Chiara Ghetti

Retropubic versus Transobturator Midurethral Slings for Stress Incontinence

BACKGROUND Midurethral slings are increasingly used for the treatment of stress incontinence, but there are limited data comparing types of slings and associated complications. METHODS We performed a multicenter, randomized equivalence trial comparing outcomes with retropubic and transobturator midurethral slings in women with stress incontinence. The primary outcome was treatment success at 12 months according to both objective criteria (a negative stress test, a negative pad test, and no retreatment) and subjective criteria (self-reported absence of symptoms, no leakage episodes recorded, and no retreatment). The predetermined equivalence margin was +/-12 percentage points. RESULTS A total of 597 women were randomly assigned to a study group; 565 (94.6%) completed the 12-month assessment. The rates of objectively assessed treatment success were 80.8% in the retropubic-sling group and 77.7% in the transobturator-sling group (3.0 percentage-point difference; 95% confidence interval [CI], -3.6 to 9.6). The rates of subjectively assessed success were 62.2% and 55.8%, respectively (6.4 percentage-point difference; 95% CI, -1.6 to 14.3). The rates of voiding dysfunction requiring surgery were 2.7% in those who received retropubic slings and 0% in those who received transobturator slings (P=0.004), and the respective rates of neurologic symptoms were 4.0% and 9.4% (P=0.01). There were no significant differences between groups in postoperative urge incontinence, satisfaction with the results of the procedure, or quality of life. CONCLUSIONS The 12-month rates of objectively assessed success of treatment for stress incontinence with the retropubic and transobturator approaches met the prespecified criteria for equivalence; the rates of subjectively assessed success were similar between groups but did not meet the criteria for equivalence. Differences in the complications associated with the two procedures should be discussed with patients who are considering surgical treatment for incontinence. (ClinicalTrials.gov number, NCT00325039.)

Two-Year Outcomes After Sacrocolpopexy With and Without Burch to Prevent Stress Urinary Incontinence

OBJECTIVES: To report anatomic and functional outcomes 2 years after sacrocolpopexy in stress-continent women with or without prophylactic Burch colposuspension. METHODS: In the Colpopexy and Urinary Reduction Efforts (CARE) trial, stress-continent women undergoing sacrocolpopexy were randomized to receive or not receive a Burch colposuspension. Outcomes included urinary symptoms, other pelvic symptoms, and pelvic support. Standardized pelvic organ prolapse quantification examinations and validated outcome measures including the Pelvic Floor Distress Inventory and the Pelvic Floor Impact Questionnaire were completed before surgery and at several postoperative intervals, including at 2 years. RESULTS: This analysis is based on 302 of 322 randomized participants. Most were Caucasian (94%), with a mean age of 62±10 years (mean±standard deviation). Two years after surgery, 32.0% and 45.2% of women in the Burch and control groups, respectively, met the stress incontinence endpoint (presence of symptoms or positive cough stress test or interval treatment for stress incontinence, P=.026). The apex was well supported (point C within 2 cm of total vaginal length) in 95% of women, and this was not affected by concomitant Burch (P=.18). There was a trend toward fewer urgency symptoms in the Burch group (32.0% versus 44.5% no Burch, P=.085). Twenty participants experienced mesh or suture erosions. CONCLUSION: The early advantage of prophylactic Burch colposuspension for stress incontinence that was seen at 3 months remains at 2 years. Apical anatomic success rates are high and not affected by concomitant Burch. CLINICAL TRIAL REGISTRATION: www.clinicaltrials.gov, ClinicalTrials.gov, NCT00065845 LEVEL OF EVIDENCE: I

The role of apical vaginal support in the appearance of anterior and posterior vaginal prolapse.

OBJECTIVE: To describe how simulated apical support affects the appearance of prolapse in the anterior and posterior vagina using a modification of the Pelvic Organ Prolapse Quantification (POP-Q) examination. METHODS: Women with prolapse stage II or greater were examined using the POP-Q. To simulate apical support, the posterior blade of a standard Graves speculum was positioned over the posterior vagina to support the vaginal apex while remeasuring points Aa and Ba and over the anterior vagina to support the apex while remeasuring points Ap and Bp. Change in anterior and posterior POP-Q points and prolapse stage with apical support were calculated. RESULTS: One hundred ninety-seven women were enrolled with mean age of 62±14 years, median parity of 2 (range 0–8), and mean body mass index of 28±5 kg/m2. By standard POP-Q, 36% had stage II prolapse, 54% had stage III, and 10% had stage IV prolapse. With simulated apical support, point Ba changed to stage 0 or I in 55% of cases and point Bp changed to stage 0 or I in 30% (P<.001 for each point). Mean change for point Ba with apical support was 3.5±2.6 cm and point Bp was 1.9±2.9 cm (P<.001). CONCLUSION: When the POP-Q examination is performed with simulated apical support, the critical role of level I vaginal support on the position of the anterior and posterior vagina, particularly the anterior vagina, becomes apparent. LEVEL OF EVIDENCE: II

