Study: Pubic Bone Stabilization Slings Don't Cause Osteomyelitis

ST. LOUIS – Treatment of urinary incontinence by means of a pubic bone stabilization sling – a suburethral sling that is anchored to the pubic bone using titanium screws – is highly effective and is not associated with an increased risk of osteomyelitis, according to findings from the largest prospective observational study to date.

Although concerns that the procedure could cause osseous complications have been circulating for years and have discouraged some surgeons from using the pubic bone stabilization sling, only 1 case occurred in the 2,331 patients in the study, for an incidence of 0.000043%, Dr. S. Robert Kovac reported at the 19th International Pelvic Reconstructive and Vaginal Surgery Conference, which was sponsored by the Society of Pelvic Reconstructive Surgeons.

Patients were treated for intrinsic sphincter dysfunction (ISD) and/or stress urinary incontinence (SUI), and were followed for a mean of 13 years, and up to 17 years at four different institutions, said Dr. Kovac, the John D. Thompson Distinguished Professor of Gynecologic Surgery and director of the center for pelvic reconstructive surgery and urogynecology at Emory University, Atlanta. His associates are Dr. P.D. Dietz, Dr. M. Muniz, and Dr. S.H. Cruikshank.

Follow-up was done by exams, questionnaires, and telephone conversations.

The cure rate for those with ISD and/or SUI who had total dryness was 92%.

In a prospective study published in 2004, the incidence of osteomyelitis was 0.08% in 1,228 patients who underwent transvaginal bone anchor fixation in female pelvic reconstructive surgery, Dr. Kovac noted (Urology 2004; 64:669-74).

By comparison, abdominal sacrocolpopexy is associated with an osteomyelitis incidence of 11%, according to reports in the literature, Dr. Kovac said.

“I think we got off on the wrong track,” he said of the unfounded fears regarding osteomyelitis in patients undergoing pubic bone stabilization (PBS) sling procedures.

Dr. Kovac, who developed the PBS sling procedure more than 20 years ago, said that more than 350,000 have been performed worldwide, and that in all that time he hasn’t seen a single case of osteomyelitis or osteitis pubis in any of his patients who underwent the procedure.

Furthermore, the PBS sling has the lowest complication rate and the best long-term outcomes of the various suburethral slings currently used for urinary incontinence, he said.

Currently, the procedure is performed transvaginally by placing a suburethral sling of Biodesign Surgisis over the midurethra, and securing it with titanium bone screws to the posterior-inferior pubis to restore proper anatomy for continence.

In addition to the high cure rate and low complication rate, the approach has several other advantages, Dr. Kovac said, including the following:

• It is a totally vaginal, unified approach; all defects can be treated during one procedure.

• There is efficacy for both urethral hypermobility and ISD-related SUI.

• It functions as a retropubic procedure, a vaginal Marshall-Marchetti-Krantz (MMK) operation without the need for an abdominal incision.

• It is easy to learn and teach.

• There is low or no pain.

• There is rapid return to normal voiding postoperatively.

• There is no need for blindly placed trocars.

• Surgical time is less than 30 minutes.

• There is no need for mesh, so there are no mesh-related complications.

• There is no voiding dysfunction; it is truly tension free.

The procedure also has little reliance on cystoscopy, although Dr. Kovac said that he recommends cystoscoping all patients to avoid potential bladder-related hazards.

Dr. Kovac disclosed that he is a consultant for Cook Medical Inc. and Ethicon-Endo Surgery Inc., but he sold his patent on the PBS sling to American Medical Systems and has no financial interest in the procedure.

ST. LOUIS – Treatment of urinary incontinence by means of a pubic bone stabilization sling – a suburethral sling that is anchored to the pubic bone using titanium screws – is highly effective and is not associated with an increased risk of osteomyelitis, according to findings from the largest prospective observational study to date.

Although concerns that the procedure could cause osseous complications have been circulating for years and have discouraged some surgeons from using the pubic bone stabilization sling, only 1 case occurred in the 2,331 patients in the study, for an incidence of 0.000043%, Dr. S. Robert Kovac reported at the 19th International Pelvic Reconstructive and Vaginal Surgery Conference, which was sponsored by the Society of Pelvic Reconstructive Surgeons.

Patients were treated for intrinsic sphincter dysfunction (ISD) and/or stress urinary incontinence (SUI), and were followed for a mean of 13 years, and up to 17 years at four different institutions, said Dr. Kovac, the John D. Thompson Distinguished Professor of Gynecologic Surgery and director of the center for pelvic reconstructive surgery and urogynecology at Emory University, Atlanta. His associates are Dr. P.D. Dietz, Dr. M. Muniz, and Dr. S.H. Cruikshank.

Follow-up was done by exams, questionnaires, and telephone conversations.

The cure rate for those with ISD and/or SUI who had total dryness was 92%.

In a prospective study published in 2004, the incidence of osteomyelitis was 0.08% in 1,228 patients who underwent transvaginal bone anchor fixation in female pelvic reconstructive surgery, Dr. Kovac noted (Urology 2004; 64:669-74).

By comparison, abdominal sacrocolpopexy is associated with an osteomyelitis incidence of 11%, according to reports in the literature, Dr. Kovac said.

