How Do Surgical Interventions for Neurogenic Lower Urinary Tract Dysfunction Impact Quality of Life?

ABSTRACT

Objective

Adult patients with neurogenic lower urinary tract dysfunction (NLUTD) often have urinary symptoms that impact their quality of life (QOL). Our objective is to identify and summarize studies evaluating QOL changes across different NLUTD surgical interventions.

Methods

A systematic rapid evidence review was carried using EMBASE and MEDLINE. We included adult patients (> 18 years old) with NLUTD who underwent a relevant surgery and had a measurement of QOL. We included pre‐post study designs (primary focus) and cross‐sectional studies (secondary focus). Studies were reviewed and data extracted by multiple assessors. Standardized data extraction tables were used, and qualitative synthesis was performed.

Results

Of the 1074 screened articles 26 were included. There were 3/15 studies that evaluated reconstructive surgery (augmentation and/or catheterisable channel) pre‐post intervention (n = 94 patients); there was a 7%–28% relative improvement in bladder related and overall QOL using validated questionnaires, and a large magnitude of improvement in studies using unvalidated questionnaires. There were 3/7 studies that looked at urinary diversion pre‐post intervention (n = 153 patients) and showed an approximately 20%–60% improvement in validated questionnaires assessing bladder specific quality of life, and 0%–25% improvement in overall quality of life. Finally, 3/4 studies were pre‐post stress incontinence surgeries (n = 67 patients) and they found an improvement in the ICIQ questionnaire scores and study‐specific questionnaires.

Conclusion

The literature supporting a change in QOL in adult NLUTD patients undergoing surgical interventions is extremely limited due to a lack of pre‐post studies, and the frequent use of unvalidated outcome measures.

1. Introduction

Neurogenic lower urinary tract dysfunction (NLUTD) is a condition where control of bladder function is impaired due to a neurological disease [1]. Common causes of NLUTD include congenital neurological conditions like spina bifida (SB), as well as acquired neurological conditions such as spinal cord injury (SCI) and multiple sclerosis (MS). Patients with NLUTD often suffer from urinary symptoms including frequency, urgency, incontinence and poor bladder emptying. These urinary symptoms may give rise to more severe complications such as recurrent urinary tract infections (UTI), urolithiasis, and renal damage. Aside from affecting patient's physical health, the urinary incontinence episodes, frequent infections, and dependence on caretakers for urinary care can negatively impact a person's social functioning and quality of life (QOL) [2, 3, 4, 5]. Therefore, goals of NLUTD treatment include preserving renal function, improving bladder symptoms, minimizing complications, and enhancing a person's QOL.

Some treatment strategies for NLUTD include behavioral interventions, medications, and minimally invasive procedures [4] When these initial treatments fail, patients may be offered surgical interventions. In some cases, these more invasive options are required due to a defined risk to the patients’ health (such as progressive renal deterioration), and in this situation, it is often easier to counsel a patient about the potential benefits of these surgeries. However, if these surgeries are considered solely to improve a patients’ QOL, for example, to decrease urinary incontinence, or to enable easier self‐catheterization, understanding the potential magnitude of QOL improvement, and the evidence supporting a QOL improvement is essential. The objective of this systematic review is to identify and synthesize the research studies that have evaluated the changes in QOL in patients with NLUTD undergoing bladder reconstruction, urinary diversion or stress incontinence surgery.

2. Methods

A systematic rapid evidence review was conducted for this study. The review process follows closely to that of a traditional systematic review [6] (such as dual screening of articles, and standardized data extraction). Search strategies were developed a priori with the help of a librarian from our institution, and a bibliographic search was done using EMBASE and MEDLINE. Two authors independently screened articles, and disagreements were reviewed by a third author to reach a final decision. However, given the limited literature that we expected to find based on previous studies [7], the lack of randomized trials, and the known quality issues, we did not perform a formal risk of bias assessment, or examine publication bias or selective reporting within studies (which is in keeping with rapid evidence review methodology). Ethics approval was not required as this study only involved secondary analysis of publicly available data.

