今日の臨床サポート

骨盤臓器脱

著者: 古山将康 医療法人藤井会 石切生喜病院

監修: 小林裕明 鹿児島大学大学院医歯学総合研究科生殖病態生理学

著者校正/監修レビュー済:2021/12/22
患者向け説明資料

概要・推奨   

  1. 保存的治療から開始し、手術療法では人工物を用いない手術から選択する。難治例や再発例ではメッシュを用いる手術を考慮する。難治例、若年例には腹腔鏡、ロボットによる仙骨腟固定術も有効である。
 
薬剤監修について:
オーダー内の薬剤用量は日本医科大学付属病院 薬剤部 部長 伊勢雄也 以下、林太祐、渡邉裕次、井ノ口岳洋、梅田将光による疑義照会のプロセスを実施、疑義照会の対象については著者の方による再確認を実施しております。
※薬剤中分類、用法、同効薬、診療報酬は、エルゼビアが独自に作成した薬剤情報であり、 著者により作成された情報ではありません。
尚、用法は添付文書より、同効薬は、薬剤師監修のもとで作成しております。
※同効薬・小児・妊娠および授乳中の注意事項等は、海外の情報も掲載しており、日本の医療事情に適応しない場合があります。
※薬剤情報の(適外/適内/⽤量内/⽤量外/㊜)等の表記は、エルゼビアジャパン編集部によって記載日時にレセプトチェックソフトなどで確認し作成しております。ただし、これらの記載は、実際の保険適応の査定において保険適応及び保険適応外と判断されることを保証するものではありません。また、検査薬、輸液、血液製剤、全身麻酔薬、抗癌剤等の薬剤は保険適応の記載の一部を割愛させていただいています。
(詳細はこちらを参照)
著者のCOI(Conflicts of Interest)開示:
古山将康 : 特に申告事項無し[2022年]
監修:小林裕明 : 講演料(中外製薬株式会社,アストラゼネカ株式会社),研究費・助成金など(シスメックス株式会社),奨学(奨励)寄付など(中外製薬株式会社)[2022年]

改訂のポイント:
  1. 定期レビューを行った(変更なし)。
  1. 経腟メッシュ手術は術後のメッシュ脱出などのトラブルが増加し欧米では中断している。日本では日本製のテフロンメッシュ(ORIHIME®)が採用され、日本女性骨盤底医学会に症例登録して施行することとなっている。

病態・疫学・診察

疾患情報(疫学・病態)  
  1. 性器脱は骨盤底臓器が腟壁を押す形で下垂・脱出するヘルニアの状態を指し、肛門から直腸壁が重積のような形で脱出する直腸脱を合わせて、骨盤臓器脱(pelvic organ prolapse、 POP)と呼ばれる。
  1. 骨盤臓器脱の進展は骨盤底臓器の支持機構の破綻による。発症には素因(人種や遺伝的要素)、誘発因子(妊娠・分娩、手術既往)、助長因子(肥満、便秘、慢性の咳、職業など)、非代償性因子(加齢、エストロゲン低下、組織の萎縮)が関わる。
  1. 骨盤臓器脱は無症状の患者が多く医療機関の受診率が一定でないため正確な有病率は不明であるが、20~80歳の女性で有症状の骨盤臓器脱の頻度は約3%とされる[1]
  1. 米国の20~80歳までに骨盤臓器脱もしくは尿失禁で手術を受ける生涯リスクは11.1%であった。手術後の再手術は29.2%に施行されていた[2]
  1. Women’s Health Initiative Study(WHI研究)によると一般女性の診察結果では子宮脱が14%、膀胱瘤は34%、直腸瘤が19%の有病率であった。人種間の差としては黒人は骨盤臓器脱の発症頻度は少なく、ヒスパニックは子宮脱、アジア系は膀胱瘤の発症が高い[3]
  1. 20~59歳までの女性の約30%、50歳代の女性の約55%、出産経験者の女性の44%が何らかの骨盤臓器脱症状を有する[4]
  1. 子宮脱矯正リングペッサリーが保存的治療で用いられる。わが国のペッサリーのメーカーでは月約6,000個の受注があり、骨盤臓器脱患者の約50%にリングが使用されていると仮定すると、骨盤臓器脱のために受診する新規患者は毎年14万人程度いると推定される。
  1. 分娩は大きな誘発因子であるが、この調査では分娩回数とは相関していなかった。他の研究では1回の分娩で4倍、2回の分娩で8倍、3回では9倍、4回では10倍のリスクがあるとの報告もある[5]
問診・診察のポイント  
問診:
  1. 外陰部の下垂感を自覚した状況(場所、時間、視認か触知か、腹圧の有無)

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文献 

Ingrid Nygaard, Matthew D Barber, Kathryn L Burgio, Kimberly Kenton, Susan Meikle, Joseph Schaffer, Cathie Spino, William E Whitehead, Jennifer Wu, Debra J Brody, Pelvic Floor Disorders Network
Prevalence of symptomatic pelvic floor disorders in US women.
JAMA. 2008 Sep 17;300(11):1311-6. doi: 10.1001/jama.300.11.1311.
Abstract/Text CONTEXT: Pelvic floor disorders (urinary incontinence, fecal incontinence, and pelvic organ prolapse) affect many women. No national prevalence estimates derived from the same population-based sample exists for multiple pelvic floor disorders in women in the United States.
OBJECTIVE: To provide national prevalence estimates of symptomatic pelvic floor disorders in US women.
DESIGN, SETTING, AND PARTICIPANTS: A cross-sectional analysis of 1961 nonpregnant women (>or=20 years) who participated in the 2005-2006 National Health and Nutrition Examination Survey, a nationally representative survey of the US noninstitutionalized population. Women were interviewed in their homes and then underwent standardized physical examinations in a mobile examination center. Urinary incontinence (score of >or=3 on a validated incontinence severity index, constituting moderate to severe leakage), fecal incontinence (at least monthly leakage of solid, liquid, or mucous stool), and pelvic organ prolapse (seeing/feeling a bulge in or outside the vagina) symptoms were assessed.
MAIN OUTCOME MEASURES: Weighted prevalence estimates of urinary incontinence, fecal incontinence, and pelvic organ prolapse symptoms.
RESULTS: The weighted prevalence of at least 1 pelvic floor disorder was 23.7% (95% confidence interval [CI], 21.2%-26.2%), with 15.7% of women (95% CI, 13.2%-18.2%) experiencing urinary incontinence, 9.0% of women (95% CI, 7.3%-10.7%) experiencing fecal incontinence, and 2.9% of women (95% CI, 2.1%-3.7%) experiencing pelvic organ prolapse. The proportion of women reporting at least 1 disorder increased incrementally with age, ranging from 9.7% (95% CI, 7.8%-11.7%) in women between ages 20 and 39 years to 49.7% (95% CI, 40.3%-59.1%) in those aged 80 years or older (P < .001), and parity (12.8% [95% CI, 9.0%-16.6%], 18.4% [95% CI, 12.9%-23.9%], 24.6% [95% CI, 19.5%-29.8%], and 32.4% [95% CI, 27.8%-37.1%] for 0, 1, 2, and 3 or more deliveries, respectively; P < .001). Overweight and obese women were more likely to report at least 1 pelvic floor disorder than normal weight women (26.3% [95% CI, 21.7%-30.9%], 30.4% [95% CI, 25.8%-35.0%], and 15.1% [95% CI, 11.6%-18.7%], respectively; P < .001). We detected no differences in prevalence by racial/ethnic group.
CONCLUSION: Pelvic floor disorders affect a substantial proportion of women and increase with age.

