INCIDENCE OF PUBIC OSTEOMYELITIS AFTER BLADDER
NECK SUSPENSION USING BONE ANCHORS
ROGER P. GOLDBERG, MARIE BLANCHE TCHETGEN, PETER K. SAND, SUMANA KODURI,
RAYMOND RACKLEY, RODNEY APPELL, AND PATRICK J. CULLIGAN
To determine the incidence of pubic osteomyelitis after bladder neck suspension using supra-
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.
ubic 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.
2004 ELSEVIER INC.
ALL RIGHTS RESERVED
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
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UROLOGY 63 (4), 2004
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