Pamela Moalli

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.)

Remodeling of vaginal connective tissue in patients with prolapse.

OBJECTIVE: As pelvic organ prolapse progresses, the morphology of the vagina dramatically changes. The objective of this study was to determine whether these changes observed clinically correlate with histologic and biochemical evidence of tissue remodeling METHODS: After informed consent, full-thickness biopsies of the vaginal apex were obtained at the time of surgery from 77 women. The tissue of 15 premenopausal women with less than stage II prolapse (controls) was compared with that of 62 women with prolapse divided according to their menopausal status. All specimens were examined histologically. Scanning confocal microscopic analysis of fluorescent micrographs was used to quantitate collagen subtypes I, III, and V. Collagen fiber orientation was analyzed by scanning electron microscopy. Gelatin zymography was used to quantitate the expression of the proenzyme and active forms of matrix metalloproteinases (MMP) –2 and –9. Median values were compared using Mann-Whitney U or Kruskal-Wallis tests, where appropriate RESULTS: Vaginal collagen fibers are arranged in a whorled pattern, with collagen III as the predominant fibrillar collagen. The amount of total collagen in the vagina was increased in women with prolapse relative to women without prolapse (P = .054) primarily due to increased expression of collagen III (P = .031). There was no difference in the expression of proMMP-2, active MMP-2, or proMMP-9; however, active MMP-9 was increased in patients with prolapse (P = .030) CONCLUSION: The increase in collagen III and active MMP-9 expression in the vaginal tissues of patients with prolapse suggests that this tissue is actively remodeling under the biomechanical stresses associated with prolapse. Level of Evidence: II-2

Tissue mechanics, animal models, and pelvic organ prolapse: A review

Pelvic floor disorders such as pelvic organ prolapse, urinary incontinence, and fecal incontinence affect a large number of women each year. The pelvic floor can be thought of as a biomechanical structure due to the complex interaction between the vagina and its supportive structures that are designed to withstand the downward descent of the pelvic organs in response to increases in abdominal pressure. Although previous work has highlighted the biochemical changes that are associated with specific risk factors (i.e. parity, menopause, and genetics), little work has been done to understand the biomechanical changes that occur within the vagina and its supportive structures to prevent the onset of these pelvic floor disorders. Human studies are often limited due to the challenges of obtaining large tissue samples and ethical concerns. Therefore, it is necessary to investigate the use of animal models and their importance in understanding how different risk factors affect the biomechanical properties of the vagina and its supportive structures. In this review paper, we will discuss the different animal models that have been previously used to characterize the biomechanical properties of the vagina: including non-human primates, rodents, rabbits, and sheep. The anatomy and preliminary biomechanical findings are discussed along with the importance of considering experimental conditions, tissue anisotropy, and viscoelasticity when characterizing the biomechanical properties of vaginal tissue. Although there is not a lot of biomechanics research related to the vagina and pelvic floor, the future is exciting due to the significant potential for scientific findings that will improve our understanding of these conditions and hopefully lead to improvements in the prevention and treatment of pelvic disorders.

Risk factors associated with pelvic floor disorders in women undergoing surgical repair.

OBJECTIVE To identify demographic, obstetric, and gynecologic risk factors associated with the development of pelvic floor disorders in women who undergo surgical correction. METHODS We conducted a case–control study, with cases selected from all women who had surgery by our urogynecology service from July 1, 1999 to July 1, 2000 and who had a first obstetric delivery at Magee Womens Hospital (n = 80). Controls were patients seen in the general gynecology office over the same time period who had no complaints associated with pelvic floor disorders in the previous 3 years, less than stage I prolapse on pelvic examination, and first obstetric delivery at Magee Womens Hospital (n = 176). Demographic, obstetric, and gynecologic variables were compared between cases and controls. RESULTS There were no significant differences in race, current age, gravidity, or parity. Cases were more likely than controls to have a higher body mass index (BMI) (28.6 ± 6.3 versus 26.4 ± 6.1 kg/m2, P = .01), to be younger at first delivery (25.8 ± 5.3 versus 28.4 ± 4.9 years, P < .001), to have undergone a forceps delivery (64% versus 44%, P ≤ .001), and to have had previous gynecologic surgery (34% versus 16%, P = .003). Using logistic regression modeling, all of these factors were found to be independently associated with pelvic floor disorders. After menopause, use of hormone replacement therapy 5 or more years was protective (P = .001). CONCLUSION In our surgical patients, younger age at first delivery, higher BMI, forceps delivery, and history of gynecologic surgery were significantly associated with subsequent development of pelvic floor disorders.