PMID 18799443
A L Olsen, V J Smith, J O Bergstrom, J C Colling, A L Clark
Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence.
Obstet Gynecol. 1997 Apr;89(4):501-6. doi: 10.1016/S0029-7844(97)00058-6.
Abstract/Text OBJECTIVE: To determine the incidence of surgically managed pelvic organ prolapse and urinary incontinence in a population-based cohort, and to describe their clinical characteristics.
METHODS: Our retrospective cohort study included all patients undergoing surgical treatment for prolapse and incontinence during 1995; all were members of Kaiser Permanente Northwest, which included 149,554 women age 20 or older. A standardized data-collection form was used to review all inpatient and outpatient charts of the 395 women identified. Variables examined included age, ethnicity, height, weight, vaginal parity, smoking history, medical history, and surgical history, including the preoperative evaluation, procedure performed, and details of all prior procedures. Analysis included calculation of age-specific and cumulative incidences and determination of the number of primary operations compared with repeat operations performed for prolapse or incontinence.
RESULTS: The age-specific incidence increased with advancing age. The lifetime risk of undergoing a single operation for prolapse or incontinence by age 80 was 11.1%. Most patients were older, postmenopausal, parous, and overweight. Nearly half were current or former smokers and one-fifth had chronic lung disease. Reoperation was common (29.2% of cases), and the time intervals between repeat procedures decreased with each successive repair.
CONCLUSION: Pelvic floor dysfunction is a major health issue for older women, as shown by the 11.1% lifetime risk of undergoing a single operation for pelvic organ prolapse and urinary incontinence, as well as the large proportion of reoperations. Our results warrant further epidemiologic research in order to determine the etiology, natural history, and long-term treatment outcomes of these conditions.

PMID 9083302
Susan L Hendrix, Amanda Clark, Ingrid Nygaard, Aaron Aragaki, Vanessa Barnabei, Anne McTiernan
Pelvic organ prolapse in the Women's Health Initiative: gravity and gravidity.
Am J Obstet Gynecol. 2002 Jun;186(6):1160-6.
Abstract/Text OBJECTIVE: The purpose of this study was to describe the prevalence of and correlates for pelvic organ prolapse.
STUDY DESIGN: This was a cross-sectional analysis of women who enrolled in the Women's Health Initiative Hormone Replacement Therapy Clinical Trial (n = 27,342 women). Baseline questionnaires ascertained demographics and personal habits. A baseline pelvic examination assessed uterine prolapse, cystocele, and rectocele. Descriptive statistics and logistic regression models were used to investigate factors that were associated with pelvic organ prolapse.
RESULTS: In the 16,616 women with a uterus, the rate of uterine prolapse was 14.2%; the rate of cystocele was 34.3%; and the rate of rectocele was 18.6%. For the 10,727 women who had undergone hysterectomy, the prevalence of cystocele was 32.9% and of rectocele was 18.3%. After controlling for age, body mass index, and other health/physical variables, African American women demonstrated the lowest risk for prolapse. Hispanic women had the highest risk for uterine prolapse. Parity and obesity were strongly associated with increased risk for uterine prolapse, cystocele, and rectocele.
CONCLUSION: Pelvic organ prolapse is a common condition in older women. The risk for prolapse differs between ethnic groups, which suggests that the approaches to risk-factor modification and prevention may also differ. These data will help address the gynecologic needs of diverse populations.

PMID 12066091
E C Samuelsson, F T Victor, G Tibblin, K F Svärdsudd
Signs of genital prolapse in a Swedish population of women 20 to 59 years of age and possible related factors.
Am J Obstet Gynecol. 1999 Feb;180(2 Pt 1):299-305.
Abstract/Text OBJECTIVE: Our objective was to study the prevalence of genital prolapse and possible related factors in a general population of women 20 to 59 years of age.
STUDY DESIGN: Of 641 eligible women in a primary health care district, 487 (76%) answered a questionnaire and accepted an invitation to a gynecologic health examination.
RESULTS: The prevalence of any degree of prolapse was 30.8%. Only 2% of all women had a prolapse that reached the introitus. In a set of multivariate analyses, age (P <.0001), parity (P <.0001), and pelvic floor muscle strength (P <.01)-and among parous women, the maximum birth weight (P <.01)-were significantly and independently associated with presence of prolapse, whereas the woman's weight and sustained hysterectomy were not.
CONCLUSIONS: Signs of genital prolapse are frequently found in the female general population but are seldom symptomatic. Of factors associated with genital prolapse found in this study, pelvic floor muscle strength appears to be the only one that could be affected.

