Abdominal sacrocolpopexy and urinary incontinence: surgical planning based on urodynamics.

OBJECTIVE: The objective of the study was to evaluate the use of urodynamics to determine the need for incontinence surgery at the time of abdominal sacrocolpopexy (ASC). STUDY DESIGN: The records of 441 women undergoing ASC during 2005-2007 were reviewed. Group 1 consisted of 204 women (46.3%) with urodynamic stress incontinence (USI), including occult USI, who underwent incontinence surgery with ASC. Group 2 consisted of 237 women (53.7%) without USI who underwent ASC alone. Primary outcome measures were any complaint of postoperative incontinence (stress or urge) or new-onset urgency/frequency (UF). RESULTS: At a mean follow-up of 46.6 weeks, the overall rate of incontinence was low and similar for both groups (13.4% in group 1 and 13.3% in group 2 [P = .967]), as was new-onset UF: 18.6% in group 1 and 11.5% in group 2 (P = .195). CONCLUSION: Urodynamic evaluation appears to be useful in determining the need for incontinence surgery at the time of ASC.

Treatment modalities, health care resource utilization, and costs in patients diagnosed with interstitial cystitis.

OBJECTIVE: The aim of this study was to examine treatment modalities, health care resource utilization, and costs in patients diagnosed with interstitial cystitis (IC). STUDY DESIGN: Patients with a diagnosis of IC were identified from a national managed care administration claims database and classified into treatment cohorts. All-cause health care resource utilization and costs were calculated by treatment cohort. RESULTS: Patients treated with narcotics plus nonnarcotic analgesics were associated with higher mean health care costs. Patient cohorts treated with some of the more common oral therapies for interstitial cystitis, including pentosan polysulfate sodium, amitriptyline, and hydroxyzine, were associated with lower costs. Physician visits were fewest among patients treated with pentosan polysulfate sodium plus amitriptyline and hydroxyzine. Physician visits were higher for cohorts that included dimethyl sulfoxide plus cystoscopy or bladder irrigation, or narcotics plus nonnarcotic analgesics. CONCLUSION: Interstitial cystitis is associated with substantial costs and health care resource utilization.

Posterior vaginal sling experience in elderly patients yields poor results.

OBJECTIVE: The objective of the study was to evaluate our experience with the posterior vaginal sling in an elderly population. STUDY DESIGN: Elderly patients with significant vaginal prolapse underwent a posterior vaginal sling using the IVS Tunneller device (Tyco Healthcare, United States Surgical, Norwalk, CT). Primary failure was defined as a postoperative pelvic organ prolapse quantitative point C (the apex of the vagina) within 2 cm of the preoperative value. Secondary failure was defined as any portion of the anterior or posterior vaginal walls protruding to or beyond the hymeneal ring (pelvic organ prolapse quantitative points Aa or Ap equal to or greater than 0). RESULTS: Twenty-one patients underwent the procedure; 19 were seen for follow up. The average age was 70 years (range 60-78). Twelve patients had primary or secondary failures (12 of 19, 63%). There were 5 primary failures (5 of 19, 26%) and 7 secondary failures (7 of 19, 37%). The mean time to failure was 7 weeks (range 1-18). CONCLUSION: In our elderly population, the posterior vaginal sling has a high failure rate, occurring early in the postoperative period.

Current issues in the diagnosis of painful bladder syndrome/interstitial cystitis.

PBS/IC, which was traditionally thought to be a rare condition, is increasingly thought to be a frequent cause of CPP. Failure to consider the bladder as a component of this pain is common, primarily because of the similarity in symptoms to other urogynecologic conditions. The diagnosis of PBS/IC has been one of exclusion; as a result, PBS/IC is frequently misdiagnosed as urogenital infection, OAB or endometriosis, among other conditions with similar symptomatology. Such misdiagnosis results in unnecessary and ineffective pharmacologic or even surgical interventions. Diagnosis of PBS/IC and appropriate management early in the disease process afford women a better outcome and a better quality of life. Making PBS/IC a diagnosis of inclusion is necessary to attain this goal. Two additions to the diagnostic armamentarium, the PUF Patient Symptom Scale and the PST, can help to identify women whose presenting complaints of CPP might have a bladder component. The high correlation between these 2 tools allows clinicians to administer the noninvasive PUF questionnaire as an initial screening device to identify women suspected of having IC. If PBS/IC is diagnosed early in the disease process, it can be treated successfully in most patients.

