Neurourology and Urodynamics 35:8–14 (2016)

Patient Reported Outcomes Measures in Neurogenic Bladder and Bowel: A Systematic Review of the Current Literature Darshan P. Patel,1* Sean P. Elliott,2 John T. Stoffel,3 William O. Brant,1 James M. Hotaling,1 and Jeremy B. Myers1 1

The Center for Reconstructive Urology and Men’s Health, University of Utah, Salt Lake City, Utah 2 Department of Urology, University of Minnesota, Minneapolis, Minnesota 3 Department of Urology, University of Michigan, Ann Arbor, Michigan

Aim: To describe existing bladder and bowel specific quality of life (QoL) measurement tools, QoL in patients with multiple sclerosis (MS), spinal cord injury (SCI), Parkinson’s Disease (PD), stroke, or spina bifida (SB) affected by bladder or bowel dysfunction, and the impact of specific bladder and bowel management on QoL. Methods: We performed a systematic review in PubMed/Medline databases in accordance with the PRISMA statement for English publications between January 1, 2000 and January 1, 2014. Articles were first screened based on their abstract and select full-text articles were then reviewed for eligibility. Articles with no QoL or PROM assessing urinary or bowel dysfunction were excluded. Risk of bias assessment included randomization, incomplete outcomes data, selective outcomes reporting, and other biases. All articles were graded using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system as per the Cochrane Handbook for Systematic Reviews of Interventions. Results: The most common QoL measurement tool for urinary and bowel dysfunction was the Medical Outcomes Study SF-36. Twelve (24%) studies used only non-validated QoL questionnaires. Only three urinary or bowel specific QoL measures were found: the Qualiveen questionnaire, the FICQoL, and the QoL-BM. Several studies identified instances were clinical and patientreported outcomes were inconsistent particularly with indwelling urinary catheter usage and reconstructive surgery. Additionally, certain clinical outcomes surrogates commonly used as primary outcomes measures may not correlate with the patient reported outcomes (PRO). Conclusions: Current PRO measures (PROM) and QoL assessments are heterogeneous and several inconsistencies in clinical and PRO for various management options exist. Standardized PROM will help identify optimal bladder and bowel management for patients with neurologic conditions. Neurourol. Urodynam. 35:8–14, 2016. # 2014 Wiley Periodicals, Inc. Key words: fecal incontinence; neurogenic; neurogenic bowel; patient reported outcomes; quality of life; urinary bladder; urinary incontinence

INTRODUCTION

Urinary and bowel dysfunction adversely impacts quality of life (QoL) and restricts both physical and social activities. Patients with multiple sclerosis (MS), spinal cord injury (SCI), Parkinson’s Disease (PD), stroke, or spina bifida (SB), who may be restricted by their underlying neurologic condition, may have a compounded negative effect on their QoL from bladder or bowel dysfunction. These patients often have similar urinary and bowel symptoms significantly impacting QoL, independent of their underlying neurologic condition. Medical complications including urinary tract infections and fecal impaction as well as interpersonal and socialization difficulties due to catheterizations, incontinence episodes, and diet modifications immensely impact QoL in this population.1,2 Although many studies explore the affect of bladder/bowel dysfunction and specific bladder/bowel interventions on QoL in the neurologically intact population, similar studies are lacking in neurogenic bladder and bowel. Likewise, the association of clinical outcomes with patient reported outcomes (PRO) for bladder and bowel interventions is not well defined. Since most interventions for bladder and bowel dysfunction are directed toward an improvement in QoL for patients with life-long neurologic conditions, it is surprising that PRO are not routinely addressed as a primary outcome measure. #

2014 Wiley Periodicals, Inc.

A systematic review was conducted to describe (i) existing bladder and bowel specific QoL measurement tools, (ii) QoL in patients with MS, SCI, PD, stroke, or SB affected by bladder or bowel dysfunction, and (iii) the impact of specific bladder and bowel management on QoL. A better understanding of PRO measures (PROM) in those with neurologic conditions will identify optimal patient-centered bladder and bowel management strategies.

