Jerry L. Lowder

Anticholinergic therapy vs. onabotulinumtoxinA for urgency urinary incontinence

BACKGROUND Anticholinergic medications and onabotulinumtoxinA are used to treat urgency urinary incontinence, but data directly comparing the two types of therapy are needed. METHODS We performed a double-blind, double-placebo-controlled, randomized trial involving women with idiopathic urgency urinary incontinence who had five or more episodes of urgency urinary incontinence per 3-day period, as recorded in a diary. For a 6-month period, participants were randomly assigned to daily oral anticholinergic medication (solifenacin, 5 mg initially, with possible escalation to 10 mg and, if necessary, subsequent switch to trospium XR, 60 mg) plus one intradetrusor injection of saline or one intradetrusor injection of 100 U of onabotulinumtoxinA plus daily oral placebo. The primary outcome was the reduction from baseline in mean episodes of urgency urinary incontinence per day over the 6-month period, as recorded in 3-day diaries submitted monthly. Secondary outcomes included complete resolution of urgency urinary incontinence, quality of life, use of catheters, and adverse events. RESULTS Of 249 women who underwent randomization, 247 were treated, and 241 had data available for the primary outcome analyses. The mean reduction in episodes of urgency urinary incontinence per day over the course of 6 months, from a baseline average of 5.0 per day, was 3.4 in the anticholinergic group and 3.3 in the onabotulinumtoxinA group (P=0.81). Complete resolution of urgency urinary incontinence was reported by 13% and 27% of the women, respectively (P=0.003). Quality of life improved in both groups, without significant between-group differences. The anticholinergic group had a higher rate of dry mouth (46% vs. 31%, P=0.02) but lower rates of catheter use at 2 months (0% vs. 5%, P=0.01) and urinary tract infections (13% vs. 33%, P<0.001). CONCLUSIONS Oral anticholinergic therapy and onabotulinumtoxinA by injection were associated with similar reductions in the frequency of daily episodes of urgency urinary incontinence. The group receiving onabotulinumtoxinA was less likely to have dry mouth and more likely to have complete resolution of urgency urinary incontinence but had higher rates of transient urinary retention and urinary tract infections. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health Office of Research on Womens Health; ClinicalTrials.gov number, NCT01166438.).

Adverse events over two years after retropubic or transobturator midurethral sling surgery: findings from the Trial of Midurethral Slings (TOMUS) study.

OBJECTIVE To describe surgical complications in 597 women over a 24-month period after randomization to retropubic or transobturator midurethral slings. STUDY DESIGN During the Trial of Midurethral Slings study, the Data Safety Monitoring Board regularly reviewed summary reports of all adverse events using the Dindo Surgical Complication Scale. Logistic regression models were created to explore associations between clinicodemographic factors and surgical complications. RESULTS A total of 383 adverse events were observed among 253 of the 597 women (42%). Seventy-five adverse events (20%) were classified as serious (serious adverse events); occurring in 70 women. Intraoperative bladder perforation (15 events) occurred exclusively in the retropubic group. Neurologic adverse events were more common in the transobturator group than in retropubic (32 events vs 20 events, respectively). Twenty-three (4%) women experienced mesh complications, including delayed presentations, in both groups. CONCLUSION Adverse events vary by procedure, but are common after midurethral sling. Most events resolve without significant sequelae.

Episiotomy in the United States : has anything changed?

OBJECTIVE The objective of the study was to describe episiotomy rates in the United States following recommended changes in clinical practice. STUDY DESIGN The National Hospital Discharge Survey, a federal data set sampling inpatient hospitals, was used to obtain data based on International Classification of Diseases, Clinical Modification, 9th revision, diagnosis and procedure codes from 1979 to 2004. Age-adjusted rates of term, singleton, vertex, live-born spontaneous vaginal delivery, operative vaginal delivery, cesarean delivery, episiotomy, and anal sphincter laceration were calculated. Census data for 1990 for women 15-44 years of age was used for age adjustment. Regression analysis was used to evaluate trends in episiotomy. RESULTS The rate of episiotomy with all vaginal deliveries decreased from 60.9% in 1979 to 24.5% in 2004. Anal sphincter laceration with spontaneous vaginal delivery declined from 5% in 1979 to 3.5% in 2004. Rates of anal sphincter laceration with operative delivery increased from 7.7% in 1979 to 15.3% in 2004. The age-adjusted rate of operative vaginal delivery declined from 8.7 in 1979 to 4.6 in 2004, whereas cesarean delivery rates increased from 8.3 in 1979 to 17.2 per 1000 women in 2004. CONCLUSION Routine episiotomy has declined since liberal usage has been discouraged. Anal sphincter laceration rates with spontaneous vaginal delivery have decreased, likely reflecting the decreased usage of episiotomy. The decline in operative vaginal delivery corresponds to a sharp increase in cesarean delivery, which may indicate that practitioners are favoring cesarean delivery for difficult births.

