Douglass S. Hale

Does the Prolift system cause dyspareunia

OBJECTIVE The purpose of this study was to determine the de novo dyspareunia rate with the Prolift procedure. STUDY DESIGN All Prolift cases performed between August 2005 and August 2007 were evaluated. The rate of de novo dyspareunia was calculated by chart review. Type and degree of dyspareunia were assessed by self-administered questionnaire. Demographics, use of hormone therapy, failure rate, and willingness to have the surgery again were summarized using descriptive statistics. RESULTS The rate of de novo dyspareunia was 16.7%. Over 75% of patients with de novo dyspareunia described the pain as mild or moderate. Most described dyspareunia with insertion. Eighty-three percent of respondents with de novo dyspareunia would have the procedure done again. CONCLUSION The Prolift is associated with a 17% de novo dyspareunia rate. Despite this, most would have the surgery done again.

OnabotulinumtoxinA Improves Health-Related Quality of Life in Patients With Urinary Incontinence Due to Idiopathic Overactive Bladder: A 36-Week, Double-Blind, Placebo-Controlled, Randomized, Dose-Ranging Trial

BACKGROUND Patients with urgency urinary incontinence (UUI) due to overactive bladder (OAB) refractory to oral antimuscarinics have limited therapeutic options. OnabotulinumtoxinA appears to be an effective new treatment. OBJECTIVE Assess disease-specific quality-of-life outcomes and general health-related quality-of-life (HRQOL) outcomes following treatment with onabotulinumtoxinA in patients with idiopathic OAB and UUI inadequately managed with antimuscarinics. DESIGN, SETTING, AND PARTICIPANTS A phase 2, randomized, double-blind, placebo-controlled, dose-ranging study conducted at 40 sites from July 2005 to June 2008 with 313 patients (288 females) with idiopathic OAB experiencing eight or more UUI episodes per week and eight or more micturitions per day at baseline, with follow-up of 36 wk. INTERVENTION Intradetrusor onabotulinumtoxinA (50 U, 100 U, 150 U, 200 U, or 300 U) or placebo. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS HRQOL was assessed using the urinary Incontinence-Specific Quality-of-Life Instrument (I-QOL), the Kings Health Questionnaire (KHQ) symptom component, and the Medical Outcomes Study 36-Item Short-Form Health Survey. Descriptive statistics were used for absolute scores/changes from baseline. Within-group changes from baseline were assessed using paired t tests. Change from baseline for each onabotulinumtoxinA group compared with placebo was analyzed using an analysis of covariance model. RESULTS AND LIMITATIONS OnabotulinumtoxinA treatment at doses≥100 U produced significantly greater improvements than placebo in the I-QOL total and subscale scores at all follow-up visits from week 2 through week 24 (p<0.05). OnabotulinumtoxinA doses≥100 U produced significantly greater improvements than placebo in the KHQ symptom score at a majority of follow-up visits. HRQOL instruments demonstrated low to moderate correlations (Spearman correlation range: 0.01-0.51) with the symptoms of UUI recorded using daily diary data, with I-QOL demonstrating the highest correlations. A study limitation was that certain quality-of-life measures were exploratory and not validated. CONCLUSIONS A single onabotulinumtoxinA treatment with doses≥100 U resulted in statistically significant and clinically meaningful improvement in HRQOL by week 2 compared with placebo, and this improvement was sustained for ≤36 wk in patients with idiopathic OAB and UUI who were inadequately managed by oral antimuscarinics. TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT00168454.

Effect of tension-free vaginal tape procedure on urodynamic continence indices.

OBJECTIVE To assess the difference in measured urethral function before and after tension‐free vaginal tape procedure (TVT). METHODS Women who underwent TVT for genuine stress incontinence with or without intrinsic sphincter deficiency completed this study. Multichannel urodynamic testing was performed preoperatively and 6 weeks postoperatively. Maximum urethral closure pressure and pressure transmission ratio were recorded. Valsalva leak point pressures were determined at 150 mL and at full bladder capacity. Resting and straining urethral angles were measured using the cotton swab technique. Subjects completed both the Incontinence Impact Questionnaire and Urodynamic Distress Inventory preoperatively and postoperatively. RESULTS Thirty‐five consecutive women were studied. Twenty‐three (65.7%) had a preoperative diagnosis of intrinsic sphincter deficiency as defined by maximum urethral closure pressure less than 20 cm H2O and/or Valsalva leak point pressure less than 60 cm H2O. Subjective and objective success rates were 91% and 83%, respectively. Subjects showed an 86.8% (95% CI 71.9%, 100.0%) improvement in their Incontinence Impact Questionnaire score and a 72.9% (95% CI 62.6%, 83.1%) improvement in their Urodynamic Distress Inventory score. The mean change in maximum urethral closure pressure was −1.3 cm H2O (95% CI −5.9, 3.3), whereas the pressure transmission ratio increased 15.7% (95% CI 5.0%, 26.3%). The mean decrease in straining urethral angle was 16.3° (95% CI −23.9°, −8.7°). Cured subjects demonstrating hypermobility preoperatively continued to do so postoperatively. CONCLUSION There was a significant increase in pressure transmission ratio, but not maximum urethral closure pressure, after TVT. These changes are similar to those reported after retropubic urethropexy and traditional sling procedures. The effectiveness of the TVT sling does not appear to depend on a clinically significant change in the straining urethral angle.