Christopher Chapple led the peer review process as the Associate Editor responsible for the paper. Potential conflicts of interest: All conflicts of interest, including specific financial interests and relationships and affiliations relevant to the subject matter and materials discussed in this manuscript (employment/affiliation, grants or funding, honoraria, stock ownership or options, expert testimony, royalties, or patents filed, received, or pending), are the following: DPP was supported by a generous reconstructive urology educational grant from American Medical Systems, Inc., Minnetonka, MN. Grant sponsor: American Medical Systems, Inc.  Correspondence to: Darshan P. Patel, The Center for Reconstructive Urology and Men’s Health, University of Utah Health Care, 30 N 1900 E, RM 3B208B, Salt Lake City, UT 84132. E-mail: [email protected] Received 25 July 2014; Accepted 21 August 2014 Published online 18 October 2014 in Wiley Online Library (wileyonlinelibrary.com). DOI 10.1002/nau.22673

Patient Reported Outcomes in Neurogenic Bladder and Bowel METHODS

In accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) statement, we conducted a systematic review in May 2014 in the PubMed/ Medline databases for publications between January 1, 2000 and January 1, 2014.3 The review was limited to English language publications with full text access. We queried these databases using the keyword string ((‘‘urinary incontinence’’ [MeSH] OR ‘‘fecal incontinence’’ [MeSH] OR ‘‘urinary bladder, neurogenic [MeSH]’’ OR ‘‘neurogenic bowel’’ [MeSH]) AND (‘‘quality of life’’ [MeSH] OR ‘‘patient reported outcomes’’) AND (‘‘Multiple Sclerosis’’[Mesh] OR ‘‘Spinal Cord Injuries’’[Mesh] OR ‘‘Parkinson Disease’’[Mesh] OR ‘‘Stroke’’[Mesh] OR ‘‘Spinal Dysraphism’’[Mesh])). Conference abstracts were not considered. When more than one paper reported results about the same population, the most recent paper was considered. Articles were first screened based on their abstract and select full-text articles were then reviewed for eligibility. Articles with no QoL or PROM assessing urinary or bowel dysfunction were excluded. Studies were evaluated based upon study population, design, baseline characteristics, QoL measurement tools, urinary/bowel specific QoL, interventions, major results/conclusions, and study limitations. Risk of bias assessment included randomization, incomplete outcomes data, selective outcomes reporting, and other biases. The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system was used to grade all articles.4

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with incomplete results). The 51 articles included a total of 14,262 patients.2,5–58 Study Designs

Characteristics of included studies on urinary dysfunction and bowel dysfunction are summarized in Tables I and II, respectively. Fifty-nine percent of included studies were retrospective cohort or cross-sectional studies and suffered from poor response rates, selective outcomes reporting, incomplete data, small sample size and unclear inclusion/ exclusion criteria. Most studies were single-center, but 24% were multi-institutional. Seventeen studies were prospective cohort studies. Many of the prospective studies were limited by small sample sizes, lack of adequate controls and randomization, and short or incomplete follow-up data. Only four randomized controlled trials were included in this review.5–8 Three of the randomized trials compared patients randomized to placebo, 200 IU, and 300 IU of OnabotulinumtoxinA (BoNT-A) detrusor injections for UI in neurogenic detrusor overactivity. Although these studies were double-blinded, placebo-controlled randomized trials with a significant sample size, long-term impact of this specific intervention on QoL is uncertain. QoL assessment occurred within 6 weeks of the procedure and as a secondary outcome.5–7 The fourth randomized trial investigated the role of pelvic floor therapy, biofeedback, and/or neuromuscular electrical stimulation on bladder dysfunction in patients with MS; however, this study had no control, poor randomization, and a sample size of 30 participants.8