2.1. Study Selection

Our systematic review was designed to identify studies meeting the following criteria:

• Population: Studies with at least 50% of the population having NLUTD, or a subgroup analysis specifically of NLUTD patients, and at least 75% of the population being adults (> 18 years of age).

• Intervention: Surgical procedures related to NLUTD (stress incontinence surgeries [slings and artificial urinary sphincters]), bladder reconstruction (which includes bladder augmentation and/or catheterisable channels), or urinary diversion.

• Comparison: Pre‐post studies (primary), cross‐sectional (secondary)

• Outcome: A numerical measure of QOL or satisfaction, either overall or urinary specific.

We excluded conference abstracts and articles that did not report on primary research results (such as letters to the editor, editorials, review articles and guidelines). We limited the studies to those published in English. We excluded case reports (define as n ≤ 3 patients). The search was carried out with no date restrictions and was based on literature as of January 2023.

2.2. Data Sources and Search Strategy

We identified studies through an unstructured literature review, and then used this, in consultation with a university librarian to identified key words and index terms that were relevant to our systematic search strategy. We conducted a pre‐planned online search in January 2023 of EMBASE and Medline. Relevant search terms included combinations of “bladder augmentation,” “neurogenic bladder AND quality of life,” “continent urinary diversion OR catheterisable channel OR mitrofanoff OR monti),” “urethral sling,” “quality of life.” We validated the search strategy by ensuring the articles identified in the unstructured literature review were included in the final search. We used the Covidence website to combine and screen the identified abstracts, and to organize the review of the relevant full text documents. Articles were reviewed for inclusion by two authors independently; disagreements were resolved by a third author.

2.3. Data Extraction and Analysis

We used a pre‐designed template to collect study information; accuracy of the data extraction was verified in a subset of studies by a second author. Strengths and limitations of the relevant studies were identified after full text review by the authors, and summarized in a narrative format. Due to the expected heterogeneity of the studies, no meta‐analysis could be done on the results, and a qualitative review of the studies was reported. For studies that reported pre‐post QOL scores using a validated questionnaire, we calculated the relative change in the score.

3. Results

We identified 1074 unique articles; these were screened as shown in Figure 1, and after exclusions a total of 26 studies were considered relevant.

Figure 1.

Flow chart of study identification and screening.

There were 15 studies that evaluated QOL in adult patients who had NLUTD reconstructive surgery (augmentation and/or catheterisable channel). Three (n = 94) performed a pre‐post QOL assessment (summarized in Table 1, with further study details in supplemental Table 1). Lima et al.'s study [8], (the only one that used validated questionnaires), showed that after augmentation +/‐ catheterisable channel, the Medical Outcomes Survey Short Form 36 (SF‐36), which measures overall QOL, had a 28% relative improvement in emotional aspects, 21% relative improvement in functional capacity, 14% relative improvement in general health, and 13% relative improvement in social aspects; vitality and mental health domains improved by < 10%. On the Qualiveen questionnaire (which measures urinary specific QOL), there was a 20%–28% relative improvement in the inconvenience, limitations, fears, impact on daily activities domains and specific impact of urinary problems (SIUP) [8]. Unvalidated QOL measures in the remaining two studies showed an 86% improvement in symptom score assessing overall QOL and a 3‐point increase on a 5‐point scale for questions on self‐esteem, self‐image, and coping with disability [9, 10]. There were 12 studies that assessed post NLUTD reconstruction surgery QOL (Table S2). Satisfaction with surgery was the most common question used to assess QOL post‐surgery, with majority of patients from each study indicating they were satisfied (50%–95%).

Table 1.

Pre‐post studies performed on neurogenic lower urinary tract dysfunction (NLUTD) patients undergoing bladder reconstruction

