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1.  Depressive symptoms in women seeking surgery for pelvic organ prolapse 
Introduction and hypothesis
To compare depressive symptoms in women with and without prolapse and evaluate impact on quality of life.
Methods
This is a secondary analysis of a case–control study assessing the effect of prolapse on body image. Cases had prolapse and sought surgery (Pelvic Organ Prolapse Quantification stage ≥2). Controls had stage ≤1. Subjects completed the Pelvic Floor Impact Questionnaire (PFIQ), Pelvic Floor Distress Inventory, and the Patient Health Questionnaire-9 (PHQ-9) at baseline. Cases completed measures 6 months post-operatively. We report: (1) the comparison of cases and controls at baseline and (2) comparison of baseline and post-operative scores in cases.
Results
Baseline questionnaires were completed by 75 cases and 65 controls; 57 cases completed post-operative measures. Cases were 5-fold more likely than controls to have depressive symptoms. Cases with depressive symptoms had higher PFIQ scores than cases without symptoms. PHQ-9 scores improved post-operatively.
Conclusions
Depressive symptoms are common in women with prolapse and a decrease following surgical treatment.
doi:10.1007/s00192-010-1106-4
PMCID: PMC2877142  PMID: 20333505
Depressive symptoms; Quality of life; Pelvic organ prolapse; Surgery
2.  Synthetic Graft Use in Vaginal Prolapse Surgery: Objective and Subjective Outcomes 
Introduction
This study reports one year outcomes in women who underwent transvaginal pelvic organ prolapse (POP) surgery with Prolift® transvaginal mesh.
Methods
Pre and post-operative objective vaginal (Pelvic Organ Prolapse Quantification, POP-Q) and subjective symptom and impact assessments (Pelvic Floor Distress Inventory-20, PFDI-20; Pelvic Floor Impact Questionnaire-7, PFIQ-7, respectively) were performed. Post- operative vaginal tenderness, stricture and patient satisfaction were also obtained. Paired t-tests were utilized for analysis.
Results
Mean age was 61.8±9.8 years; mean follow-up interval was 425.0±80.0 days (range: 237–717). POP-Q measurements of Ba, Bp, and C were significantly improved (all p-values <0.001). PFDI and PFIQ subscales scores significantly improved (all p-values ≤0.004). Thirty-five of 48 (73%) were completely satisfied, 2 (4%) were not satisfied. Complications [n(%)] included graft exposure [1(2%)], dyspareunia [2(4%)], and granulation tissue [3(6%)].
Conclusions
Women undergoing transvaginal repair of POP with the Prolift® mesh system showed significant improvement in one-year anatomic and subjective measures.
doi:10.1007/s00192-009-0953-3
PMCID: PMC3251967  PMID: 19714287
Pelvic organ prolapse; surgery; Prolift® mesh; graft; outcomes
3.  TVT-Secur (Hammock) Versus TVT-Obturator: A Randomized Trial of Suburethral Sling Operative Procedures 
Objectives
This study aimed to compare TVT-Secur (TVT-S) and TVT-Obturator (TVT-O) suburethral slings for treatment of stress urinary incontinence (SUI).
Methods
This was a single-center, nonblinded, randomized trial of women with SUI who were randomized to TVT-S or TVT-O from May 2007 to April 2009. The primary outcome, SUI on cough stress test (CST), and quality-of-life and symptom questionnaires (Pelvic Floor Distress Inventory [PFDI-20] and Pelvic Floor Impact Questionnaire [PFIQ-7]) were assessed at 12 weeks and 1 year.
Results
Forty-three women were randomized to TVT-S and 44 to TVT-O. There were no differences in median baseline PFDI-20 and PFIQ-7. Twenty-two (52.4%) of 42 participants randomized to TVT-S had a positive CST result at evaluation after 12 weeks or 1 year, whereas 4 (9.1%) of the 44 in the TVT-O group had a positive CST result. The intent-to-treat analysis showed that the risk of a positive CST result was 6 times higher after TVT-S than TVT-O (risk ratio, 6.0; 95% confidence interval [CI], 2.3–16.0). Among women not lost to follow-up, the risk ratio for a positive CST result after TVT-S compared with TVT-O was 17.9 (95% CI, 2.5–128.0) at 12 weeks and 3.5 (95% CI, 1.1–11.0) at 1 year. Both TVT-S and TVT-O resulted in improved quality of life and symptoms at 12 weeks. There was no difference between the groups for PFDI-20 (P = 0.40) or PFIQ-7 (P = 0.43). A similar pattern was seen at 1 year (P = 0.85 and P = 0.36).
Conclusions
The TVT-S seems to have a higher risk of positive postoperative CST result; however, the procedures result in similar improvements in quality of life and symptoms.
doi:10.1097/SPV.0b013e31823bdbcf
PMCID: PMC3712515  PMID: 22453267
TVT-Secur; TVT-Obturator; stress incontinence; efficacy
4.  Changes in Sexual Function and Comparison of Questionnaires Following Surgery for Pelvic Organ Prolapse 
Yonsei Medical Journal  2013;55(1):170-177.
Purpose
The aim of this study was to evaluate the effect of surgical repair of pelvic organ prolapse on female sexual function and to assess correlations between the two using two current standardized questionnaires.
Materials and Methods
From October 2009 to September 2010, 143 patients with posterior compartment or combined vaginal prolapse were included. We assessed surgical outcomes according to anatomical change in the vagina and results of the Female Sexual Function Index (FSFI) and Pelvic Organ Prolapse/Urinary Incontinence Sexual Function questionnaire (PISQ-12) both pre- and postoperatively.
Results
Among the 143 preoperative patients, 99 and 84 patients responded to the PISQ-12 and FSFI, respectively. The mean PISQ-12 score increased after surgery (p<0.001). Specifically, postoperative scores for questions 8 and 12 were higher than their respective preoperative scores (p<0.001). Postoperatively, mean FSFI score changed only slightly (p=0.76), and only the score for the satisfaction domain was improved (p=0.023). In regards to vaginal anatomy, vaginal length was significantly greater postoperatively (6.99±0.18 vs. 7.56±1.08, p<0.001), and postoperative vaginal caliber was narrowed to a two-finger width.
Conclusion
In this study, surgery for pelvic organ prolapse was shown to affect female sexual function. Moreover, menopause was associated with a change in postoperative sexual function.
doi:10.3349/ymj.2014.55.1.170
PMCID: PMC3874915  PMID: 24339303
Pelvic organ prolapse; sexual function; female sexual dysfunction; Female Sexual Function Index; Pelvic Organ Prolapse/Urinary Incontinence Sexual Function questionnaire
5.  Further Validation of the Short Form Versions of the Pelvic Floor Distress Inventory (PFDI) and Pelvic Floor Impact Questionnaire (PFIQ) 
Neurourology and urodynamics  2011;30(4):541-546.