PMID 9988790
J Mant, R Painter, M Vessey
Epidemiology of genital prolapse: observations from the Oxford Family Planning Association Study.
Br J Obstet Gynaecol. 1997 May;104(5):579-85.
Abstract/Text OBJECTIVE: To explore the epidemiology of uterovaginal and post-hysterectomy prolapse.
DESIGN: Cohort study.
SETTING: Seventeen large family planning clinics in England and Scotland.
POPULATION: 17,032 women who attended family planning clinics between 1968 and 1974, aged between 25 and 39 years at study entry.
METHODS: Annual follow up by interview, postal or telephone questionnaire until July 1994. Further details on all hospital admissions were obtained from the hospital discharge summaries. All women were flagged at time of recruitment in the NHS central registers.
MAIN OUTCOME MEASURE: In-patient admission with diagnosis of prolapse (ICD codes 8th Revision 623.0-623-9).
RESULTS: The incidence of hospital admission with prolapse is 2.04 per 1000 person-years of risk. Age, parity, calendar period and weight were significantly associated with risk of an inpatient admission with prolapse after adjustment for principal confounding factors. Significant trends were observed with regard to smoking status and obesity (Quetelet Index) at entry to the study and risk of prolapse. Social class, oral contraceptive use and height were not significantly associated with risk of prolapse. The incidence of prolapse which required surgical correction following hysterectomy was 3.6 per 1000 person-years of risk. The cumulative risk rises from 1% three years after a hysterectomy to 5% 15 years after hysterectomy. The risk of prolapse following hysterectomy is 5.5 times higher (95% CI 3.1-9.7) in women whose initial hysterectomy was for genital prolapse as opposed to other reasons.
CONCLUSION: Among the potential risk factors that were investigated, parity shows much the strongest relation to prolapse.

PMID 9166201
G M Ghoniem, F Walters, V Lewis
The value of the vaginal pack test in large cystoceles.
J Urol. 1994 Sep;152(3):931-4.
Abstract/Text To detect possible stress urinary incontinence associated with but masked by large cystoceles protruding through the vaginal orifice, a vaginal pack test was done in conjunction with video fluoro-urodynamic studies. Sixteen female patients with large cystoceles did not demonstrate stress urinary incontinence on clinical examination and were included in this study. Additionally, 10 healthy female volunteers underwent the same test to study the effect of a vaginal pack on urethral dynamics. The vaginal pack revealed the presence of stress urinary incontinence in 11 patients (69%): 3 (19%) with type II (vesicourethral hypermobility) and 8 (50%) with type III (internal sphincteric deficiency). After insertion of the vaginal pack, urodynamic studies showed that the closing proximal urethral pressure in patients with stress urinary incontinence was significantly lower than in continent patients (p < 0.05). No significant change in urethral pressures was noted in volunteer subjects after vaginal pack insertion. Fluoroscopy showed kinking of the posterior urethra and enlargement of the most dependent portion of the cystocele, that is the lower half of the hourglass image. Our study suggests that the mechanisms of continence in these patients are multifactorial, including urethral kinking, urethral compression and pressure dissipation. The vaginal pack test is easy to perform, increases visualization of the vesicourethral unit when used with fluoroscopy, and can aid in the selection of patients who would benefit from anti-incontinence surgery and/or cystocele repair.

PMID 8051758
R C Bump, A Mattiasson, K Bø, L P Brubaker, J O DeLancey, P Klarskov, B L Shull, A R Smith
The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction.
Am J Obstet Gynecol. 1996 Jul;175(1):10-7.
Abstract/Text This article presents a standard system of terminology recently approved by the International Continence Society, the American Urogynecologic Society, and the Society of Gynecologic Surgeons for the description of female pelvic organ prolapse and pelvic floor dysfunction. An objective site-specific system for describing, quantitating, and staging pelvic support in women is included. It has been developed to enhance both clinical and academic communication regarding individual patients and populations of patients. Clinicians and researchers caring for women with pelvic organ prolapse and pelvic floor dysfunction are encouraged to learn and use the system.

PMID 8694033
Hans Peter Dietz
Pelvic floor ultrasound in prolapse: what's in it for the surgeon?
Int Urogynecol J. 2011 Oct;22(10):1221-32. doi: 10.1007/s00192-011-1459-3. Epub 2011 Jun 9.
Abstract/Text Pelvic reconstructive surgeons have suspected for over a century that childbirth-related trauma plays a major role in the aetiology of female pelvic organ prolapse. Modern imaging has recently allowed us to define and reliably diagnose some of this trauma. As a result, imaging is becoming increasingly important, since it allows us to identify patients at high risk of recurrence, and to define underlying problems rather than just surface anatomy. Ultrasound is the most appropriate form of imaging in urogynecology for reasons of cost, access and performance, and due to the fact that it provides information in real time. I will outline the main uses of this technology in pelvic reconstructive surgery and focus on areas in which the benefit to patients and clinicians is most evident. I will also try and give a perspective for the next 5 years, to consider how imaging may transform the way we deal with pelvic floor disorders.

PMID 21656320
V Wu, S A Farrell, T F Baskett, G Flowerdew
A simplified protocol for pessary management.
Obstet Gynecol. 1997 Dec;90(6):990-4.
Abstract/Text OBJECTIVE: To evaluate a simplified protocol for pessary management.
METHODS: Women with symptomatic pelvic organ prolapse who opted for pessaries were enrolled in a prospective simplified protocol for pessary management. After the initial pessary fitting, they were seen at 2 weeks for reexamination and thereafter at 3- to 6-month intervals.
RESULTS: One hundred ten women (mean age 65 years) were enrolled, and 81 (74%) of them were fitted successfully with a pessary. Life-table analysis showed that 66% of those who used a pessary for more than 1 month were still users after 12 months and 53% were still users after 36 months. The severity of pelvic prolapse did not predict the likelihood of pessary failure except in cases of complete vaginal eversion. Patients complaining of stress incontinence were less likely to have a successful pessary fitting and more likely to opt for surgery. Current hormone use and substantial perineal support do not predict greater likelihood of pessary fitting success. No serious complications from using the pessary were observed in the study sample.
CONCLUSION: Stringent guidelines calling for frequent pelvic examinations during pessary use can be relaxed safely. Pessaries can be offered as a safe long-term option for the management of pelvic prolapse.