Study	Patient Population	Sex/Age	Intervention	Time from surgery to QOL assessment	QOL Measure	Relative Change in QOL
Lima, 2008	SCI, myelomeningocele, myelitis N = 67	45 M, 22 F/median 30 years	Bladder augmentation +/‐ catheterisable channel + /‐ureteral implantation + /‐ cutaneous appendicostomy	6 months	SF‐36a	28% improvement in emotional aspects 21% improvement in functional capacity 14% improvement in general health 13% improvement in social aspects < 10% improvement in vitality and mental health
					Qualiveenb	20%–28% score reduction in inconvenience, limitations, fears, and impact on daily activities domains 24% score reduction in Specific Impact of Urinary Problems
Watanabe, 1996	SCI, MS, diabetic neuropathy N = 18	0 M, 18 F/mean 37 years	Augmentation +/‐ catheterisable channel or ileocystomy, or pubovaginal sling urethral compression alone	Mean 18 months	Study‐specific questionnairec	3‐point improvement (1–4) in self‐esteem 3‐point improvement (1–4) in self‐image 3‐point improvement (1–4) in ability to cope with disability Body image and overall satisfaction with urological treatment improved in all 18 patients
Zachoval, 2003	MS N = 9	2 M, 7 F/mean 39 years	Augmentation cystoplasty	Mean 11 months	Study‐specific symptom scored	86% (5.0–0.7) score reduction

^a Medical Outcomes Study Short Form 36, measures overall QoL. Score range 0–100, higher numbers indicate better QOL.

^b Qualiveen, measures specific impact of urinary problems (SIUP) on QOL and general QOL. Score range 0–4, with lower numbers indicating better QOL.

^c Nine‐part questionnaire to score numerically the effect of the reconstruction on sexuality and quality of life issues, score range 0–5, 0 being worse and 5 being best.

^d Overall QOL questionnaire using a 0–6 scale, where 0 means excellent and 6 means unbearable.

Seven studies evaluated QOL in adult patients who had NLUTD and a urinary diversion. Within this group, three studies (n = 153 patients) compared pre‐post urinary diversion QOL (summarized in Table 2, with further study details in Table S3). Guillotreau et al. used the validated Qualiveen and SF‐36 in their study [11]. They showed that cystectomy with ileal conduit urinary diversion significantly improved the Qualiveen limitations and constraints domains, and the SIUP index (by 63%, 20%, and 28%, respectively) for patients with NLUTD from MS, SCI, and SB. The Qualiveen fears and feelings domains and all domains of the SF‐36 had no statistically significant change [11]. Legrand et al. [12] also used Qualiveen to evaluate pre‐post QOL in their study; they showed that patients with MS who underwent an incontinent urinary diversion had 60% improvement in the discomfort domain and a 47% improvement in the feeling's domain; overall QOL and bladder‐related QOL in this cohort improved by 45% and 95%, respectively [12]. In Schultz et al.'s paper [13], a validated general QOL measurement tool, World Health Organization's Quality of Life questionnaire (WHOQOL‐BREF), as well as an unvalidated urinary problem‐specific quality of life questionnaire, were used to evaluate the effect of ileal conduit/continent diversion on QOL. Physical function, psychological function, and environmental function domains of WHOQOL‐BREF had a statistically significant improvement, ranging from 7% to 25% [13]. All 3 domains of bladder‐specific quality of life (impaired activity and function, emotional function, live with the problem) had statistically significant relative improvements great than 70% [13]. There were four studies in the urinary diversion group that assessed post‐surgery QOL. (Table S4). Two of these studies assessed QOL by asking patients whether there's improvement in QOL post‐surgery, and both reported an improvement of QOL in > 50% of the patients (67%–90%).

Table 2.

Pre‐post studies performed on neurogenic lower urinary tract dysfunction (NLUTD) patients undergoing urinary diversion

Study	Patient Population	Sex/Age	Intervention	Time from surgery to QOL assessment	QOL Measure	Relative Change in QOL
Guillotreau, 2011	MS, SCI, SB and other neurological diseases N = 48	10 M, 38 F/mean 51 years	Ileal conduit urinary diversion	Not available	SF‐36a Qualiveenb	No statistically significant improvement in any domains 63% score reduction in limitations 20% score reduction in constraints 28% score reduction in SIUP index
Legrand, 2011	MS N = 53	6 M, 47 F/median 51 years	Incontinent urinary diversion	Median 75 months	Qualiveen	60% improvement in discomfort 47% improvement in feelings 45% improvement in overall QOL 95% improvement in health‐related QOL
Schultz, 2015	MS, SCI, myelomeningocele, and other neurological conditions N = 52	9 M, 43 F/median 51 years	Ileal conduit/continent urinary diversion	12 months	WHOQOL BREFbc Study‐specificd	25% improvement in physical function 7% improvement in psychological function 8% improvement in environmental function 75% score improvement in impaired activity and function 79% score improvement in emotional function 74% score improvement in live with the problem

^a Medical Outcomes Study 36‐Item Health Survey version 2, score range 0–100, with higher scores indicating better QOL.

