Neurourology and Urodynamics 34:693–698 (2015)

Trends in Reoperation for Female Stress Urinary Incontinence: A Nationwide Study 1

Ming-Ping Wu,1,2 Cheng-Yu Long,3 Ching-Chung Liang,4 Shih-Feng Weng,5,6 and Yat-Ching Tong7*

Division of Urogynecology and Pelvic Floor Reconstruction, Department of Obstetrics and Gynecology, Chi Mei Foundation Hospital, Tainan, Taiwan 2 Center of General Education, Chia Nan University of Pharmacy and Science, Tainan, Taiwan 3 Department of Obstetrics and Gynecology, Kaohsiung Municipal Hsiao-Kang Hospital, Kaohsiung, Taiwan 4 Department of Obstetrics and Gynecology, Chang Gung Memorial Hospital, Linkou Medical Center, Chang Gung University College of Medicine, Taoyuan, Taiwan 5 Department of Hospital and Health Care Administration, Chia Nan University of Pharmacy and Science, Tainan, Taiwan 6 Department of Medical Research, Chi Mei Medical Center, Tainan, Taiwan 7 Department of Urology, Medical College and Hospital, National Cheng Kung University, Tainan, Taiwan Aims: Using the National Health Insurance (NHI) database in Taiwan, the study aimed to evaluate the rates and associated factors for reoperation of female stress incontinence. Methods: Records of female patients who had received a primary surgical treatment for stress incontinence from January 2000 to December 2006 were retrieved. Among these, patients who had reoperations during follow-up till December 2010 were identified. The data were analyzed for reoperation rates, surgery methods, patient demography, surgeon, and hospital attributes. Results: Among 14,613 patients with a mean follow-up of 86.28  26.76 months, 563 (3.85%) had reoperations, an incidence rate of 54.37 per 10,000 person year (PY). Injection procedures had the highest reoperation rate of 893.30/10,000 PY. The adjusted hazard ratio (HR) of reoperation was higher for mid-urethral sling when compared to pubovaginal sling (HR 1.54, 95% CI 1.16– 2.05) or retropubic urethropexy including Burch operation (HR 1.30, 95% CI 1.04–1.61). Surgeons with high service volumes tended to have fewer reoperations. No correlations were noted between the reoperation rate with patient age, surgeon age/gender, year of operation and hospital status. However, urologists had higher reoperation rates than gynecologists. For repeat surgery, the majority of patients chose the same specialty but different surgical types. Mid-urethral sling was used most commonly in 48.85% of reoperations. Conclusions: Substantial number of patients need reoperation for stress incontinence. The choice of primary surgery type and surgeon specialty may affect the reoperation rates. Mid-urethral sling is the most common reoperation choice. Neurourol. Urodynam. 34:693–698, 2015. # 2014 Wiley Periodicals, Inc. Key words: mid-urethral sling; reoperation; surgery; urine incontinence INTRODUCTION

Stress urinary incontinence is a common female health problem.1,2 In a population-based, cross-sectional survey conducted in Canada, Germany, Italy, Sweden, and the United Kingdom, 8.7% of the adult female population reported symptoms of stress urinary incontinence (SUI).3 Up to 80% of women with urinary incontinence would experience negative impact on their quality of life.4 Surgical therapy for this condition has existed for over 100 years and about 200 different surgical procedures were described.5 In the modern era, bladder neck needle suspension, retropubic colpo-suspension, pubic vaginal sling, and tension-free mid-urethral sling have been the mainstay operative methods. These surgeries were designed to prevent involuntary loss of urine through the urethra during periods of increased intraabdominal pressure by several mechanisms: repositioning urethra; creating urethral compression; improving urethral coaptation; and offering dynamic mid-urethral support.5,6 However, post-operative SUI recurrence is a common problem.7,8 A health-care database survey in the United States showed a 14.5% 9-year cumulative incidence rate for repeat SUI surgery.9 The Taiwan National Health Insurance (NHI) program was started in March 1995. All Taiwanese inhabitants are required by law to join the program and pay variable amount of premium according to their income status. When people receive medical services, the Bureau of National Health Insurance (BNHI) pays a major part of the expenses to the #