RESULTS Study Populations Literature Search Results

A flow diagram with the results of our literature search is shown in Figure 1. Of the 122 abstracts screened, 56 full text studies were assessed and subsequently five studies were excluded (4 studies with no QoL-related results and 1 study

The study population was heterogeneous including 11,574 SCI patients, 1,380 MS patients, 813 spina bifida patients, 391 stroke patients, and 205 PD patients. Children and adolescents made up 11.4% of the population. Mean age was 40.1 years and the mean ratio of men to women was 1.1:1. QoL Measurement Tools

A variety of QoL measurement tools were used by included studies (Table III). Only three urinary or bowel specific QoL measurement tools designed for patients with neurologic conditions were found: the Qualiveen for urinary dysfunction in SCI and MS, the Fecal Incontinence and Constipation Quality of Life (FICQoL) for SB, and the Quality of Life Scoring Tool related to Bowel Management (QoL-BM) for SCI and MS. The most common QoL measurement tools for urinary dysfunction were the Medical Outcomes Study Short Form 36-Item and 12Item Health Survey or SF-36 and SF-12 (27%), Qualiveen questionnaire (19%), Incontinence Impact Questionnaire SF or IIQ7-SF (11%), King’s Health Questionnaire or KHQ (11%), Incontinence Quality of Life or I-QoL (8%), and the International Consultation on Incontinence Modular Questionnaire for Overactive Bladder or ICIQ-OAB (8%). The most common QoL measurement tools for bowel dysfunction were the SF-36 (27%), FICQoL (18%), and the QoL-BM (9%). Twelve (24%) studies used only non-validated QoL questionnaires. Impact of Bladder Dysfunction on QoL

Fig. 1. PRISMA flow diagram for literature search.

Neurourology and Urodynamics DOI 10.1002/nau

Fourteen studies reported the impact of neurogenic bladder and/or UI on QoL. Patients with urinary dysfunction and SCI, stroke, PD, or MS had significantly worse QoL outcomes, especially in physical functioning, mental health, and socialization when compared to neurologically intact patients with normal,

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Patel et al.

TABLE I. Characteristics of Studies on Urinary Dysfunction Study Hicken et al.2 Schurch et al.5 Cruz et al.6 Ginsberg et al.7 McClurg et al.8 Akkoc et al.9 Cameron et al.10 Raviv et al.11 Vaughan et al.12 Vastenholt et al.13 Gobbi et al.14 Martens et al.15 Patki et al.16 Kuo et al.17 Kulaksizoglu et al.18 Kuo et al.19 Chen et al.20 Kuo et al.21 Khastgir et al.22 Zommick et al.23 Walsh et al.24 Pazooki et al.25 MacNeily et al.26 Legrand et al.27 Edwards et al.44 Oh et al.45 Bonniaud et al.49 Bonniaud et al.50 Liu et al.52 Pannek et al.53 Eyigor et al.54 Cornege et al.55 Bonniaud et al.56 Ragab et al.57 Hall et al.58 Sakakibara et al.42 Lemelle et al.46 Kalpakjian et al.47 Noonan et al.48

GRADE

Study design

Population

n

QoL assessment tool

2 2 2 2 2 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 0 1 1

Cross-sectional RCT RCT RCT RCT Cross-sectional Retrospective cohort Prospective cohort Prospective cohort Cross-sectional Prospective cohort Retrospective cohort Prospective cohort Prospective cohort Prospective cohort Prospective cohort Prospective cohort Prospective cohort Retrospective cohort Cross-sectional Retrospective cohort Retrospective cohort Prospective cohort Retrospective cohort Retrospective cohort Prospective cohort Cross-sectional Prospective cohort Cross-sectional Prospective cohort Retrospective cohort Cross-sectional Cross-sectional Cross-sectional Cross-sectional Cross-sectional Cross-sectional Prospective cohort Retrospective cohort

SCI SCI, MS MS, SCI MS, SCI MS SCI SCI MS PD SCI MS SCI SCI SCI PD SCI SCI SCI, MS SCI SCI SCI SCI SB MS Stroke SCI MS MS SCI SCI MS SB SCI PD Stroke, MS PD SB SCI SCI