^b Qualiveen, validated for spinal cord injury and Multiple sclerosis patients, score range 0–4, with lower numbers indicating better QOL. This tool measures specific impact of urinary problems (SIUP) on QOL and general QOL. General QOL has a score range of ‐2 to 2, with higher numbers indicating better QOL.

^c World Health Organization's quality of life questionnaire, general quality of life questionnaire with 26 items. Physical function domain assesses pain, energy, sleep, mobility, activities, medication, work. Psychological function domain assesses positive feelings, cognition, self‐esteem, body image, negative feelings, spirituality. Social domain assesses personal relations, social support, sex. Environmental domain assesses safety and security, home environment, finance, health and social care, information, leisure, physical environment, transport. Each domain is transformed to a scale from 0 to 100, with higher scores indicating better quality of life.

^d Urinary problem‐specific quality of life, assesses how urinary condition has influenced different activities and function (seven items considering, among others, reduced drinking before traveling and bedtime, getting too little sleep at night, not able to drive for 2 h, not taking part in sport and cultural activities) and emotional function. Lower scores indicate better QOL.

There were four studies that evaluated QOL after stress incontinence surgery in NLUTD, and three of these (n = 67 patients) measured pre‐post QOL (summarized in Table 3, with further study details in Table S5). A year after Advance Male sling placement, the overall assessment of continence‐related QOL improved from 2.6/10 to 7.2/10 and the validated ICIQ‐SF score improved by 71% [14]. After > 1 year follow from midurethral sling placement, 68% felt their QOL had “improved” with an average of 8.1 point improvement on the ICIQ questions [15]. Among nine female patients receiving both Botox injection and suburetheral sling treatment, their mean ICIQ score went from 17.6, preoperatively, to 0.3, postoperatively, reflecting a 98% improvement in bladder‐related QOL [16]. One small study (n = 12) reported high self‐reported satisfaction among people with various causes of NLUTD who underwent a midurethral sling (Table S6).

Table 3.

Pre‐post studies performed on neurogenic lower urinary tract dysfunction (NLUTD) patients undergoing stress incontinence surgery

Study	Patient Population	Sex/Age	Intervention	Time from surgery to QOL assessment	QOL Measure	Relative Change in QOL
Groen, 2012	Meningomyelocele, lower SCIN = 20	20 M/mean 23 years	AdVance suburethral male sling	12 months	ICIQ‐SF1	71% (14 to 4) improvement in score
					Study‐specific2	VAS scale for improvement increased from 2.6 to 7.2
Patki, 2008	Traumatic SCI N = 9	9 F/mean 57 years	Combined Botox injection and suburethral sling		ICIQ	Score improved from 17.6 to 0.3
				Mean 19 months	Study‐specific	78% of patients very satisfied with surgery 12% satisfied with surgery
Sakalis, 2018	SCI female patients with pure stress or mixed urine incontinence N = 38	38 F/mean 56 years	Mid‐urethral tape	12 months	ICIQ Q3‐5	8.1 point improvement in Q3‐Q5
					Study‐specific	68% of patients felt improved QOL 10% of patients felt no difference 11% of patients had deterioration in QOL

^a International Consultation on Incontinence‐Short Form, assesses symptoms and impact of incontinence, score range 0–21, with lower scores indicating less symptom severity and impact of continence.

^b Visual Analog Scale, validated tool for measurement of QOL in urogynecologic surgery, score range 0–10. Higher score indicates greater improvement.

