Halina Zyczynski

Abdominal sacrocolpopexy: A comprehensive review

OBJECTIVE: To summarize published data about abdominal sacrocolpopexy and to highlight areas about which data are lacking. DATA SOURCES: We conducted a literature search on MEDLINE using Ovid and PubMed, from January,1966 to January, 2004, using search terms “sacropexy,” “sacrocolpopexy,” “sacral colpopexy,” “colpopexy,” “sacropexy,” “colposacropexy,” “abdominal sacrocolpopexy” “pelvic organ prolapse and surgery,” and “vaginal vault prolapse or surgery” and included articles with English-language abstracts. We examined reference lists of published articles to identify other articles not found on the electronic search. METHODS OF STUDY SELECTION: We examined all studies identified in our search that provided any outcome data on sacrocolpopexy. Because of the substantial heterogeneity of outcome measures and follow-up intervals in case studies, we did not apply meta-analytic techniques to the data. TABULATION, INTEGRATION, AND RESULTS: Follow-up duration for most studies ranged from 6 months to 3 years. The success rate, when defined as lack of apical prolapse postoperatively, ranged from 78–100% and when defined as no postoperative prolapse, from 58–100%. The median reoperation rates for pelvic organ prolapse and for stress urinary incontinence in the studies that reported these outcomes were 4.4% (range 0–18.2%) and 4.9% (range 1.2% to 30.9%), respectively. The overall rate of mesh erosion was 3.4% (70 of 2,178). Some reports found more mesh erosions when concomitant total hysterectomy was done, whereas other reports did not. There were no data to either support or refute the contentions that concomitant culdoplasty or paravaginal repair decreased the risk of failure. Most authors recommended burying the graft under the peritoneum to attempt to decrease the risk of bowel obstruction; despite this, the median rate (when reported) of small bowel obstruction requiring surgery was 1.1% (range 0.6% to 8.6%). Few studies rigorously assessed pelvic symptoms, bowel function, or sexual function. CONCLUSION: Sacrocolpopexy is a reliable procedure that effectively and consistently resolves vaginal vault prolapse. Patients should be counseled about the low, but present risk, of reoperation for prolapse, stress incontinence, and complications. Prospective trials are needed to understand the effect of sacrocolpopexy on functional outcomes.

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.)

Long-term Outcomes Following Abdominal Sacrocolpopexy for Pelvic Organ Prolapse

IMPORTANCE More than 225 000 surgeries are performed annually in the United States for pelvic organ prolapse (POP). Abdominal sacrocolpopexy is considered the most durable POP surgery, but little is known about safety and long-term effectiveness. OBJECTIVES 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, AND PARTICIPANTS Long-term follow-up of the randomized, masked 2-year Colpopexy and Urinary Reduction Efforts (CARE) trial of women with stress continence who underwent abdominal sacrocolpopexy between 2002 and 2005 for symptomatic POP and also received either concomitant Burch urethropexy or no urethropexy. Ninety-two percent (215/233) of eligible 2-year CARE trial completers were enrolled in the extended CARE study; and 181 (84%) and 126 (59%) completed 5 and 7 years of follow-up, respectively. The median follow-up was 7 years. MAIN OUTCOMES AND MEASURES Symptomatic POP failure requiring retreatment or self-reported bulge; or anatomic POP failure requiring retreatment or Pelvic Organ Prolapse Quantification evaluation demonstrating descent of the vaginal apex below the upper third of the vagina, or anterior or posterior vaginal wall prolapse beyond the hymen. Stress urinary incontinence (SUI) with more than 1 symptom or interval treatment; or overall UI score of 3 or greater on the Incontinence Severity Index. RESULTS By year 7, the estimated probabilities of treatment failure (POP, SUI, UI) from parametric survival modeling for the urethropexy group and the no urethropexy group, respectively, were 0.27 and 0.22 for anatomic POP (treatment difference of 0.050; 95% CI, -0.161 to 0.271), 0.29 and 0.24 for symptomatic POP (treatment difference of 0.049; 95% CI, -0.060 to 0.162), 0.48 and 0.34 for composite POP (treatment difference of 0.134; 95% CI, -0.096 to 0.322), 0.62 and 0.77 for SUI (treatment difference of -0.153; 95% CI, -0.268 to 0.030), and 0.75 and 0.81 for overall UI (treatment difference of -0.064; 95% CI, -0.161 to 0.032). Mesh erosion probability at 7 years (estimated by the Kaplan-Meier method) was 10.5% (95% CI, 6.8% to 16.1%). CONCLUSIONS AND RELEVANCE During 7 years of follow-up, abdominal sacrocolpopexy failure rates increased in both groups. Urethropexy prevented SUI longer than no urethropexy. Abdominal sacrocolpopexy effectiveness should be balanced with long-term risks of mesh or suture erosion. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00099372.

