Accepted Manuscript Title: The Effect of Episiotomy on Pelvic Organ Prolapse Assessed by Pelvic Organ Prolapse Quantification System Author: Hakan Aytan Ekrem C. Tok Devrim Ertunc Osman Yasa PII: DOI: Reference:

S0301-2115(13)00583-6 http://dx.doi.org/doi:10.1016/j.ejogrb.2013.11.010 EURO 8327

To appear in:

EURO

Received date: Revised date: Accepted date:

6-6-2013 1-11-2013 13-11-2013

Please cite this article as: AYTAN H, TOK EC, ERTUNC D, YASA O, The Effect of Episiotomy on Pelvic Organ Prolapse Assessed by Pelvic Organ Prolapse Quantification System, European Journal of Obstetrics & Gynecology and Reproductive Biology (2013), http://dx.doi.org/10.1016/j.ejogrb.2013.11.010 This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

*Manuscript

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THE EFFECT OF EPISIOTOMY ON PELVIC ORGAN PROLAPSE ASSESSED BY PELVIC ORGAN PROLAPSE QUANTIFICATION SYSTEM Hakan AYTAN a

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Ekrem C. TOK b Devrim ERTUNC b

Associate Professor, MD. Mersin University Faculty of Medicine, Department of Obstetrics

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and Gynecology Mersin, Turkey b

Professor, MD. Mersin University Faculty of Medicine, Department of Obstetrics and

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Gynecology Mersin, Turkey

Research Assistant, MD. Mersin University Faculty of Medicine, Department of Obstetrics

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Osman YASA c

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and Gynecology Mersin, Turkey

Address for Correspondence: Hakan AYTAN

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Address: Fatih Mah. 30014. Sok. Yali Apt. 7/14, Mezitli, Mersin, Turkey Tel: + 90 5056833866

E-mail: [email protected] Fax: +90 (324) 4814835

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Condensation Episiotomy has no effect on pelvic organ prolapse assessed by pelvic organ prolapse

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quantification system

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INTRODUCTION Pelvic organ prolapse (POP) is a common problem with a significant social and financial burden. More than 338,000 procedures for prolapse are performed annually in the United States.1 Although several risk factors such as age, obesity, smoking, menopause,

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connective tissue disorders and genetics have been described, obstetric trauma, especially vaginal parturition has been suggested as the most important factor in the pathogenesis of

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urogenital prolapse.2-3

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Episiotomy was performed liberally until late 1980’s with a belief that it prevented

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excessive perineal damage which might lead to pelvic relaxation later in life.4 However, aftercoming randomized controlled studies asserted that episiotomy could not provide the

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maternal and fetal benefits reported by its proponents.5-7 It has even been shown to subject the patient to increased risk of perineal body injury and anal sphincter damage.8 As a result of

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increased concern and evidence, American College of Obstetricians and Gynecologists (ACOG) has eventually recommended restricted use of episiotomy in selected patients.9 The

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effect of episiotomy on pelvic floor (PF) function has been investigated on several questionnaire-based studies.10,11 A meta-analysis that collected the findings of these studies reported that episiotomy, either median or mediolateral, did not associate with reduced risk of PF dysfunction related complaints such as self-reported involuntary loss of urine,

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incontinence of stool or flatus, and sexual dysfunction.12 Pelvic organ prolapse quantification (POP-Q) system was introduced in 1996 by

International Continence Society (ICS) to allow researchers to report their findings in a standardized fashion and to diminish the intra- and interobserver variability.13 Although the functional and electrophysiological outcomes of episiotomy on the PF function are evaluated

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in a number of studies, there is no study regarding the anatomic effects of episiotomy on PF.

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For this reason, we performed POP-Q system in a cohort of women who delivered vaginally.

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MATERIALS AND METHODS This prospective study was designed to assess all the eligible women admitted to gynecology clinics for a six-month period (June 2008 to December 2008) who had a history of at least one vaginal birth with or without an episiotomy and whose birth records were

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attainable. Women who were pregnant, gave birth within the preceding 6 months period, had a known history of pre-pregnant prolapse, had a history of hysterectomy or any operation

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performed for POP and stress urinary incontinence, refused to participate and to whom POP-

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Q examination could not be performed (due to anatomic or orthopedic problems) were excluded. Women were considered to have episiotomy if they had episiotomy in any vaginal

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delivery. A total of 549 patients with an age range of 19 to 70 consisted the study group. The

subject gave written informed consent.