Depressive symptoms in women seeking surgery for pelvic organ prolapse

Introduction and hypothesisTo compare depressive symptoms in women with and without prolapse and evaluate impact on quality of life.MethodsThis 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.ResultsBaseline 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.ConclusionsDepressive symptoms are common in women with prolapse and a decrease following surgical treatment.

Prophylactic bilateral oophorectomy or removal of remaining ovary at the time of hysterectomy in the United States, 1979-2004

OBJECTIVE The purpose of this study was to describe national rates and trends of prophylactic bilateral oophorectomy or remaining oophorectomy (BO/RO) at hysterectomy in women without specific gynecologic disease. STUDY DESIGN Data from the National Hospital Discharge Survey were analyzed for 1979-2004. Hysterectomies were divided into 2 groups: (1) hysterectomy with BO/RO and (2) hysterectomy alone (> or =1 ovary remaining). Age-adjusted rates (AARs) were calculated with 2000 US census data. RESULTS Approximately 3,686,000 hysterectomies with BO/RO were performed from 1979-2004. AARs of hysterectomy with BO/RO decreased during this period; the AARs in women > or =50 years old increased. The number of hysterectomies alone was 5,461,100, and AARs of hysterectomy alone decreased significantly from 2.9 per 1000 women in from 1979-1981 to 1.1 per 1000 women in 2001 (P < .001). The proportion of women who underwent hysterectomy with BO/RO increased from 29% in 1979 to 45% in 2004. CONCLUSION Although AARs of prophylactic BO/RO decreased from 1979-2004, the actual proportion of BO/RO at hysterectomy increased.

Prolapse severity, symptoms and impact on quality of life among women planning sacrocolpopexy

Objectives: To explore the relationship between severity of pelvic organ prolapse (POP), symptoms of pelvic dysfunction and quality of life using validated measures. Method: Baseline data from 314 participants in the Colpopexy And Urinary Reduction Efforts (CARE) trial were analyzed. Pelvic symptoms and impact were assessed using the Pelvic Floor Distress Inventory (PFDI) and the Pelvic Floor Impact Questionnaire (PFIQ). PFDI and PFIQ scores were compared by prolapse stage and history of incontinence or POP surgery. Regression analyses were performed to identify other predictors of symptoms and impact. Results: Women were predominantly (90%) Caucasian and had mean age of 61 years. Women with stage II POP, especially those with prior surgery, reported more symptoms and impact than women with more advanced POP. There were no other significant predictors of symptoms or life impact. Conclusions: Women planning sacrocolpopexy with stage II prolapse and prior pelvic surgery reported more symptoms and quality of life impact than those with more advanced prolapse.

Symptoms of Combined Prolapse and Urinary Incontinence in Large Surgical Cohorts

OBJECTIVE: To estimate whether prolapse severity is a major contributor to urinary incontinence severity, as measured by validated incontinence questionnaires. METHODS: We analyzed data from two large female stress urinary incontinence (SUI) surgical cohorts: the Stress Incontinence Surgical Treatment Efficacy Trial (SISTEr) study (N=655) and the subsequent Trial of Mid-Urethral Slings (TOMUS) study (N=597). All participants completed a standardized baseline assessment including validated measures of symptom severity, quality of life, objective measures of urine loss (Urogenital Distress Inventory [UDI], Medical, Epidemiologic, and Social Aspects of Aging questionnaire, Incontinence Impact Questionnaire, and pad test), as well as the Pelvic Organ Prolapse Quantification assessment. Groups were compared using the &khgr;2; test (categorical measures) or the one-way analysis of variance (continuous measures). Statistical significance was defined as P<.05. RESULTS: The SISTEr and TOMUS samples were similar for many variables including age (52 and 53 years, respectively), nulliparity (9% and 12%), prior urinary incontinence (UI) surgery (14% and 13%), and prior hysterectomy (31% and 28%), but other differences necessitated separate analysis of the two cohorts. There was not a statistically significant difference in UDI scores according to prolapse stage in either study population. Patients with prior surgery for pelvic organ prolapse and SUI had more incontinence symptoms and were more bothered by their UI regardless of prolapse stage. CONCLUSION: Prolapse stage is not strongly or consistently associated with incontinence severity in women who select surgical treatment of SUI. Prior pelvic organ prolapse and UI surgery is associated with worse UI severity and bother. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00064662 and NCT00325039. LEVEL OF EVIDENCE: II

