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The Use of Biomaterials in Incontinence Surgery
European Urology Supplements
European Urology Supplements 1 (2002) 12±16
The Use of Biomaterials in Incontinence Surgery Bart Bemelmans* Unit for Functional Urology, University Medical Center, Nijmegen, The Netherlands
Abstract Introduction: We describe a minimally-invasive surgical technique using a naturally-derived porcine dermal collagen (PelvicolTM Implant) that can be used in the treatment of all types of urinary stress incontinence and does not rely on permanent sutures. Patients and Methods: Sling procedures using the PelvicolTM Implant were carried out in 27 patients (age range 31± 76 years; average 52 years) with genuine stress incontinence over a 12-month period. Patients had primary genuine stress urinary incontinence (SUI) (n 14), and mixed SUI complicated by complaints of urgency or frequency and a previous history of surgery (n 13). Detrusor instability was ruled out in all patients via cystometry, and patients were followed up for a minimum period of 6 months. Results: In patients with genuine SUI, 86% of patients remained dry. In patients with mixed SUI, a small number of retentions and de novo urgencies were observed and 62% of patients remained dry. The mean time to insert the sling was 20 minutes and mean operation time was 45 minutes. There were no serious bleeds or infections. Three bladder perforations occurred, but the slings were repositioned with no further problems. Conclusions: This new surgical procedure can be used either as a tension-free sling in Type II patients or as a classical sling in complicated Type III incontinence patients. It is easy to teach and perform, it is fast and costeffective, and it provides a good alternative to TVT. # 2002 Elsevier Science B.V. All rights reserved. Keywords: Stress urinary incontinence; SUI; Type II; Type III; Porcine dermal collagen; PelvicolTM Implant 1. Introduction When undertaking surgery for stress incontinence it is necessary to choose the procedure that is most appropriate to the patient's condition. Patients can be subdivided into those with `bad sphincters', i.e. Type III urinary stress incontinence (intrinsic sphincter de®ciency, ISD) and those with 'good sphincters', i.e. Type II genuine stress incontinence (hypermobile urethra). Different surgical procedures are required for each type of incontinence. The Burch colposuspension technique is classically used in the surgical treatment of patients with Type II incontinence. The tension-free vaginal sling or TVT is ideally suited to patients with primary stress urinary incontinence (SUI) who have simple, genuine stress * Tel. 31-24-361 6712. E-mail address: [email protected] (B. Bemelmans).
incontinence, no complaints of overactive bladder or detrusor instability, and have had no prior surgery. TVT is not recommended for use in repeat surgical procedures, complicated cases, or for patients with ISD (Type III incontinence). A classical tight sling is recommended for patients with Type III incontinence, despite the risk of urinary retention. This technique is ideally suited to those patients who have had multiple operations and who have had only minor or no prolapse who present with a low maximum urethral closure pressure (MUCP < 20 cm H2O) and Valsalva leak point pressure (VLPP < 60 cm H2O). In such cases it is necessary to prove the existence of severe stress incontinence. There is some doubt as to whether TVT can be used in Type III incontinence, and these patients would normally rely on a classical sling operation. A key advantage of the acellular dermal collagen PelvicolTM Implant is that it allows the sling procedure to be carried out in either a tension-free fashion
1569-9056/02/$ ± see front matter # 2002 Elsevier Science B.V. All rights reserved. PII: S 1 5 6 9 - 9 0 5 6 ( 0 2 ) 0 0 1 4 8 - 3
B. Bemelmans / European Urology Supplements 1 (2002) 12±16