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study protocol was approved by the Ethics Committee of University of Mersin, and each

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Subjects were questioned to provide the practitioner with a summary of the patient’s medical, surgical, family, and social history and included questions that are relevant to current

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prescriptions (hormonal therapy, anti-diabetics, anti-hypertensives, medications for overactive bladder or constipation), habits (smoking) and allergies, medical conditions (diabetes mellitus, chronic hypertension, cardiopulmonary diseases), surgical, obstetric, gynecologic, and social history. Detailed information on obstetric history was collected by interview and hospital

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records. The information about the type of episiotomy was collected from the hospital records and pelvic examinations. The most commonly used and taught methods of episiotomies in Turkey are as follows: Episiotomies are performed when the perineum is bulging and when about 4 cm of fetal scalp is visible during a contraction. The incision is placed at 7 o’clock position for mediolateral episiotomies and extend about 4 cm the direction of the right ischial tuberosity at an angle of 45 degrees to the vertical line. For midline episiotomies, the perineum is incised about one-half the length of perineum from the midline of the posterior

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fourchette toward the anus.8 Anthropometric measures were recorded before the vaginal exam. Body mass index (BMI) was calculated as weight in kilograms divided by height in meters squared. Waist-to-hip ratio (WHR) was calculated by dividing circumferences of waist to hip. Ethnic differences were not addressed because the patients have a similar ethnic

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background. All examinations were performed by ET, DE, or under the supervision of these authors

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with a ruler. The staging of POP conformed to the standards and terminology set forth by the

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ICS.13 An overall stage was assigned to each patient, according to the most severely

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prolapsing compartment.

Because no data have been published previously on the effect of episiotomy on POP-Q

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stages, the study power was based upon predicted changes in the percent of POP, using data derived from the literature.3 Based on the suggestion that episiotomy would be protective

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against POP and assuming an approximate incidence of 30% of any degrees of POP and 1.5 times lower incidence in women with episiotomy, 175 patients in each group would be

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sufficient to detect a difference at a significance level of 5% with a power of 80% (G*Power v2.0). However, during the 6 months study period instead of 175 patients, only 110 patients without episiotomy could be gathered as there was a trend to perform routine episiotomy for delivery in the previous years. All statistical analyses were performed using SPSS v17.0

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(SPSS Inc., Chicago, IL) for Windows (Microsoft, Redmon, Washington). The baseline characteristics were compared by using Student’s t test for continuous variables and X2 or Fischer exact test for binary data. The POP-Q index values of the groups were compared by Student’s t test. Stepwise multiple linear regression analyses were performed to find out the independent effects of episiotomy on each POP-Q indices. The effects of episiotomy on POPQ stages were calculated using ordinal regression analyses after adjustment for possible confounders as listed in table 3. A P value 0.05, Table 2). However, the position of Ap point

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was significantly higher (-2.46+0.95 vs. -2.24+1.05, P=0.03), and the measurements of genital hiatus (gh), perineal body (pb) and total vaginal length (tvl) were significantly lower in

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episiotomy group than in non-episiotomy group (P II by ICS (P > 0.05, Table 3). Former studies which generally used Baden-Walker

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classification reported an incidence of about 30% to 50% of genital prolapse in women.14,15 In a recent study from Turkey the rate of isolated anterior prolapse which was defined as

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protrusion of anterior vaginal wall at or beyond the hymenal ring (POP-Q, stage > II) was found to be 33% and 38% in women with and without episiotomies respectively. In the same study mixed type prolapse was observed in 32% and 28% in patients with and without episiotomies.16

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In the current study, no statistically significant relationship was found between

episiotomy and general POP-Q stage in women who delivered vaginally. In their systematic review Hartmann et al. reported that the impact of episiotomy on the development of prolapse remains unknown.12 Handa et al. in their recent study reported that no increase in prolapse was seen in association with episiotomy. Instead these investigators found a potential association between spontaneous laceration and prolapse in vaginally delivered women 5–10 years after first delivery.17 Tegerstedt et al.18 compared 197 women with episiotomy to

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women without episiotomy and found 1.7 times (95% CI, 1.2 – 2.4) increased risk for genital prolapse. However, the most important problem in this study is the inclusion of women with cesarean section (C/S) in the group of women without episiotomies. Keeping in mind that C/S has a protective effect on pelvic organ prolapse,2 the inclusion of patients with C/S in the

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group of women without an episiotomy erroneously leads to the conclusion that episiotomy increases the risk of POP. That is why we think that inclusion of women with vaginal

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parturition in the current study reflects the real effect of episiotomy on POP prevalence.