Aims
To evaluate validity and responsiveness of PFDI and PFIQ short forms across 4 multi-center studies and develop conversion formulas between short and long versions.
Methods
1006 participants in 4 prospective studies of pelvic floor disorders completed long versions of the PFDI, PFIQ and SF-36 (or SF-12) at baseline and 3 and 12 months after treatment. Responses were used to calculate scores for the short versions. We calculated correlations between scale versions using Pearson’s correlation coefficient and compared their relative responsiveness using the standardized response mean.
Results
PFDI and PFIQ short form scale scores demonstrated excellent correlations with long versions and similar responsiveness. Responsiveness was good to excellent for PFDI-20 urinary and prolapse scales, moderate for PFDI-20 colorectal scale and each of the PFIQ-7 scales, and poor for SF-36 (or SF-12) summary scores. Conversion formulas demonstrated excellent goodness of fit.
Conclusions
The long and short forms of the PFDI and PFIQ correlate well and have similar overall responsiveness in participants from 4 different prospective multicenter studies consisting of diverse patient populations with a broad range of pelvic floor disorders. The short forms provide a reliable and valid alternative in situations where reduced response burden is desired.
doi:10.1002/nau.20934
PMCID: PMC3759146  PMID: 21344495
quality of life; pelvic organ prolapse; urinary incontinence; pelvic floor; questionnaires; responsiveness
6.  Genital prolapse in women 
Clinical Evidence  2012;2012:0817.
Introduction
Prolapse of the uterus or vagina is usually the result of loss of pelvic support, and causes mainly non-specific symptoms. It may affect over half of women aged 50 to 59 years, but spontaneous regression may occur. Risks of genital prolapse increase with advancing parity and age, increasing weight of the largest baby delivered, and hysterectomy.
Methods and outcomes
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of non-surgical treatments in women with genital prolapse? What are the effects of surgical treatments in women with anterior vaginal wall prolapse? What are the effects of surgical treatments in women with posterior vaginal wall prolapse? What are the effects of surgical treatments in women with upper vaginal wall prolapse? What are the effects of using different surgical materials in women with genital prolapse? We searched: Medline, Embase, The Cochrane Library, and other important databases up to August 2011 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Results
We found 15 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
Conclusions
In this systematic review, we present information relating to the effectiveness and safety of the following interventions: abdominal Burch colposuspension; abdominal sacral colpopexy; abdominal sacrohysteropexy; anterior colporrhaphy with mesh reinforcement; laparoscopic surgery; mesh or synthetic grafts; native (autologous) tissue; open abdominal surgery; pelvic floor muscle exercises; posterior colporrhaphy (with or without mesh reinforcement); posterior intravaginal slingplasty (infracoccygeal sacropexy); sacrospinous colpopexy (vaginal sacral colpopexy); sutures; traditional anterior colporrhaphy; transanal repair; ultralateral anterior colporrhaphy alone or with cadaveric fascia patch; vaginal hysterectomy; vaginal oestrogen; vaginal pessaries; and vaginal sacrospinous colpopexy.
Key Points
Prolapse of the uterus or vagina is usually the result of loss of pelvic support, and causes mainly non-specific symptoms. It may affect over half of women aged 50 to 59 years, but spontaneous regression may occur. Risks of genital prolapse increase with advancing parity and age, increasing weight of the largest baby delivered, and hysterectomy.
We don't know whether pelvic floor muscle exercises or vaginal oestrogen improve symptoms in women with genital prolapse, as we found few studies of adequate quality. The consensus is that vaginal pessaries are effective for relief of symptoms in women waiting for surgery, or in whom surgery is contraindicated, but we don't know this for sure.
In women with anterior vaginal wall prolapse, anterior vaginal wall repair may be more effective than Burch colposuspension at reducing recurrence, and adding mesh reinforcement to anterior colporrhaphy can reduce recurrence. Burch colposuspension may be more effective than anterior vaginal wall repair at reducing stress incontinence.
In women with posterior vaginal wall prolapse, posterior colporrhaphy is more likely to prevent recurrence compared with transanal repair of rectocoele or enterocoele. We don't know whether adding mesh reinforcement improves success rates in women having posterior colporrhaphy.
In women with upper vaginal wall prolapse, abdominal sacral colpopexy reduces the risk of recurrent prolapse, and of postoperative dyspareunia and stress incontinence compared with sacrospinous colpopexy. Posterior intravaginal slingplasty may be as effective as vaginal sacrospinous colpopexy at preventing recurrent prolapse. Vaginal hysterectomy and repair may reduce the need for re-operation and may be more effective at reducing symptoms, compared with abdominal sacrohysteropexy.
We don't know how surgical treatment compares with non-surgical treatment in women with prolapse of the upper, anterior, or posterior vaginal wall.
PMCID: PMC3635656  PMID: 22414610
7.  Translation and linguistic validation of Korean version of short form of pelvic floor distress inventory-20, pelvic floor impact questionnaire-7 
Obstetrics & Gynecology Science  2013;56(5):330-332.
The short forms of pelvic floor distress inventory (PFDI) and pelvic floor impact questionnaire (PFIQ) are useful disease specific questionnaires evaluating symptoms, quality of life for pelvic floor disorders. The purpose is to develop linguistic validation of the PFDI-20 and PFIQ-7 questionnaires. Three types of Korean version of questionnaires have been used in four locations of University Hospitals in Korea. Each version of questionnaires was developed by forward translation and back-translation by bilingual translators and was verified by the patients with pelvic floor disorder and healthy persons. For harmonization of 3 types of questionnaires, four authors reviewed, discussed all discrepancies, incorporated and produced a new version. The multi-step processes of translation and linguistic validation of the Korean version of PFDI-20 and PFIQ-7 questionnaire were completed. Further process of validation of Korean version of these questionnaires is required.
doi:10.5468/ogs.2013.56.5.330
PMCID: PMC3784132  PMID: 24328023
Pelvic organ prolapse; Questionnaire; Translations; Urinary incontinence
8.  A multicenter prospective trial evaluating fetal bovine dermal graft (Xenform® Matrix) for pelvic reconstructive surgery 
BMC Urology  2010;10:21.
