Int Urogynecol J DOI 10.1007/s00192-014-2573-9

REVIEW ARTICLE

Surgery for urinary incontinence in women 65 years and older: a systematic review Karin Franzen & Gunnel Andersson & Jenny Odeberg & Patrik Midlöv & Eva Samuelsson & Karin Stenzelius & Margareta Hammarström

Received: 22 July 2014 / Accepted: 4 November 2014 # The International Urogynecological Association 2014

Abstract Introduction and hypothesis Urinary incontinence (UI) is common among the elderly, but the literature is sparse on the surgical treatment of UI among the elderly. This systematic review aims to assess the effectiveness of surgical interventions as treatment for urinary incontinence in the elderly population ≥65 years of age.

Electronic supplementary material The online version of this article (doi:10.1007/s00192-014-2573-9) contains supplementary material, which is available to authorized users K. Franzen School of Medicine, Örebro University, Örebro, Sweden K. Franzen (*) Department of Obstetrics and Gynecology, Örebro University Hospital, 701 85 Örebro, Sweden e-mail: [email protected] G. Andersson School of Health and Medical Sciences, Örebro University, Örebro, Sweden J. Odeberg Swedish Council on Health Technology Assessment (SBU), Stockholm, Sweden P. Midlöv Center for Primary Health Care Research, Lund University, Malmö, Sweden E. Samuelsson Department of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden

Methods Randomized controlled trials (RCT) and prospective nonrandomized studies (NRS) were included. The databases PubMed (NLM), EMBASE (Elsevier), Cochrane Library (Wiley), and Cinahl (EBSCO) were searched for the period 1966 up to October 2013. The population had to be ≥65 years of age and had to have undergone urethral sling procedures, periurethral injection of bulking agents, artificial urinary sphincter surgery, bladder injection treatment with onabotulinumtoxin A or sacral neuromodulation treatment. Eligible outcomes were episodes of incontinence/urine leakage, adverse events, and quality of life. The studies included had to be at a moderate or low risk of bias. Mean difference (MD) or standard mean difference (SMD)as well as risk difference (RD) and the 95 % CI were calculated. Results Five studies—all on the suburethral sling procedure in women— that fulfilled the inclusion criteria were identified. The proportion of patients reporting persistent SUI after surgery ranged from 5.2 to 17.6 %. One study evaluating quality of life (QoL) showed a significant improvement after surgery. The complication rates varied between 1 and 26 %, mainly bladder perforation, bladder emptying disturbances, and de novo urge. Conclusion The suburethral sling procedure improves continence as well as QoL among elderly women with SUI; however, evidence is limited. Keywords Elderly . Surgery . Systematic review . Urinary incontinence

K. Stenzelius Department of Care Science, Malmö University, Malmö, Sweden

Introduction

M. Hammarström Department of Clinical Science and Education, Karolinska Institutet, Södersjukhuset, Stockholm, Sweden

Urinary incontinence (UI) is common among the elderly, affecting between 30 and 40 % of those older than 64 [1].

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As the elderly proportion of the population increases, so will the number of people with incontinence. Urinary incontinence has a negative impact on the social life, reducing activity and increasing dependency on care and relatives. UI is also a burden for caregivers of the frail elderly, often relatives. It is not uncommon for UI to be a major factor in the frail elderly, requiring hospitalization or nursing home care [2, 3]. Studies on the surgical treatment of UI for age groups over 65 are sparse in the literature and they are seldom the subject or subgroup for evaluation. Several studies do report good outcomes for the sling procedure among women around 50 years and the complication rate is less than 5 % [4, 5], but the situation in women aged 65 or older is left unaddressed [5]. In a retrospective study of 54 women aged 70 to 85 years it has been reported that the risk of serious adverse events after any elective gynecological surgery was about 5 %, but was more related to comorbidity than to advancing age [6]. The Swedish Government initiated in 2011 a nationwide survey to investigate care of the elderly over 65 years of age. The Swedish Council on Technology Assessment in Health Care (SBU) performed a systematic review dealing with the effectiveness of surgical interventions as treatment of urinary incontinence in the elderly (≥65 years) population as a part of this undertaking. The SBU report no. 219 forms the basis of this article [7].