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In a their retrospective study Cam et al. reported a significantly lower rate of central defects which was defined as presence of a central bulge and diminished vaginal rugae on the

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anterior vaginal wall in women with a history of mediolateral episiotomy than in the others (21% vs. 38%, respectively, p=0.009) and suggested that mediolateral episiotomy prevents

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central defects.16 Similarly in the present study prolapse of Ap point was found to be

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significantly lower in the episiotomy group when compared with the control (-2.46+0.95 vs 2.24+1.05 respectively, p=0.03); however episiotomy was not found to be an independent

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predictor of prolapse of Ap in the regression analysis. Instead rather than episiotomy, BMI, parity, and menopause status were found to be independent predictors of Ap. Trowbridge et al.19 searched the measurements of POP-Q indices in a general cohort. They observed that the degree of prolapse of Bp point was increasing with the number of

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vaginal births. We found that the degree of prolapse of Bp point was higher in women with episiotomy, even after correction for possible confounders, especially the parity. These observations point out that the episiotomy may not be protective, rather may have incremental effect on the prolapse of Bp point. Although there are several hypotheses, the functional and anatomical relations of pelvic organ support are not completely understood. According to the 3-level support hypothesis, the support of Bp point is supplied by level II. The level II is composed of mainly pubocervical and pubovesical ligaments which are responsible for the

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support of vagina, rectum and bladder.20 However, none of these anatomic parts are injured with episiotomy incision. Actually, episiotomy incision disrupts the integrity of Denonvillier fascia (rectovaginal septum) which’s role is not much mentioned in the pelvic organ support. Denonvillier fascia is also a part of endopelvic fascia that extends from the perineal body

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upward and continues with the puborectal ligament.21 It is possible that the disruption of this structure by episiotomy may lead to the prolapse of Bp point.

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The pb is the central point for the attachment of the perineal musculature, and lies

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beneath and supports the pelvic diaphragm. It is suggested that the failure to reattach the endopelvic fascia to the pb at the time of vaginal delivery leads to POP.22 The width of pb was

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shown to decrease with the number of vaginal births in the study of Trowbridge et al.19 However, they did not consider the episiotomy state of the subjects. We found a significant

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inverse association between the presence of episiotomy and the size of pb in multivariate

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analysis. The women with episiotomy had significantly smaller mean pb measurement than women without an episiotomy (3.15+0.85 vs. 3.33+0.72, P=0.04, Table 2). It seems that the

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size of pb reduces with the number of vaginal deliveries, and episiotomy causes further diminishment. The role of pb in the anatomic and physiologic support of pelvic organs have been emphasized in a number of reviews,22,23 however, the importance of the size of pb in POP-Q system remains to be clarified.

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We observed a significant association between episiotomy and the width of gh in

univariate; and tvl in uni- and multivariate analyses. Although the importance of these measurements is not clear, there are previous studies suggesting a correlation between the vaginal delivery and the width of gh.24 We think that the negative association of tvl and gh with episiotomy may result from cicatrisan process of this intervention.

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There are several limitations of this study. One of the limitations of the study that could not be controlled was that the episiotomies had been performed by different doctors during the deliveries of the women and the method of episiotomy might not have been exactly the same. As another limitation, like in other European countries, mediolateral episiotomy

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was the most performed episiotomy type. There were only 31 patients (7.1%) with median episiotomy, and they were assessed with mediolateral episiotomy group, together.

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Furthermore, we included only women with intact uterus to observe the effect of episiotomy

the study. Studies with larger sample sizes are necessary.

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on the natural history of POP. Another important limitation was the under power (61.1%) of

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In conclusion, although episiotomy did not change overall POP-Q stage, it had certain negative effects on several POP-Q indices. That is why, before conclusion that episiotomy

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had no protective or causative effect on POP, the productivity of this staging system and the

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effects of episiotomy on individual points on genital support should be argued in the future.

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REFERENCES 1. Popovic JR, Kozak LJ. National hospital discharge survey: annual summary, 1998. Vital Health Stat 13 2000; 148:1-194. 2. Drutz HP, Alarab M. Pelvic organ prolapse: demographics and future growth

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prospects. Int Urogynecol J Pelvic Floor Dysfunct 2006; 17 (Suppl 1): 6-9.

3. Nygaard I, Barber MD, Burgio KL, et al. Pelvic Floor Disorders Network. Prevalence

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of symptomatic pelvic floor disorders in US women. JAMA 2008; 300: 1311-6.

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4. Klein MC, Kaczorowski J, Robbins JM, Gauthier RJ, Jorgensen SH, Joshi AK. Physicians’ beliefs and behaviour during a randomized controlled trial of episiotomy:

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consequences for women in their care. CMAJ 1995; 153: 769-779.