106 59 275 416 30 195 7510 28 20 42 21 163 37 33 16 38 38 55 32 21 6 10 31 53 361 132 180 121 142 41 37 102 128 49 45 115 460 65 70

SF-12, CHART, SWLS I-QoL, SF-36 I-QOL I-QOL Kings, IIQ-30, MSQoL-54 KHQ SWLS, CHART, SF-36 Non-validated form ICIQ-OAB Qualiveen KHQ Qualiveen, SF-36 ICIQ IIQ7-SF SEAPI questionaire IIQ7-SF UDI-6, QoL-I IIQ7-SF Non-validated form Non-validated form Non-validated form Non-validated form Parkin QoL Qualiveen SF-12 SF-36 Qualiveen-SF, MSQoL-54 Qualiveen KHQ, SF-36 Qualiveen Turkish I-QoL SEIQoL-DW Qualiveen, SF-12, IPSS IIQ7-SF Non-validated form SF-36, VSP SCI-SCS SF-36, non-validated form

GRADE, Grading of Recommendations, Assessment, Development, and Evaluation; RCT, Randomized Control Trial; IIQ7-SF, Incontinence Impact Questionnaire 7 item Short Form; KHQ, King’s Health Questionnaire; I-QoL, Incontinence Quality of Life; QoL-BM, Quality of Life Scoring Tool related to Bowel Management for SCI; IPSS, International Prostate Symptom Score; FICQOL, Fecal Incontinence and Constipation Quality of Life; ICIQ-OAB, International Consultation on Incontinence Modular Questionnaire for Overactive Bladder; SEIQoL-DW, Schedule for the Evaluation of Individual QoL-Direct Weight; SEAPI: Stress, Emptying, Anatomy, Protection, Inhibition Incontinence QoL, UDI6, Urinary Distress Inventory 6; SF-36/SF-12, Medical Outcomes Study Short Form 36-Item or 12-Item; VSP, Vecu-Sante-Percu; MSQoL54, Multiple Sclerosis QoL 54-item; CHART, Craig Handicap Assessment and Reporting Technique; SWLS, Satisfaction with Life Scale; SCI-SCS, Secondary Conditions Scale.

independent bladder function. Hicken et al.2 noted a significant difference in the physical health domain of SF-12, total Satisfaction with Life Scale (SWLS) score, and the Craig Handicap Assessment and Reporting Technique (CHART) total score and physical independence, mobility, and occupation domains, for SCI patients with dependent (assisted bladder management) versus independent bladder management (P < 0.001–0.05). However, there was no significant difference in the mental health domain of SF-12 or the social integration and economic self-sufficiency domains of CHART for dependent versus independent bladder management patients.2 Two studies highlighted QoL and patient satisfaction with different bladder management methods.9,10 Akkoc et al.9 grouped 195 traumatic SCI patients based on their bladder management methods: normal spontaneous micturition (NSM), micturition with assisted maneuvers (MAM), intermittent catheterization performed by patient (IC-P), intermittent Neurourology and Urodynamics DOI 10.1002/nau

catheterization performed by attendant (IC-A), and indwelling catheter (IDC). These investigators showed patients using IC-A had the worst QoL measures on the KHQ especially in areas of physical limitations, emotions, and social limitations (P < 0.01). Patients with IDC had improved or similar QoL scores when compared to IC-A in domains of incontinence impact, role limitation, physical limitations, and emotions.9 This observation is unexpected since previous studies report increased complications and urinary tract infections with IDC. Cameron et al.10 addressed medical and psychosocial complications with specific bladder management methods including IDC, condom catheter (CC), or clean intermittent catheterization (CIC). The SWLS, CHART, and Perceived Health questionnaires were gathered for 7,510 patients from the National SCI Statistical Center dataset. Those SCI patients with normal voiding had significantly better QoL and PRO for the CHART physical independence, mobility, occupation, and social