Background
A prospective multicenter clinical study was performed to evaluate the safety and efficacy of a bovine dermal graft (Xenform® Matrix, Boston Scientific, Natick, MA, USA) during vaginal reconstructive surgery.
Methods
Forty-five women with ICS stage 2 or higher pelvic organ prolapse (POP) were enrolled at 4 centers. POP-Q, pelvic floor function (PFDI-20), sexual function (PISQ-12), and patient satisfaction tools were used to assess subjects at baseline, and at 2 and 6 weeks, and 3, 6 and 12 months post surgery. The significance of symptom score changes at 6 months and 1 year were determined by the t-test for paired data. Forty-three of the 45 patients completed the 12 month study.
Results
The majority of the subjects had cystocele (98%) and/or rectocele (84%) defects at study entry. At 12 months, 74% of the defects had improved to a stage 0 or 1. Mean PFDI-20 scores improved by 72% (p < 0.001) at 12 months, and PISQ-12 scores were maintained during the follow-up period indicating no decline in sexual function. Three subjects experienced one serious adverse event each; one of the adverse events (constipation) was deemed by the study physician to be unrelated to Xenform®. One subject had severe pyelonephritis resulting in dialysis. This subject had a previous history of pyelonephritis, sepsis and acute renal failure. The third subject had a reported recurrent cystocele of moderate severity, possibly related to the device. No graft related erosions or pain lasting more than 30 days were reported. No subjects withdrew due to an adverse event.
Conclusion
This study is the first to investigate the use of Xenform® Matrix in vaginal reconstructive surgery among patients with POP. Significant improvement was maintained at 12 months utilizing both objective and subjective assessment tools, confirming the safety and efficacy of this material in vaginal surgery.
Trial Registration
ClinicalTrials.gov NCT01244165
doi:10.1186/1471-2490-10-21
PMCID: PMC3017018  PMID: 21144043
9.  Genital prolapse in women 
Clinical Evidence  2009;2009:0817.
Introduction
Prolapse of the uterus or vagina is usually the result of loss of pelvic support, and causes mainly non-specific symptoms. It may affect over half of women aged 50 to 59 years, but spontaneous regression may occur. Risks of genital prolapse increase with advancing parity and age, increasing weight of the largest baby delivered, and hysterectomy.
Methods and outcomes
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of non-surgical treatments in women with genital prolapse? What are the effects of surgical treatments in women with anterior vaginal wall prolapse? What are the effects of surgical treatments in women with posterior vaginal wall prolapse? What are the effects of surgical treatments in women with upper vaginal wall prolapse? What are the effects of using different surgical materials in women with genital prolapse? We searched: Medline, Embase, The Cochrane Library, and other important databases up to June 2009 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Results
We found 14 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
Conclusions
In this systematic review, we present information relating to the effectiveness and safety of the following interventions: abdominal Burch colposuspension; abdominal sacral colpopexy; abdominal sacrohysteropexy; anterior colporrhaphy with mesh reinforcement; laparoscopic surgery; mesh or synthetic grafts; native (autologous) tissue; open abdominal surgery; pelvic floor muscle exercises; posterior colporrhaphy (with or without mesh reinforcement); posterior intravaginal slingplasty (infracoccygeal sacropexy); sacrospinous colpopexy (vaginal sacral colpopexy); sutures; traditional anterior colporrhaphy; transanal repair; ultralateral anterior colporrhaphy alone or with cadaveric fascia patch; vaginal hysterectomy; vaginal oestrogen; vaginal pessaries; and vaginal sacrospinous colpopexy.
Key Points
Prolapse of the uterus or vagina is usually the result of loss of pelvic support, and causes mainly non-specific symptoms. It may affect over half of women aged 50 to 59 years, but spontaneous regression may occur. Risks of genital prolapse increase with advancing parity and age, increasing weight of the largest baby delivered, and hysterectomy.
We don't know whether pelvic floor muscle exercises or vaginal oestrogen improve symptoms in women with genital prolapse, as we found no studies of adequate quality. The consensus is that vaginal pessaries are effective for relief of symptoms in women waiting for surgery, or in whom surgery is contraindicated, but we don't know this for sure.
In women with anterior vaginal wall prolapse, anterior vaginal wall repair may be more effective than Burch colposuspension, and recurrence can be further reduced by adding mesh reinforcement to anterior colporrhaphy.
In women with posterior vaginal wall prolapse, posterior colporrhaphy is more likely to prevent recurrence than transanal repair of rectocoele or enterocoele. We don't know whether adding mesh reinforcement improves success rates in women having posterior colporrhaphy.
In women with upper vaginal wall prolapse, abdominal sacral colpopexy reduces the risk of recurrent prolapse, dyspareunia, and stress incontinence compared with sacrospinous colpopexy. Posterior intravaginal slingplasty may be as effective as vaginal sacrospinous colpopexy at preventing recurrent prolapse. Vaginal hysterectomy and repair may reduce the need for re-operation and may be more effective at reducing symptoms, compared with abdominal sacrohysteropexy.
We don't know how surgical treatment compares with non-surgical treatment in women with prolapse of the upper, anterior, or posterior vaginal wall.
PMCID: PMC2907774  PMID: 21726473
10.  Effect of pelvic floor muscle training compared with watchful waiting in older women with symptomatic mild pelvic organ prolapse: randomised controlled trial in primary care 
Objective To compare the effects of pelvic floor muscle training and watchful waiting on pelvic floor symptoms in a primary care population of women aged 55 years and over with symptomatic mild pelvic organ prolapse.
Design Randomised controlled trial.
Setting Dutch primary care.
Participants Women aged 55 years or over with symptomatic mild prolapse (leading edge above the hymen) were identified by screening. Exclusion criteria were current prolapse treatment or treatment in the previous year, malignancy of pelvic organs, current treatment for another gynaecological disorder, severe/terminal illness, impaired mobility, cognitive impairment, and insufficient command of the Dutch language.
Interventions Pelvic floor muscle training versus watchful waiting.
Main outcome measures The primary outcome was change in bladder, bowel, and pelvic floor symptoms measured with the Pelvic Floor Distress Inventory-20 (PFDI-20), three months after the start of treatment. Secondary outcomes were changes in condition specific and general quality of life, sexual function, degree of prolapse, pelvic floor muscle function, and patients’ perceived change in symptoms.