Management of patients with interstitial cystitis or chronic pelvic pain of bladder origin: a consensus report.

BACKGROUND: Interstitial cystitis (IC) remains a challenging disease to treat, but increased awareness, better diagnostic tools, and effective pharmacologic agents can help non-urologists successfully manage this condition. Interstitial cystitis is much more prevalent than previously thought and is often misdiagnosed. Left untreated, IC can have a deleterious effect on the quality of life of the affected individual. In-office symptom-based techniques have been developed to screen for the presence of IC in both women and men presenting with symptoms of chronic pelvic pain (CPP) or chronic prostatitis (CP), and effective pharmacologic treatments exist that can provide acute and long-term symptom relief. Individual patient response to therapy varies, with some patients taking up to several months to achieve an optimal therapeutic response. To optimize patient response, a comprehensive algorithm for the diagnosis and management of IC should be utilized. Symptoms and progress should be assessed at each follow-up visit and changes in therapy made accordingly. Patients should be encouraged to learn as much as possible about IC and to take charge of the management of symptoms using their physician for guidance in decision making. The importance of this aspect of therapy should be reinforced at each subsequent visit. The entire office staff also has an important role in understanding and acknowledging each patient's pain and frustration as well as in providing support and education about IC. SCOPE: This paper presents recommendations from a multidisciplinary panel for the evaluation, diagnosis, treatment, and follow-up care of patients with IC or CPP of bladder origin.

Elevate and Uterine Preservation: Two-Year Results.

OBJECTIVE: To evaluate efficacy of the Elevate Anterior and Apical (EAA) in the repair of pelvic organ prolapse (POP) when performed after previous hysterectomy and with or without uterine preservation during POP surgery. MATERIALS AND METHODS: One hundred forty-two women with anterior vaginal prolapse and/or apical descent ≥ stage II were enrolled. The primary outcome was treatment failure defined as > stage II POP-Q during follow-up using the Last observed Failure Carried Forward method. Three sub-groups were analysed: baseline previous hysterectomy (N = 61); concomitant hysterectomy (N = 29), and preserved uterus/no hysterectomy (N = 51). Demographics, primary and secondary outcomes, and extrusion were compared between the groups. A P value less than 0.05 was considered statistically significant. RESULTS: Anatomic success shows significant and durable improvement at 24 months. The success for the apical compartment ranged between 93.8% and 100%. Success was slightly lower for the anterior compartment (70.8-89.1%). No statistically significant difference between the 3 subgroups. Age was the only patient characteristic to be found different between the 3 subgroups. In addition, there was no difference in overall intraoperative complications (P = 0.263). Mesh extrusion was found in all groups: 3 of 61 (4.9%) had previous hysterectomy; 4 of 29 (13.8%) had concomitant hysterectomy; and 1 of 51 (2.0%) had uterus preserved (P = 0.094). There appears to be a trend toward higher extrusion when a hysterectomy was performed with the EAA. CONCLUSIONS: Anatomic success and complications for the EAA do not appear to be significantly impacted when the uterus is removed before or during surgery or preserved. There may be a trend toward increased mesh extrusion when a hysterectomy is performed. However, larger cohort studies are needed to determine if concomitant hysterectomy impact extrusion.

Elevate anterior/apical: 12-month data showing safety and efficacy in surgical treatment of pelvic organ prolapse.