Patient Reported Outcomes in Neurogenic Bladder and Bowel

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TABLE II. Characteristics of Studies on Bowel Dysfunction Study Faaborg et al.28 Nanigian et al.29 Coggrave et al.30 Gulick et al.31 Kim et al.32 Pardee et al.33 Popolo et al.34 Choi et al.35 Lombardi et al.36 Ok et al.37 Branagan et al.43 Liu et al.51 Sakakibara et al.42 Lemelle et al.46 Kalpakjian et al.47 Noonan et al.48

GRADE

Study design

1 1 1 1 1 1 1 1 1 1 1 1 1 0 1 1

Cross-sectional Cross-sectional Cross-sectional Cross-sectional Cross-sectional Retrospective cohort Prospective cohort Prospective cohort Retrospective cohort Cross-sectional Retrospective cohort Prospective cohort Cross-sectional Cross-sectional Prospective cohort Retrospective cohort

Population SCI SB SCI MS SCI SCI SCI SB SCI SB SCI SCI PD SB SCI SCI

n

QoL assessment tool

159 144 1334 502 388 241 36 53 39 23 32 128 115 460 65 70

Non-validated form FICQOL Non-validated form QoL-BM Non-validated form Randall QoL survey Non-validated form Non-validated form SF-36 FICQOL Non-validated form SF-36 Non-validated form SF-36, VSP SCI-SCS SF-36, non-validated form

GRADE, Grading of Recommendations, Assessment, Development, and Evaluation; RCT, Randomized Control Trial; IIQ7-SF, Incontinence Impact Questionnaire 7 item Short Form; KHQ, King’s Health Questionnaire; I-QoL, Incontinence Quality of Life; QoL-BM, Quality of Life Scoring Tool related to Bowel Management for SCI; IPSS, International Prostate Symptom Score; FICQOL, Fecal Incontinence and Constipation Quality of Life; ICIQ-OAB, International Consultation on Incontinence Modular Questionnaire for Overactive Bladder; SEIQoL-DW, Schedule for the Evaluation of Individual QoL - Direct Weight, SEAPI: Stress, Emptying, Anatomy, Protection, Inhibition Incontinence QoL; UDI6, Urinary Distress Inventory 6; SF-36/SF-12, Medical Outcomes Study Short Form 36-Item or 12-Item; VSP, Vecu-Sante-Percu; MSQoL-54, Multiple Sclerosis QoL 54-item; CHART, Craig Handicap Assessment and Reporting Technique; SWLS, Satisfaction with Life Scale; SCI-SCS, Secondary Conditions Scale.

integration domains, total SWLS score, and Perceived Health Status score compared to patients with bladder dysfunction (P < 0.001). There was no significant difference among the IDC, CC, or CIC group for total SWLS score, CHART social integration domain, and the Perceived Health Status score. Although IDC led to increased hospitalizations and pressure ulcers in this study, the rates of patient satisfaction and perceived health status were similar to patients using CC or CIC. This observation identifies another inconsistency between recommended best practices and PRO for different bladder management methods.10

TABLE III. Summary of Common QoL Questionnaires

Questionnaire SF-36 Qualiveen IIQ7 I-QoL SF-12 KHQ FICQoL ICIQ-OAB MSQoL-54 CHART QoL-BM

Items 36 30 7 22 12 21 51 4 54 27 11

Population

Bladder/bowel specific questions

Frequency among studies (%)

General SCI, MS General General General General SB General MS SCI SCI

None Bladder Bladder Bladder None Bladder Bowel Bladder Bladder/Bowel None Bowel

18 12 10 8 6 6 4 4 4 4 2

SF-36/SF-12, Medical Outcomes Study Short Form 36-Item or 12-Item; IIQ7-SF, Incontinence Impact Questionnaire 7 item Short Form; I-QoL, Incontinence Quality of Life; KHQ, King’s Health Questionnaire; FICQOL, Fecal Incontinence and Constipation Quality of Life; ICIQ-OAB, International Consultation on Incontinence Modular Questionnaire for Overactive Bladder; MSQoL-54, Multiple Sclerosis QoL 54-item; CHART, Craig Handicap Assessment and Reporting Technique; QoL-BM, Quality of Life Scoring Tool related to Bowel Management.