Results Of the 287 women who were randomised to pelvic floor muscle training (n=145) or watchful waiting (n=142), 250 (87%) completed follow-up. Participants in the intervention group improved by (on average) 9.1 (95% confidence interval 2.8 to 15.4) points more on the PFDI-20 than did participants in the watchful waiting group (P=0.005). Of women in the pelvic floor muscle training group, 57% (82/145) reported an improvement in overall symptoms from the start of the study compared with 13% (18/142) in the watchful waiting group (P<0.001). Other secondary outcomes showed no significant difference between the groups.
Conclusions Although pelvic floor muscle training led to a significantly greater improvement in PFDI-20 score, the difference between the groups was below the presumed level of clinical relevance (15 points). Nevertheless, 57% of the participants in the intervention group reported an improvement of overall symptoms. More studies are needed to identify factors related to success of pelvic floor muscle training and to investigate long term effects.
Trial registration Dutch Trial Register (www.trialregister.nl) identifier: NTR2047.
doi:10.1136/bmj.g7378
PMCID: PMC4273538  PMID: 25533442
11.  Anatomical and Functional Outcomes of Posterior Intravaginal Slingplasty for the Treatment of Vaginal Vault or Uterine Prolapse: A Prospective, Multicenter Study 
Korean Journal of Urology  2010;51(3):187-192.
Purpose
We aimed to evaluate the anatomical and functional outcomes of posterior intravaginal slingplasty (P-IVS) for the treatment of a vaginal vault or uterine prolapse (VP/UP).
Materials and Methods
This was a 12-month prospective, multicenter, observational study. Women aged over 30 years who presented with stage II or greater VP/UP underwent P-IVS by four urologists at four university hospitals. Preoperatively, pelvic examination by use of the Pelvic Organ Prolapse Quantification (POP-Q) system, the Pelvic Floor Distress Inventory (PFDI) questionnaire, the 3-day frequency volume chart, and uroflowmetry were completed. At the 12-month follow-up, changes in the POP-Q, PFDI, frequency volume chart, and uroflowmetry parameters were assessed. Cure was defined as VP/UP stage 0 and improvement as stage I.
Results
The cure and improvement rates among the 32 women were 65.6% and 34.4%, respectively. All subscale scores of the Urinary Distress Inventory, the general subscale score of the Pelvic Organ Prolapse Distress Inventory, and the rectal prolapse subscale score of the Colo-Rectal-Anal Distress Inventory were significantly improved. There were no significant changes in the frequency volume chart or uroflowmetry parameters. There was one case of surgery-related transfusion.
Conclusions
Trans-vaginal repair by P-IVS is an effective and safe procedure for restoring the anatomical defect and improving the associated pelvic floor symptoms in women with VP/UP.
doi:10.4111/kju.2010.51.3.187
PMCID: PMC2855447  PMID: 20414395
Prospective studies; Treatment outcome; Pelvic organ prolapse
12.  Sexual satisfaction in the elderly female population: A special focus on women with gynecologic pathology 
Maturitas  2011;70(3):210-215.
Sexual function in aging women
Sexuality is an integral part of human expressions. Mental health plays a major role in sexuality. Several psychological interventions are proposed to increase the sexual quality of life in older women with diverse gynecologic pathology. A biopsychosocial approach utilizing brief strategies can be easily implemented in clinics to help women of all ages increase their sexual quality of life.
The impact of female pelvic floor disorders on sexual function in older women
Female pelvic floor disorders include urinary incontinence, pelvic organ prolapse, and fecal incontinence. These disorders increase dramatically with increasing age. Urinary incontinence has been demonstrated to have a negative impact on a woman’s sexual function. Among sexually active older women with urinary incontinence, 22% report being moderately or extremely worried that sexual activity would cause urine loss. An increased prevalence of sexual distress [9% (6/76) vs. 1.3% (2/216), p=0.005] has been reported in sexually active women over 40 years old with urinary incontinence. Treatment of urinary incontinence can improve sexual function in older women. Among sexually active women (N=53) who underwent midurethral slings procedures for the correction of urinary incontinence, increased coital frequency, decrease fear of incontinence with coitus, decreased embarrassment due to incontinence was reported six months after surgery. Pelvic organ prolapse, a hernia of the vagina resulting in a visible vaginal bulge, has also been associated with a negative impact on sexual function. Women with advanced pelvic organ prolapse (POP-Q stage III or IV) have been demonstrated to have decreased body image reporting that they are more self-conscious about their appearance [adjusted odds ratio (AOR) 4.7; 95% confidence interval (CI) 2.9, 51], feel less feminine (AOR 4.0; 95% CI 1.2, 15) and less sexually attractive (AOR 4.6; 95% CI 1.4, 17) compared with women who have normal pelvic support. Both vaginal and abdominal approaches to surgical correction of pelvic organ prolapse have been demonstrated to improve sexual function.
Mental health
Mental health plays a major role in older woman’s sexuality. Sexual interest and satisfaction is tied to emotional expressivity, women’s self-worth, feelings of depression and loneliness as well as cognitive function. Research has shown that both general practitioners and specialists lack training in sexual assessments. Behavioral health specialists, such as a psychologist, can play an integral role in helping to facilitate communication between the patient and the provider. A main focus of communication training is to facilitate open and genuine conversation between the provider and the patient. Providers are encouraged to ask open ended questions while patients are encouraged to discuss symptoms while coping with an internal state of anxiety.
Despite the known prevalence of sexual dysfunction among older women, few studied empirically based interventions have been published with these women. This speaks to the general assumption among medical professionals that having the “sex talk” in older women with gynecological pathology is not important or relevant. A biopsychosocial approach utilizing some of the aforementioned brief strategies can be easily implemented in comprehensive gynecology clinics in order to help women of all ages increase their sexual quality of life.
doi:10.1016/j.maturitas.2011.07.015
PMCID: PMC3598121  PMID: 21943557
Sexuality; Elderly women; Psychosocial model; Urogynecology; Mental health; Gynecology; Gynecologic pathology
13.  Vaginal surgery for pelvic organ prolapse using mesh and a vaginal support device 
Bjog   2008;115(3):391-397.
Objectives
To describe a new surgical procedure for pelvic organ prolapse using mesh and a vaginal support device (VSD) and to report the results of surgery.
Design
A prospective observational study
Setting
Two tertiary referral Urogynaecology practices.
Population
Ninety-five women with International Continence Society pelvic organ prolapse quantification stage 2 or more pelvic organ prolapse who underwent vaginal surgery using mesh augmentation and a VSD.
Methods
Surgery involved a vaginal approach with mesh reinforcement and placement of a VSD for 4 weeks. At 6 and 12 months, women were examined for prolapse recurrence, and visual analogue scales for satisfaction were completed. Women completed quality-of-life (QOL) questionnaires preoperatively and at 6 and 12 months.