PMID 9397117
Zeelha Abdool, Ranee Thakar, Abdul H Sultan, Reeba S Oliver
Prospective evaluation of outcome of vaginal pessaries versus surgery in women with symptomatic pelvic organ prolapse.
Int Urogynecol J. 2011 Mar;22(3):273-8. doi: 10.1007/s00192-010-1340-9. Epub 2010 Dec 16.
Abstract/Text INTRODUCTION AND HYPOTHESIS: The aim of this study is to evaluate and compare the effectiveness of pessaries and surgery in women with symptomatic pelvic organ prolapse.
METHODS: A total of 554 women with symptomatic pelvic organ prolapse (POP) were recruited and treated with either a vaginal pessary (n = 359) or surgery (n = 195). Using the validated Sheffield POP questionnaire, outcomes were evaluated and then compared at 1 year.
RESULTS: At 1 year, the only significant difference between the two groups was increased frequency of intercourse in the surgery group (54% vs 46%; p = 0.028), which was not significant when controlled for age. There was a statistically significant improvement in prolapse, urinary, bowel, and sexual function in both pessary users and those treated surgically.
CONCLUSIONS: One year after treatment, women with POP report similar improvement in urinary, bowel, sexual function, and quality of life parameters when treated with pessary or surgical correction.

PMID 21161179
Geoffrey W Cundiff, Cindy L Amundsen, Alfred E Bent, Kimberly W Coates, Joseph I Schaffer, Kris Strohbehn, Victoria L Handa
The PESSRI study: symptom relief outcomes of a randomized crossover trial of the ring and Gellhorn pessaries.
Am J Obstet Gynecol. 2007 Apr;196(4):405.e1-8. doi: 10.1016/j.ajog.2007.02.018.
Abstract/Text OBJECTIVE: The aim of this randomized crossover trial was to compare symptom relief and change in life impact for women using the ring with support and Gellhorn pessaries.
STUDY DESIGN: Subjects were randomized to use each pessary for 3 months. Outcome data included a visual analog satisfaction score, and quality of life questionnaires. Analysis included student's t-test, Wilcoxan Signed-rank test and logistical regression.
RESULTS: Subjects were primarily white, parous, postmenopausal women with a mean age of 61. The median POPQ stage was III. We enrolled 134 subjects and collected 3-month data on 94 ring and 99 Gellhorn subjects. There were statistically and clinically significant improvements in the majority of the PFDI and many PFIQ scales with both pessaries, but no clinically significant differences between the two pessaries.
CONCLUSIONS: The ring with support and Gellhorn pessaries are effective and equivalent in relieving symptoms of protrusion and voiding dysfunction.

PMID 17403437
Charles W Nager, Holly E Richter, Ingrid Nygaard, Marie Fidela Paraiso, Jennifer M Wu, Kimberly Kenton, Shanna D Atnip, Cathie Spino, Pelvic Floor Disorders Network (PFDN)
Incontinence pessaries: size, POPQ measures, and successful fitting.
Int Urogynecol J Pelvic Floor Dysfunct. 2009 Sep;20(9):1023-8. doi: 10.1007/s00192-009-0866-1. Epub 2009 Jun 16.
Abstract/Text INTRODUCTION AND HYPOTHESIS: The aim of the study was to determine whether successful incontinence pessary fitting or pessary size can be predicted by specific POPQ measurements in women without advanced pelvic organ prolapse.
METHODS: In a multicenter study, women with stress urinary incontinence (SUI) and POPQ stage < or = 2 were randomized to three treatment arms: (1) incontinence pessary, (2) behavioral therapy, or (3) both. This study evaluates incontinence pessary size, POPQ measures, and successful fitting in the 266 women assigned to treatment arms 1 and 3.
RESULTS: Two hundred thirty-five women (92%) were successfully fitted with an incontinence ring (n = 122) or dish (n = 113). Hysterectomy, genital hiatus (GH), and GH/total vaginal length (TVL) ratios did not predict unsuccessful fitting (p > 0.05). However, mean TVL was greater in women successfully fitted (9.6 vs. 8.8 cm, p < 0.01). Final pessary diameter was not predicted by TVL, point D, or point C (p > 0.05).
CONCLUSIONS: The vast majority of women with SUI can be successfully fitted with an incontinence pessary, but specific POPQ measures were not helpful in determining incontinence pessary size.

PMID 19533009
Minita Patel, Colleen Mellen, David M O'Sullivan, Christine A LaSala
Impact of pessary use on prolapse symptoms, quality of life, and body image.
Am J Obstet Gynecol. 2010 May;202(5):499.e1-4. doi: 10.1016/j.ajog.2010.01.019. Epub 2010 Feb 20.
Abstract/Text OBJECTIVE: We sought to evaluate whether use of a vaginal pessary would change body image, bother symptoms, and quality of life in women with pelvic organ prolapse.
STUDY DESIGN: Women presenting for pessary insertion completed the short forms of Pelvic Floor Distress Inventory-20, Pelvic Floor Impact Questionnaire, and Body Image Scale. After successful pessary insertion and use for at least 3 months, subjects completed the surveys again. Scores were compared with a paired t test.
RESULTS: A total of 75 subjects were enrolled and follow-up responses were available for 54 subjects for analysis. Body Image Scale scores showed a significant decrease (6.1-3.4; P<.001), indicating an improvement in these women's perception of themselves, as did Pelvic Floor Distress Inventory-20 scores (81.34-45.83; P<.001) and Pelvic Floor Impact Questionnaire scores (50.32-17.98; P=.003).
CONCLUSION: The use of a pessary for 3 months reduces bother symptoms and improves both quality of life and perception of body image in women.

