pubic bone anchors.
Methods. The target population consisted of 290 consecutive women who underwent bladder neck
suspension using suprapubic bone anchors between June 1994 and November 1999 at two referral centers.
A structured telephone questionnaire was designed to elicit any history of clinical symptoms suspicious for
pubic osteomyelitis. Positive responses were followed up by a detailed review of the medical records.
Nonresponders were evaluated by chart review, with negative cases included only if the documented
follow-up reached 1 year.
Results. The sample consisted of 225 women, representing 77.6% of the study population, with a mean age
of 69.7 years (range 40 to 88) and a mean follow-up of 31.8 months (range 13.4 to 42.2). Of the 225
women, 179 (80%) completed the telephone survey; 46 patients (20%) were evaluated by long-term chart
review. Three patients (1.3%) reported positive responses to the screening questionnaire and were con-
firmed to have developed pubic osteomyelitis. Each had undergone exploratory laparotomy, anchor re-
moval, bony debridement, and prolonged parenteral antibiosis. The most common noninfectious complaints
were irritative voiding symptoms and pubic or groin pain responding to "conservative" therapy (3.5%),
including 1 case of osteitis pubis. One subject underwent repeated operation because of erosion of the sling
sutures into the bladder.
Conclusions. The estimated incidence of osteomyelitis after bone-anchored bladder neck suspension was
1.3%. Although postoperative osteomyelitis is rare, each case incurs substantial morbidity and a compli-
cated postoperative course. UROLOGY 63: 704–708, 2004. 2004 Elsevier Inc.
Pubic bone anchors have been available as an abandon their use. The morbidity associated with
adjunct in urinary incontinence surgery since pubic osteomyelitis after bone anchoring has been 1992. Using a relatively small surgical dissection, well however, its incidence after pu- bone anchors can provide a stable, fixed point for bic bone anchor placement during female pelvic suture attachment. Advocates of this technology reconstructive surgery has not been established.
cite, in addition, the possibility of a reduced oper- We undertook this retrospective study to deter- ative time compared with traditional anchoring mine the incidence of postoperative pubic osteo- techniques. Despite these technical attributes of myelitis within a large cohort of women who un- bone anchors, others have criticized the lack of scientific evidence establishing their efficacy and incontinence using bone anchors.
More specifically, concern over postopera-tive pubic osteomyelitis has led some surgeons to MATERIAL AND METHODS
From the Evanston Continence Center, Northwestern University The study population included all 290 consecutive patients Medical School, Evanston, Illinois; and Division of Urology, undergoing bladder neck suspension using suprapubic bone Cleveland Clinic Foundation, Cleveland, Ohio anchors, by one of four attending surgeons, between June Reprint requests: Roger P. Goldberg, M.D., M.P.H., Evanston 1994 and November 1999. Bone anchor procedures were Continence Center, Northwestern University Medical School, identified through a manual review of the case lists encom- 1000 Central Avenue, Suite 730, Evanston, IL 60201 passing the defined study period. Of the 290 patients, 171 Submitted: November 19, 2002, accepted (with revisions): women underwent surgery at the Cleveland Clinic and 119 November 5, 2003 women at the Evanston Continence Center.
review data were retrieved from postoperative progress notes TABLE I. Telephone questionnaire
and visual analog symptom questionnaires quantifying pelvicand pubic pain symptoms, which had been completed by the 1. Since your incontinence operation, have you had any patients at each office visit. Patients with a postoperative fol- problems or complications? low-up of less than 1 year were excluded from the final prev- 2. Have you been hospitalized, or treated at any alence calculation, because although no cases suspicious for medical facility, since the placement of your bone osteomyelitis were found, the possibility of delayed presenta- tion could not be excluded.
3. Have you received antibiotics, or other medications, since the surgery? 4. Have you undergone any radiology testing, as a result of pelvic discomfort or fevers? 5. Do you have pain in your lower abdomen, groin, hip, The review of the operative records revealed 171 thigh, or pelvis? Did you have this kind of pain at consecutive bone anchor procedures at the Cleve- some point after your surgery? land Clinic from 1994 to 1999 and 119 cases at the 6. Do you have difficulty walking? Evanston Continence Center. The overall study 7. Is there any drainage, redness, or tenderness in the population consisted of 290 subjects. The cohort area where the bone anchors were placed? was characterized by a mean age of 69.7 years(range 40 to 88) and a mean parity of 2.8 (range 0to 9). Fifty-six percent were postmenopausal and Bone anchor operations included the modified 43% were using hormonal replacement therapy. A Pereyra with Mitek GII anchors, in situ sling, vaginal wall substantial number of previous reconstructive sur- sling, and fascial patch sling procedures. Depending on the gical procedures had been performed in these specific incontinence operation performed, either a singletransverse midline incision or two separate suprapubic inci- women, reflecting the referral practice settings at sions (2.5 cm) to each side of the midline were used. Mono- each institution. These included prior hysterec- filament nonabsorbable sutures were used for the bone an- tomy (33%), retropubic urethropexy (7.5%), nee- choring procedure in all cases. The suture ends were attached dle suspension (2.5%), suburethral sling proce- to the bone anchors and anchored into the pubic rami bilater- dure (0.8%), and colporrhaphy (14%). At the time ally, 1 cm lateral to the midline on each side, at the level of thepubic tubercle. One of several commercially available devices of the stress incontinence operation, concomitant (Microvasive, Mitek, AMS) was used to either drill or press the procedures included vaginal hysterectomy (13%), anchor into the cortex of the pubic symphysis at its superior anterior (51%) and posterior (46%) colporrhaphy, portion, with metallic "shoulders" preventing the anchor from sacrospinous vault suspension (35%), enterocele penetrating too deeply into the bone. Suture arms were passed repair (38%), and McCall culdoplasty (5%).