Main outcome measures
Objective success of surgery at 6 and 12 months following surgery. Secondary outcomes were subjective success, complications, QOL outcomes and patients’ satisfaction.
Results
Objective success rate was 92 and 85% at 6 and 12 months, respectively. Subjective success rate was 91 and 87% at 6 and 12 months, respectively. New prolapse in nonrepaired compartments accounted for 7 of 12 (58%) failures at 12 months. Two of 4 mesh exposures required surgery. Sexual dysfunction was reported by 58% of sexually active women preoperatively and 23% at 12 months. QOL scores significantly improved at 12 months compared with baseline (P < 0.0001).
Conclusion
Vaginal surgery using mesh and a VSD is an effective procedure for pelvic organ prolapse. However, further studies are required to establish the role of the surgery described in this study.
Please cite this paper as:Carey M, Slack M, Higgs P, Wynn-Williams M, Cornish A. Vaginal surgery for pelvic organ prolapse using mesh and a vaginal support device. BJOG 2008;115:391–397.
doi:10.1111/j.1471-0528.2007.01606.x
PMCID: PMC2253712  PMID: 18190377
Mesh; prolapse; vaginal support device
14.  Posterior repair and sexual function 
OBJECTIVE
The purpose of this study was to determine the effect of posterior repair (PR) on sexual function in patients who have undergone incontinence and/or pelvic reconstructive surgery.
STUDY DESIGN
A cohort study of women who underwent incontinence and/or prolapse surgery was performed. Participants completed the pelvic organ prolapse urinary incontinence sexual questionnaire (PISQ) before and after the operation. PISQ scores were compared between women who underwent PR and women who did not.
RESULTS
Of 73 study participants, 30 women underwent PR; 43 women did not (no PR). Although there was no difference in dyspareunia between groups pre-op, dyspareunia prevalence post-op was significantly lower in the no PR group. Preoperative PISQ scores were similar between groups. After the operation, both groups significantly improved their PISQ scores, without a difference between groups.
CONCLUSION
Although the incidence of dyspareunia differed between PR and no PR groups, overall improvement in sexual function was reflected in improved total PISQ scores that occurred irrespective of PR performance.
doi:10.1016/j.ajog.2007.03.054
PMCID: PMC3097466  PMID: 17618777
dyspareunia; incontinence; posterior repair; prolapse; sexual function
15.  Female sexual function and pelvic floor disorders 
Obstetrics and gynecology  2008;111(5):1045-1052.
Objectives
Sexual function is an important dimension of adult life and yet very little is known about the relationships between female sexuality and chronic health conditions, including pelvic floor disorders. Our goal was to investigate the hypothesis that pelvic floor disorders are associated with female sexual problems, independent of other related factors.
Methods
The study population included 301 adult women seeking outpatient gynecologic and urogynecologic care. Pelvic floor disorders were assessed with the Pelvic Floor Disorders Inventory-20 (PFDI) and the Pelvic Organ Prolapse Quantification examination. Sexual function was assessed with the Personal Experiences Questionnaire. Using ordinal regression analysis, we identified characteristics and conditions associated with decreased libido, infrequent orgasm, decreased arousal, and dyspareunia.
Results
Sexual function was poorer among 78 women (26%) without a current sexual partner than among 223 with a partner (p<0.01). Among the 223 with a current partner, women with a high PFDI score were significantly more likely to report decreased arousal (p<0.01), infrequent orgasm (p<0.01) and increased dyspareunia (p<0.01). A similar pattern was observed for the urinary, colorectal-anal, and prolapse scales of the PFDI, although some associations were marginally significant. Stage III–IV prolapse was significantly associated with infrequent orgasm (p=0.02), but other sexual complaints were not more common with increasing prolapse stage.
Conclusion
Pelvic floor symptoms are significantly associated with reduced sexual arousal, infrequent orgasm, and dyspareunia. Clinicians who care for women with pelvic floor disorders should be aware of this association and should specifically address sexual concerns with women seeking treatment of incontinence and prolapse.
doi:10.1097/AOG.0b013e31816bbe85
PMCID: PMC2746737  PMID: 18448734
16.  PELVIC FLOOR SYMPTOMS AND QUALITY OF LIFE ANALYSES IN WOMEN UNDERGOING SURGERY FOR RECTAL PROLPASE 
The world journal of colorectal surgery  2013;3(3):services.bepress.com/wjcs/vol3/iss3/art1/.
Objective
Characterize pelvic floor symptom distress and impact, sexual function and quality of life in women who underwent rectal prolapse surgery.
Methods
Subjects undergoing rectal prolapse surgery from 2004–2009 completed questionnaires including the Pelvic Floor Distress Inventory, Pelvic Floor Impact Questionnaire, and the Prolapse/Urinary Incontinence Sexual Questionnaire. Baseline demographic, medical, and surgical characteristics were extracted by chart review. Demographic and clinic outcomes of women undergoing transperineal and abdominal approaches were compared. Wilcoxon rank-sum test was used for continuous variables and Fisher’s exact test for categorical measures.
Results
45 were identified; two deceased at follow-up. 28/43 subjects (65.1%) responded to the questionnaires. Mean time from original procedure was 3.9 ± 3.1 years. No differences in median total Pelvic Floor Distress Inventory, Pelvic Floor Impact Questionnaire, and subscale scores, and Prolapse/Urinary Incontinence Sexual Questionnaire scores in women undergoing open rectopexy versus transperineal proctectomy were seen (all p>0.05). 26 (60%) participants answered the Prolapse/Urinary Incontinence Sexual Questionnaire, nine reported sexual activity within the last month. All underwent abdominal procedures.
Conclusion
There are few colorectal or other pelvic floor symptoms after rectal prolapse repair. Robust prospective studies are needed to more fully characterize and understand issues associated with rectal prolapse surgery in women.
PMCID: PMC4219513  PMID: 25379122
17.  Treatment of uterine prolapse stage 2 or higher: a randomized multicenter trial comparing sacrospinous fixation with vaginal hysterectomy (SAVE U trial) 
BMC Women's Health  2011;11:4.
Background
Pelvic organ prolapse is a common health problem, affecting up to 40% of parous women over 50 years old, with significant negative influence on quality of life. Vaginal hysterectomy is currently the leading treatment method for patients with symptomatic uterine prolapse. Several studies have shown that sacrospinous fixation in case of uterine prolapse is a safe and effective alternative to vaginal hysterectomy. However, no large randomized trials with long-term follow-up have been performed to compare efficacy and quality of life between both techniques.