Copyright (c) 2010 Mosby, Inc. All rights reserved.
PMID 20171608
Jeffrey L Clemons, Vivian C Aguilar, Eric R Sokol, Neil D Jackson, Deborah L Myers
Patient characteristics that are associated with continued pessary use versus surgery after 1 year.
Am J Obstet Gynecol. 2004 Jul;191(1):159-64.
Abstract/Text OBJECTIVE: The purpose of this study was to identify patient characteristics in women with symptomatic pelvic organ prolapse that is associated with continued pessary use versus surgery after 1 year.
STUDY DESIGN: Fifty-nine women with symptomatic pelvic organ prolapse who were satisfied with their pessary at 2 months were evaluated prospectively at 1 year. Characteristics of women who continued to use a pessary were compared with women who underwent pelvic reconstructive surgery to identify predictors for continued pessary use versus surgery.
RESULTS: Forty-three women (73%) continued pessary use, and 16 women (27%) underwent surgery. Characteristics that were associated with continued pessary use were older age (76 vs 61 years; p <.001) and poor surgical risk (26% vs 0%; P =.03). Characteristics that were associated with surgery were sexual activity (81% vs 26%; P <.001), stress incontinence (44% vs 16%; P =.03), stage III-IV posterior vaginal wall prolapse (44% vs 16%; P =.03), and desire for surgery at the first visit (63% vs 12%; P <.001). Age >or=65 years was the best cut-off value for continued pessary use, with sensitivity of 95% (95% CI, 84%, 99%) and a positive predictive value of 87% (95% CI, 74%, 94%). Logistic regression demonstrated that age >or=65 years ( P <.001), stage III-IV posterior vaginal wall prolapse ( P =.007), and desire for surgery ( P =.04) were independent predictors.
CONCLUSION: Age >or=65 years was associated highly with continued pessary use. Desire for surgery and stage III-IV posterior vaginal wall prolapse were associated with discontinued pessary use and pelvic reconstructive surgery.

PMID 15295358
Lesley-Ann M Hanson, Jane A Schulz, Catherine G Flood, Bonita Cooley, Florence Tam
Vaginal pessaries in managing women with pelvic organ prolapse and urinary incontinence: patient characteristics and factors contributing to success.
Int Urogynecol J Pelvic Floor Dysfunct. 2006 Feb;17(2):155-9. doi: 10.1007/s00192-005-1362-x. Epub 2005 Jul 26.
Abstract/Text OBJECTIVE: An aging population has resulted in higher prevalence of urinary incontinence (UI) and pelvic organ prolapse (POP). This study examines a nurse-run clinic and analyzes the factors contributing to successful pessary use.
STUDY DESIGN: A retrospective chart review of 1,216 patients was completed. History, pelvic examination and pessary fitting was done. Data was analyzed utilizing a categorical model of maximum-likelihood estimation to investigate relationships.
RESULTS: Median patient age was 63 years. Median number of pessaries tried was two. Eighty-five percent of post-menopausal women were on hormone replacement therapy (HRT) prior to fitting. Highest success rate of 78% was in the group on both systemic and local HRT. Success rates ranged from 58% for urge incontinence to 83% for uterine prolapse. Prior vaginal surgery was a factor impacting success. In our series highest success rates for fitting were obtained with ring pessaries, ring with support, and gellhorns.
CONCLUSIONS: This model is a viable, option for the conservative management of UI and POP. Local HRT plays an important role in successful pessary fitting. Complications are rare.

PMID 16044204
Martina F Mutone, Colin Terry, Douglass S Hale, J Thomas Benson
Factors which influence the short-term success of pessary management of pelvic organ prolapse.
Am J Obstet Gynecol. 2005 Jul;193(1):89-94. doi: 10.1016/j.ajog.2004.12.012.
Abstract/Text OBJECTIVE: The purpose of this study was to identify patient criteria which may affect the outcome of a pessary trial.
STUDY DESIGN: Records of 407 patients presenting with symptomatic pelvic organ prolapse who had a trial of pessary management were reviewed. Success was defined both by the initial fitting as well as by whether the patient was using the pessary at the 3-week follow-up visit. Outcomes were compared using chi-square test, 2-sample Student t test, or the Wilcoxon rank sum test, as appropriate. Statistical analysis was carried out at a significance of .05.
RESULTS: One hundred sixty-eight patients (41%) were successfully fitted and continuing to use a pessary at the time of the 3-week follow-up visit. The likelihood of a successful pessary trial was significantly lower in subjects with a past history of hysterectomy (P<.001) or known reconstructive surgery for prolapse (P=.010). There was no association between the stage of prolapse and pessary trial outcome. There was no significance found in the relationship between the predominant location of support loss and the pessary trial outcome at the 3-week follow-up visit.
CONCLUSION: The type and severity of pelvic organ prolapse do not influence the likelihood of a successful pessary fitting, and should not be used as a basis on which to select patients for pessary management.

PMID 16021064
Sang Wook Bai, Bo Sung Yoon, Ja Young Kwon, Jong Seung Shin, Sei Kwang Kim, Ki Hyun Park
Survey of the characteristics and satisfaction degree of the patients using a pessary.
Int Urogynecol J Pelvic Floor Dysfunct. 2005 May-Jun;16(3):182-6; discussion 186. doi: 10.1007/s00192-004-1226-9. Epub 2004 Dec 1.
Abstract/Text The objective of this study was to evaluate characteristics, satisfaction degree, and problems of patients using a pessary for pelvic organ prolapse. A total of 104 patients who had been fitted with a pessary and available for follow-up for pelvic organ prolapse management were enrolled. The patients answered questions on general characteristics, indications for pessary use, complications from pessary use, satisfaction degree, and frequency of removal. The results indicated that 76 (73.0%) patients had at least more than one medical illness and 86 (82.7%) patients complained of lower urinary symptoms such as incontinence, urgency, frequency, or nocturia. Eighty-four (80.7%) patients used pessaries as they were not surgical candidates due to poor medical status or old age. After using a pessary, 76 (73.1%) patients had symptoms such as bleeding, erosion, or foul odor; 70.2% of the women answered that they were satisfied or more than satisfied and 19.1% of the patients removed their pessaries, of whom 80.0% were unable to continue use due to repeated expulsion of the pessary and uncomfortable fitting. These data suggest that the pessary tends to be used for high-risk patients due to medical problems or old age. Despite the high frequency of complications from pessary use, it was seen that the frequency of removing the pessary was low and the satisfaction degree was high. Most of the complications were not thought to be serious. To decrease the frequency of complications, the regular follow-up visit and proper management of pessary use were thought to be needed. Further studies are warranted on tailor-fitting the pessary by variable use and relieving the symptoms associated with the lower urinary tract.