or a tight fashion, and therefore it can be used to treat patients with either Type II or III stress incontinence. This paper will present a simple surgical technique and a surgical material (PelvicolTM Implant) that can be successfully applied to any type of stress incontinence. 2. Sling procedures in the treatment of female stress incontinence Sling procedures have been used for almost a century in the treatment of female urinary incontinence. Surgeons need sling materials that are chemically inert, non-allergenic, not liable to become infected, resistant to mechanical stress (a tight sling requires a strong sling), able to be sterilised, not physical modi®ed by body tissues, non-carcinogenic (particularly applicable to younger patients in whom the material will be implanted long-term), and which are both convenient and affordable. 2.1. Synthetic slings Synthetic slings have been used for many years in the treatment of stress incontinence and have shown approximately comparable success rates in the order of 70% (Table 1). However, concerns regarding the long-term safety of synthetic materials have arisen because of the risk of urethral erosions and infections (Table 1). Silicone sling material was withdrawn from the market due to severe erosion problems, and the polyester sling material (ProteGen1) was recalled in January 1999. The number of wound infections and erosions seen with Te¯on is high, and it is therefore recommended that patients should be warned of this complication rate and told that graft removal may be necessary [1]. Erosion is also seen with Gore-Tex1, and the high rejection rate dictates that caution be exercised when using Gore-Tex1 in stress incontinence. Table 1 Clinical trials evaluating the use of synthetic biomaterials in pubovaginal sling procedures for the surgical treatment of stress incontinence Material
Success rate (%) Complications
Polytetra¯uoroethylene (PTFE; Te¯on1)
61 72
Wound infection (40%) [1] Erosion/retention (15%) [5]
Expanded PTFE (Gore-Tex1)
87 65
Erosion (4%) [6] Rejection (around 30%) [7]
Silicone Polyester (ProteGen1) Prolene1 (TVT)
Terminated Recalled 87
Erosion [8] Erosion/infection [9] de novo detrusor instability (6%) [10]
13
2.2. Bio-compatible sling (PelvicolTM Implant) Porcine dermal slings have shown promising results in the surgical treatment of stress incontinence [2]. PelvicolTM Implant was developed by scientists at Dundee University with the aim of producing a permanent biological implant that is compatible with human tissue [3]. PelvicolTM Implant is a ®brous, acellular, cross-linked porcine dermal collagen that is non-allergenic, non-toxic and does not elicit a foreign body response [3]. It is completely free of remnants of DNA and entirely free of foot and mouth disease [4]. Once implanted into human tissue, the implant is a biocompatible, sterile and strong biological matrix that is permanently incorporated into the host tissue [3]. In this respect, PelvicolTM Implant ful®ls many of the characteristics of the ideal sling material. 3. Bio-compatible sling in the surgical treatment of stress incontinence Described here is a minimally-invasive surgical technique using a naturally-derived porcine dermal collagen (PelvicolTM Implant) that can be used in the treatment of all types of urinary stress incontinence and does not rely on permanent sutures. 3.1. Patients Sling procedures using the PelvicolTM Implant were carried out in 27 patients (age range 31±76 years; average 52 years) with genuine stress incontinence over a 12-month period. Patients had primary genuine SUI (n 14), and mixed SUI complicated by complaints of urgency or frequency and a previous history of surgery (n 13). Detrusor instability was ruled out in all patients via cystometry, and patients were followed up for a minimum period of 6 months. 3.2. Surgical technique Although PelvicolTM Implant comes ready to use `off the shelf' (Fig. 1), it was soaked in antibiotic solution as an added precaution against infection. A 12 2 cm length of PelvicolTM Implant was sutured with PDS resorbable sutures. Following a thorough vaginal lavage, the bladder was drained completely and a tiny suprapubic incision made. A small midline incision of the vaginal wall was then made, followed by lateral dissection with scissors (Fig. 2a). These steps took no longer than a few minutes. The surgeon's ®nger was then inserted into the retropubic space (Fig. 2b) and an instrument was passed down through the suprapubic incision to make contact with the ®nger (Fig. 2c).
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B. Bemelmans / European Urology Supplements 1 (2002) 12±16
Fig. 1. Illustration of a PelvicolTM Implant (slide 1).