Fecal and urinary incontinence in primiparous women

OBJECTIVE: To prospectively investigate the relationship between anal sphincter tears and postpartum fecal and urinary incontinence. METHODS: The Childbirth and Pelvic Symptoms study was a prospective cohort study performed by the Pelvic Floor Disorders Network to estimate the prevalence of postpartum fecal and urinary incontinence in primiparous women: 407 with clinically recognized anal sphincter tears during vaginal delivery, 390 without recognized sphincter tears (vaginal controls), and 124 delivered by cesarean before labor. Women were recruited postpartum while hospitalized and interviewed by telephone 6 weeks and 6 months postpartum. We assessed fecal and urinary incontinence symptoms using the Fecal Incontinence Severity Index and the Medical, Epidemiological, and Social Aspects of Aging Questionnaire, respectively. Odds ratios were adjusted for age, race, and clinical site. RESULTS: Compared with the vaginal control group, women in the sphincter tear cohort reported more fecal incontinence (6 weeks, 26.6% versus 11.2%; adjusted odds ratio [AOR] 2.8, 95% confidence interval [CI] 1.8–4.3; 6 months, 17.0% versus 8.2%; AOR 1.9, 95% CI 1.2–3.2), more fecal urgency and flatal incontinence, and greater fecal incontinence severity at both times. Urinary incontinence prevalence did not differ between the sphincter tear and vaginal control groups. Six months postpartum, 22.9% of women delivered by cesarean reported urinary incontinence, whereas 7.6% reported fecal incontinence. CONCLUSION: Women with clinically recognized anal sphincter tears are more than twice as likely to report postpartum fecal incontinence than women without sphincter tears. Cesarean delivery before labor is not entirely protective against pelvic floor disorders. LEVEL OF EVIDENCE: II-3

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

The role of preoperative urodynamic testing in stress-continent women undergoing sacrocolpopexy: the Colpopexy and Urinary Reduction Efforts (CARE) randomized surgical trial

The aim of this study is to describe results of reduction testing in stress-continent women undergoing sacrocolpopexy and to estimate whether stress leakage during urodynamic testing with prolapse reduction predicts postoperative stress incontinence. Three hundred twenty-two stress-continent women with stages II–IV prolapse underwent standardized urodynamics. Five prolapse reduction methods were tested: two at each site and both performed for each subject. Clinicians were masked to urodynamic results. At sacrocolpopexy, participants were randomized to Burch colposuspension or no Burch (control). P-values were computed by two-tailed Fisher’s exact test or t-test. Preoperatively, only 12 of 313 (3.7%) subjects demonstrated urodynamic stress incontinence (USI) without prolapse reduction. More women leaked after the second method than after the first (22% vs. 16%; p = 0.012). Preoperative detection of USI with prolapse reduction at 300ml was pessary, 6% (5 of 88); manual, 16% (19 of 122); forceps, 21% (21 of 98); swab, 20% (32 of 158); and speculum, 30% (35 of 118). Women who demonstrated preoperative USI during prolapse reduction were more likely to report postoperative stress incontinence, regardless of concomitant colposuspension (controls 58% vs. 38% (p = 0.04) and Burch 32% vs. 21% (p = 0.19)). In stress-continent women undergoing sacrocolpopexy, few women demonstrated USI without prolapse reduction. Detection rates of USI with prolapse reduction varied significantly by reduction method. Preoperative USI leakage during reduction testing is associated with a higher risk for postoperative stress incontinence at 3 months. Future research is warranted in this patient population to evaluate other treatment options to refine predictions and further reduce the risk of postoperative stress incontinence.