2014 Wiley Periodicals, Inc.

contracted health-care providers. The BNHI has contracts with most hospitals and clinics in Taiwan, which submit patient case files and financial claims on a monthly basis. This insurance program covered 93.1% of the Taiwan inhabitants in 1999, and 99.2% in 2009 for a population around 23 million. Over these years, the BNHI has gathered a large amount of statistical information on the clinical practices of the entire country. The National Health Insurance Research Database (NHIRD) was therefore established by the National Health Research Institute (NHRI) with the aim of promoting research studies into current and emerging medical issues in Taiwan. Previous studies using this database have shown an increasing incidence of patients with lower urinary tract symptoms (LUTS) seeking medical services;10 and a notable growth and changing trends in surgical treatments for female SUI.11 Eric Rovner led the peer-review process as the Associate Editor responsible for the paper. Potential Conflicts of Interest: Nothing to disclose. Grant sponsor: Chi Mei Foundation Hospital, Tainan, Taiwan; Grant numbers: CMFHR10231; 10243  Correspondence to: Prof. Yat-Ching Tong, Department of Urology, National Cheng Kung University Hospital, 138, Sheng Li Road, Tainan, Taiwan. E-mail: [email protected] Received 21 February 2014; Accepted 2 June 2014 Published online 27 July 2014 in Wiley Online Library (wileyonlinelibrary.com). DOI 10.1002/nau.22648

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In this study, patients who had reoperation for SUI were identified from the NHIRD. Clinical and demographic data were analyzed. The main purposes of the study were to investigate: (1) the reoperation rates among different types of primary surgeries for SUI; (2) possible variables that could influence the reoperation rates, including: patient age, surgeon age, surgeon specialty, and hospital accreditation level; and (3) the patients’ preferences for repeat surgeries with regard to surgery and surgeon choices. MATERIALS AND METHODS Data Source

Permission was obtained for the use of data in this study from the NHIRD. Three types of NHI files were retrieved: (1) the in-patient expenditure file containing itemized hospital bills, dates of admission and discharge, codes for diagnoses, treatments, and surgeries (based upon the International Classification of Diseases, 9th Revision, Clinical Modification, ICD-9-CM), as well as patient demography; (2) the registry of the contracted medical facility with information on hospital accreditation level and geographical location; and (3) the registry for medical personnel with information on the attending physician’s age, sex, and medical specialty. Confidentiality was assured by using anonymous identifiers for the patients, doctors and hospitals. The study was conducted by abiding to the regulations of the NHIRD and obtained exemption from approval by Institutional Review Board of Chi Mei Foundation Hospital (10202-E08). Study Subjects

The study subjects were female patients who had received a primary surgery for SUI between January 2000 and December 2006. The NHI data were available from 1996 onwards, so patients with prior SUI surgeries done during 1996–1999 were excluded. All recruited patients were followed till the end of December 2010 or the time when reoperation occurred. During the follow-up periods, those who received reoperation for SUI were identified. The anti-incontinence surgeries were classified into five types: (1) Retropubic urethropexy (RPU, ICD-9-CM code 59.5), including Marshall–Marchetti–Kranz procedure, Burch colposuspension; (2) traditional pubovaginal sling (PVS, ICD-9 code 59.4); (3) mid-urethral sling (MUS, ICD-9 code 59.79), including tension free vaginal tape (TVT, Gynecare, Johnson and Johnson, Ethicon, Inc., Somerville, NJ), its modification with either inside-out or outside-in trans-obturator tapes, singleincision slings and other similar designs placed in the midurethra; (4) vaginal procedures including Kelly plication (ICD-9CM 59.3), needle suspension (ICD-9-CM 59.6) such as Stamey, Raz operations; and (5) periurethral injection (ICD-9 code 59.72) with bulking agents. Although the ICD-9 codes do not categorically distinguish between PVS and MUS, there has been a general consensus from the Taiwan Association of Medical Affairs to classify MUS as ICD-9 code 59.79; while PVS as 59.4. Data Analysis

Three aspects of information were analyzed: (1) patient attributes (age and surgical types); (2) surgeon attributes (specialty, age and gender); and (3) hospital attributes (accreditation level and hospital ownership). Hospital levels were divided into medical centers, regional hospitals, and local hospitals in accordance with the Department of Health Neurourology and Urodynamics DOI 10.1002/nau

accreditation policy in Taiwan. Hospital ownerships were classified into government hospitals, private for-profit hospitals, and private non-profit hospitals. The timing and types of surgery used for primary operation and reoperation were also analyzed. Statistical Analysis