OBJECTIVE: This study aimed to assess the safety and efficacy of the Elevate Anterior/Apical transvaginal mesh procedure in pelvic organ prolapse (POP) repair at 12-months follow-up. METHODS: This prospective, multicenter, multinational study enrolled 142 patients experiencing anterior vaginal prolapse with or without apical descent (POP-Q ≥ stage II). Each patient received a single-incision transvaginal polypropylene mesh implantation anchored to the sacrospinous ligaments bilaterally. Primary outcome was treatment success defined as POP-Q less than or equal to stage I at 1 year using the Last Failure Carried Forward method. Secondary outcomes included validated quality-of-life measures. Fourteen subjects who received a concomitant posterior apical support procedure were excluded from the analysis. RESULTS: Of the 128 subjects, 112 (87.5%) completed the 12-months follow-up. The mean age was 64.7 years. The anatomic success rate was 87.7% (95% confidence interval, 80.3%-93.1%) for the anterior compartment and 95.9% (95% confidence interval, 88.5%-99.1%) for the apical compartment. POP-Q measurements (Aa, Ba, and C) improved significantly (P < 0.001) with no significant changes to TVL (P = 0.331). Related adverse events reported at greater than 2% were mesh exposure (8; 6.3%), urinary tract infection (7; 5.5%), transient buttock pain (5; 3.9%), de novo stress incontinence (5; 3.9%), retention (5; 3.9%), dyspareunia (3; 3.2%), and hematoma (3; 2.3%). All quality-of-life scores significantly improved from baseline (P < 0.001). CONCLUSIONS: Twelve-month data show that Elevate Anterior/Apical support procedure completed through a single vaginal incision yields favorable objective and subjective outcomes.

Effect of suture selection on the rate of suture or mesh erosion and surgery failure in abdominal sacrocolpopexy.

OBJECTIVE: : To determine if suture type used for mesh attachment in abdominal sacrocolpopexy increases the rate of erosion/infection. METHODS: : Two groups were temporally divided from June 1996 to May 2001 where braided permanent sutures (2-0 Ethibond, Ethicon, Somerville, New Jersey) were exclusively used for graft placement (n = 161) and from August 2001 to May 2006 where exclusively monofilament delayed absorbable (2-0 PDS, Ethicon) was used (n = 254). Data were analyzed for demographics, medical history, presenting/postoperative physical examination, concomitant surgeries, and complications. RESULTS: : Mesh/suture exposure rate was 3.7% (6/161) with Ethibond. There were no erosions with PDS (P = 0.002). Colpopexy failure was 1.7% (2/116) with Ethibond and 0% (0/235) with PDS (P = 0.11). CONCLUSIONS: : Delayed absorbable, monofilament suture appears to reduce the risk of graft/suture erosion without increasing surgical failure.

A comprehensive review of suburethral sling procedure complications.

The study objective was to review the existing literature regarding complications of anti-incontinence sling procedures. PubMed listings using keywords related to slings and associated complications with no date or language restrictions through May 2007 and the Manufacturer and User Facility Device Experience Database were searched for specific device- and procedure-related complications. Where no information was available, published abstracts were cited. Published reports of complications for all types of anti-incontinence sling procedures are analyzed and reported. Sling-related complications are multiple but can be summarized from studies on 13737 cumulative patients as involving: voiding dysfunction (8 studies, 881 patients, 16.3% average overall incidence [OI]); detrusor overactivity (20 studies, 1950 patients, 15.4% OI); urinary retention (14 studies, 943 patients, 14.2% OI); erosion/extrusion (19 studies, 2197 patients, 6.03% OI); impact on quality of life-dyspareunia (2 studies, 175 patients, 4.3% OI); infections-most often urinary tract infections but severe infections such as abscess are reported (19 studies, 1487 patients, 5.5% OI); hematoma-most often pelvic or vaginal (4 studies, 3691 patients, 2% OI); pain (6 studies, 597 patients, 7.3% OI); abdominal and pelvic organ injury-bladder, urethra, vagina, and intestines (10 studies, 1816 patients, 3.3% OI); systemic complications-deep vein thrombosis, sepsis (case reports); and death (case reports). Cure rates for all slings are as follows: subjective (16 studies, 1541 patients, 95% OI, range 63%-99%), objective (15 studies, 1203 patients, 82% OI, range 51%-97%), and failure (8 studies, 599 patients, 11.5% OI, range 4%-37%). It is likely that sling-related complications are under-reported in the published medical literature and in the Manufacturer and User Facility Device Experience Database. This review reports on the incidence of known complications for all types of slings. Some complications are common to all sling techniques; however, with development of minimally invasive slings, device-related complications are reported and compared.

The emerging presence of interstitial cystitis in gynecologic patients with chronic pelvic pain.