PMID 15578156
Jeffrey L Clemons, Vivian C Aguilar, Tara A Tillinghast, Neil D Jackson, Deborah L Myers
Risk factors associated with an unsuccessful pessary fitting trial in women with pelvic organ prolapse.
Am J Obstet Gynecol. 2004 Feb;190(2):345-50. doi: 10.1016/j.ajog.2003.08.034.
Abstract/Text OBJECTIVE: Our purpose was to estimate the percentage of women with symptomatic pelvic organ prolapse who had a successful pessary fitting trial, to identify pelvic examination parameters that are associated with an unsuccessful pessary fitting trial, and to identify the most commonly used pessary for each stage of prolapse.
STUDY DESIGN: In a prospective, observational study, 100 consecutive women with symptomatic pelvic organ prolapse were examined, staged, and fitted with either a ring or Gellhorn pessary. A successful pessary fitting trial occurred if a woman continued to use a pessary 1 week after being fitted. Women were then divided into two groups on the basis of whether they had a successful pessary fitting trial: group 1 was successful, and group 2 was unsuccessful. Pelvic examination parameters were evaluated as risk factors for an unsuccessful pessary fitting trial.
RESULTS: Group 1 had 73 women, and group 2 had 27 women. A short vaginal length (< or =6 cm) and a wide vaginal introitus (4 fingerbreadths accommodated) were associated with group 2 (11% vs 0%, P=.02, and 22% vs 7%, P=.04, respectively). Ring pessaries were used more with stage II and III prolapse (100% and 71%, respectively), whereas Gellhorn pessaries were used more with stage IV prolapse (64%, P<.001).
CONCLUSION: Seventy-three women (73%) with symptomatic pelvic organ prolapse had a successful pessary fitting trial. A short vaginal length and a wide vaginal introitus were risk factors for an unsuccessful pessary fitting trial. Gellhorn pessaries are more often needed with stage IV prolapse.

PMID 14981372
V L Handa, M Jones
Do pessaries prevent the progression of pelvic organ prolapse?
Int Urogynecol J Pelvic Floor Dysfunct. 2002 Nov;13(6):349-51; discussion 352. doi: 10.1007/s001920200078.
Abstract/Text Pessaries are used for the management of pelvic organ prolapse, but it is unknown whether a pessary will prevent progression of this condition. The purpose of this study was to describe the course of pelvic organ prolapse among women using a pessary for at least 1 year. Among 56 consecutive women fitted with a pessary, 19 (33.9%) continued its use under our care for at least 1 year. We compared baseline and follow-up examinations, using the Pelvic Organ Prolapse Quantitation examination system. At baseline, 16 (84.2%) had stage 3 or 4 prolapse. After 1 year we observed a significant improvement in the stage of disease ( P = 0.045, Wilcoxon signed rank test). Four women (21.1%, 95% confidence interval -0.2, 43.7%) had an improvement in stage. No women had worsening in stage of prolapse. These data suggest that there may be a therapeutic effect associated with the use of a supportive pessary.

PMID 12466904
R L Holley, R E Varner, B P Gleason, L A Apffel, S Scott
Recurrent pelvic support defects after sacrospinous ligament fixation for vaginal vault prolapse.
J Am Coll Surg. 1995 Apr;180(4):444-8.
Abstract/Text BACKGROUND: Multiple studies have shown sacrospinous ligament fixation to be highly effective therapy for vaginal vault prolapse. Several authors have suggested that the marked vaginal retroversion subsequent to sacrospinous ligament fixation may predispose to recurrent pelvic support defects in the anterior fascial segment, resulting in cystocele or urethrocele, or both.
STUDY DESIGN: Thirty-six patients, 46 to 86 years of age, were examined at six weeks postoperatively and at long-term follow-up evaluation 15 to 79 months (median of 42 months) after sacrospinous ligament fixation and repair of associated pelvic support defects. The examinations, by an unbiased examiner, were done to identify and grade recurrent pelvic support defects.
RESULTS: At the six week postoperative visit, one patient had a small enterocele, and none of the patients demonstrated vaginal vault prolapse. At the long-term follow-up visit, 33 (92 percent) of the patients had cystoceles, six (17 percent) had rectoceles, two (6 percent) had enteroceles, and three (8 percent) demonstrated recurrent vaginal vault prolapse. Most cystoceles were small and asymptomatic.
CONCLUSIONS: A high rate of success in the treatment of prolapse of the upper vagina by sacrospinous ligament fixation was observed. Pelvic support defects at long-term follow-up evaluation occurred more commonly in the anterior fascial segment. Retroversion and fixation of the upper vagina predisposes the anterior fascial segment to excess pressure and a higher incidence of cystocele than could be attributed to the effects of aging and menopause.

PMID 7719548
Abstract/Text
PMID 13956565
Masayasu Koyama, Susumu Yoshida, Shinsuke Koyama, Kazuhide Ogita, Tadashi Kimura, Koichiro Shimoya, Yuji Murata, Ichiro Nagata
Surgical reinforcement of support for the vagina in pelvic organ prolapse: concurrent iliococcygeus fascia colpopexy (Inmon technique).
Int Urogynecol J Pelvic Floor Dysfunct. 2005 May-Jun;16(3):197-202. doi: 10.1007/s00192-004-1240-y. Epub 2004 Oct 23.
Abstract/Text To reinforce the support of the vagina, concurrent use of iliococcygeus fascia colpopexy with the McCall culdeplasty was scheduled for primary uterine prolapse. Forty-five women with primary uterine prolapse without stress urinary incontinence were treated by McCall culdeplasty alone or McCall culdeplasty plus iliococcygeus fascia colpopexy for suspension of the upper portion of the vagina. Recurrence of vaginal support defects were carefully followed for 15-50 months. Additional iliococcygeus fascia colpopexy did not change with the axis of the vagina obtained by McCall culdeplasty, although it prolonged total operation time by 32 min and increased blood loss by 94 ml. Two cases (8.3%) had postoperative vaginal defects in the group undergoing combined procedures and seven recurrent cases (33.3%) were observed in the group undergoing McCall culdeplasty alone. The durability of the combined procedures was superior to that of the modified McCall culdeplasty alone by Kaplan-Meier analysis. These results suggest that iliococcygeus fascia colpopexy is reasonably safe and strengthens not only the attachment of the upper part of the vagina but also that of the anterolateral vaginal wall.