5. Sartore A, De Seta F, Maso G, Pregazzi R, Grimaldi E, Guaschino S. The effects of

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Gynecol 2004; 103: 669-673

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mediolateral episiotomy on pelvic floor function after vaginal delivery. Obstet

6. Woolley RJ. Benefits and risks of episiotomy: a review of the English-language

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literature since 1980: part I. Obstet Gynecol Surv 1995; 50: 806-820. 7. Woolley RJ. Benefits and risks of episiotomy: a review of the English-language literature since 1980: part II. Obstet Gynecol Surv 1995; 50: 821-835. 8. Aytan H, Tapisiz OL, Tuncay G, Avsar FA. Severe perineal lacerations in nulliparous

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women and episiotomy type. Eur J Obstet Gynecol Reprod Biol. 2005; 121:46-50

9. American College of Obstetricians-Gynecologists. ACOG Practice Bulletin. Episiotomy. Clinical Management Guidelines for Obstetrician-Gynecologists. Number 71, April 2006. Obstet Gynecol 2006; 107: 957-62. 10. Klein MC, Gauthier RJ, Robbins JM, et al. Relationship of episiotomy to perineal trauma and morbidity, sexual dysfunction, and pelvic floor relaxation. Am J Obstet Gynecol 1994; 171: 591-8.

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11. Fritel X, Schaal JP, Fauconnier A, Bertrand V, Levet C, Pigné A. Pelvic floor disorders 4 years after first delivery: a comparative study of restrictive versus systematic episiotomy. BJOG 2008; 115: 247-52. 12. Hartmann K, Viswanathan M, Palmieri R, Gartlehner G, Thorp J, Lohr KN. Outcomes

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of routine episiotomy: a systematic review. JAMA 2005; 293: 2141–48. 13. Bump RC, Mattiasson A, Bø K, et al. The standardization of terminology of female

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pelvic organ prolapse and pelvic floor dysfunction. Am J Obstet Gynecol 1996; 175:

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10-7.

14. Hendrix SL, Clark A, Nygaard I, Aragaki A, Barnabei V, McTiernan A. Pelvic organ

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prolapse in the Women's Health Initiative: gravity and gravidity. Am J Obstet Gynecol 2002; 186: 1160-6.

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15. Kjerulff KH, Erickson BA, Langenberg PW. Chronic gynecological conditions reported by US women: findings from the National Health Interview Survey, 1984 to

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1992. Am J Public Health 1996; 86: 195-9. 16. Cam C, Asoglu MR, Selcuk S. Does mediolateral episiotomy decrease central defects

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of the anterior vaginal wall? Arch Gynecol Obstet 2012; 285: 411– 15. 17. Handa VL, Blomquist JL, McDermott KC. Pelvic Floor Disorders after Vaginal Birth Effect of Episiotomy, Perineal Laceration, and Operative Birth. Obstet Gynecol 2012; 119: 233–9.

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18. Tegerstedt G, Miedel A, Maehle-Schmidt M, Nyrén O, Hammarström M. Obstetric risk factors for symptomatic prolapse: a population-based approach. Am J Obstet Gynecol 2006; 194: 75-81. 19. Trowbridge ER, Fultz NH, Patel DA, DeLancey JO, Fenner DE. Distribution of pelvic organ support measures in a population-based sample of middle-aged, community-

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dwelling African American and white women in southeastern Michigan. Am J Obstet Gynecol 2008; 198: e1-6. 20. DeLancey JOL. Structural anatomy of the posterior pelvic compartment as it relates to rectocele. Am J Obstet Gynecol 1999; 180: 815–23.

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21. Nichols DH, Randall CL () Posterior colporrhaphy and perineorrhaphy in vaginal surgery, 4th edn. Williams & Wilkins, Baltimore, 1996, pp 257–289.

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22. Woodman PJ, Graney DO. Anatomy and physiology of the female perineal body with

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relevance to obstetrical injury and repair. Clin Anat 2002; 15: 321-34.

23. Albo M, Dupont MC, Raz S. Transvaginal correction of pelvic prolapse. J Endourol

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1996; 10: 231-9.

24. Liang CC, Tseng LH, Horng SG, Lin IW, Chang SD. Correlation of pelvic organ

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prolapse quantification system scores with obstetric parameters and lower urinary tract

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18: 537-41.