Materials and methods Data collection The design was a systematic review including randomized controlled trials (RCT) and prospective controlled nonrandomized studies (NRS). The databases PubMed (NLM), EMBASE (Elsivier), Cochrane Library (Wiley), and Cinahl (EBSCO) were searched, for the period 1966 up to October 2013. The search string is shown in Appendix S1. To identify further studies, reference lists were used. The abstract and titles were screened independently by two reviewers (KF and GA) using eligibility criteria. Full-text copies were retrieved if either of the reviewers considered a study potentially eligible. The two reviewers screened all fulltext copies and consensus was achieved for eligibility.

periurethral injection of bulking agents, artificial urinary sphincter surgery, bladder injection treatment with onabotulinumtoxin A and sacral neuromodulation treatment. Advanced invasive urinary tract surgery and treatments no longer commonly performed such as colposuspension (Burch) were not included. There was no limit in terms of follow-up time. Eligible outcomes were episodes of incontinence/urine leakage, adverse events, and quality of life. The groups—intervention and control—had to include at least 20 subjects. In studies without a control group, the study had to include at least 40 patients. The studies had to be written in English. Analysis Eligible studies were assessed for methodical bias using a structured professional judgment procedure that is standard practice at SBU, similar to those used in other health technology assessment reviews (see Web Appendix S2 “Critical Appraisal” forms). The studies were scored as having a low, moderate or high risk of bias (Fig. 1). To be included in further analysis and meta-analysis, the studies had to be at a moderate or low risk of bias. When possible, data synthesis was performed using Rev Man (5.1). Inverse variance and a random effects model were used. The random effects model was used owing to clinical heterogeneity. For continuous outcomes the mean difference (MD) or standard mean difference (SMD) and the 95 % CI were estimated. For dichotomous outcomes we estimated the risk difference (RD) and the 95 % CI. Data extracted from the studies included were summarized in evidence tables (see Table 1). The conclusions were based on a synthesis of the research evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach [8].

Abstracts 1121 Excluded abstracts 732 Retrieved from reference lists 6

Arcles in full text 389 Excluded arcles 380 Included arcles 9

Study eligibility The population had to be 65 years of age or older with urinary incontinence. Studies with sub-group analyses of subjects 65 years or older were also included. The following urological surgical treatments were included: urethral sling procedures,

Study quality High 0

Study quality Moderate 5

Fig. 1 Flowchart of the studies included

Study quality Low 4

Country Population

Evidence table Intervention

Israel

UK

Groutz et Israel al. [12]

Gordon et al. [11]

Outcome results

Participants: n=34 (7); mean age: 75.4± 4.6 years Postoperative complications

Quality of life: I-QOL

Components: the Subjective Incontinence; control group were Patient satisfaction (raw waiting for 6 months scores) (Likert-type scale) before submitting to the same surgery Follow up: 6 months Objective incontinence; no information

Control

Eligibility: women SUI or MUI, uro-dynamically Components: TVT Components: TVT; Subjective incontinence: no confirmed concomitant prolapse concomitant prolapse information surgery was surgery was performed in 84 % of performed in 67 % of cases cases. Severity of UI: no information Participants: elderly, Participants: younger Objective incontinence: age≥70 ,n=157 (34, age ≤69, n=303 (95, persistent SUI (examination at 1-year follow up) at 1-year follow up); with full bladder, 1-h pad mean age: 57.8±7.9 test); persistent UUI (confirmed urodynamically) Setting: no information Quality of life: no information Study period: March 1998 to no information Complications/adverse effects Subjective incontinence: no Eligibility: women uro-dynamically proven SUI Components: TVT-O; Components: TVT-O; information; or MUI concomitant prolapse concomitant prolapse Objective incontinence: surgery was surgery was persistent urodynamic SUI performed in 90 % performed in 70 % of the cases (n=180) (according to ICS), (n=87) of the cases symptomatic; persistent OAB Severity of UI: no information Follow-up: mean Follow-up mean Quality of life: no information (elderly): 27± (younger):31± 17 months (range 3– 16 months 58 months) Setting: no information Participants: n Participants: n Complications/adverse effects (elderly≥70)=97 (2); (younger≤69)=256 Elderly: 2 (2.1 %), younger: 5 Study period: no information mean age: 75±4.1 (15); mean age: 55± (2.1 %) 8.6 Eligibility: women with urodynamic SUI Components: TVT Components: TVT Subjective incontinence, Sample: older women were case matched to a surgery surgery 6 weeks; no incontinence younger cohort for BMI, parity, mode of symptoms; persistent SUI;

