Objective
We sought to investigate the incidence of hip and proximal lower extremity pain following transobturator midurethral sling and evaluate the association between pain and body mass index (BMI).
Study Design
This was a retrospective cohort study of all transobturator midurethral sling procedures from July 2008 through June 2009. The primary outcome was postoperative hip or proximal lower extremity pain.
Results
Four urogynecologists performed 226 procedures. The incidence of postoperative hip or proximal lower extremity pain was 15.5%. Women of normal BMI had a higher risk of developing pain than obese women (risk ratio, 2.51; 95% confidence interval, 1.01–6.22). While not statistically significant, overweight women were twice as likely as obese women to develop the primary outcome (risk ratio, 1.99; 95% confidence interval, 0.79–4.99).
Conclusion
Women of normal BMI have an increased risk of hip and proximal lower extremity pain following transobturator midurethral sling compared with obese women.
Suburethral slings are the most commonly performed surgical procedures for the treatment of stress urinary incontinence (SUI). The minimally invasive midurethral sling procedures offer the estimated 20% of women with SUI a high likelihood of surgical cure, with relatively little associated morbidity. Since the tension-free vaginal tape (TVT) procedure described by Ulmsten et al came into clinical practice in the mid-1990s, over 1 million women have undergone the procedure. Although minimally invasive, TVT is associated with complications, such as bowel and vascular injuries.
More recently, several midurethral sling modifications have been described in an effort to minimize morbidity associated with the retropubic approach. Perhaps the most widespread modification is the transobturator adaptation, in which passage of the tape is through the obturator foramen, rather than retropubically through the space of Retzius, thereby decreasing potential complications. Several transobturator systems are currently available, including both outside-in and inside-out techniques.
The transobturator approach has demonstrated a similar cure rate as the retropubic approach. While minimizing bladder and vascular injury, other risks remain with the transobturator approach, including mesh erosion, urinary retention, voiding dysfunction, abscess formation, pain, and neuropathy. The greater potential for injury leading to clinically significant pain or neuropathy remains one of the greatest concerns with the transobturator approach.
Lower extremity pain and neuropathies resulting from transobturator midurethral slings have not been thoroughly studied. In 1 study, Meschia et al reported a 5% incidence of thigh pain among 117 patients following the procedure. Laurikainen et al randomized women to traditional TVT and transobturator groups, and found a 16% incidence of groin pain among 131 patients undergoing transobturator sling. Boyles et al examined the national Manufacturer and User Facility Device Experience Database run by the Food and Drug Administration to investigate procedure complications. They reported 4 cases of neuropathy and 9 cases of pain, but given limitations of the database, incidence rates could not be calculated. A small number of case reports detail patients with postoperative pain severe enough to necessitate sling removal. While postoperative pain is a known potential complication of the transobturator midurethral sling procedures, little data exist to inform clinicians as to its incidence, severity, or risk factors.
Suburethral slings have been evaluated in patients with a wide range of body mass indexes (BMI) and found to be safe. A case-control study of women with BMI (kg/m 2 ) >40 and a retrospective cohort study of patients with BMI >35 both concluded TVT was safe with little, if any, influence on efficacy due to BMI. In contrast, Hellberg et al noted a significantly decreased cure rate in patients with BMI >35, but deemed it acceptable given the safety and simplicity of the procedure. Killingsworth et al conducted a prospective trial of TVT and found no differences in cure or complication rates based on BMI. However, there are no equivalent studies of transobturator midurethral slings. No evidence exists regarding the effect of BMI on the risk of postoperative lower extremity pain or other complications following transobturator slings. Clinical observations at our institution prompted our investigation into BMI as a possible risk factor for development of postoperative pain.
The primary objectives of our study were to investigate the incidence of hip and proximal lower extremity pain following transobturator midurethral sling procedures and to evaluate the association between pain and BMI. A secondary objective was to evaluate the association between BMI and sling failure.
Materials and Methods
We conducted a retrospective cohort study of all patients undergoing the TVT obturator (Ethicon Inc, Somerville, NJ) procedure at our institution from July 2008 through June 2009. Study approval was obtained from the Mount Auburn Hospital Institutional Review Board, Cambridge, MA. Charts were abstracted for demographic, preoperative, operative, and postoperative data, including potential risk factors for postoperative pain, such as age and operative time. The primary outcome was postoperative hip or proximal lower extremity (groin, thigh, leg, or inguinal) pain, and the exposure was BMI categorized as follows: underweight (<18.5), normal (18.5-24.9), overweight (25.0-29.9), and obese (≥30.0). Charts were reviewed for any documented postoperative pain reports at time of routine postoperative visit or in a documented telephone call. Subjective patient-reported lower extremity pain was the primary outcome. A secondary objective was to evaluate the association between BMI and patient-reported transobturator midurethral sling failure. Therefore, potential risk factors for sling failure, including parity and maximum urethral closure pressure on preoperative urodynamics, were also abstracted.
Data are presented as means with SD, medians with the interquartile range, or proportions. The t test, χ 2 , or Fisher’s exact test was used as appropriate. Log binomial regression was used to calculate risk ratios (RRs) and 95% confidence intervals (CIs) for the primary outcome. Logistic regression was used to calculate odds ratios and 95% CI for sling failure to use Firth estimation to deal with the absence of events in the normal-weight group. Models were adjusted for preoperative variables that were associated with both the exposure and outcome. P values < .05 were considered statistically significant.