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symptoms in primiparae postpartum. Int Urogynecol J Pelvic Floor Dysfunct 2007;

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Table

Table 1. Comparison of the baseline characteristics of the subjects [mean + SD, median (IQR) or n (%)]

Age (yrs)

Episiotomy (-) n = 110 43.2 + 9.5

Episiotomy (+) n = 439 42.8 + 9.7

Postmenopausal

32 (29.4%)

135 (30.8%)

Body mass index (kg/m2)

28.7 + 4.9

27.1 + 4.5

Waist-to-hip ratio

0.80 + 0.06

0.78 + 0.07

Smoking

18 (16.5%)

118 (26.9%)

0.03

Parity

3.0 + 1.5

2.7 + 1.6

0.06

Age at first birth (yrs)

21.8 + 3.7

Birtweight of first child (g)

3149 + 589

Maximal birthweight (g) Years since last child birth

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0.001 0.04

3155 + 414

0.91

3542 + 588

3529 + 422

0.80

7 (11.0)

7 (9.75)

0.57

3 (2.7%)

38 (8.7%)

0.02

6 (5.5%)

47 (9.8%)

0.04

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0.33

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Anal sphincter injury

0.78

21.4 + 4.2

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Instrumental delivery

P value 0.74

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Table

Table 2. Comparison of pelvic organ prolapse quantification indices (mean + SD) Student’s t test

Statistically significant associations

0.80

Waist-to-hip ratio, parity, menopause

Ba

- 2.92 + 1.08

-2.88 + 1.04

0.20

Waist-to-hip ratio, parity, menopause

C

- 5.28 + 2.14

-5.23 + 1.67

0.82

Body mass index, parity, menopause

D

- 3.75 + 1.08

- 3.50 + 1.04

0.39

Body mass index, parity

Bp

- 2.88 + 1.08

-2.66 + 1.07

0.06

Parity, episiotomy

Ap

- 2.24 + 1.05

-2.46 + 0.95

0.03

Body mass index, parity, menopause

gh

3.75 + 1.08

3.50 + 1.04

0.02

Body mass index, waist-to-hip ratio,

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P value

- 1.83 + 1.18

Episiotomy (+) (mean+SD) -1.86 + 1.13

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Episiotomy (-) (mean+SD)

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Points

Multiple linear regression analysis

parity, menopause

pb

3.33 + 0.72

3.15 + 0.85

0.04

Menopause, maximum birth weight,

7.91 + 1.25

0.01

Menopause,

maximum

birthweight,

episiotomy

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8.23 + 1.12

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tvl

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episiotomy

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Table

Table 3. Distribution of POP-Q stages according to the presence and the type of episiotomy Episiotomy (+) n = 439 120 (27.3%)

I

33 (30.0%)

178 (40.6%)

II

40 (36.4%)

138 (31.4%)

III

1 (0.9%)

3 (0.6%)

IV

1 (0.9%)

0 (0.0%)

AOR [95% CI] *

Ref (1.0)

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0

Episiotomy (-) n = 110 35 (31.8%)

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POP-Q Stage

-0.24 [(-0.65) – (0.18)]

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POP-Q, Pelvic organ prolapse quantification

* Ordinal regression analyses (P = 0.26); the relation was adjusted for age, body mass index,

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waist-to-hip ratio, menopausal status, tobacco use, educational and socioeconomical status, gravidity, parity, age at first birth, maximum birtweight, instrumental delivery and anal

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sphincter injury.

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Table

Table 4. Factors affecting stage of pelvic organ prolapse assessed with pelvic organ prolapse quantification system.

AOR

95% CI

p

Age

1.0

0.97 – 1.02

0.70

BMI

1.02

0.98 – 1.06

0.32

Parity

3.21

1.24 – 7.39

0.02

Maximum birth weight

1.12

1.02 – 3.09

Cigarette smoking

1.04

0.69 – 1.56

WHR

2.80

1.16 – 5.37

0.03

Menopause status

1.60

0.36 – 0.99

0.03

Chronic diseases

1.03

0.94 – 1.12

0.59

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Variable

0.05

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0.87

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AOR: adjusted odds ratio, CI: confidence interval, BMI: body mass index, WHR: waist to hip ratio,

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Table

Without episiotomy n (%) p (n:439) 141 (32.1) 0.23

Anterior

32 (29.1)

119 (27.1)

0.68

Posterior

28 (25.5)

101 (23)

0.59

Central

5 (4.5)

20 (4.6)

0.99

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Variable

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Any stage ≥II prolapse

With episiotomy n (%) (n:110) 42 (38.2)

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Table 5. Comparison of stage ≥2 compartment prolapse in patients with and without episiotomy.

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The effect of episiotomy on pelvic organ prolapse assessed by pelvic organ prolapse quantification system.

This study aimed to assess the association between episiotomy and measures of pelvic organ prolapse quantification system (POP-Q) in a cohort of women...
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