Comparison between dynamic cystocolpoproctography and dynamic pelvic floor MRI: pros and cons: Which is the “functional” examination for anorectal and pelvic floor dysfunction?

Abstract“Functional” imaging of anorectal and pelvic floor dysfunction has assumed an important role in the diagnosis and management of these disorders. Although defecography has been widely practiced for decades to evaluate the dynamics of rectal emptying, debate concerning its clinical relevance, how it should be done and interpreted continues. Due to the recognition of the association of defecatory disorders with pelvic organ prolapse in women, the need to evaluate the pelvic floor as a unit has arisen. To meet this need, defecography has been extended to include not only evaluation of defecation disorders but also the rest of the pelvic floor by opacifying the small bowel, vagina, and the urinary bladder. The term “dynamic cystocolpoproctography” (DCP) has been appropriately applied to this examination. Rectal emptying performed with DCP provides the maximum stress to the pelvic floor resulting in complete levator ani relaxation. In addition to diagnosing defecatory disorders, this method of examination demonstrates maximum pelvic organ descent and provides organ-specific quantification of organ prolapse, information that is only inferred by means of physical examination. It has been found to be of clinical value in patients with defecation disorders and the diagnosis of associated prolapse in other compartments that are frequently unrecognized by history taking and the limitations of physical examination. Pelvic floor anatomy is complex and DCP does not show the anatomical details pelvic magnetic resonance imaging (MRI) provides. Technical advances allowing acquisition of dynamic rapid MRI sequences has been applied to pelvic floor imaging. Early reports have shown that pelvic MRI may be a useful tool in pre-operative planning of these disorders and may lead to a change in surgical therapy. Predictions of hypothetical increase cancer incidence and deaths in patients exposed to radiation, the emergence of pelvic floor MRI in addition to questions relating to the clinical significance of DCP findings have added to these controversies. This review analyses the pros and cons between DCP and dynamic pelvic floor MRI, addresses imaging and interpretive controversies, and their relevance to clinical management.

Tobacco use is a risk factor for mesh erosion after abdominal sacral colpoperineopexy

OBJECTIVE The purpose of this study was to evaluate the association between smoking and vaginal mesh erosion after abdominal sacral colpoperineopexy with the use of type 1 polypropylene mesh. STUDY DESIGN All cases of mesh erosion (n = 27) that were diagnosed between October 2003 and June 2006 were identified and compared with matched control cases (n = 81). Control cases were matched for age, diabetes mellitus status, hypoestrogenic state (menopausal status, chronic steroid use, use of hormone therapy), abdominal-vaginal rectocele repair, culdoplasty, and concomitant hysterectomy. Demographic data, surgical characteristics, and postoperative complications were also compared between groups. Continuous data were compared using 2-sample Student t tests. Categoric data were compared with the use of Pearson Chi-square tests. RESULTS The odds of experiencing mesh erosion was significantly greater in smokers than in nonsmokers (odds ratio, 4.4; 95% CI, 1.3, 14.4; P = .010) when potential confounders were similar between groups. CONCLUSION Tobacco use is a risk factor for vaginal mesh erosion after abdominal sacral colpoperineopexy with the use of type 1 polypropylene mesh.

Abdominovaginal sacral colpoperineopexy: patientperceptions, anatomical outcomes, and graft erosions

This is a retrospective analysis of 169 consecutive patients who underwent the abdominovaginal sacral colpoperineopexy. POP-Q measurements, patient willingness to have the same surgery again, and mesh erosions were recorded during follow-up visits. Patients whose erosion responded to office excision were defined as having minor mesh erosion. Patients with persistent erosions requiring outpatient surgical excisions were defined as having major mesh erosion. For the 122 patients with 12-month follow-up, all POP-Q points improved (p<0.005) compared with preoperative measurements. The response to the question “Would you go through the same surgery again?” was “yes” 77.3% of the time and “no” 4.9% of the time. Minor mesh erosion rate was 5.9% (10/169). Major erosion rate was 0.6% (1/169). In conclusion, when combined with paravaginal defect repair and Burch urethropexy, the abdominovaginal sacral colpoperineopexy effectively addresses all support defects in patients with advanced prolapse. The procedure is associated with a high level of patient willingness to have the same surgery again, and it is achieved with low erosion rate.