PMID 15875235
Linda Brubaker, Geoffrey W Cundiff, Paul Fine, Ingrid Nygaard, Holly E Richter, Anthony G Visco, Halina Zyczynski, Morton B Brown, Anne M Weber, Pelvic Floor Disorders Network
Abdominal sacrocolpopexy with Burch colposuspension to reduce urinary stress incontinence.
N Engl J Med. 2006 Apr 13;354(15):1557-66. doi: 10.1056/NEJMoa054208.
Abstract/Text BACKGROUND: We designed this trial to assess whether the addition of standardized Burch colposuspension to abdominal sacrocolpopexy for the treatment of pelvic-organ prolapse decreases postoperative stress urinary incontinence in women without preoperative symptoms of stress incontinence.
METHODS: Women who did not report symptoms of stress incontinence and who chose to undergo sacrocolpopexy to treat prolapse were randomly assigned to concomitant Burch colposuspension or to no Burch colposuspension (control) and were evaluated in a blinded fashion three months after the surgery. The primary outcomes included measures of stress incontinence (symptoms, stress testing, or treatment) and measures of urge symptoms. Enrollment was stopped after the first interim analysis because of a significantly lower frequency of stress incontinence in the group that underwent the Burch colposuspension.
RESULTS: Of 322 women who underwent randomization, 157 were assigned to Burch colposuspension and 165 to the control group. Three months after surgery, 23.8 percent of the women in the Burch group and 44.1 percent of the controls met one or more of the criteria for stress incontinence (P<0.001). There was no significant difference between the Burch group and the control group in the frequency of urge incontinence (32.7 percent vs. 38.4 percent, P=0.48). After surgery, women in the control group were more likely to report bothersome symptoms of stress incontinence than those in the Burch group who had stress incontinence (24.5 percent vs. 6.1 percent, P<0.001).
CONCLUSIONS: In women without stress incontinence who are undergoing abdominal sacrocolpopexy for prolapse, Burch colposuspension significantly reduced postoperative symptoms of stress incontinence without increasing other lower urinary tract symptoms.

Copyright 2006 Massachusetts Medical Society.
PMID 16611949
Abstract/Text OBJECTIVES: Our purpose was to determine whether a vaginal or abdominal approach is more effective in correcting uterovaginal prolapse.
STUDY DESIGN: Eighty-eight women with cervical prolapse to or beyond the hymen or with vaginal vault inversion > 50% of its length and anterior vaginal wall descent to or beyond the hymen were randomized to a vaginal versus abdominal surgical approach. Forty-eight women underwent a vaginal approach with bilateral sacrospinous vault suspension and paravaginal repair, and 40 women underwent an abdominal approach with colposacral suspension and paravaginal repair. Ancillary procedures were performed as indicated. Detailed pelvic examination was performed postoperatively by the nonsurgeon coauthor yearly up to 5 years. The women were examined while standing during maximum strain. Surgery was classified as optimally effective if the woman remained asymptomatic, the vaginal apex was supported above the levator plate, and no protrusion of any vaginal tissue beyond the hymen occurred. Surgical effectiveness was considered unsatisfactory if the woman was symptomatic, the apex descended > 50% of its length, or the vaginal wall protruded beyond the hymen.
RESULTS: Eighty women (vaginal 42, abdominal 38) were available for evaluation at 1 to 5.5 years (mean 2.5 years). The groups were similar in age, weight, parity, and estrogen status, and 56% had undergone prior pelvic surgery. There was no significant difference between the groups in morbidity, complications, hemoglobin change, dyspareunia, pain, or hospital stay. The vaginal group had longer catheter use, more urinary tract infections, more incontinence, decreased operative time, and lower hospital charge. Surgical effectiveness was optimal in 29% of the vaginal group and 58% of the abdominal group and was unsatisfactory leading to reoperation in 33% of the vaginal group and 16% of the abdominal group. The reoperations included procedures for recurrent incontinence in 12% of the vaginal and 2% of the abdominal groups. The relative risk of optimal effectiveness by the abdominal route is 2.03 (95% confidence interval 1.22 to 9.83), and the relative risk of unsatisfactory outcome using the vaginal route is 2.11 (95% confidence interval 0.90 to 4.94).
CONCLUSIONS: Reconstructive pelvic surgery for correction of significant pelvic support defects was more effective with an abdominal approach.