into the vagina, using Vesica suture passers or Pereyra needles.
They were fastened to either autologous rectus fascia (fascial Of the 225 women in the final study sample, 179 patch sling) or the vaginal wall (Vesica, Pereyra, vaginal wall (80%) completed the telephone survey; 46 patients sling). The free suture ends were then brought back into the (20%) were evaluated by long-term chart review retropubic space and through the suprapubic incision using only, with progress notes or visual analog ques- one of these specialized needles.
tionnaires available for review at a mean interval of In every case, the pubic area was shaved and prepared with povidone-iodine. The abdominal and vaginal operative areas 19.5 months. Forty-five of these individuals were were considered individual sterile fields. The patients received unreachable by telephone or had died. One patient broad-spectrum intravenous antibiotics perioperatively, con- declined interview; her chart review up to 18 sisting of either a first-generation cephalosporin or multiagent months revealed no infectious complications.
therapy with gentamicin and clindamycin or vancomycin. Su- The mean follow-up was 31.8 months (range prapubic incisions were irrigated with an antibiotic (Bacitra-cin) solution after bone anchor placement and again just be- 13.4 to 42.2). One or more positive survey re- fore closure. Oral cephalosporin was continued for a period of sponses were observed for 6.7% of the sample.
at least 5 days postoperatively. To decrease the risk of contam- Three patients (1.3%) reported positive responses ination, care was taken to keep the sutures completely away to the screening questionnaire and were confirmed from the vaginal field until the time of fixation to the vaginal to have developed pubic osteomyelitis. Each of epithelium or sling material.
The structured telephone questionnaire used for these individuals had undergone exploratory lapa- long-term follow-up consisted of seven open-ended questions rotomy, anchor removal, bony debridement, and intended to elicit clinical evidence of possible pelvic infection.
prolonged parenteral antibiosis. Intraoperative The questions were designed to maximize sensitivity and to cultures for all cases revealed polymicrobial, mixed detect all cases suspicious for previously treated or ongoing aerobic, and anaerobic flora.
osteomyelitis. Urogynecology or female urology fellows, whohad no direct participation in the initial surgical procedures, The first patient with pubic osteomyelitis had a conducted the telephone interviews. Patients were instructed history of renal transplant 6 years prior and was to report both immediate and delayed symptoms and any post- taking chronic immunosuppressive agents (cyclo- operative medical attention or treatment, regardless of where sporine, Imuran, and Florinef). Her medical his- it was received. Any positive questions were followed up with tory was also notable for insulin-dependent diabe- additional patient interview and a review of the hospital andoffice records. For patients unreachable by telephone after tes mellitus. Her pelvic reconstructive surgery multiple attempts, chart reviews were conducted. The chart included an in situ sling with drill-in pubic bone UROLOGY 63 (4), 2004
anchors. Three weeks after surgery, the patient de- cause of erosion of the sling sutures into the blad- veloped low-grade fevers accompanied by pain in der, diagnosed 12 months after the initial surgery.
her left pelvic area with radiation to the hip. Pubic The fourth patient was diagnosed with osteitis pu- bone tenderness was notable on examination. Nu- bis, 6 weeks postoperatively. Her treatment had clear bone scanning showed increased uptake sug- included oral cephalosporin and a nonsteroidal an- gestive of pubic osteomyelitis. Computed tomog- ti-inflammatory medication for 2 weeks, and she raphy revealed soft-tissue inflammation without reported no residual pain symptoms at the time of other specific findings. The patient underwent sur- her study participation. The inclusion of the first, gical exploration 12 weeks after the initial surgery.
second, and fourth patients resulted in a 1.3% rate Both bone anchors had dislodged, and extensive of adverse postoperative symptoms not consistent periosteal debridement was performed.