The SAVE U trial is designed to compare sacrospinous fixation with vaginal hysterectomy in the treatment of uterine prolapse stage 2 or higher in terms of prolapse recurrence, quality of life, complications, hospital stay, post-operative recovery and sexual functioning.
Methods/design
The SAVE U trial is a randomized controlled multi-center non-inferiority trial. The study compares sacrospinous fixation with vaginal hysterectomy in women with uterine prolapse stage 2 or higher. The primary outcome measure is recurrence of uterine prolapse defined as: uterine descent stage 2 or more assessed by pelvic organ prolapse quantification examination and prolapse complaints and/or redo surgery at 12 months follow-up. Secondary outcomes are subjective improvement in quality of life measured by generic (Short Form 36 and Euroqol 5D) and disease-specific (Urogenital Distress Inventory, Defecatory Distress Inventory and Incontinence Impact Questionnaire) quality of life instruments, complications following surgery, hospital stay, post-operative recovery and sexual functioning (Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire). Analysis will be performed according to the intention to treat principle. Based on comparable recurrence rates of 3% and considering an upper-limit of 7% to be non-inferior (beta 0.2 and one sided alpha 0.025), 104 patients are needed per group.
Discussion
The SAVE U trial is a randomized multicenter trial that will provide evidence whether the efficacy of sacrospinous fixation is similar to vaginal hysterectomy in women with uterine prolapse stage 2 or higher.
Trial registration
Netherlands Trial Register (NTR): NTR1866
doi:10.1186/1472-6874-11-4
PMCID: PMC3045971  PMID: 21324143
18.  Outcomes of vaginal hysterectomy for uterovaginal prolapse: a population-based, retrospective, cross-sectional study of patient perceptions of results including sexual activity, urinary symptoms, and provided care 
BMC Women's Health  2009;9:9.
Background
Vaginal hysterectomy is often used to correct uterovaginal prolapse, however, there is little information regarding outcomes after surgery in routine clinical practice. The objective of this study was to investigate complications, sexual activity, urinary symptoms, and satisfaction with health care after vaginal hysterectomy due to prolapse.
Methods
We analyzed data from the Swedish National Register for Gynecological Surgery (SNRGS) from January 1997 to August 2005. Women participating in the SNRGS were asked to complete surveys at two and six months postoperatively. Of 941 women who underwent vaginal hysterectomy for uterovaginal prolapse, 791 responded to questionnaires at two months and 682 at six months. Complications during surgery and hospital stay were investigated. The two-month questionnaire investigated complications after discharge, and patients' satisfaction with their health care. Sexual activity and urinary symptoms were reported and compared in preoperative and six-month postoperative questionnaires.
Results
Almost 60% of women reported normal activity of daily life (ADL) within one week of surgery, irrespective of their age. Severe complications occurred in 3% and were mainly intra-abdominal bleeding and vaginal vault hematomas. Six months postoperative, sexual activity had increased for 20% (p = 0.006) of women and urinary urgency was reduced for 50% (p = 0.001); however, 14% (n = 76) of women developed urinary incontinence, 76% (n = 58) of whom reported urinary stress incontinence. Patients were satisfied with the postoperative result in 93% of cases and 94% recommended the surgery.
Conclusion
Vaginal hysterectomy is a patient-evaluated efficient treatment for uterovaginal prolapse with swift recovery and a low rate of complication. Sexual activity and symptoms of urinary urgency were improved. However, 14% developed incontinence, mainly urinary stress incontinence (11%). Therefore efforts to disclose latent stress incontinence should be undertaken preoperatively.
doi:10.1186/1472-6874-9-9
PMCID: PMC2675521  PMID: 19379514
19.  Defining Success After Surgery for Pelvic Organ Prolapse 
Obstetrics and gynecology  2009;114(3):600-609.
OBJECTIVES
To describe pelvic organ prolapse surgical success rates using a variety of definitions with differing requirements for anatomic, symptomatic, or re-treatment outcomes.
METHODS
Eighteen different surgical success definitions were evaluated in participants who underwent abdominal sacrocolpopexy within the Colpopexy and Urinary Reduction Efforts trial. The participants’ assessments of overall improvement and rating of treatment success were compared between surgical success and failure for each of the definitions studied. The Wilcoxon rank sum test was used to identify significant differences in outcomes between success and failure.
RESULTS
Treatment success varied widely depending on definition used (19.2–97.2%). Approximately 71% of the participants considered their surgery “very successful,” and 85.2% considered themselves “much better” than before surgery. Definitions of success requiring all anatomic support to be proximal to the hymen had the lowest treatment success (19.2–57.6%). Approximately 94% achieved surgical success when it was defined as the absence of prolapse beyond the hymen. Subjective cure (absence of bulge symptoms) occurred in 92.1% while absence of re-treatment occurred in 97.2% of participants. Subjective cure was associated with significant improvements in the patient’s assessment of both treatment success and overall improvement, more so than any other definition considered (P<.001 and <.001, respectively). Similarly, the greatest difference in symptom burden and health-related quality of life as measured by the Pelvic Organ Prolapse Distress Inventory and Pelvic Organ Prolapse Impact Questionnaire scores between treatment successes and failures was noted when success was defined as subjective cure (P<.001).
CONCLUSION
The definition of success substantially affects treatment success rates after pelvic organ pro-lapse surgery. The absence of vaginal bulge symptoms postoperatively has a significant relationship with a patient’s assessment of overall improvement, while anatomic success alone does not.
doi:10.1097/AOG.0b013e3181b2b1ae
PMCID: PMC2904469  PMID: 19701041
20.  Factorial comparison of two transvaginal surgical approaches and of perioperative behavioral therapy for women with apical vaginal prolapse: The OPTIMAL Randomized Trial 
IMPORTANCE
Over 300,000 surgeries are performed annually in the United States for pelvic organ prolapse. Sacrospinous ligament fixation (SSLF) and uterosacral ligament suspension (ULS) are commonly performed transvaginal surgeries to correct apical prolapse. Little is known about their comparative efficacy and safety, and it is unknown whether perioperative behavioral therapy with pelvic floor muscle training (BPMT) improves outcomes of prolapse surgery.
OBJECTIVE
To compare outcomes between 1) SSLF and ULS and 2) perioperative BPMT and usual perioperative care in women undergoing surgery for vaginal prolapse and stress urinary incontinence.