Neurourology and Urodynamics DOI 10.1002/nau

Impact of Interventions for Bladder Dysfunction and UI on QoL

Most studies in this review explored the impact on QoL and PRO for a urinary intervention. QoL outcomes measures were usually secondary to clinical outcomes measures in assessing specific intervention in most studies. Three studies explored the use of conservative pelvic floor therapy and biofeedback in improving QoL for those with UI.8,11,12 These studies reported improved overall QoL scores versus baseline for MS and PD patients. Only one of these studies was randomized. McClurg et al. randomized 30 MS patients to pelvic floor therapy (PFT, group 1), PFT þ biofeedback (group 2), or PFT þ biofeedback þ neuromuscular electrical stimulation (group 3). Multiple QoL measurement tools were used including the KHQ, IIQ-30, and the Multiple Sclerosis QoL-54 (MSQoL-54). At 9 weeks, a statistically significant improvement was seen in the symptom severity domain of KHQ with groups 2 and 3 versus 1 (P ¼ 0.034) and total IIQ-30 score and domains of physical activity, emotional health, and social relationships for group 3 versus 1 and 2 (P ¼ 0.03). There was no difference between total MSQOL-54 scores and the specific urinary, bowel and sexual function questions among the three groups.8 Three studies reporting QoL measures with neuromodulation for neurogenic bladder dysfunction were included.13–15 These studies were limited to SCI and MS patients. Martens et al.15 assessed QoL using the Qualiveen and SF-36 after the Brindley procedure (dorsal root rhizotomy and anterior sacral nerve root neuromodulation) in a cross-sectional study of 93 SCI patients and 70 age-matched controls. This group observed a statistically significant improvement in QoL on most areas of the Qualiveen questionnaire particularly for the overall QoL index, mean Specific Impact of Urinary Problems index, limitation, constraints, fear, and feeling domains for patients using neuromodulation and/or rhizotomy versus controls (all P < 0.001). However, no difference was seen for physical roles and emotional limitations, bodily pain, vitality, social function, and mental health domains for SF-36.15

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Nine studies investigated the use of BoNT-A injections for neurogenic UI; the effect on QoL was assessed as a secondary outcome measure using tools such as the IIQ-7, I-QoL, and ICIQ.5–7,16–21 BoNT-A detrusor injections may offer short-term improvement in QoL for neurogenic detrusor overactivity in patients with neurologic conditions.5–7,16–21 The three randomized, placebo-controlled trials studying BoNT-A, noted a statistically significant improvement in total I-QoL score with both 200 U BoNT-A and 300 U BoNT-A versus placebo (all P < 0.05).5–7 Evidence evaluating reconstructive surgery in QoL improvement is not as clear as data for other interventions. Six studies examined reconstructive surgery for urinary dysfunction and its affect on QoL in SCI and SB patients.22–27 Many studies utilized non-validated subjective questionnaires and contained very small sample sizes (median: n ¼ 26). MacNeily et al.26 studied 31 SB patients who underwent surgery for continent catheterizable channel and/or enterocystoplasty, bladder neck suspension, or continent cecostomy. Patients undergoing surgery and 50 age-matched controls with SB were provided a QoL measurement tool previously studied in SB patients. There was no statistically significant improvement in overall QoL after surgery compared to baseline or compared to agematched controls. However, the authors did report improvement in objectively defined incontinence.26 Impact of Bowel Dysfunction and FI on QoL