TVT, elderly vs younger

Participants: n=35 (4)

Setting: a multicenter study, three different university hospitals Study period: October 2002 to March 2005 Mean age: 76.5± 5.2 years

Follow-up 6 months

Severity of UI: no information

TVT in the elderly Campeau Canada Eligibility: women >70 years of age; fit for Components: TVT et al. [9] surgery, ≥1 IE/day; SUI proven by a positive method stress test/ 24 h pad test >2 g; stable bladder with normal compliance on CMG, PVR6 months Followup: 6 weeks and Follow-up: 6 weeks and Objective incontinence: no 6 months 6 months information Participants: age >65, Participants: age 70 years of age with SUI; 22/ Components: TVT et al. 76 of the patients had previously undergone surgery; 12/76 had [16] surgery for SUI 24/76 (31 %); OAB of which 4 combined surgery (5.2 %) had preoperative detrusor over-activity TVT and prolapse and were treated with anti-muscarinics Severity of UI: no information Follow-up: mean time: 25.6 months; range: 16–49 months Setting: no information Participants: n=76 (2); mean age: 75.6 Study period: March 1998 to February 2001 (range: 70–91) years, median:76 years

Karantanis et al. [14]

Study

Table 1 (continued)

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Fig. 2 The presence of de novo urge, remaining stress urinary incontinence (SUI) or urge urinary incontinence (UUI) in elderly women compared with younger women after tension-free vaginal tape (TVT) operation/surgery

to be of moderate quality and were further included (Table 1) [9, 11, 12, 14, 16].

Results Only 9 studies fulfilled the inclusion criteria (Fig. 1) [9–17]. Four of those were not included in the analysis because of the high risk of bias (low study quality) [10, 13, 15, 17]. This was due to small populations, the lack of description of those lost to follow-up and/or lack of a control group. Five studies—all evaluating the suburethral sling procedure—were considered Table 2

Study design Of these 5 studies, 1 was an RCT of 69 women aged 70 or older with SUI (Table 1), randomized to either prompt TVT surgery or to wait for 6 months before being exposed to

Complications/adverse events in patients after TVT

Study

Randomized controlled studies Campeau et al. [9] Prospective observational studies Gordon et al. [11] Karantanis et al. [14] Sevestre et al. [16] Groutz et al. [12]

Bladder perforation, % (n/N)

Bladder emptying disturbances, % (n/N)

De novo urge, % (n/N)

22.6 (7/31)

12.9 (4/31)

3.2 (1/31)

1.3 (2/157) nd

2.5 (4/157) nd

1.3 (1/76) nd

26.3 (20/76) 3.1 (3/97)

18 (17/95) 2.9 (1/34) 21 (16/76) 11.9 (5/42)

Int Urogynecol J Table 3

Summary of findings of the suburethral sling procedure

Outcome

No. of patients (study design)

Overall assessment

Quality of evidence

Comments

Urine leakage

58 (1 RCT) [9]

++ +

−1 study quality −1 imprecision −2 study quality −1 imprecision −1 study quality −1 imprecision −1 study quality −1 imprecision −2 study quality −1 study quality −1 imprecision

QoL

58 (1 RCT) [9]

Reduced leakage (self-assessment) Reduced leakage (subjective/objective) Improved (I-QoL)

Complications De novo urge

58 (1 RCT) [9]

ns

++

247 (4 NRS) [11, 12, 14, 16] 58 (1 RCT) [9]

Increased risk Increased risk

+ ++

233 (2 NRS) [11, 12, 14, 16]

Increased risk

+

58 (1 RCT) [9]

Increased risk

++

328 (3 NRS) [11, 12, 14, 16]

Increased risk

+

247 (4 NRS) [11, 12, 14, 16]