Emerging data are changing the pelvic pain paradigm for gynecologic patients. Historically, interstitial cystitis (IC) was rarely considered as a cause of chronic pelvic pain (CPP), but recent data suggest that IC is a common cause of CPP in gynecologic patients and perhaps is even the most common cause. It is important to consider the bladder as a generator of symptoms early in the evaluation of the gynecologic patient with CPP. New tools have been developed to aid the gynecologist in ruling out IC in patients with CPP, including a new IC symptom questionnaire and the Potassium Sensitivity Test (PST). By determining whether the pain is of bladder origin, the physician can more successfully treat the patient with CPP.

Rational approaches to the treatment of patients with interstitial cystitis.

Symptoms of interstitial cystitis can usually be successfully managed with heparinoid therapy to theoretically alter bladder urothelial abnormalities, and with oral medications to inhibit neural upregulation or to control mast cell dysfunction. Other forms of care ranging from intravesical therapy to endoscopic, percutaneous, or open surgery are options that may be used singly or in combination to optimize symptom reduction.

The prevalence of interstitial cystitis, endometriosis, adhesions, and vulvar pain in women with chronic pelvic pain.

STUDY OBJECTIVE: To estimate the prevalence of bladder-origin pain, intraperitoneal pathology, and vulvar pain in patients undergoing laparoscopy for chronic pelvic pain (CPP). DESIGN: Prospective, observational one-site (Canadian Task Force classification II-2). SETTING: Referral gynecology specialty private practice. PARTICIPANTS: Sixty-four patients undergoing laparoscopy for CPP were prospectively assessed to establish the source of their CPP over a 12-month period. INTERVENTIONS: All patients received an intravesical potassium sensitivity test (PST), cystoscopy with double-fill hydrodistension, a physical examination for vulvar pain, and laparoscopy to assess the presence of peritoneal pathology. The validated pelvic pain/urgency/frequency (PUF) screening questionnaire was given to all patients to assess symptoms. MEASUREMENTS AND MAIN RESULTS: Forty-four patients (69%) were found to have a positive PST indicating pain of bladder origin due to bladder epithelial dysfunction. Cystoscopic findings diagnosed only seven cases of classic interstitial cystitis (11%). Laparoscopic findings revealed biopsy-proven endometriosis in 28% and adhesions in 64%. Vulvar pain was diagnosed on examination in 20%. Assessment of intraperitoneal pathology and bladder-origin pain accurately diagnosed 95% of patients. There was no statistical difference in the prevalence of endometriosis, adhesions, or vulvar pain when groups were stratified to PST-positive or -negative groups. Bladder pain, peritoneal pathology, and vulvar pain are independent risk factors of CPP although a trend of severity was noted in patients who had worse symptoms (increased voids per day, urgency, pain, and PUF scores). Patients with increased symptoms had a higher likelihood of having pain from bladder epithelial damage and intraperitoneal pathology. CONCLUSIONS: The etiology of CPP may arise from multiple sites in the pelvis including the bladder, pelvic peritoneum, and vulva. This study demonstrated that in a group of women undergoing a comprehensive work-up for CPP, the bladder was the predominant pain generator. A work-up for CPP should include an assessment of bladder epithelial function and an assessment for intraperitoneal pathology.

Abnormal urinary potassium metabolism in patients with interstitial cystitis.