An instrument with a tunnel wider than that of a Stamey needle was used in order to accommodate the sling. The sling was then passed through the vaginal space, and the PDS suture was pulled so that the sling came out retropubically. The second suture was then pulled through the suprapubic region by the clamp. The surgeon held the sling in place (Fig. 2d) while the assistant manipulated the suture strings to perfectly position the sling midurethrally (Fig. 3), just as it is positioned in the TVT procedure. A vicryl suture was used to stitch the sling to the periurethral tissue to ensure that it could not slip to the bladder neck (where it has potential to cause irritation) (Fig. 4). At the end of the operation the vaginal incision was closed, and the PDS sutures were knotted over the rectus sheath. At this stage the use of a suprapubic catheter was optional. The suprapubic skin incision was then closed, and a vaginal tampon with betadine was inserted to ensure decontamination of the operative ®eld and prevent vaginal haematoma.
Fig. 2. (a) Illustration of lateral section being made with scissors; (b) insert ®nger into the retropubic space; (c) pass instrument down through suprapubic incision; (d) the sling is held in place.
3.3. Results In patients with genuine SUI the success rate of the procedure was extremely high, with 86% of patients remaining dry. The outcome was more complicated in patients with mixed SUI: a small number of retentions and de novo urgencies were observed and 62% of patients remained dry. The mean operation time was 45 minutes, but the mean time reported to insert the
B. Bemelmans / European Urology Supplements 1 (2002) 12±16
15
Fig. 3. Sling sutures are manipulated to position the sling midurethrally.
Fig. 4. The sling is stitched to periurethral tissue.
sling was only 20 minutes. There were no serious bleeds or infections. Three bladder perforations occurred, but the slings were repositioned with no further problems. 4. Conclusions This new surgical procedure is very easy to teach and perform, is both fast and cost-effective, and therefore provides a good alternative to TVT. Importantly, it can
be used either as a tension-free sling in Type I/II patients or as a classical sling in complicated Type III incontinence patients. Further research is needed to compare the relative safety and success rate of PelvicolTM Implant with TVT and other synthetic products. Recent epidemiological evidence suggests that 30±50% of all adult females suffer from some degree of stress incontinence, and therefore it is anticipated that the use of surgery with tension-free vaginal slings (TVT or bio-compatible sling) will increase in the future.
16
B. Bemelmans / European Urology Supplements 1 (2002) 12±16
Patients with stress incontinence have historically been reluctant to come forward because therapies were of the inadequacy of previous treatments. However, the
availability of new, effective and simple therapies for patients with stress incontinence will offer them a brighter future.
References [1] Weinberger MW, Ostergard DR. Long-term clinical and urodynamic evaluation of the polytetra¯uoroethylene suburethral sling for treatment of genuine stress incontinence. Obstet Gynecol 1995;86(1):92±6. [2] Jarvis GJ, Fowlie A. Clinical and urodynamic assessment of the porcine dermis bladder sling in the treatment of genuine stress incontinence. Br J Obstet Gynaecol 1985;92:1189±91. [3] Harper C. PemacolTM: clinical experience with a new biomaterial. Hosp Med 2001;62(2):90±5. [4] Data on File. PelvicolTM Acellular Collagen Matrix Foot and Mouth Disease. Tissue Science Laboratories, plc. Manufacturers Statement, March 2001. [5] Errando C, Batista JE, Arano P. Polytetra¯uoroethylene sling for failure in female stress incontinence surgery. World J Urol 1996;14(Suppl 1):S48±50.
[6] Barbalias G, Liatsikos E, Barbalias D. Use of slings made of indigenous and allogenic material (Gore-Tex) in type III urinary incontinence and comparison between them. Eur Urol 1997;31(4):394±400. [7] Debodinance P, De Bievre O, Parmentier D, Dubrulle R, Ouerleu D, Crepin G. The ``hazards'' of using a Gore-Tex sling in the treatment of stress urinary incontinence. J Gynecol Obstet Biol Reprod (Paris) 1994;23(6):665±70 (French). [8] Duckett JR. Constantine. complications of silicone sling insertion for stress urinary incontinence. J Urol 2000;163(6):1835±7. [9] Kobashi KC, Dmochowski R, Mee SL, Mostwin J, Nitti VW, Zimmern PE, Leach GE. Erosion of woven polyester pubovaginal sling. Urology 1999;162(6):2070±2. [10] Haab F, Traxer O, Ciofu C. Tension-free vaginal tape: why an unusual concept is so successful. Curr Opin Urol 2001;11(3):293±7.