DESIGN, SETTING AND PARTICIPANTS
Multi-center, 2×2 factorial randomized trial of 374 women undergoing surgery to treat both apical vaginal prolapse and stress urinary incontinence was conducted between 2008 and 2013 at 9 U.S. medical centers. Two-year follow-up rate was 84.5%.
INTERVENTIONS
Surgical intervention: Transvaginal surgery including mid-urethral sling with randomization to SSLF (n = 186) or ULS (n=188); Behavioral intervention: Randomization to perioperative BPMT (n = 186) or usual care (n=188).
MAIN OUTCOME MEASURES
The primary outcome for the surgical intervention (surgical success) was defined as: 1) no apical descent greater than one-third into vaginal canal or anterior or posterior vaginal wall beyond the hymen (anatomic success); 2) no bothersome vaginal bulge symptoms and 3) no retreatment for prolapse at 2 years. For the behavioral intervention, primary outcome at 6 months was urinary symptom scores (Urinary Distress Inventory; range 0–300, higher scores worse), and primary outcomes at 2 years were prolapse symptom scores (Pelvic Organ Prolapse Distress Inventory; range 0–300, higher scores worse) and anatomic success.
RESULTS
At 2 years, surgical group was not significantly associated with surgical success rates [ULS 59.2% (93/154) vs. SSLF 60.5% (92/152), OR 0.9 (95% CI 0.6, 1.5)] or serious adverse event rates [ULS 16.5% (31/188) vs. SSLF 16.7% (31/186), OR 0.9 (95% CI 0.5, 1.6)]. BPMT was not associated with greater improvements in urinary scores at 6 months [treatment difference −6.7 (95% CI −19.7, 6.2)], prolapse scores at 24 months [treatment difference −8.0 (95% CI −22.1, 6.1)] or anatomic success at 24 months.
CONCLUSIONS AND RELEVANCE
Two years after vaginal surgery for prolapse and stress urinary incontinence, neither ULS nor SSLF was significantly superior to the other for anatomic, functional, and or adverse event outcomes. Perioperative BPMT did not improve urinary symptoms at 6 months or prolapse outcomes at 2 years.
doi:10.1001/jama.2014.1719
PMCID: PMC4083455  PMID: 24618964
21.  Hysteropexy in the treatment of uterine prolapse stage 2 or higher: a multicenter randomized controlled non-inferiority trial comparing laparoscopic sacrohysteropexy with vaginal sacrospinous hysteropexy (LAVA-trial, study protocol) 
BMC Women's Health  2014;14(1):112.
Background
Pelvic organ prolapse is a common health problem: the lifetime risk of undergoing surgery for pelvic organ prolapse by the age of 85 years is 19%. Pelvic organ prolapse has significant negative effects on a woman’s quality of life. Worldwide, vaginal hysterectomy is the leading treatment method for patients with symptomatic uterovaginal prolapse. Several studies have shown that vaginal sacrospinous hysteropexy and laparoscopic sacrohysteropexy are safe and effective alternatives in treating uterine descent. To date, it is unclear which of these techniques leads to the best operative result and the highest patient satisfaction. Therefore, we conducted the LAVA trial.
Methods
The LAVA trial is a randomized controlled multicenter non-inferiority trial. The study compares laparoscopic sacrohysteropexy with vaginal sacrospinous hysteropexy in women with uterine prolapse stage 2 or higher. The primary outcome of this study is surgical success of the apical compartment at 1 and 5 years follow-up. Secondary outcomes are subjective improvement on urogenital symptoms and quality of life (assessed by disease-specific and general quality of life questionnaires), complications following surgery, hospital stay, post-operative recovery, sexual functioning and costs-effectiveness. Evaluation will take place pre-operatively, and 6 weeks, 6 months, 12 months and annually till 60 months after surgery. Validated questionnaires will be used.
Analysis will be performed according to the intention to treat principle. Based on comparable recurrence rates of 3% and a non-inferiority margin of 10%, 62 patients are needed in each arm to prove the hypothesis with a 95% confidence interval.
Discussion
The LAVA trial is a randomized controlled multicenter non-inferiority trial that will provide evidence whether the efficacy of laparoscopic sacrohysteropexy is non-inferior to vaginal sacrospinous hysteropexy in women with symptomatic uterine prolapse stage 2 or higher.
Trial registration
Netherlands Trial Register (NTR): NTR4029
doi:10.1186/1472-6874-14-112
PMCID: PMC4254385  PMID: 25231240
Pelvic organ prolapse; Uterine descent; Hysteropexy; Vaginal sacrospinous hysteropexy; Laparoscopic sacrohysteropexy
22.  Outcomes following vaginal Prolapse repair and mid Urethral Sling (OPUS) trial 
Background
Many women without preexisting stress urinary incontinence (SUI) who undergo vaginal surgery to correct pelvic organ prolapse will develop symptoms of SUI. A concomitant prophylactic anti-incontinence procedure may prevent SUI symptom development in women undergoing vaginal prolapse surgery.
Purpose
To present the rationale, design and methodology of a randomized controlled surgical trial (RCT), the Outcomes Following Vaginal Prolapse Repair and Mid Urethral Sling (OPUS) Trial. The primary aims of this RCT are to determine (1) whether the prevalence of post-operative urinary incontinence (UI) differs between stress continent women receiving vaginal prolapse repair with concomitant tension-free vaginal tape (TVT®; a sling procedure commonly used to treat SUI) and those with only sham incisions at 3 months post surgery (2) whether it is more cost-effective to place a TVT prophylactically than to treat the SUI symptoms postoperatively as they occur over a 12 month period after the index surgery.. The study also incorporates a patient preference trial (PPT).
Methods
Primary outcome, defined as signs (positive cough stress test), symptoms (per validated questionnaire) and/or need for treatment of SUI and its associated cost, at 3 and 12 months post-operatively. Secondary outcomes consist of group differences in lower urinary tract and prolapse symptoms, health related quality of life, measures of vaginal anatomy, and surgical complications.
Limitations
Given the invasive nature of surgical intervention trials, some individuals may be reluctant to agree with random assignment, potentially impacting result generalizability. To evaluate the magnitude and direction of non-participation bias, the PPT will enroll a sample of those who decline participation in the RCT but are otherwise eligible.