Complications Bladder perforation

Complications Bladder emptying disturbances

surgery [9]. Three studies had each a control group comprising younger people (Table 1) [11, 12, 14] (1 was a case control study and 2 were NRS). The fifth study was a prospective observational study, but lacked a control group (Table 1) [16]. Evaluation of UI The RCT study showed no differences between the groups at baseline. After 6 months the treatment group was significantly more satisfied according to all parameters studied, including an evaluation of quality of life. None of the studies reported the severity of UI before surgery. The endpoint after follow-up was 6 weeks to 1 year after surgery and cure was defined as the subjective absence of urinary leakage in two studies [14, 16] and as an evaluation of persistent UI at urodynamic assessment in 2 studies [11, 12]. The proportion of patients reporting persistent SUI after surgery ranged from 5.2 to 17.6 %. In the 3 studies comparing elderly and younger women, the outcome was as good among older women as among younger (RD 0.03, 95 % CI −0.03 to 0.08 for persistent SUI (Fig. 2). In the study without a control group, 67 % of the 76 women aged >70 years with SUI or MUI considered themselves cured 16 to 49 months after surgery [16]. Three percent to 21 % of the patients developed de novo urgency postoperatively (Table 2). In 3 out of 4 observation studies, between 16 and 90 % of the women were also subjected to concomitant prolapse surgery [11, 12, 16]. The type and number of complications reported are presented in Table 2. Most common complications are bladder perforation, bladder emptying disturbances, and urge. Severe complications were reported in 6 out of 157 women aged 65

++

−2 study quality −1 imprecision −1 study quality −1 imprecision −2 study quality −1 imprecision

or older compared with 1 out of 303 among younger women in one of the studies [11]. All these women had undergone concomitant prolapse repair. The summary of findings based on a synthesis of the research evidence using GRADE is shown in Table 3. There were no studies identified regarding suburethral sling surgery in the frail elderly. We were not able to include any studies regarding treatment with bulking agents or bladder injections with onabotulintoxin A for elderly or the frail elderly. Nor could we find any studies fulfilling our criteria for surgery using an artificial sphincter or sacral neuromodulation for men or women or sling procedures for men.

Discussion Main findings From this systematic review it can be concluded that the suburethral sling procedure increases continence and thus QoL among elderly women with SUI. Complications were de novo urge, bladder perforation, and bladder emptying disturbances. Severe complications did occur, most frequently when concomitant prolapse surgery had been performed. Strengths and limitations Certain problems were identified throughout the work when reviewing the articles. The setting and study design on surgical procedures seldom included people aged 65 or older. If

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within the age range, they were seldom identifiable as a separate group. Studies with persons 60 years old or older were excluded since our criterion for the elderly was age 65 or older. Thus, age per se is a problem when evaluating the studies. Another obstacle was the varying inclusion and exclusion criteria used in the studies for the setting of study populations with regard to UI, and the type and severity of the UI were seldom apparent in the inclusion criteria. The variation in endpoints and definitions of cure in the literature on the surgical treatment of UI made them almost uncomparable. Furthermore, the studies were mostly prospective case control studies and only one RCT was found. The evaluation was also aggravated owing to concomitant prolapse surgery in a proportion of cases in 3 studies, in spite of which the studies were included. Interpretation The ICS Committee on Research require that, with regard to research on UI definitions on outcome and endpoints, studies must include evaluation of quality of life, which was the endpoint in only one of the studies fulfilling our inclusion criteria. The ICS Committee [18] has also requested that clinical trials in lower urinary tract dysfunction (2003) should include patient centered outcomes: cure, improvement, and failure should be stated with precise definitions. Objective outcomes should be reported with the appropriate statistical statements and that adverse events with definitions must be stated. It is apparent from our review that study design has to be improved in terms of age, inclusion and exclusion criteria, concomitant diseases, and outcome/endpoints, in addition to adverse events.

Conclusion Although urinary incontinence occurs with increasing frequency among older women there is a lack of high-quality studies on this population. However, the studies analyzed did include nearly 400 patients, and the existing evidence suggests that midurethral slings are as efficacious at treating urinary incontinence in elderly women as among women

Surgery for urinary incontinence in women 65 years and older: a systematic review.

Urinary incontinence (UI) is common among the elderly, but the literature is sparse on the surgical treatment of UI among the elderly. This systematic...
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