European Urology Supplements 1 (2002) 12±16
The Use of Biomaterials in Incontinence Surgery Bart Bemelmans* Unit for Functional Urology, University Medical Center, Nijmegen, The Netherlands
Abstract Introduction: We describe a minimally-invasive surgical technique using a naturally-derived porcine dermal collagen (PelvicolTM Implant) that can be used in the treatment of all types of urinary stress incontinence and does not rely on permanent sutures. Patients and Methods: Sling procedures using the PelvicolTM Implant were carried out in 27 patients (age range 31± 76 years; average 52 years) with genuine stress incontinence over a 12-month period. Patients had primary genuine stress urinary incontinence (SUI) (n 14), and mixed SUI complicated by complaints of urgency or frequency and a previous history of surgery (n 13). Detrusor instability was ruled out in all patients via cystometry, and patients were followed up for a minimum period of 6 months. Results: In patients with genuine SUI, 86% of patients remained dry. In patients with mixed SUI, a small number of retentions and de novo urgencies were observed and 62% of patients remained dry. The mean time to insert the sling was 20 minutes and mean operation time was 45 minutes. There were no serious bleeds or infections. Three bladder perforations occurred, but the slings were repositioned with no further problems. Conclusions: This new surgical procedure can be used either as a tension-free sling in Type II patients or as a classical sling in complicated Type III incontinence patients. It is easy to teach and perform, it is fast and costeffective, and it provides a good alternative to TVT. # 2002 Elsevier Science B.V. All rights reserved. Keywords: Stress urinary incontinence; SUI; Type II; Type III; Porcine dermal collagen; PelvicolTM Implant 1. Introduction When undertaking surgery for stress incontinence it is necessary to choose the procedure that is most appropriate to the patient's condition. Patients can be subdivided into those with `bad sphincters', i.e. Type III urinary stress incontinence (intrinsic sphincter de®ciency, ISD) and those with 'good sphincters', i.e. Type II genuine stress incontinence (hypermobile urethra). Different surgical procedures are required for each type of incontinence. The Burch colposuspension technique is classically used in the surgical treatment of patients with Type II incontinence. The tension-free vaginal sling or TVT is ideally suited to patients with primary stress urinary incontinence (SUI) who have simple, genuine stress * Tel. 31-24-361 6712. E-mail address: [email protected] (B. Bemelmans).
incontinence, no complaints of overactive bladder or detrusor instability, and have had no prior surgery. TVT is not recommended for use in repeat surgical procedures, complicated cases, or for patients with ISD (Type III incontinence). A classical tight sling is recommended for patients with Type III incontinence, despite the risk of urinary retention. This technique is ideally suited to those patients who have had multiple operations and who have had only minor or no prolapse who present with a low maximum urethral closure pressure (MUCP < 20 cm H2O) and Valsalva leak point pressure (VLPP < 60 cm H2O). In such cases it is necessary to prove the existence of severe stress incontinence. There is some doubt as to whether TVT can be used in Type III incontinence, and these patients would normally rely on a classical sling operation. A key advantage of the acellular dermal collagen PelvicolTM Implant is that it allows the sling procedure to be carried out in either a tension-free fashion
1569-9056/02/$ ± see front matter # 2002 Elsevier Science B.V. All rights reserved. PII: S 1 5 6 9 - 9 0 5 6 ( 0 2 ) 0 0 1 4 8 - 3
B. Bemelmans / European Urology Supplements 1 (2002) 12±16
or a tight fashion, and therefore it can be used to treat patients with either Type II or III stress incontinence. This paper will present a simple surgical technique and a surgical material (PelvicolTM Implant) that can be successfully applied to any type of stress incontinence. 2. Sling procedures in the treatment of female stress incontinence Sling procedures have been used for almost a century in the treatment of female urinary incontinence. Surgeons need sling materials that are chemically inert, non-allergenic, not liable to become infected, resistant to mechanical stress (a tight sling requires a strong sling), able to be sterilised, not physical modi®ed by body tissues, non-carcinogenic (particularly applicable to younger patients in whom the material will be implanted long-term), and which are both convenient and affordable. 