Conclusion
This sham-controlled RCT will provide important information for patients and surgeons regarding both the short- and long-term optimal treatment approach for stress continent women undergoing a vaginal surgery for prolapse. Non-participation bias will be estimated.
doi:10.1177/1740774509102605
PMCID: PMC2878478  PMID: 19342469
Stress Urinary Incontinence; Pelvic Organ Prolapse; Surgical Intervention; Mid-urethral slings; Tension-free Vaginal Tape; Prophylactic Incontinence Procedure; Patient Preference Trial; Randomized Controlled Trial
23.  Ethnicity and variations of pelvic organ prolapse bother 
Introduction and hypothesis
To determine if prolapse symptom severity and bother varies among non-Hispanic white, Hispanic, and Native American women with equivalent prolapse stages on physical examination.
Methods
This was a retrospective chart review of new patients seen in an academic urogynecology clinic from January 2007 to September 2011. Data were extracted from a standardized intake form, including patients’ self-identified ethnicity. All patients underwent a Pelvic Organ Prolapse Quantification (POPQ) examination and completed the Pelvic Floor Distress Inventory-20 (PFDI-20) with its Pelvic Organ Prolapse Distress Inventory (POPDI) subscale.
Results
Five hundred and eighty-eight new patients were identified with pelvic organ prolapse. Groups did not differ by age, prior prolapse, and/or incontinence surgery, or sexual activity. Based on POPDI scores, Hispanic and Native American women reported more bother compared with non- Hispanic white women with stage 2 prolapse (p<0.01). Level of bother between Hispanic and Native American women with stage 2 prolapse (p=0.56) was not different. In subjects with ≥ stage 3 prolapse, POPDI scores did not differ by ethnicity (p=0.24). In multivariate stepwise regression analysis controlling for significant factors, Hispanic and Native American ethnicity contributed to higher POPDI scores, as did depression.
Conclusions
Among women with stage 2 prolapse, both Hispanic and Native American women had a higher level of bother, as measured by the POPDI, compared with non-Hispanic white women. The level of symptom bother was not different between ethnicities in women with stage 3 prolapse or greater. Disease severity may overshadow ethnic differences at more advanced stages of prolapse.
doi:10.1007/s00192-013-2145-4
PMCID: PMC3922120  PMID: 23807143
Ethnicity; Hispanic; Native American; Pelvic organ prolapse; Symptom bother
24.  Long-Term Patient Satisfaction With Michigan Four-Wall Sacrospinous Ligament Suspension for Prolapse 
Obstetrics and gynecology  2013;122(5):10.1097/AOG.0b013e3182a7f0d5.
Objective
To describe patient satisfaction after Michigan four-wall sacrospinous ligament suspension for prolapse and identify factors associated with satisfaction.
Methods
Four hundred fifty-three patients were asked to rate their satisfaction with surgery and complete validated quality-of-life instruments. Postoperative support was extracted from the medical record and assessed when possible. Factors independently associated with patients who were “highly satisfied” were identified with multivariable logistic regression.
Results
Sixty-two percent (242/392) reported how satisfied they were 8.0±1.7 years later. Fifty-seven percent had failed prior prolapse surgery, and 56% had a preoperative prolapse ≥4 cm beyond the hymen. Ninety percent were satisfied; 76% were “completely” or “very” satisfied and they were considered “highly satisfied” for analysis. Fourteen percent reporting being “moderately” satisfied and they were considered among those “less satisfied.” Women with lower scores on the postoperative Pelvic Floor Distress Inventory-20 were more likely to be “highly satisfied.” Postoperative anatomic data was available for 67% (162/242) and vaginal support was observed at or above the hymen in 86%. Women with preoperative Baden Walker grade 3 or 4 prolapse were more likely than those with grade 2 prolapse to be “highly satisfied.” Women with advanced postoperative prolapse (Grade 3 or 4) were less likely and those with Grade 2 support were as likely to be “highly satisfied” as those with Grade 0 or 1 support.
Conclusion
The Michigan four-wall sacrospinous ligament suspension is an anatomically effective approach to vault suspension with a high rate of long-term patient satisfaction. Postoperative vaginal support at the hymen does not negatively affect patient’s satisfaction.
doi:10.1097/AOG.0b013e3182a7f0d5
PMCID: PMC3860104  PMID: 24104775
25.  Long-term Outcomes Following Abdominal Sacrocolpopexy for Pelvic Organ Prolapse 
Importance
Over 225,000 surgeries are performed annually in the U.S. for pelvic organ prolapse (POP). Abdominal sacrocolpopexy is considered the most durable POP surgery, but little is known about long-term effectiveness and adverse events.
Objective
To describe anatomic and symptomatic outcomes up to 7 years after abdominal sacrocolpopexy, and to determine whether these are affected by concomitant anti-incontinence surgery (Burch urethropexy).
Design, setting, participants
Long-term follow-up of the randomized, masked 2-year CARE trial (Colpopexy And urinary Reduction Efforts). Participants were stress continent women undergoing abdominal sacrocolpopexy between 2002–5 for symptomatic POP randomized to concomitant urethropexy or not. 92% (215/233) of eligible 2-year CARE trial completers enrolled into this extended study with 181 (84%) and 126 (59%) completing 5 and 7 years follow-up, respectively. Median follow-up was 7 years.
Main Outcome Measures
POP: Symptomatic failure: POP retreatment or reporting bulge on Pelvic Floor Distress Inventory (PFDI); Anatomic failure: POP retreatment or Pelvic Organ Prolapse Quantification demonstrating descent of the vaginal apex descend below upper third of the vagina or anterior or posterior vaginal wall prolapse beyond the hymen.
Urinary incontinence (UI): Stress UI: more than 1 stress urinary incontinence symptom on PFDI or interval treatment; Overall UI: score ≥ 3 on Incontinence Severity Index.
Results
By year 7, the estimated probabilities of failure (POP, SUI, UI) from parametric survival modeling for the urethropexy and no urethropexy groups respectively were were 0.27 and 0.22 for anatomic POP (difference 0.050; 95% CI −0.161, 0.271), 0.29 and 0.24 for symptomatic POP (0.049; −0.060, 0.162), 0.48 and 0.34 for composite POP (0.134; −0.096, 0.322), 0.62 and 0.77 for SUI (−0.153; −0.268, 0.030) 0.75 and 0.81 for overall UI (−0.064; −0.161, 0.032). Mesh erosion probability estimated by Kaplan-Meier method was 10.5% (95% CI 6.8, 16.1) at 7 years.
Conclusion and Relevance
Over seven years, abdominal sacrocolpopexy failure rates increased in both randomized groups. Urethropexy prevented SUI longer than no urethropexy. Abdominal sacrocolpopexy effectiveness must be balanced with long-term risks of mesh and /or suture erosion.
doi:10.1001/jama.2013.4919
PMCID: PMC3747840  PMID: 23677313

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