PURPOSE: If most patients with interstitial cystitis (IC) have epithelial leakage allowing urinary K to penetrate the interstitium and provoke symptoms, urinary K should be lower in untreated patients than in healthy subjects and it should increase with successful heparinoid treatment. This study tested these hypotheses. MATERIALS AND METHODS: Na, K and creatinine (Cr) were determined in spot urine samples from new, symptomatic, untreated patients with IC meeting all National Institute of Diabetes and Digestive and Kidney Diseases clinical diagnostic criteria, returning patients with IC reporting 50% or greater symptom improvement after 4 or greater months of oral heparinoid therapy and control subjects, and in 24-hour urine samples from new untreated patients and controls. RESULTS: In spot urine specimens of 37 new patients with IC K-to-Cr ratios were significantly lower than in 18 controls (0.51 vs 0.88 mg/mg Cr, p = 0.001). A total of 50 successfully treated patients with IC had significantly higher K-to-Cr ratios than those in 37 new patients (0.66 vs 0.51 mg/mg Cr, p = 0.025). Na-to-Cr ratios in the 3 groups were not significantly different. In 24-hour urine specimens 30 new patients had lower average K (31.0 vs 46.2 mEq/l, p = 0.01) and lower K-to-Cr ratios (0.43 vs 0.52 mg K/mg Cr, p = 0.01) than in 47 controls, while Na was not significantly different. CONCLUSIONS: Our finding of lower urinary K in new, untreated patients supports the concept of abnormal epithelial permeability and K absorption in IC. Higher urinary K in successfully treated vs untreated patients may reflect decreasing urinary K absorption due to mucosal repair and a resulting decrease in epithelial permeability. K/mg Cr appears accurate for normalizing urinary K.

Infected abdominal sacrocolpopexies: diagnosis and treatment.

The abdominal sacrocolpopexy is an excellent procedure to surgically treat vaginal vault prolapse. A synthetic graft is often used to support the vaginal apex, but has the potential to become infected or erode, requiring its removal or revision. The purpose of this paper is to report our experience in the management of patients with infected synthetic grafts after abdominal sacrocolpopexy. A review of the patient databases from three specialty gynecology centers was performed from March 1996 to June 2002. Only patients with an infected graft after an abdominal sacrocolpopexy were included in the study; patients with either suture or graft erosion responding to conservative treatment were excluded. Twenty-two women, ages 37-73 years, developed infection of the synthetic graft after an abdominal sacrocolpopexy (1-60 months after their initial surgery, mean 8.8 months). The infected materials included polytetrafluoroethylene (PTFE, Goretex, n =15) and polypropylene (n=7). Nine of the 15 PTFE meshes and four of the seven polypropylene meshes were placed at the time of a contaminated case (abdominal hysterectomy [n=12], colon resection [n=1]). Eighteen (82%) of the infected grafts involved braided permanent suture to attach the graft to the vaginal wall, monofilament/non-braided permanent suture was used in three patients, and suture type could not be determined in one. All graft removals were attempted vaginally, and this was successful in 16 cases (73%). Two patients experienced significant bleeding: the first patient required an emergency laparotomy and the second patient's bleeding was controlled with packing. A rectovaginal fistula occurred 3 weeks postoperatively in one patient. Synthetic graft infection should be considered as the differential diagnosis in a patient who has undergone an abdominal sacrocolpopexy. Transvaginal removal is preferred, but is fraught with potentially serious complications. The use of braided permanent sutures to affix the graft to the vagina may be associated with mesh infections.

Mini-incisional Burch urethropexy: a less invasive method to accomplish a time-tested procedure for treatment of genuine stress incontinence.

The purpose of this study was to evaluate the feasibility, safety and efficacy of performing the Burch urethropexy (BU) and the abdominal paravaginal repair (APR) through a 1.5-2.5 in suprapubic incision. A prospective clinical study was undertaken by four urogynecologists. Seventy-three patients, each with a urodynamic and clinical diagnosis of genuine stress incontinence, underwent a BU procedure, with 33 of the 73 having concomitant APR through the same incision. The duration of surgery and any complications were recorded. Postoperative outcome tests included subjective incontinence questionnaire, cough stress testing, pad testing, measurement of residual volumes, and analgesia requirements. The BU procedure was accomplished in 72 of 73 patients, with 1 requiring conversion to a 5 in incision. The mean operative time was 64.6 +/-21.9 (SD) min. Intraoperatively, 1 patient was noted to have a suture in the bladder. All patient having only a BU (40) went home on the day of surgery or the first postoperative day, and all patients with BU and APR went home within 2 days. All but 1 patient met the criteria for catheter removal within 7 days, with 1 patient suffering obstructive voiding. At a mean follow-up of 9 months, cough stress test and questionnaire demonstrated complete cure in 70 of 72 patients tested. Pad testing confirmed cure in all of the 46 patients who consented to the test. We conclude that the standard Burch procedure and paravaginal repair can be accomplished safely and with excellent short-term efficacy through a 1.5-2.5 in incision.