Abdominal, laparoscopic, and robotic surgery for pelvic organ prolapse.

Abdominal correction of pelvic organ prolapse remains a viable option for patients and surgeons. The transition from open procedures to less invasive laparoscopic and robotic-assisted surgeries is evident in the literature. This article reviews the surgical options available for pelvic organ prolapse repair and their reported outcomes. Procedures reviewed include apical support (sacral, uterosacral, and others), and abdominal anterior and posterior vaginal wall support. Long-term follow-up and appropriately designed studies will further help direct surgeons in deciding which approach to incorporate into their practice.

De novo stress urinary incontinence after negative prolapse reduction stress testing for total vaginal mesh procedures: incidence and risk factors

OBJECTIVE The primary objective was to estimate the incidence of de novo stress urinary incontinence after total vaginal mesh procedures in women with negative preoperative urodynamics with prolapse reduction. Secondary objective was to identify associated risk factors. STUDY DESIGN A retrospective cohort study with a nested case-control study of women who underwent total vaginal mesh procedures without midurethral sling after a negative preoperative urodynamics. RESULT Sixty patients were included in the final analysis. Fifteen (25%) patients were diagnosed with de novo stress urinary incontinence. Although no significant associated risk factors were identified, there was a trend for higher gravidity and better anterior wall support among women who had stress urinary incontinence develop. CONCLUSION The incidence of de novo stress urinary incontinence after total vaginal mesh procedures in this cohort was 25%. Patients should be appropriately counseled regarding the same.

Grafts in pelvic reconstructive surgery.

Introduction The use of graft material in surgery to replace or augment native tissue is not new. Early use of graft materials in the battlefield and in animal studies date back to antiquity. What is new is the rapid development and marketing of graft materials now available for surgeons. At the present time, there are at least 10 synthetic materials, 8 allografts, and 2 xenografts available from which surgeons may choose. Many more are in development. Clinicians must realize that unlike the U.S. Food and Drug Administration (FDA) requirements for medications, much less stringent requirements are needed to gain approval for graft use in humans. The main requirement is to show ‘‘equivalency’’ to products already approved. Although there are guidelines published by the Center for Devices and Radiologic Health, they remain just that, guidelines. Data on graft use is sparse with the majority of evidence provided by case series. This gives little scientific evidence on which to base clinical use. The rational for graft use in support procedures is not unfounded. If literature outside of urogynecology is examined, hernia data can serve as an example. Incisional hernia studies demonstrate the superiority of mesh in a long-term randomized trial when compared with suture repair. For all size incisional hernias, the recurrence rate for suture repair was twice that seen when mesh was used. For smaller incisional hernias, recurrence rates were 67% in suture repair compared with 17% after mesh repair, median follow up 75 and 81 months, respectively. Moreover, pain was less with mesh repair, possibly because of less tension on tissue when mesh was used. The doubling of the failure rate seen in this study is similar to the doubling of the failure rate reported when vaginal reconstructive surgery relying on native tissue is compared with abdominal mesh reconstructive surgery. Correspondence: Douglass S. Hale, MD, 1633 N. Capitol Ave., Suite 436, Indianapolis, IN 46202-1227. E-mail: DHale@Clarian.org

High uterosacral ligament vaginal vault suspension: comparison of absorbable vs. permanent suture for apical fixation

Introduction and hypothesisThe primary objective of this study was to compare outcomes of absorbable and permanent suture for apical support with high uterosacral ligament vaginal vault suspension (HUSLS). The secondary objective was to investigate the rate of suture erosion.MethodsThis was a retrospective study of patients who underwent HUSLS with delayed absorbable and primarily permanent suture. Apical support was calculated as a new variable: Percent of Perfect Ratio (POP-R). This variable measures apical support as the position of the apex in relation to vaginal length.ResultsAt 1-year follow-up, there was no significant difference in apical support between the two groups. The number of patients who suffered from suture erosion in the cohort that received permanent suture was 11 (22%).ConclusionsPermanent suture, in comparison with delayed absorbable suture, for HUSLS does not offer significantly better apical support at short-term follow-up. It is also associated with a high rate of suture erosion.