FI and neurogenic bowel was evaluated in six studies of SB, SCI, and MS patients.28–33 In a cross-sectional analysis of 92 children and adolescents with SB versus 52 controls, Nanigian et al. observed a statistically significant difference for all 7 QoL domains of FICQOL, including bowel program, dietary management, symptoms, travel and socialization, family relationships, caregiver emotional impact, and financial impact (P < 0.0001– 0.033).29 Gulick used the QoL-BM questionnaire in patients with MS to evaluate the impact of bowel dysfunction. Patients primarily effected with fecal incontinence had worse QoL on the total QoL-BM scale and management and relationships subscales versus those with primary constipation or normal bowel function (P < 0.01).31 Additionally, inconsistencies in clinical and patient reported measures were also noted in studies on bowel dysfunction. In 127 SCI patients, Pardee et al.33 reported no association between patient satisfaction with current bowel regimen and time devoted to bowel management. This is unanticipated since less time devoted to bowel management should intuitively lead to greater patient satisfaction. Impact of Interventions for Bowel Dysfunction and FI on QoL

There was limited evidence evaluating interventions for bowel dysfunction or FI and impact on QoL. Two studies, Popolo et al.34 for SCI patients and Choi et al.35 for SB patients, studied PRO following implementation of a transanal irrigation regimen. Both studies reported significant improvement on non-validated QoL questionnaires in areas of travel and socialization, caregiver support, family relationships, and financial impact. Lombardi et al. studied sacral neuromodulation for neurogenic bowel in 39 SCI patients. This group showed a statistically significant improvement in the SF-36 domains of general health, mental health, social functioning, and role emotional after sacral neuromodulation procedure (all P < 0.05).36 Ok and Kurzrock studied 23 SB patients who underwent the Malone Antegrade Continence Enema (ACE) Procedure. The FICQOL tool was administered at baseline and at Neurourology and Urodynamics DOI 10.1002/nau

6 months following the ACE procedure. They found a significant improvement in bother/anxiety about FI for child or caretaker when leaving the home, patient anxiety about having an episode of FI, and caretaker bother/depression/anxiety (all P < 0.05). No improvements were seen in areas of diet modifications, family relationships, and financial impact.37 DISCUSSION

QoL is significantly worse for patients with MS, SCI, PD, stroke, or SB affected by urinary or bowel dysfunction. Multiple bladder and bowel management options for neurogenic patients are available including conservative therapies, medications, minimally invasive/endoscopic treatments and major reconstructive surgeries but the impact on these interventions on QoL has been poorly described. Additionally, several studies have shown positive clinical results are not always associated with favorable PRO.9,10,33 QoL reporting is very heterogeneous for patients with neurologic conditions affected by bladder or bowel dysfunction. There are three urinary or bowel specific QoL measures included in this review: the Qualiveen questionnaire for urinary dysfunction in SCI and MS, the FICQoL for bowel dysfunction in SB, and the QoL-BM for bowel dysfunction in SCI and MS. These questionnaires have not been validated in larger, heterogeneous populations and the correlation of results with existing overall and disease specific QoL questionnaires is unclear. For instance, Martens et al.15 presented an improvement in Qualiveen scales with dorsal rhizotomy and/or sacral neuromodulation in SCI patients, but did not observe a similar improvement on the validated SF-36 assessing overall QoL. Many studies in this review solely utilize questionnaires that assess overall QoL measurements, not specifically validated for the patient population of interest. The Medical Outcomes Study Short Form 36-Item and 12-Item Health Survey (SF-36 and SF12) are overall QoL tools encountered most frequently in our review. These questionnaires assess general, physical, and emotional health as well as limitations on activities of daily living and socialization. They do not include any specific domains regarding urinary and bowel dysfunction and therefore, may overlook specific PRO and satisfaction with urinary and bowel management strategies.38 The same is true for questionnaires designed primarily to assess QoL for specific neurologic conditions, which may only include a few general questions on urinary or bowel dysfunction. Disease-specific questionnaires captured in this review include the MSQoL-54, CHART, and SWLS. For example, McClurg et al.8 reported changes on the urinary specific KHQ and IIQ-30 within specific treatment groups but did not observe a similar change in QoL as measured by the MSQoL-54. Urinary specific QoL tools, such as the I-QOL, KHQ, IIQ7, and ICIQ-OAB, have also been used frequently in assessment of urinary dysfunction in patients with neurologic conditions. These tools have a high validity and reliability for neurologically intact patients affected by overactive bladder or stress urinary incontinence but may not have adequate sensitivity and specificity to assess subtle effects on QoL following urinary interventions in those with neurologic conditions.39–41 Our review identifies several instances where clinical and PRO do not correlate with each other. Cameron et al.10 demonstrated a similar perception of one’s health and total SWLS score regardless of IDC, CC, or CIC usage for bladder management; yet, CIC is strongly recommended by clinicians based on reduced urinary tract infections and hospitalization rates versus IDC. Similarly, certain clinical outcomes surrogates commonly used as primary outcomes measures, may not