Effect of a preoperative self-catheterization video on anxiety: a randomized controlled trial

Introduction and hypothesisThe purpose of this study was to determine if a clean intermittent self-catheterization (CISC) instructional video could improve anxiety in women undergoing prolapse and/or incontinence surgery.MethodsA total of 199 women were randomized to preoperative CISC video or routine counseling prior to prolapse/incontinence surgery. Patient anxiety, satisfaction, and concerns about CISC were evaluated using the State-Trait Anxiety Inventory-State (STAI-S) and study-specific visual analog scale (VAS) questions at four perioperative time points.ResultsSTAI-S and VAS anxiety measures were similar at baseline between groups; no significant differences were seen by group at any time point. STAI-S scores varied considerably over time, with highest scores at voiding trial failure and lowest scores at postoperative visit. Women in the video group had improved STAI-S scores and reported less worry and more comfort with CISC immediately following video viewing. Women with anxiety/depression had higher STAI-S scores at voiding trial failure and discharge and reported less anxiety reduction following video viewing compared to non-anxious/non-depressed peers.ConclusionsWomen undergoing prolapse/incontinence surgery have significant perioperative anxiety, which is exacerbated by voiding trial failure. Preoperative CISC video viewing decreases anxiety scores immediately following viewing, but this effect is not sustained at voiding trial failure. Women with baseline anxiety/depression exhibit less anxiety score improvement after video viewing and have overall higher anxiety scores perioperatively.

Risk factors for surgically managed pelvic organ prolapse and urinary incontinence.

with 15,000 IU of tinzaparin twice daily was initiated after delivery and changed to warfarin treatment after a week. The filter was removed uneventfully on the 14th day under local anesthesia through a right subclavian puncture. Venous thrombo-embolism remains the most common cause of direct maternal deaths [1]. Adequate management in pregnancy requires prompt and accurate diagnosis as well as a standardized anticoagulant regimen. In instances where the thrombus is unstable, surgical management with an IVC filter is effective. An IVC filter was used temporarily to facilitate induction of labor and allow for vaginal delivery, a safer option for this patient with extensive and mobile bilateral deep-vein thrombosis involving both common femoral veins. There was a previous report on the use of an IVC filter in a twinpregnancy of 26 weeks. The patient entered spontaneous labor at 36th weeks and underwent forceps delivery [3]. When the clot involves the common iliac veins or lower IVC, the risk of pulmonary embolism is high [2] and surgical interruption of the IVC prevents a large and often fatal thrombo-embolism [3]. The transvenous placement of filters provides a simple method of interrupting the IVC, and in combination with standard anticoagulation therapy, is an effective management in high-risk patients. The multidisciplinary approach was the key to successful outcome in this patient.

Sleep quality in women seeking care for pelvic organ prolapse

OBJECTIVES To identify the prevalence of sleep disturbance in women seeking treatment for pelvic organ prolapse (POP) and identify correlates of poor sleep quality in this population by using a validated sleep scale. STUDY DESIGN This is a cohort study of female patients with pelvic organ prolapse. MAIN OUTCOME MEASURES Pittsburgh Sleep Quality Index (PSQI), Pelvic Floor Disorders Inventory (PFDI), and Pelvic Floor Impact Questionnaire (PFIQ) measures were completed. Demographic data, medical comorbidities, medications, and physical examinations were also recorded. RESULTS 407 Women were enrolled. Analysis was performed on the 250 subjects who completed all PSQI components. Subjects were predominantly white, with a mean age of 61 ± 11 years and mean BMI of 28 ± 5 kg/m(2). The majority (71%) had Stage III prolapse. Half (N=127) had poor sleep quality (PSQI > 5). Women with poor sleep quality were younger, had more medical comorbidities, more pelvic floor symptoms, more nocturia, more depressive symptoms, and took more time to fall asleep. Factors associated with sleep quality were evaluated using multivariable linear regression models. Worse sleep scores were associated with each of the PFDI subscores (urinary, prolapse, bowel), depressive symptoms, severe nocturia symptoms, and number of comorbidities. CONCLUSIONS Poor sleep is prevalent in women with prolapse. Pelvic floor symptoms as measured by PFDI sub-scales, were associated with poor sleep quality. Future studies are needed to better understand how sleep disturbances may contribute to the impact of pelvic floor symptoms on quality of life.