone who has had urinary reconstruction. 3. Cystoscopy/cytology for patients who have had an augmentation should not be routine. Obtain when: a) a change in upper or lower tract status noted on imaging b) there is gross hematuria c) recurrent symptomatic UTI d) increasing incontinence e) pelvic pain 4. Immunosuppression/transplant prior BK virus 5. Routine yearly gynecologic assessment 6. Pregnancy monitored at a multidisciplinary center (need GU backup) particularly if prior urologic reconstruction.

15 Research Gaps There is no strong evidence for any urologic management. Our reviews have revealed primarily been retrospective case studies, anecdotal reports and opinion. The primary issue for management begins in the newborn and questions proactive vs expectant care. The current CDC-Newborn Urologic Protocol has been established to determine the best course of management through a prospective program. Assessing renal function in the spina bifida population is difficult. It is appreciated the a simple creatinine is not always reliable. GFR is likely a better parameter but it also has limitations. There is value in DMSA scanning to assess upper tract status and deterioration but universal availability limits its utility.

16 Research Gaps We recognize that continence, bladder\bowel, are important factors for self-image and socialization. However, the definition and interpretation of incontinence may vary between the patient, caregiver, and physician. An improved understanding of patient, caregiver, and physician expectations are needed. Transition of care enhances independence but is it at the risk of renal injury or increased incontinence? Data from transition and adult clinics will be required to truly assess the risk of independence. QOL remains the primary issue and interfaces with all aspects of care. Few QOL studies have been undertaken with vetted questionnaires. Much needed in order to determine the effectiveness of any management.

17 References See individual appendices

Neurogenic Bladder. Spina Bifida Education Day Conference SBA of Northeastern New York Albany, New York April 14, Eric Levey, M.D.

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