2.1. Synthetic slings Synthetic slings have been used for many years in the treatment of stress incontinence and have shown approximately comparable success rates in the order of 70% (Table 1). However, concerns regarding the long-term safety of synthetic materials have arisen because of the risk of urethral erosions and infections (Table 1). Silicone sling material was withdrawn from the market due to severe erosion problems, and the polyester sling material (ProteGen1) was recalled in January 1999. The number of wound infections and erosions seen with Te¯on is high, and it is therefore recommended that patients should be warned of this complication rate and told that graft removal may be necessary [1]. Erosion is also seen with Gore-Tex1, and the high rejection rate dictates that caution be exercised when using Gore-Tex1 in stress incontinence. Table 1 Clinical trials evaluating the use of synthetic biomaterials in pubovaginal sling procedures for the surgical treatment of stress incontinence Material
Success rate (%) Complications
Polytetra¯uoroethylene (PTFE; Te¯on1)
61 72
Wound infection (40%) [1] Erosion/retention (15%) [5]
Expanded PTFE (Gore-Tex1)
87 65
Erosion (4%) [6] Rejection (around 30%) [7]
Silicone Polyester (ProteGen1) Prolene1 (TVT)
Terminated Recalled 87
Erosion [8] Erosion/infection [9] de novo detrusor instability (6%) [10]
13
2.2. Bio-compatible sling (PelvicolTM Implant) Porcine dermal slings have shown promising results in the surgical treatment of stress incontinence [2]. PelvicolTM Implant was developed by scientists at Dundee University with the aim of producing a permanent biological implant that is compatible with human tissue [3]. PelvicolTM Implant is a ®brous, acellular, cross-linked porcine dermal collagen that is non-allergenic, non-toxic and does not elicit a foreign body response [3]. It is completely free of remnants of DNA and entirely free of foot and mouth disease [4]. Once implanted into human tissue, the implant is a biocompatible, sterile and strong biological matrix that is permanently incorporated into the host tissue [3]. In this respect, PelvicolTM Implant ful®ls many of the characteristics of the ideal sling material. 3. Bio-compatible sling in the surgical treatment of stress incontinence Described here is a minimally-invasive surgical technique using a naturally-derived porcine dermal collagen (PelvicolTM Implant) that can be used in the treatment of all types of urinary stress incontinence and does not rely on permanent sutures. 3.1. Patients Sling procedures using the PelvicolTM Implant were carried out in 27 patients (age range 31±76 years; average 52 years) with genuine stress incontinence over a 12-month period. Patients had primary genuine SUI (n 14), and mixed SUI complicated by complaints of urgency or frequency and a previous history of surgery (n 13). Detrusor instability was ruled out in all patients via cystometry, and patients were followed up for a minimum period of 6 months. 3.2. Surgical technique Although PelvicolTM Implant comes ready to use `off the shelf' (Fig. 1), it was soaked in antibiotic solution as an added precaution against infection. A 12 2 cm length of PelvicolTM Implant was sutured with PDS resorbable sutures. Following a thorough vaginal lavage, the bladder was drained completely and a tiny suprapubic incision made. A small midline incision of the vaginal wall was then made, followed by lateral dissection with scissors (Fig. 2a). These steps took no longer than a few minutes. The surgeon's ®nger was then inserted into the retropubic space (Fig. 2b) and an instrument was passed down through the suprapubic incision to make contact with the ®nger (Fig. 2c).
14
B. Bemelmans / European Urology Supplements 1 (2002) 12±16
Fig. 1. Illustration of a PelvicolTM Implant (slide 1).
An instrument with a tunnel wider than that of a Stamey needle was used in order to accommodate the sling. The sling was then passed through the vaginal space, and the PDS suture was pulled so that the sling came out retropubically. The second suture was then pulled through the suprapubic region by the clamp. The surgeon held the sling in place (Fig. 2d) while the assistant manipulated the suture strings to perfectly position the sling midurethrally (Fig. 3), just as it is positioned in the TVT procedure. A vicryl suture was used to stitch the sling to the periurethral tissue to ensure that it could not slip to the bladder neck (where it has potential to cause irritation) (Fig. 4). At the end of the operation the vaginal incision was closed, and the PDS sutures were knotted over the rectus sheath. At this stage the use of a suprapubic catheter was optional. The suprapubic skin incision was then closed, and a vaginal tampon with betadine was inserted to ensure decontamination of the operative ®eld and prevent vaginal haematoma.
