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      Primary and repeat surgical treatment for female pelvic organ prolapse and incontinence in parous women in the UK: a register linkage study

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          Abstract

          Objectives

          To determine the lifetime risk of undergoing pelvic floor surgery in a cohort of UK parous women and the re-operation rates for pelvic floor surgery, time intervals for repeat surgery and independent risk factors for undergoing primary and repeat pelvic floor surgery.

          Study design

          A register linkage study.

          Main outcome measures

          The primary outcome was lifetime risk of parous women in the UK undergoing pelvic floor surgery for pelvic organ prolapse (POP), urinary incontinence (UI), and rectal prolapse or faecal incontinence (RP-FI). Secondary outcomes were re-operation rates and time interval of repeat surgery for POP/UI, and independent risk factors for undergoing primary and repeat pelvic floor surgery.

          Results

          34 631 women identified from the Aberdeen Maternity and Neonatal Database were linked with the Scottish Morbidity Records databases of NHS Scotland to assess relevant outcomes. The lifetime risk for women by age 80 years of undergoing any form of pelvic floor surgery was 12.2%. 2130 (6.2%) women had at least one pelvic floor surgery, of whom 407 (19%) had repeat operations. The median time intervals (IQR) between index and repeat UI and POP surgery were 2.80 (0.94–8.07) years and 3 (1.00–8.25) years, respectively. There is a reduced lifetime risk of pelvic floor surgery in women who had all deliveries by caesarean section (p<0.001) and those aged <20 years at first delivery (p=0.021). Women who sustained at least one perineal laceration (in the absence of a classified perineal tear) during delivery or who had at least one instrumental delivery with forceps use were at increased risk (p<0.001 and p=0.015, respectively).

          Conclusions

          Our study shows that in the UK more than one in 10 parous women will require at least one surgical procedure for pelvic floor disorders over their lifetime. The study also identifies independent risk and protective factors for pelvic floor surgery in parous women.

          Article summary

          Article focus
          • Lifetime risk of undergoing various types of pelvic floor surgery in a cohort of UK women.

          • Re-operation rates for various types of pelvic floor surgery and time intervals for repeat surgery.

          • Independent risk factors for undergoing primary and repeat pelvic floor surgery.

          Key messages
          • The lifetime risk for women by age 80 years undergoing any form of pelvic floor surgery was 12.2%.

          • The re-operation rate for pelvic floor surgery was 19%.

          • There was a reduced lifetime risk of pelvic floor surgery in women who had all deliveries by caesarean section only and those aged <20 years at first delivery, while women who sustained at least one perineal laceration during delivery or who had at least one instrumental delivery with the use of forceps were at increased risk.

          Strengths and limitations of this study
          • To our knowledge, this is the first study to report the lifetime risk for women in the UK of undergoing surgical treatment for pelvic floor dysfunction.

          • As the study represents the general population rather than a selected population, we are confident that our findings are generalisable to the UK or indeed any European population.

          • The Aberdeen Maternity and Neonatal Database and Scottish Morbidity Records (SMR) databases used in this study are subjected to quality control measures at regular intervals and there are numerous consistency checks in place to ensure the validity of data entry.

          • We were unable to link 27% of women with the SMR databases.

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          Most cited references14

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          Systematic review and economic modelling of the effectiveness and cost-effectiveness of non-surgical treatments for women with stress urinary incontinence.