Sexual Function 6 Months After First Delivery

OBJECTIVE: To explore the association of anal sphincter laceration and sexual function 6 months postpartum in the Childbirth and Pelvic Symptoms (CAPS) cohort. METHODS: The primary CAPS study, a prospective cohort study, was designed to estimate the postpartum prevalence and incidence of urinary and fecal incontinence. Three cohorts of new mothers (vaginal delivery with a third- or fourth-degree anal sphincter tear, vaginal delivery without a third- or fourth-degree anal sphincter tear, and cesarean delivery without labor) were compared at 6 months postpartum. Sexual function was assessed with the Pelvic Organ Prolapse/Urinary Incontinence/Sexual Function Short Form Questionnaire (PISQ-12). Urinary and fecal incontinence were assessed using the Medical Epidemiological and Social Aspects of Aging questionnaire and the Fecal Incontinence Severity Index, which is embedded within the Modified Manchester Health Questionnaire. RESULTS: Most women (459 [90%]) of those with partners reported sexual activity at the 6-month visit. Fewer women whose delivery was complicated by anal sphincter laceration reported sexual activity when compared with those who delivered vaginally without sphincter laceration (88 compared with 94%, P=.028). The mean PISQ-12 score (39±4) did not differ between delivery groups (P=.92). Pain (responses of “sometimes,” “usually,” or “always”) during sex affected one of three sexually active women (164 [36%]). CONCLUSION: At 6 months postpartum, primiparous women who delivered with anal sphincter laceration are less likely to report sexual activity. LEVEL OF EVIDENCE: II

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

Vaginal degeneration following implantation of synthetic mesh with increased stiffness

To compare the impact of the prototype prolapse mesh Gynemesh PS with that of two new‐generation lower stiffness meshes, UltraPro and SmartMesh, on vaginal morphology and structural composition.

Deterioration in biomechanical properties of the vagina following implantation of a high-stiffness prolapse mesh

To define the impact of prolapse mesh on the biomechanical properties of the vagina by comparing the prototype Gynemesh PS (Ethicon) to two new‐generation lower stiffness meshes, SmartMesh (Coloplast) and UltraPro (Ethicon).

Predictors of Treatment Failure 24 Months After Surgery For Stress Urinary Incontinence

PURPOSE We identified baseline demographic and clinical factors associated with treatment failure after surgical treatment of stress urinary incontinence. MATERIALS AND METHODS Data were obtained from 655 women randomized to Burch colposuspension or autologous rectus sling. Of those, 543 (83%) had stress failure status assessed at 24 months (269 Burch, 274 sling). Stress failure (261) was defined as self-report of stress urinary incontinence by the Medical, Epidemiological, and Social Aspects of Aging questionnaire, positive stress test or re-treatment for stress urinary incontinence. Nonstress failure (66) was defined as positive 24-hour pad test (more than 15 ml) or any incontinent episodes by 3-day voiding diary with none of the 3 criteria for stress failure. Subjects not meeting any failure criteria were considered a treatment success (185). Adjusting for surgical treatment group and clinical site, logistic regression models were developed to predict the probability of treatment failure. RESULTS Severity of urge incontinence symptoms (p = 0.041), prolapse stage (p = 0.013), and being postmenopausal without hormone therapy (p = 0.023) were significant predictors for stress failure. Odds of nonstress failure quadrupled for every 10-point increase in Medical, Epidemiological, and Social Aspects of Aging questionnaire urge score (OR 3.93 CI 1.45, 10.65) and decreased more than 2 times for every 10-point increase in stress score (OR 0.36, CI 0.16, 0.84). The associations of risk factors and failure remained similar regardless of surgical group. CONCLUSIONS Two years after surgery, risk factors for stress failure are similar after Burch and sling procedures and include greater baseline urge incontinence symptoms, more advanced prolapse, and menopausal not on hormone replacement therapy. Higher urge scores predicted failure by nonstress specific outcomes.

Tensile properties of commonly used prolapse meshes.

Introduction and hypothesisTo improve our understanding of the differences in commonly used synthetic prolapse meshes, we compared four newer generation meshes to Gynecare PS™ using a tensile testing protocol. We hypothesize that the newer meshes have inferior biomechanical properties.MethodsMeshes were loaded to failure (n = 5 per group) generating load–elongation curves from which the stiffness, the load at failure, and the relative elongation were determined. Additional mesh samples (n = 3) underwent a cyclic loading protocol to measure permanent elongation in response to subfailure loading.ResultsWith the exception of Popmesh, which displayed uniform stiffness, other meshes were characterized by a bilinear behavior. Newer meshes were 70–90% less stiff than Gynecare™ (p < 0.05) and more readily deformed in response to uniaxial and cyclical loading (p < 0.001).ConclusionRelative to Gynecare™, the newer generation of prolapse meshes were significantly less stiff, with irreversible deformation at significantly lower loads.