Patient Reported Outcomes in Neurogenic Bladder and Bowel 33

correlate with the PRO; Pardee et al. showed an ambiguous relationship between time devoted to bowel management and patient satisfaction in SCI patients. Most concerning is the inconsistency in clinical outcomes and impact on QoL following reconstructive surgery. MacNeily et al.26 demonstrated a statistically significant improvement in objectively defined incontinence following continent catheterizable channel creation in SB patients. However, this was not associated with a similar improvement in their QoL assessment compared to baseline and matched non-surgical controls.26 Although several urinary and bowel-specific QoL tools for patients with SCI and MS exist (Qualiveen questionnaire, FICQoL, and QoL-BM), these questionnaires have not been validated in larger, heterogeneous populations to assess reliability, precision of the language, viability of administration, and capability of measuring change longitudinally in response to treatments. Validation will allow for increased data quality and better comparability among studies and institutions. Inconsistencies between clinical outcomes and PRO for bladder and bowel interventions are common and the true improvement in QoL with these procedures is unclear. PRO should be primary outcomes for urinary/bowel interventions intended to improve QoL in patients with chronic neurologic conditions. PRO have a number of advantages over many traditional clinical indicators including high data reliability and validity, greater discrimination within levels of impairment, and fewer burdens for patients and health care providers. Additionally, PROM require patients’ conscious participation and encourage involvement in their own personal healthcare issues. Standardized PROM adequately assessing urinary and bowel specific concerns and overall QoL are needed for patients with underlying neurologic conditions. They must demonstrate high reliability and validity, greater discrimination within levels of impairment, and impose few burdens on patients, caregivers, and health care providers. Addressing PRO and addressing discrepancies with common clinical outcomes will identify optimal bladder and bowel management strategies for patients with neurologic conditions. CONCLUSION

MS, SCI, PD, Stroke, and SB patients with bladder and bowel dysfunction have poor QoL especially in areas of physical health, mental health, sexual health, socialization, and travel. Although there are ample clinical outcomes data regarding current management techniques, PRO for these bladder and bowel interventions are limited to select heterogeneous studies. Although three urinary or bowel specific questionnaires exist for SCI and MS patients (Qualiveen, FICQoL, and QoL-BM), these tools have not been validated in larger, representative populations. Most previous studies have relied on non-validated QoL tools or tools originally validated for another disease entity to assess QoL and PRO. Standardized PROM will identify optimal bladder and bowel management for patients with neurologic conditions and recognize barriers to adherence and patient compliance affecting patients and caregivers. ACKNOWLEDGMENTS

None. REFERENCES 1. Chiaffarino F, Parazzini F, Lavezzari M, et al. Impact of urinary incontinence and overactive bladder on quality of life. Eur Urol 2003;43:535–8.

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Patient reported outcomes measures in neurogenic bladder and bowel: A systematic review of the current literature.

To describe existing bladder and bowel specific quality of life (QoL) measurement tools, QoL in patients with multiple sclerosis (MS), spinal cord inj...
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