PMID 8987919
V F MARSHALL, A A MARCHETTI, K E KRANTZ
The correction of stress incontinence by simple vesicourethral suspension.
Surg Gynecol Obstet. 1949 Apr;88(4):509-18.
Abstract/Text
PMID 18113320
Abstract/Text
PMID 13571326
Fréderic Caquant, Pierre Collinet, Philippe Debodinance, Juan Berrocal, Olivier Garbin, Claude Rosenthal, Henri Clave, Richard Villet, Bernard Jacquetin, Michel Cosson
Safety of Trans Vaginal Mesh procedure: retrospective study of 684 patients.
J Obstet Gynaecol Res. 2008 Aug;34(4):449-56. doi: 10.1111/j.1447-0756.2008.00820.x.
Abstract/Text AIM: To study peri-surgical complications after cure of genital prolapse by vaginal route using interposition of synthetic prostheses Gynemesh Prolene Soft (Gynecare) following the Trans Vaginal Mesh (TVM) technique.
METHODS: The present retrospective multicentered study comprised 684 patients who underwent surgery at seven French centers between October 2002 and December 2004. All patients had a genital prolapse >or=3 (C3/H3/E3/R3) according to International continence society (ICS) classification. According to each case, prosthetic interposition was total, or anterior only or posterior only. Patients were systematically seen 6 weeks, 3 months and 6 months after surgery. Multivaried statistical analysis followed a model of logistic regression applied to each post-surgical complication.
RESULTS: The mean age of patients was 63.5 years (30-94). The mean follow-up period was 3.6 months. 84.3% of patients were post-menopause, 24.3% had hysterectomy, 16.7% previous cure of prolapse, and 11.1% cure of stress urinary incontinence (SUI). During the procedure, hysterectomy was combined in 50.3% of cases, cervix amputation in 1.5%, and cure of SUI in 40.9%. 15.8% were treated for a cystocele only. 14.8% had only a rectocele +/- elytrocele and 69.4% had a prolapse touching both compartments, anterior and posterior. In peri-surgical complications, (2%) were five bladder wounds (0.7%), one rectal wound (0.15%) and seven hemorrhages greater that 200 mL (1%). Among early post-surgical complications (during the first month after surgery) (2.8%) were two pelvic abscesses (0.29%), 13 pelvic hematomas (1.9%), one pelvic cellulitis (0.15%), two vesicovaginal fistulas and one rectovaginal fistula (0.15%). Among late post-surgical complications (33.6%) there were 77 granulomas or prosthetic expositions (11.3% [6.7% in the vaginal anterior wall, 2.1% in the vaginal posterior wall and 4.8% in the fornix]), 80 prosthetic retractions (11.7%), 36 relapse of prolapse (6.9%) and 37 SUI de novo (5.4%). Multivaried analysis shows that previous history of hysterectomy or placing of an isolated anterior prosthesis increase the risk of peri-surgical complication; preserved uterus and isolated posterior prosthesis lessen the risk of granulomas and prosthetic retractions; and association of a Richter's intervention increases the rate of prosthetic retractions.
CONCLUSION: Cure of genital prolapse with synthetic prostheses interposed by vaginal route is now reliable and can be reproduced with a low rate of peri- and early post-surgical complications. However, our study shows a certain number of late post-surgical complications after insertion of strengthening synthetic vaginal implants (prosthetic expositions and prosthetic retractions). These retrospective results will soon be compared to a prospective study.

PMID 18937698
Sara J Mucowski, Catalin Jurnalov, John Y Phelps
Use of vaginal mesh in the face of recent FDA warnings and litigation.
Am J Obstet Gynecol. 2010 Aug;203(2):103.e1-4. doi: 10.1016/j.ajog.2010.01.060. Epub 2010 Mar 15.
Abstract/Text Choosing to use mesh in vaginal reconstructive surgery for pelvic organ prolapse or stress urinary incontinence is perplexing in the face of recent US Food and Drug Administration (FDA) warnings. In October 2008, the FDA alerted practitioners to complications associated with transvaginal placement of surgical mesh. Litigation is another concern. A Google search of "transvaginal mesh" results in numerous hits for plaintiff attorneys seeking patients with complications related to use of mesh. In light of a recent decision by the US Supreme Court and strategies by manufactures of medical devices to escape liability, it is imperative that gynecologic surgeons using transvaginal mesh document proper informed consent in the medical records. The purpose of this commentary is not to deter gynecologic surgeons from using transvaginal mesh when appropriate, but to provide an overview of current medical-legal controversies and stress the importance of documenting informed consent.

Copyright (c) 2010 Mosby, Inc. All rights reserved.
PMID 20227672
Mary P FitzGerald, Holly E Richter, Sohail Siddique, Peter Thompson, Halina Zyczynski, Ann Weber for the Pelvic Floor Disorders Network
Colpocleisis: a review.
Int Urogynecol J Pelvic Floor Dysfunct. 2006 May;17(3):261-71. doi: 10.1007/s00192-005-1339-9. Epub 2005 Jun 28.
Abstract/Text OBJECTIVE: To summarize published data about colpocleisis and to highlight areas about which data are lacking.
DATA SOURCES: We conducted a literature search on Medline using Ovid and PubMed, from 1966 to January 2004, using search terms "colpocleisis", "colpectomy", "vaginectomy", "pelvic organ prolapse (POP) and surgery", and "vaginal vault prolapse and surgery" and included articles with English-language abstracts. We examined reference lists of published articles to identify other articles not found on the electronic search.
METHODS OF STUDY SELECTION: We examined all studies identified in our search that provided any outcome data on colpocleisis. Because of the heterogeneity of outcome measures and follow-up intervals in case series, we did not apply meta-analytic techniques to the data.
RESULTS: Colpocleisis for POP is apparently successful in nearly 100% of patients in recent series. The rate of reoperation for stress incontinence or POP after colpocleisis is unknown. Concomitant elective hysterectomy is associated with increased blood loss and length of hospital stay, without known improvement in outcomes. Few studies systematically assess pelvic symptoms. The role of preoperative urodynamic testing to direct optimal management of urinary incontinence and retention remains to be established in this setting.
CONCLUSIONS: Colpocleisis is an effective procedure for treatment of advanced POP in patients who no longer desire preservation of coital function. Complications are relatively common in this group of elderly patients. Prospective trials are needed to understand the impact of colpocleisis on functional outcomes and patient satisfaction.

PMID 15983731
Abstract/Text BACKGROUND: Pelvic floor muscle training is the most commonly used physical therapy treatment for stress urinary incontinence. It is sometimes recommended for mixed and less commonly for urge urinary incontinence.
OBJECTIVES: The aim of this paper was to determine the effects of pelvic floor muscle training for women with urinary incontinence in comparison to no treatment, placebo or sham treatments, or other inactive control treatments.
METHOD: The Cochrane Incontinence Group Specialized Trials Register was searched up until December 1, 2004. The review included randomized or quasi-randomized trials in women with stress, urge or mixed urinary incontinence. One arm of the trial comprised pelvic floor muscle training, the other comprised either no treatment, placebo, sham, or other inactive control treatment. The trials were independently assessed for eligibility and methodological quality. Data were extracted then cross-checked by the two authors. Disagreements were resolved by discussion. The data were processed as described in the Cochrane Handbook. The trials were sub-grouped by diagnosis. Formal meta-analysis was not undertaken because of study heterogeneity.
RESULTS: Thirteen trials involving 714 women met the inclusion criteria; however, only six trials (403 women) contributed to data analysis.
CONCLUSION: Overall, the review provides support for the widespread recommendation that pelvic floor muscle training be included in first-line conservative management programs for women with stress, urge or mixed urinary incontinence.

PMID 18385628

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