Pearson’s Chi-square tests were performed to examine the differences in the distribution of the various surgical types for SUI. Incidence rate of reoperation was obtained by the number of reoperation divided by follow-up person years. The time interval for reoperation and the surgical volumes among different specialties were reported as mean  SD (standard deviation). The data were analyzed using one-way analysis of variance. Post hoc pair-wise comparisons were performed using Scheffe’s multiple comparisons. Chi-square tests and Fisher’s exact tests were used for same-or-different-surgery, same-ordifferent-specialty, and same-or-different-surgeon analyses. The risk of reoperation associated with various attributes were estimated using Cox proportional hazard models. A P-value of 260) 4,746 Surgeon gender Female 745 Male 13,868 Specialty Gynecology 11,841 Urology 2,711 Others 61 Accreditation level Medical center 9,625 Regional 4,019 Local 969 Ownership Government 3,183 Non-for-profit 7,707 Private 3,723 Total

Repeat

Crude HR (95%CI)

Adjusted HR (95% CI)

%

No.

%

35.89 6.79 16.58 30.98 8.47 1.29

172 31 72 170 51 67

3.28 3.13 2.97 3.76 4.12 35.64

1.15 (0.87–1.51) 0.97 (0.64–1.49) Reference 1.40 (1.06–1.84) 1.38 (0.96–1.97) 19.53 (13.96–27.33) 0.96 (0.89–1.03) 1.14 (1.01–1.28)

10.87 13.84 14.80 12.51 14.50 15.92 17.57

74 76 90 66 80 81 96

4.66 3.76 4.16 3.61 3.78 3.48 3.74

Reference 0.89 (0.64–1.23) 1.08 (0.79–1.48) 1.03 (0.73–1.45) 1.20 (0.86–1.67) 1.26 (0.90–1.76) 1.50 (1.08–2.07)

Reference 0.90 (0.65–1.25) 1.12 (0.82–1.55) 0.93 (0.66–1.32) 0.99 (0.70–1.39) 0.93 (0.66–1.32) 1.07 (0.77–1.50)

33.37 34.15 32.48

211 230 122

4.33 4.61 2.57

Reference 1.06 (0.88–1.27) 0.57 (0.46–0.71)

Reference 0.93 (0.75–1.14) 0.64 (0.49–0.84)

5.10 94.90

24 539

3.22 3.89

Reference 1.13 (0.75–1.71)

Reference 1.00 (0.66–1.52)

81.03 18.55 0.42

368 191 4

3.11 7.05 6.56

Reference 2.32 (1.94–2.76) 2.25 (0.84–6.02)

Reference 1.50 (1.20–1.86) 0.61 (0.22–1.71)

65.87 27.50 6.63

375 149 39

3.90 3.71 4.02

Reference 0.99 (0.82–1.20) 1.07 (0.77–1.49)

Reference 1.03 (0.83–1.28) 1.23 (0.85–1.78)

21.78 52.74 25.48 14,613

136 302 125 100

4.27 3.92 3.36 563

Reference 0.93 (0.76–1.14) 0.81 (0.64–1.04) 3.85

Reference 0.94 (0.76–1.17) 0.85 (0.65–1.11)

Reference 0.85 (0.58–1.25) 0.87 (0.66–1.15) 1.22 (0.99–1.51) 1.20 (0.88–1.64) 17.03 (12.81–22.64)

1.19 (0.90–1.57) 1.16 (0.76–1.79) Reference 1.54 (1.16–2.05) 1.36 (0.94–1.97) 14.09 (8.80–20.91) 0.95 (0.89–1.01) 1.06 (0.92–1.21)

Reference 0.98 (0.66–1.45) 0.84 0.64–1.11) 1.30 (1.04–1.61) 1.14 (0.83–1.58) 11.86 (8.24–17.06)

RPU, retropubic urethropexy; RPU LSC, laparoscopic retropubic urethropexy; PVS, traditional pubovaginal sling; MUS, mid-urethral sling; Vaginal, vaginal operations. Note 1: Patient/surgeon age as continuous variables. Note 2: ‘‘Year’’ denotes the year in which the primary operations were performed as a predictor for reoperation. Note 3: Surgery volume is stratified into three groups: high, moderate, and low according to the number of primary operations each surgeon performed in this cohort. Crude and adjusted HRs for repeat surgery were estimated by Cox proportional hazard models. 

P-value

Trends in reoperation for female stress urinary incontinence: A nationwide study.

Using the National Health Insurance (NHI) database in Taiwan, the study aimed to evaluate the rates and associated factors for reoperation of female s...
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