Trends in stress urinary incontinence inpatient procedures in the United States, 1979-2004

OBJECTIVE The purpose of this study was to describe national trends in surgery for female stress urinary incontinence (SUI). STUDY DESIGN We used data from the National Hospital Discharge Survey, a federal dataset sampling patient discharges from US inpatient hospitals. We analyzed patient and hospital demographics and International Classification of Diseases, 9th revision, Clinical Modification (ICD-9-CM) diagnostic and procedures codes for 1979-2004. Age-adjusted rates per 1000 women were calculated with 1990 US Census population data. RESULTS The number of women who have undergone SUI surgery each year increased from 48,345 in 1979 to 103,467 in 2004. In women > or = 52 years old, the age-adjusted rate more than doubled from 0.64-1.60 procedures per 1000 women; in women < 52 years old, the age-adjusted rate fell from 0.57-0.47. Age-adjusted rates for retropubic urethral suspension (ICD-9-CM, 59.5) fell from 0.37 in 1979 to 0.14 in 2004. For suprapubic sling procedures (ICD-9-CM, 59.4), the age-adjusted rates rose from 0.02 in 1979 to a peak of 0.10 in 1997 and then fell to 0.03 in 2004. Age-adjusted rates for other repair of urinary stress incontinence (ICD-9-CM, 59.79) rose from 0.06 in 1979 to 0.64 in 2004. CONCLUSION The number of women who have undergone SUI surgery increased significantly from 1979-2004. Because the National Hospital Discharge Survey data do not include ambulatory procedures, accurate information on same-day surgeries is unavailable. Currently no ICD-9-CM procedure code exists specifically for midurethral sling procedures. Both missed sampling of same-day procedures and nonspecific or inaccurate coding may explain the surprising decline in suprapubic sling procedures and the rise in rates of other repair of SUI. A national ambulatory surgical database and a specific code for midurethral sling are needed to capture these important data.

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

Trends in inpatient prolapse procedures in the United States, 1979-2006.

OBJECTIVE We sought to describe national trends for inpatient procedures for pelvic organ prolapse from 1979-2006. STUDY DESIGN The National Hospital Discharge Survey was analyzed for patient and hospital demographics, as were International Classification of Diseases, Ninth Revision, Clinical Modification diagnostic and procedures codes from 1979-2006. Age-adjusted rates (AARs) per 1000 women were calculated using the 1990 US Census data. RESULTS There was a significantly decreasing trend in the AARs for inpatient prolapse procedures, from 2.93-1.52 per 1000 women from 1979-2006. AARs for hysterectomy decreased from 8.39-4.55 per 1000 women from 1979-2006. Over the study period, AARs remained at about the 1979 level among the women>or=52 years old (2.73-2.86; P=.075). In women<52 years old, AARs declined to less than one-third of the 1979 rate (3.03-0.84; P<.001). CONCLUSION AARs for inpatient procedures for prolapse in the United States remained stable for women aged>or=52 years from 1979-2006; rates declined by two-thirds for women aged<52 years.

Trends over time with commonly performed obstetric and gynecologic inpatient procedures.

OBJECTIVES: To estimate trends over time in inpatient obstetric and gynecologic surgical procedures, and to estimate commonly performed obstetric and gynecologic surgical procedures across a womans lifespan. METHODS: Data were collected for procedures in adult women from 1979 to 2006 using the National Hospital Discharge Survey, a federal discharge dataset of U.S. inpatient hospitals, including patient and hospital demographics and International Classification of Diseases, 9th Revision, Clinical Modification procedure codes for adult women from 1979 to 2006. Age-adjusted rates per 1,000 women were created using 1990 U.S. Census data. Procedural trends over time were assessed. RESULTS: More than 137 million obstetric and gynecologic procedures were performed, comprising 26.5% of surgical procedures for adult women. Sixty-four percent were only obstetric and 29% were only gynecologic, with 7% of women undergoing both obstetric and gynecologic procedures during the same hospitalization. Obstetric and gynecologic procedures decreased from approximately 5,351,000 in 1979 to 4,949,000 in 2006. Both operative vaginal delivery and episiotomy rates decreased, whereas spontaneous vaginal delivery and cesarean delivery rates increased. All gynecologic procedure rates decreased during the study period, with the exception of incontinence procedures, which increased. Common procedures by age group differed across a womans lifetime. CONCLUSION: Inpatient obstetric and gynecologic procedures rates decreased from 1979 to 2006. Inpatient obstetric and gynecologic procedure rates are decreasing over time but still comprise a large proportion of inpatient surgical procedures for U.S. women. LEVEL OF EVIDENCE: III

Biomechanical adaptations of the rat vagina and supportive tissues in pregnancy to accommodate delivery.