4. Discussion

We sought to better understand the QOL evidence supporting the use of urologic surgical interventions in patients with NLUTD. Despite performing these surgeries for decades in people with NLUTD, we only identified 314 people who met our inclusion criteria and had pre‐post surgery QOL results published. We focused on pre‐post studies, which are a type of quasi‐experimental study that offer a simple way to test the effect of an intervention; while this type of study seeks to demonstrate a causal relationship, it is susceptible to several limitations such as concurrent time‐related changes that are independent from the intervention, selection bias, and attrition due to patients being lost to follow‐up. Most studies used either unvalidated assessments of quality of life or satisfaction, the bladder specific Qualiveen or symptom‐specific ICIQ‐SF, or the overall QOL questionnaires such as the SF‐36 and WHO‐QOL. The studies we identified were generally consistent in demonstrating an improvement in patient reported QOL after bladder reconstruction, urinary diversion and stress incontinence surgery. The one study that selected validated measures of QOL to examine bladder reconstruction surgery demonstrated that overall QOL, and bladder specific QOL both improved by about 10%–30% [8]. We identified three pre‐post urinary diversion: the bladder specific Qualiveen improved approximately 20%–60% in most domains, however one study failed to show an improvement in overall QOL, while another demonstrated an 7%–25% improvement in some domains [11, 12, 13]. Finally, stress incontinence surgery resulted in a large improvement in the incontinence specific ICIQ‐SF score, however it is important to note that this score is a mix of a patient's symptoms (i.e., frequency of incontinence), and QOL (with the single question “How much does leaking urine interfere with your everyday life?”) and it has not been specifically validated for NLUTD [14, 15, 16].

We feel that this literature review will be valuable for clinicians in a few ways. First, they can counsel NLUTD patients on the potential magnitude of benefit that a significant intervention, such as urinary diversion, may bring. Second, if they use the same validated questionnaires that have been used in these studies, they can show patients how their answers may change in some of the domains if they get an “average” benefit from the surgery. However, it is important to remember that the patients in these studies were likely carefully selected for surgical intervention by experienced neuro‐urologists, and that these results would not be expected if they were done on all NLUTD patients. Finally, this review serves to identify an important and relatively easy area of research in NLUTD; while randomized trials of these surgical interventions are not very likely, pre‐post studies offer valuable information, and more of these high‐quality studies on adult NLUTD patients undergoing bladder reconstruction, urinary diversion, and stress incontinence surgery are necessary.

There is convincing literature that bladder‐related QOL is often impaired in patients with NLUTD [7, 17, 18, 19]. When patients undergo surgeries to treat NLUTD, the goal is to prevent renal deterioration and/or improve their QOL. In the later case, it is obviously important to be able to communicate what magnitude of QOL change may be expected, especially given that markers measuring renal or bladder function don't necessarily correlate with QOL [7, 20, 21]. To put the changes we identified with surgical procedures in context, it is useful to look at the relative QOL change from other NLUTD interventions. The SONIC study randomized MS/SCI patients to anticholinergic bladder medications or placebo; those that received solifenacin 10 mg had a 20% improvement in the total incontinence‐specific I‐QOL score [22]. The use of 200 units of intravesical onabotulinum toxin in people with SCI/MS demonstrated an almost threefold improvement in the I‐QOL score at 12 weeks [23] compared to placebo. The urogenital distress score improved fivefold for neurologically normal women with stress incontinence who had a retropubic midurethral sling [24]. Obviously direct comparisons to the results reported by studies identified in this review are not possible as the patient populations and the outcome measures are different, however it does show the wide range of relative improvement in QOL people can expect with these interventions.

In our systematic review, we found that many studies looking at the impact of NLUTD surgeries on QOL only assessed post‐surgery QOL. In many of these cross‐sectional studies, self‐developed questionnaires were one of the most common QOL assessment tools. Satisfaction with surgery, improvement of QOL with surgery, and whether patients would recommend surgery to others were often used as a proxy for a properly developed and validated question. Some studies reported these QOL outcomes using percentage of patients, while others utilized VAS scales and verbal rating scales, making comparison between studies challenging. We did not focus our review on these studies as we identified a minimum number of pre‐post studies (which provide a higher level of evidence), and because there are several additional limitations to assessing QOL at a single timepoint (such as cognitive bias, choice supportive bias and theory‐driven recall bias) which can all cause an increase in perceived QOL [25], and the data reporting in many of these cross‐sectional studies was poor.