with osteomyelitis. The remaining individuals re- The second osteomyelitis case involved a 70- ported self-limited pain that appeared consistent year-old woman undergoing vaginal wall sling us- with a normal postoperative recovery, resolving ing drill-in pubic bone anchors, performed for the within 3 to 6 months.
indication of four-degree cystocele and potentialgenuine stress incontinence. She had no known underlying medical conditions increasing herbaseline risk of infection. Three weeks after sur- Concern over osteomyelitis after the use of pubic gery, she developed right groin pain, without asso- bone anchors stems from several theoretical risk ciated fever, erythema, or constitutional symp- factors for infection. Trauma and ischemia are in- toms. Four weeks postoperatively, nontender curred as the anchor is drilled or pressed into the warmth and erythema was appreciable in the su- bony cortex and the surgical area is devascularized.
prapubic region. Plain radiography revealed The presence of a foreign body presents another marked irregularity with fragmentation of the in- risk, because titanium and monofilament suture ferior pubic ramus. Computed tomography re- materials are placed into and around the bone. Fi- vealed no specific findings suggestive of osteomy- nally, the possibility of transvaginal bacterial mi- elitis. Radiolabeled leukocyte scanning showed gration along the suture into its bony insertion— increased leukocyte accumulation near the mid- particularly when the anterior vaginal wall is line, but no definite bony involvement. Surgical traversed by suture material— creates an opportu- exploration was notable for detached bone an- nity for vaginal flora to infect the retropubic space.
chors; foreign body removal and debridement was In 1977, Osborne and reported that the use of sterile scrubbing fails to sterilize the vagina The third case was notable for delayed presenta- fully, resulting in a clean, but not sterile, retropu- tion of pubic bone tenderness, at 4 months after bic field during these procedures.
modified Pereyra bladder neck suspension using Several case series have been reported on bone drill-in bone anchors. The patient's medical history anchors, reporting no or very few cases of osteo- was notable for chronic corticosteroid use for os- myelitis. None, however, were designed to deter- teoarthritis. Physical examination revealed a large, mine specifically the incidence of osteomyelitis or tender suprapubic mass, with overlying erythema.
infectious complications. reported no Computed tomography and nuclear bone scans complications using Mitek anchors in 53 women.
were both suggestive of bony involvement. Her Rare cases of suprapubic infections occurred surgical treatment included drainage of the supra- among 150 subjects in the initial series using the pubic abscess and wide debridement of the pubic Vesica however, these cases were re- periosteum. The right-sided bone anchor was ported to have resolved with oral antibiotic therapy found floating in the abscess cavity.
alone, arguing against bony involvement. Between Other postoperative symptoms were encoun- 1994 and 1999, numerous case series have been tered during the survey process. The most com- published on the and anchors, mon clinical complaints elicited by the survey were accompanying both needle suspension and sub- irritative voiding symptoms and persistence of urethral sling procedures. reported 2 chronic symptoms unrelated to the pelvic opera- cases of osteomyelitis among 71 subjects in 1997 tion (osteoarthritis, low back pain, hip discom- and none among 118 women who underwent fort). Pubic or groin pain resolving without surgi- bone-anchored suburethral sling procedures.
cal intervention and responding to "conservative" Schultheiss et recorded 1 case among 37 pro- therapy was reported by 8 women (3.5% of the cedures in 1998. Larger case series involving study sample), with the most significant as follows.
press-in bone anchoring systems have reported no One patient had persistent difficulty with bending.
cases of osteomyelitis in several case series, with Another patient reported pain with walking. The varying lengths of follow-up and no systematic third patient underwent repeated operation be- Rackley et estimated an osteo- UROLOGY 63 (4), 2004
myelitis rate on the basis of the case series pub- lead to ischemic necrosis of bone and lysis owing to lished from 1990 to 2000. After suprapubic bone phagocyte activity. As pus spreads into the vascular anchor placement, as determined by pooled statis- channels, intraosseous pressure may increase, tics, this estimated rate was 0.6%, and no statisti- leading to further impairment of blood flow and cally significant difference was found between the more ischemic changes. Histologically, with transvaginal and suprapubic routes. None of these chronic osteomyelitis, osteocytes are replaced by previous studies incorporated a uniform survey necrotic bone, and organisms are absent.
tool to screen for osteomyelitis systematically.