OBJECTIVE: We hypothesize that in pregnancy and at the time of delivery, the vagina and supportive tissues undergo dramatic alterations to accommodate passage of the fetus. In this study, we sought to characterize these changes in the rat using an established biomechanical testing protocol. METHODS: Seventy-four 3-month-old Long Evans rats divided into virgin, mid and late pregnant, vaginal delivery (immediate and 4-week postpartum), and abdominal delivery (immediate and 4-week postpartum) groups were killed. The biomechanical properties of the vagina and supportive tissues were tested intact as a complex under loading conditions that simulate downward distension. Data were analyzed using analysis of variance and post hoc comparisons. RESULTS: Mean linear stiffness (ability of the specimen to resist distension) and ultimate load at failure (maximal resistance of the specimen to distension before disruption) were decreased in pregnancy and at delivery, regardless of delivery route (Ps<.001). Maximal distension was increased at time of delivery (Ps<.001). Four weeks after vaginal delivery, all biomechanical characteristics returned to at least virgin values. CONCLUSION: In the rat, the biomechanical characteristics affording distensibility of the vagina and supportive tissues increased in pregnancy and even further at delivery. It is likely that these represent maternal tissue adaptations that facilitate delivery of the fetus(es).

Hysterectomy surgical trends: a more accurate depiction of the last decade?

OBJECTIVE The objective of the study was to describe trends in hysterectomy route at a large tertiary center. STUDY DESIGN We reviewed all hysterectomies performed at Magee-Womens Hospital from 2000 to 2010. This database was chosen over larger national surveys because it has been tracking laparoscopic procedures since 2000, well before laparoscopic hysterectomy International Classification of Diseases, ninth revision (ICD-9) procedure codes were developed. RESULTS There were 13,973 patients included who underwent hysterectomy at Magee-Womens Hospital. In 2000, 3.3% were laparoscopic (LH), 74.5% abdominal (AH), and 22.2% vaginal hysterectomy (VH). By 2010, LH represented 43.5%, AH 36.3%, VH 17.2%, and 3.0% laparoscopic converted to open (LH→AH). Hysterectomies performed for gynecological malignancy represented 24.4% of cases. The average length of stay for benign LH and VH, 1.0 ± 1.0 and 1.6 ± 1.0 days respectively, was significantly shorter than the average 3.1 ± 2.3 day stay associated with AH (P < .001). The average patient age was 46.9 ± 10.9 years for LH, 51.5 ± 12.1 years for AH, and 51.7 ± 14.1 years for VH, and over the study period there was a significant trend of increasing patient age (b1 = 0.517, 0.583, and 0.513, respectively [P < .001 for all]). CONCLUSION The percentage of LH increased over the last decade and by 2010 had surpassed AH. The 43.4% LH rate in 2010 is much higher than previously reported in national surveys. This likely is due to an increase in the number of laparoscopic procedures being performed over the last few years as well as the ability of our study to capture LH prior to development of appropriate ICD-9 procedure codes. Our unique ability to determine hysterectomy route, which predates appropriate coding, may provide a more accurate characterization of hysterectomy trends.

Lower urinary tract injury in women in the United States, 1979–2006

OBJECTIVE We sought to determine age-adjusted rates (AARs) of lower urinary tract injury and incidence in selected inpatient gynecologic and obstetric procedures. STUDY DESIGN We utilized the National Hospital Discharge Survey, 1979-2006. AARs of nonobstetric bladder and ureteral injuries and incidence of lower urinary tract injury for various hysterectomy types and deliveries were calculated for women>18 years old. RESULTS Overall AARs of ureteral injury decreased from 0.06-0.03 per 1000 women (1979-2006). AARs of inpatient gynecologic procedures decreased from 24.9-11.8 per 1000 women (1979-2006). By hysterectomy type, bladder injury was highest in laparoscopic-assisted vaginal hysterectomy (VH) (13.8 per 1000) and VH (13.1 per 1000). Ureteral injury recognized during hysterectomy was most common with radical hysterectomy (7.7 per 1000) and least common with laparoscopic-assisted VH (0 per 1000). CONCLUSION Ureteral injuries at time of inpatient surgical procedures have decreased from 1979-2006. This corresponds with a sharp decrease in inpatient gynecologic procedures.