          To assess the clinical effectiveness and cost-effectiveness of non-surgical treatments for women with stress urinary incontinence (SUI) through systematic review and economic modelling. The Cochrane Incontinence Group Specialised Register, electronic databases and the websites of relevant professional organisations and manufacturers, and the following databases: CINAHL, EMBASE, BIOSIS, Science Citation Index and Social Science Citation Index, Current Controlled Trials, ClinicalTrials.gov and the UKCRN Portfolio Database. The study comprised three distinct elements. (1) A survey of 188 women with SUI to identify outcomes of importance to them (activities of daily living; sex, hygiene and lifestyle issues; emotional health; and the availability of services). (2) A systematic review and meta-analysis of non-surgical treatments for SUI to find out which are most effective by comparing results of trials (direct pairwise comparisons) and by modelling results (mixed-treatment comparisons - MTCs). A total of 88 randomised controlled trials (RCTs) and quasi-RCTs reporting data from 9721 women were identified, considering five generic interventions [pelvic floor muscle training (PFMT), electrical stimulation (ES), vaginal cones (VCs), bladder training (BT) and serotonin-noradrenaline reuptake inhibitor (SNRI) medications], in many variations and combinations. Data were available for 37 interventions and 68 treatment comparisons by direct pairwise assessment. Mixed-treatment comparison models compared 14 interventions, using data from 55 trials (6608 women). (3) Economic modelling, using a Markov model, to find out which combinations of treatments (treatment pathways) are most cost-effective for SUI. Titles and abstracts identified were assessed by one reviewer and full-text copies of all potentially relevant reports independently assessed by two reviewers. Any disagreements were resolved by consensus or arbitration by a third person. Direct pairwise comparison and MTC analysis showed that the treatments were more effective than no treatment. Delivering PFMT in a more intense fashion, either through extra sessions or with biofeedback (BF), appeared to be the most effective treatment [PFMT extra sessions vs no treatment (NT) odds ratio (OR) 10.7, 95% credible interval (CrI) 5.03 to 26.2; PFMT + BF vs NT OR 12.3, 95% CrI 5.35 to 32.7]. Only when success was measured in terms of improvement was there evidence that basic PFMT was better than no treatment (PFMT basic vs NT OR 4.47, 95% CrI 2.03 to 11.9). Analysis of cost-effectiveness showed that for cure rates, the strategy using lifestyle changes and PFMT with extra sessions followed by tension-free vaginal tape (TVT) (lifestyle advice-PFMT extra sessions-TVT) had a probability of greater than 70% of being considered cost-effective for all threshold values for willingness to pay for a QALY up to 50,000 pounds. For improvement rates, lifestyle advice-PFMT extra sessions-TVT had a probability of greater than 50% of being considered cost-effective when society's willingness to pay for an additional QALY was more than 10,000 pounds. The results were most sensitive to changes in the long-term performance of PFMT and also in the relative effectiveness of basic PFMT and PFMT with extra sessions. Although a large number of studies were identified, few data were available for most comparisons and long-term data were sparse. Challenges for evidence synthesis were the lack of consensus on the most appropriate method for assessing incontinence and intervention protocols that were complex and varied considerably across studies. More intensive forms of PFMT appear worthwhile, but further research is required to define an optimal form of more intensive therapy that is feasible and efficient for the NHS to provide, along with further definitive evidence from large, well-designed studies.
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            Reoperation 10 years after surgically managed pelvic organ prolapse and urinary incontinence.

            This study measured the 10-year risk of reoperation for surgically treated pelvic organ prolapse and urinary incontinence (POPUI) in a community population. We conducted a prospective cohort analysis of 374 women who were > 20 years old and who underwent surgery for POPUI in 1995. The 10-year reoperation rate was 17% by Kaplan Meier analysis. Previous POPUI surgery at the time of index surgery conferred a hazard ratio of 1.9 (95% CI, 1.1-3.2; P = .018). The abdominal approach was protective against reoperation compared with the vaginal approach (hazard ratio, 0.37; 95% CI, 0.17-0.83; P = .02) With the use of Cox regression, no association was observed for age, vaginal parity, previous hysterectomy, body mass index, prolapse severity, ethnicity, chronic lung disease, smoking, estrogen status, surgical indication, or anatomic compartment. A reoperation rate of 17% is unacceptably high and likely represents an underestimate of the true rate. Most of the factors that influence reoperation have not yet been identified.
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              Epidemiologic evaluation of reoperation for surgically treated pelvic organ prolapse and urinary incontinence.

              The purpose of this study was to measure the risk of reoperation for surgically treated pelvic organ prolapse and urinary incontinence in a community-based population. A 5-year prospective, observational study was conducted of women who had undergone pelvic organ prolapse and urinary incontinence surgery in 1995. The cohort of 376 women was identified by International Classification of Diseases, 9th revision, and current procedural terminology codes in 149,554 reproductive-aged women within the Kaiser Permanente Northwest membership. Thirty-six women underwent 40 cases of reoperation. By survival analysis, 13% of women underwent reoperation by 71 months. Having undergone previous pelvic organ prolapse and urinary incontinence surgery increased the risk of reoperation to 17% compared with 12% for women who underwent a first procedure (log rank, P=.04). No association was observed with age, body mass index, parity, previous hysterectomy not for prolapse, vaginal versus abdominal approach, severity of prolapse, ethnicity, chronic lung disease, smoking, previous corticosteroid use, and estrogen status. Future reoperation is a significant risk of morbidity for women who undergo pelvic organ prolapse and urinary incontinence surgery.
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                Author and article information

                Journal
                BMJ Open
                bmjopen
                bmjopen
                BMJ Open
                BMJ Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2044-6055
                2011
                14 November 2011
                14 November 2011
                : 1
                : 2
                : e000206
                Affiliations
                [1 ]Urogynaecology, Division of Applied Health Sciences, University of Aberdeen, Aberdeen, UK
                [2 ]Population Health, Division of Applied Health Sciences, University of Aberdeen, Aberdeen, UK
                [3 ]Dugald Baird Centre for Research on Women's Health, University of Aberdeen, Aberdeen, UK
                Author notes
                Correspondence to Dr Mohamed Abdel-fattah; m.abdelfattah@ 123456abdn.ac.uk
                Article
                bmjopen-2011-000206
                10.1136/bmjopen-2011-000206
                3221293
                22102637
                932ec9e6-4e28-40a8-a247-283d7505460f
                © 2011, Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

                This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: http://creativecommons.org/licenses/by-nc/2.0/ and http://creativecommons.org/licenses/by-nc/2.0/legalcode.

                History
                : 8 June 2011
                : 14 September 2011
                Categories
                Epidemiology
                Research
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                Medicine
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