Risk factors for mesh/suture erosion following sacral colpopexy

OBJECTIVE The purpose of this study was to identify risks for mesh/suture erosions following abdominal sacral colpopexy (ASC). STUDY DESIGN We analyzed demographic, perioperative variables, and erosion status in 322 participants in the Colpopexy and Urinary Reduction Efforts study 2 years after sacral colpopexy. RESULTS The predominant graft used was synthetic mesh: woven polyester (Mersilene; Ethicon, Inc, Somerville, NJ) (42%) or polypropylene (48%). Twenty subjects (6%) experienced mesh/suture erosion. Unadjusted risk factors for mesh/suture erosion were expanded polytrafluroethylene (ePTFE) mesh (ePTFE 4/21 [19%] vs non-ePTFE 16/301 [5%]; odds ratio [OR], 4.2), concurrent hysterectomy (OR, 4.9), and current smoking (OR, 5.2). Of those with mesh erosion, most affected women (13/17) underwent at least 1 surgery for partial or total mesh removal. Two were completely resolved, 6 had persistent problems, and 5 were lost to follow-up. No resolution was documented in the 4 women who elected observation. CONCLUSION Expanded PTFE mesh should not be used for sacral colpopexy. Concurrent hysterectomy and smoking are modifiable risks for mesh/suture erosion.

Colpocleisis: a review

Objective: To summarize published data about colpocleisis and to highlight areas about which data are lacking. Data sources: We conducted a literature search on Medline using Ovid and PubMed, from 1966 to January 2004, using search terms “colpocleisis”, “colpectomy”, “vaginectomy”, “pelvic organ prolapse (POP) and surgery”, and “vaginal vault prolapse and surgery” and included articles with English-language abstracts. We examined reference lists of published articles to identify other articles not found on the electronic search. Methods of study selection: We examined all studies identified in our search that provided any outcome data on colpocleisis. Because of the heterogeneity of outcome measures and follow-up intervals in case series, we did not apply meta-analytic techniques to the data. Results: Colpocleisis for POP is apparently successful in nearly 100% of patients in recent series. The rate of reoperation for stress incontinence or POP after colpocleisis is unknown. Concomitant elective hysterectomy is associated with increased blood loss and length of hospital stay, without known improvement in outcomes. Few studies systematically assess pelvic symptoms. The role of preoperative urodynamic testing to direct optimal management of urinary incontinence and retention remains to be established in this setting. Conclusions: Colpocleisis is an effective procedure for treatment of advanced POP in patients who no longer desire preservation of coital function. Complications are relatively common in this group of elderly patients. Prospective trials are needed to understand the impact of colpocleisis on functional outcomes and patient satisfaction.

Urodynamic Measures Do Not Predict Stress Continence Outcomes After Surgery for Stress Urinary Incontinence in Selected Women

PURPOSE We determined the prognostic value of preoperative urodynamic results in patients with stress urinary incontinence. MATERIALS AND METHODS In a 9-center surgical trial, women with stress urinary incontinence were randomized to a Burch or pubovaginal sling procedure. Women were eligible for the study if they had predominant stress urinary incontinence symptoms, a positive cough stress test, a bladder capacity more than 200 ml and urethral hypermobility. Preoperative free uroflowmetry, filling cystometry and pressure flow studies were performed in all. Overall treatment success required a negative pad test, no urinary incontinence on a 3-day diary, a negative stress test, no self-reported stress urinary incontinence symptoms and no re-treatment for stress urinary incontinence. Stress specific success required all of the last 3 criteria. We examined urodynamic measures, and whether the presence of urodynamic stress incontinence, the presence of detrusor overactivity and Valsalva leak point pressure would predict surgical success. RESULTS Subjects with urodynamic stress incontinence had a 2-fold greater odds of overall success when compared with the No urodynamic stress incontinence group, but this trend did not quite reach statistical significance (OR 2.26; 95% C.I. 0.99, 5.17). Odds of stress specific success did not differ by urodynamic stress incontinence status. Subjects with detrusor overactivity did not have significantly worse success rates. Stratifying by treatment group, there was no difference in mean Valsalva leak point pressure values between surgical successes and failures. CONCLUSIONS We found a nearly statistically significant trend that women with urodynamic stress incontinence are twice as likely to have a successful overall outcome from surgical management of stress urinary incontinence as women without urodynamic stress incontinence. The level of Valsalva leak point pressure and the presence of detrusor overactivity do not predict the success outcomes after the Burch or autologous fascia sling procedures in women with pure or predominant stress urinary incontinence. The impact of urodynamic studies on surgical outcomes needs further investigation.

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.