“I think we got off on the wrong track,” he said of the unfounded fears regarding osteomyelitis in patients undergoing pubic bone stabilization (PBS) sling procedures.

Dr. Kovac, who developed the PBS sling procedure more than 20 years ago, said that more than 350,000 have been performed worldwide, and that in all that time he hasn’t seen a single case of osteomyelitis or osteitis pubis in any of his patients who underwent the procedure.

Furthermore, the PBS sling has the lowest complication rate and the best long-term outcomes of the various suburethral slings currently used for urinary incontinence, he said.

Currently, the procedure is performed transvaginally by placing a suburethral sling of Biodesign Surgisis over the midurethra, and securing it with titanium bone screws to the posterior-inferior pubis to restore proper anatomy for continence.

In addition to the high cure rate and low complication rate, the approach has several other advantages, Dr. Kovac said, including the following:

• It is a totally vaginal, unified approach; all defects can be treated during one procedure.

• There is efficacy for both urethral hypermobility and ISD-related SUI.

• It functions as a retropubic procedure, a vaginal Marshall-Marchetti-Krantz (MMK) operation without the need for an abdominal incision.

• It is easy to learn and teach.

• There is low or no pain.

• There is rapid return to normal voiding postoperatively.

• There is no need for blindly placed trocars.

• Surgical time is less than 30 minutes.

• There is no need for mesh, so there are no mesh-related complications.

• There is no voiding dysfunction; it is truly tension free.

The procedure also has little reliance on cystoscopy, although Dr. Kovac said that he recommends cystoscoping all patients to avoid potential bladder-related hazards.

Dr. Kovac disclosed that he is a consultant for Cook Medical Inc. and Ethicon-Endo Surgery Inc., but he sold his patent on the PBS sling to American Medical Systems and has no financial interest in the procedure.

ST. LOUIS – Treatment of urinary incontinence by means of a pubic bone stabilization sling – a suburethral sling that is anchored to the pubic bone using titanium screws – is highly effective and is not associated with an increased risk of osteomyelitis, according to findings from the largest prospective observational study to date.

Although concerns that the procedure could cause osseous complications have been circulating for years and have discouraged some surgeons from using the pubic bone stabilization sling, only 1 case occurred in the 2,331 patients in the study, for an incidence of 0.000043%, Dr. S. Robert Kovac reported at the 19th International Pelvic Reconstructive and Vaginal Surgery Conference, which was sponsored by the Society of Pelvic Reconstructive Surgeons.

Patients were treated for intrinsic sphincter dysfunction (ISD) and/or stress urinary incontinence (SUI), and were followed for a mean of 13 years, and up to 17 years at four different institutions, said Dr. Kovac, the John D. Thompson Distinguished Professor of Gynecologic Surgery and director of the center for pelvic reconstructive surgery and urogynecology at Emory University, Atlanta. His associates are Dr. P.D. Dietz, Dr. M. Muniz, and Dr. S.H. Cruikshank.

Follow-up was done by exams, questionnaires, and telephone conversations.

The cure rate for those with ISD and/or SUI who had total dryness was 92%.

In a prospective study published in 2004, the incidence of osteomyelitis was 0.08% in 1,228 patients who underwent transvaginal bone anchor fixation in female pelvic reconstructive surgery, Dr. Kovac noted (Urology 2004; 64:669-74).

By comparison, abdominal sacrocolpopexy is associated with an osteomyelitis incidence of 11%, according to reports in the literature, Dr. Kovac said.

“I think we got off on the wrong track,” he said of the unfounded fears regarding osteomyelitis in patients undergoing pubic bone stabilization (PBS) sling procedures.

Dr. Kovac, who developed the PBS sling procedure more than 20 years ago, said that more than 350,000 have been performed worldwide, and that in all that time he hasn’t seen a single case of osteomyelitis or osteitis pubis in any of his patients who underwent the procedure.

Furthermore, the PBS sling has the lowest complication rate and the best long-term outcomes of the various suburethral slings currently used for urinary incontinence, he said.

Currently, the procedure is performed transvaginally by placing a suburethral sling of Biodesign Surgisis over the midurethra, and securing it with titanium bone screws to the posterior-inferior pubis to restore proper anatomy for continence.

In addition to the high cure rate and low complication rate, the approach has several other advantages, Dr. Kovac said, including the following:

• It is a totally vaginal, unified approach; all defects can be treated during one procedure.

• There is efficacy for both urethral hypermobility and ISD-related SUI.

• It functions as a retropubic procedure, a vaginal Marshall-Marchetti-Krantz (MMK) operation without the need for an abdominal incision.

• It is easy to learn and teach.

• There is low or no pain.

• There is rapid return to normal voiding postoperatively.

• There is no need for blindly placed trocars.

• Surgical time is less than 30 minutes.

• There is no need for mesh, so there are no mesh-related complications.

• There is no voiding dysfunction; it is truly tension free.

The procedure also has little reliance on cystoscopy, although Dr. Kovac said that he recommends cystoscoping all patients to avoid potential bladder-related hazards.

Dr. Kovac disclosed that he is a consultant for Cook Medical Inc. and Ethicon-Endo Surgery Inc., but he sold his patent on the PBS sling to American Medical Systems and has no financial interest in the procedure.