Increased prevalence of interstitial cystitis: previously unrecognized urologic and gynecologic cases identified using a new symptom questionnaire and intravesical potassium sensitivity.

OBJECTIVES: Most individuals with interstitial cystitis (IC) have both pelvic pain and urinary urgency/frequency, and many have dyspareunia. Existing questionnaires designed to assess bladder-origin pelvic pain (IC) give little attention to pelvic pain or dyspareunia, however. On the basis of our clinical experience with more than 5000 patients with IC, we have designed a pelvic pain and urgency/frequency (PUF) symptom scale that gives balanced attention to urinary urgency/frequency, pelvic pain, and symptoms associated with sexual intercourse. METHODS: We used the intravesical potassium sensitivity test (PST) to validate the PUF scale in urologic patients suspected of having IC, gynecologic patients with pelvic pain, controls, and women attending lectures given by one of us (C.L.P.). Positive potassium sensitivity is known to be associated with a bladder epithelial dysfunction present in most individuals with IC. RESULTS: The PST was positive in 74% of patients with a PUF score of 10 to 14, 76% of those scoring 15 to 19, and 91% of those scoring 20 or higher. All controls' PUF scores were less than 3, and the rate of positive PST in controls was 0%. The PUF scores in women screened at lectures suggested that 1 in 4.5 women have IC. CONCLUSIONS: High PUF scores appear to correlate directly with a higher likelihood of positive PST in both urologic patients suspected of having IC and gynecologic patients with pelvic pain. The PUF appears to be a valid tool for detecting IC in these two populations, as well as in the general population. Use of the PUF alone may prove to be an accurate method for detecting IC. The IC prevalence may be as high as 1 in 4.5 women.

The prevalence of interstitial cystitis in gynecologic patients with pelvic pain, as detected by intravesical potassium sensitivity.

OBJECTIVE: The purpose of this study was to determine the prevalence of interstitial cystitis in a large number of gynecologic patients with pelvic pain versus control subjects, as indicated by a positive result on a potassium sensitivity test. STUDY DESIGN: Gynecologists at four US medical centers administered the potassium sensitivity test to consecutive unselected patients with pelvic pain and control subjects. Before testing, each patient with pelvic pain was given an initial clinical diagnosis on the basis of the chief symptomatic complaint(s) and was surveyed for urologic symptoms. RESULTS: Of 244 patients with pelvic pain, 197 patients (81 %) had a positive result from a potassium sensitivity test. Positive potassium sensitivity test rates were comparable across all four sites and all clinical diagnoses that included endometriosis, vulvodynia (vulvar vestibulitis), and pelvic pain. Urologic symptoms were reported by 84% of patients, but only 1.6% of the patients had received an initial diagnosis of interstitial cystitis. None of the 47 control subjects were tested positive with the potassium sensitivity test. CONCLUSION: Interstitial cystitis may be a common unrecognized cause of pelvic pain in gynecologic patients and deserves greater, if not primary, consideration in the differential diagnosis of pelvic pain.

Increased numbers of activated mast cells in endometriosis lesions positive for corticotropin-releasing hormone and urocortin.

PROBLEM: Mast cells are critical in allergic and inflammatory diseases such as interstitial cystitis, which is often clinically associated with or mistaken as endometriosis. Mast cells had previously been reported to be increased at sites of endometriosis, and tryptase may contribute to the fibrosis and inflammation characterizing endometriosis. METHOD OF STUDY: This is a pilot study of mast cell numbers and its activation in endometriosis biopsies (n = 10) by immunostaining for mast cell tryptase, corticotropin-releasing hormone (CRH) and urocortin (Ucn). RESULTS: This is the first report that tryptase positive mast cells were not only increased (64-157 mast cells/mm(2)) in human endometriosis, but also highly activated (89%) in areas strongly stained positive for CRH/Ucn. Normal endometrium was weakly positive for both CRH/Ucn. CONCLUSION: High numbers of activated mast cells are present in endometriosis sites that were strongly positive for CRH/Ucn. CRH and Ucn may activate mast cells and contribute to the fibrosis and inflammation in endometriosis.