Fig. 2. (a) Illustration of lateral section being made with scissors; (b) insert ®nger into the retropubic space; (c) pass instrument down through suprapubic incision; (d) the sling is held in place.
3.3. Results In patients with genuine SUI the success rate of the procedure was extremely high, with 86% of patients remaining dry. The outcome was more complicated in patients with mixed SUI: a small number of retentions and de novo urgencies were observed and 62% of patients remained dry. The mean operation time was 45 minutes, but the mean time reported to insert the
B. Bemelmans / European Urology Supplements 1 (2002) 12±16
15
Fig. 3. Sling sutures are manipulated to position the sling midurethrally.
Fig. 4. The sling is stitched to periurethral tissue.
sling was only 20 minutes. There were no serious bleeds or infections. Three bladder perforations occurred, but the slings were repositioned with no further problems. 4. Conclusions This new surgical procedure is very easy to teach and perform, is both fast and cost-effective, and therefore provides a good alternative to TVT. Importantly, it can
be used either as a tension-free sling in Type I/II patients or as a classical sling in complicated Type III incontinence patients. Further research is needed to compare the relative safety and success rate of PelvicolTM Implant with TVT and other synthetic products. Recent epidemiological evidence suggests that 30±50% of all adult females suffer from some degree of stress incontinence, and therefore it is anticipated that the use of surgery with tension-free vaginal slings (TVT or bio-compatible sling) will increase in the future.
16
B. Bemelmans / European Urology Supplements 1 (2002) 12±16
Patients with stress incontinence have historically been reluctant to come forward because therapies were of the inadequacy of previous treatments. However, the
availability of new, effective and simple therapies for patients with stress incontinence will offer them a brighter future.
References [1] Weinberger MW, Ostergard DR. Long-term clinical and urodynamic evaluation of the polytetra¯uoroethylene suburethral sling for treatment of genuine stress incontinence. Obstet Gynecol 1995;86(1):92±6. [2] Jarvis GJ, Fowlie A. Clinical and urodynamic assessment of the porcine dermis bladder sling in the treatment of genuine stress incontinence. Br J Obstet Gynaecol 1985;92:1189±91. [3] Harper C. PemacolTM: clinical experience with a new biomaterial. Hosp Med 2001;62(2):90±5. [4] Data on File. PelvicolTM Acellular Collagen Matrix Foot and Mouth Disease. Tissue Science Laboratories, plc. Manufacturers Statement, March 2001. [5] Errando C, Batista JE, Arano P. Polytetra¯uoroethylene sling for failure in female stress incontinence surgery. World J Urol 1996;14(Suppl 1):S48±50.
[6] Barbalias G, Liatsikos E, Barbalias D. Use of slings made of indigenous and allogenic material (Gore-Tex) in type III urinary incontinence and comparison between them. Eur Urol 1997;31(4):394±400. [7] Debodinance P, De Bievre O, Parmentier D, Dubrulle R, Ouerleu D, Crepin G. The ``hazards'' of using a Gore-Tex sling in the treatment of stress urinary incontinence. J Gynecol Obstet Biol Reprod (Paris) 1994;23(6):665±70 (French). [8] Duckett JR. Constantine. complications of silicone sling insertion for stress urinary incontinence. J Urol 2000;163(6):1835±7. [9] Kobashi KC, Dmochowski R, Mee SL, Mostwin J, Nitti VW, Zimmern PE, Leach GE. Erosion of woven polyester pubovaginal sling. Urology 1999;162(6):2070±2. [10] Haab F, Traxer O, Ciofu C. Tension-free vaginal tape: why an unusual concept is so successful. Curr Opin Urol 2001;11(3):293±7.