Early diagnosis and the initiation of antibiotic The present study design involved interviewing therapy are important to prevent necrosis; in most patients using a structured questionnaire designed cases, this will require a combination of diagnostic to capture any postoperative complications regard- modalities. Gram stain or culture of the abscess less of where or when they were treated. This may help to establish pathogenicity but cannot dif- method was intended to minimize the potential for ferentiate between soft-tissue and bony involve- bias resulting from patients seeking care at other ment. Most cases of osteomyelitis associated with facilities—a factor that may result in underestima- the female genital tract are polymicrobial, mixed tion of the true incidence of postoperative compli- aerobic, and anaerobic. The erythrocyte sedimen- cations. The population was derived from two tation rate and C-reactive protein levels should be training centers for these procedures to increase elevated with active disease, even in the absence of the sample size and to reduce the confounding ef- leukocytosis or constitutional symptoms. Because fect of operator inexperience. Potential limitations plain radiographs are not sensitive, advanced ra- of our study design should be considered, includ- diologic techniques may be required. Technetium ing 22% of the target population who were un- radionuclide scans are typically positive within 24 reachable and without adequate data for review— hours of symptom onset; as a mirror of osteoblast introducing the potential for response or "healthy activity, this test provides adequate sensitivity, volunteer" bias and underestimation of symptom but poor specificity, for diagnosing osteomyelitis.
prevalence. Our use of chart reviews might have Gallium-citrate and indium-labeled leukocyte or reduced, but could not fully eliminate, this effect.
immunoglobin scans can help differentiate osteo- Patients declining participation in the survey myelitis from fractures, tumors, or infarction. Ultra- might have been cared for at other institutions.
sonography may reveal occasional periosteal fluid Furthermore, the retrospective study design might collections, periosteal thickening, or abscesses in theoretically have introduced recall bias, although soft tissue near bone. Computed tomography will re- the typical severity of osteomyelitis-related symp- veal soft-tissue involvement more reliably than bony toms should have served to increase the accuracy involvement. Computed tomography-guided needle of event recall.
aspiration or biopsy may play a useful role for estab- The pubic osteomyelitis cases occurring within lishing the diagnosis. Magnetic resonance imaging this cohort illustrate, foremost, the potential for has equal sensitivity to bone scanning. In general, delayed presentation and also the difficulty of es- the role of diagnostic imaging in chronic osteomyeli- tablishing the diagnosis on the basis of nonspecific tis is to confirm the presence of active infection and early symptoms. The presence of these overlapping to delineate the extent of debridement necessary to and nonspecific symptoms can lead to a delayed remove necrotic bone and abnormal soft tissue com- diagnosis of early osteomyelitis because pain, fe- ver, and inflammatory signs may be attributed to Even when promptly diagnosed, the treatment of soft-tissue infection or surgical healing. Both oste- osteomyelitis centers on surgical exploration, re- itis pubis and osteomyelitis may be characterized moval of all foreign bodies, and debridement, fol- by the absence of fever, symmetric bony destruc- lowed by parenteral antibiotic therapy for 4 to 6 tion of the symphysis, pelvic pain and gait distur- weeks. The prolonged intravenous antibiotic ther- bances, a delayed onset of symptoms, and failure to apy is necessitated, in part, by the tendency of bac- improve with antibiotics alone. Although osteitis teria to escape host defenses by adhering tightly to pubis results in bony destruction of the margins of damaged bone and coating themselves and under- the symphysis, in contrast to osteomyelitis, it is lying surfaces with a protective polysaccharide- treated with rest, physical therapy, and nonsteroi- rich biofilm. Few data support the use of oral anti- dal anti-inflammatory medications. Some investi- gators have suggested that early cases of osteomy-elitis may be misdiagnosed as osteitis pubis, leading to an underestimation of infectious risk.
An indolent infection may only become apparent On the basis of this retrospective evaluation of a weeks later, when a sinus tract develops or a sur- large surgical cohort, the estimated incidence of gical wound breaks down. Chronic infection may osteomyelitis after bone-anchored bladder neck UROLOGY 63 (4), 2004
suspension is 1.3%. An additional 1.3% of women 9. Benderev TV: A modified percutaneous outpatient reported adverse postoperative symptoms that bladder neck suspension system. J Urol 152(6 Pt 2): 2316 –
were not consistent with osteomyelitis. Although 10. Leach GE: Local anesthesia for urologic procedures.
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curs substantial morbidity and a complicated post- 11. Leach GE, and Appell R: Percutaneous bladder neck operative course. Early recognition of retropubic suspension. Urol Clin North Am 23: 511–516, 1996.
abscesses, wound hematomas, unexplained consti- 12. Hom D, Desautel MG, Lumerman JH, et al: Pubovaginal tutional symptoms, or atypical pain, tenderness, or sling using polypropylene mesh and Vesica bone anchors.
Adult Urol 51: 708 –713, 1998.
gait disturbance should trigger an aggressive diag- 13. Nativ O, Levine S, Madjar S, et al: Incisionless per vag- nostic approach.
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2. Enzler M, Agins HJ, Kogan M, et al: Osteomyelitis of the 15. Schultheiss D, Hofner K, Oelke M, et al: Does bone pubis following suspension of the bladder neck with bone anchor fixation improve the outcome of percutaneous bladder anchors. J Bone Joint Surg 81: 1736 –1740, 1999.
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UROLOGY 63 (4), 2004


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