Similar to what Patel et al. [7] reported in their systematic review, we also recognized that the validated QOL tools used were very heterogenous for patients with NLUTD undergoing bladder surgery. SF‐36 has been validated in SCI patients; it measures overall QOL and contains both physical and mental health components [26]. Qualiveen and ICIQ, on the other hand, both contain items that measure urinary specific QOL [27, 28]. Qualiveen was designed specifically to measure QOL in those with neurogenic urinary disorder and it has been validated in SCI and MS patients, while ICIQ is used to assess the impact of urinary incontinence on QOL in non‐NLUTD and includes symptom based questions [27, 28, 29]. As specificity of these QOL increases (from general QOL, to bladder/disease QOL, to symptom specific QOL), the relative improvement in QOL from the surgical intervention also increases. Although there is no gold standard to measure QOL, multiple studies have suggested that using disease‐specific QOL measurement tools may capture the impact of bladder management strategies on QOL in patients with NLUTD more accurately [7, 28]. Validated QOL tools tend to be developed in a more rigorous manner; they use multiple, well‐constructed questions and response options to ensure they properly assess an entire QOL concept. Some of the unvalidated assessments of QOL that we found in this review are somewhat leading in their design, often assess a very specific symptom as a marker of QOL, and have a smaller number of response options spread across extremes (such as worst to best). This may explain some of the large relative improvements in QOL observed in the QOL assessments that relied on unvalidated questionnaires.

Combining a general QOL tool with a condition‐specific QOL can add more insight into the effect of bladder management method on NLUTD patient's QOL [30]; however, it might also make interpretation more difficult. Guillotreau et al. showed that, for NLUTD patients who underwent ileal conduit urinary diversion, there was statistically significant improvement in several domains of bladder‐related QOL (Qualiveen limitations, constraints, SIUP index), but no statistical improvement in overall QOL (SF‐36). This result is expected, however, as bladder‐related QOL considers only health in relation to bladder problems, while overall QOL consider all aspects of a person's health; thus bladder problems would generally only make up a portion of overall health, and any improvement in overall QOL would be “diluted out” by coexisting health problems that are not improved with urologic interventions, or perhaps get worse as a result of surgery. In summary, after surgery, there may be an improvement in urinary‐specific aspects of QOL, but not overall QOL, which can inform patient decision‐making when they are considering a surgical intervention.

It is important to acknowledge limitations of our study. We attempted to separate NLUTD surgical interventions into three distinct groups, however, some studies incorporated a mix of surgical interventions in the same cohort. We were only able to assess the English literature, so we may have missed studies published in other languages. Many of the studies did not report results in a way that made standard data extraction and synthesis possible, which limited the way we could present results. Across the studies QOL was assessed at different time periods after the intervention, and this may impact the interpretation of the results. In future research it will be important to consider different NLUTD populations individually, as meaningful improvements in QOL in patients with SCI may not occur in different disease conditions (such as more progressive MS, where bladder dysfunction often has associated worsening cognitive and physical symptoms. It would also be important, particularly for surgical interventions with potentially serious complications, to determine what impact these complications have on eventual QOL. To aid in interpretability we presented the relative degree of QOL change by calculating the percentage change in QOL pre‐ and post‐surgery; this should not be used to make direct comparisons between studies or surgical interventions given the different QOL questionnaires, patient populations, time periods, and follow‐up periods.

5. Conclusion

The literature supports an improvement in bladder‐specific QOL in adult NLUTD patients undergoing bladder‐related surgeries, but the number of pre‐post studies is very limited. Many studies used unvalidated QOL measures. Prospective studies with longitudinal measures of QOL are necessary in this patient population to better understand the impact of urologic surgery on QOL.

Author Contributions

All authors contributed to the study conception, design and data collection and analyses. The first draft of the manuscript was written by Wu and all authors edited this draft. All authors read and approved the final manuscript.

Ethics Statement

As this study did not involve human subjects, ethics approval was not required.

Conflicts of Interest

The authors declare no conflicts of interest.

Supporting information

Supporting information.

Data Availability Statement

Data sharing is not applicable to this article as no new data were created or analyzed in this study. Available from the corresponding author upon reasonable request.