Vito Leanza1, S.Dati2, G Leanza1
1Surgery Department, Catania University
Urogynecology Unit (Responsible Prof.V.Leanza), Catania University
2 Casilino Policlinic Hospital Urogynecologic Unit – Rome (Italy)
[Key Words: incontinence, Pre-pubic procedure, TVT, Retro-pubic, mid-urethral sling].
Objective. to evaluate the state of art of mini-invasive anti-incontinence surgical procedures.
Material and methods. Search of PubMed, Cochrane library and relevant articles from 1996 to 2015.
Results. 81 works were found. Literature showed similar cure rates among retro-pubic (71,4-91%), trans-obturator (77,3-95%) and pre-pubic (81-87,2%) anti-incontinence procedures. Mesh erosion is found in the main tension-free techniques with overlapping percentages, however, suitable precautions are able to prevent its onset. Catheterization is found in 3% of the retro-pubic technique group. The retro-pubic path may be mainly performed for the cure of recurrent stress incontinence (RSI) and intrinsic sphincter deficiency (ISD) in absence of obstructive symptoms. Due to the danger involved in the retro-pubic space, intra-operative vascular and perforating risks prevail in the retro-pubic procedure, whereas late infective complications in the trans-obturator technique are caused by the site of the mesh tip which may interfere with the movements of the thighs. No severe complications were reported in the pre-pubic procedure.
Conclusion. In the severe cases of incontinence the retro-pubic tension-free route remains the preferred; when obstructive symptoms prevail, the prepubic technique is the most appropriate; whereas for all other cases, the transobturator procedure is the most suitable. Actually, according to Literature, among the three mentioned above techniques, the transobturator is deemed in the world, the most common anti-incontinence procedure.
Female Stress Urinary Incontinence (SUI) is considered a troublesome medical problem affecting approximately 50% of women with Urinary Incontinence (UI).1
Tension-free Vaginal Tape (TVT) has been developed as a minimally invasive and effective surgical procedure used as a first-line treatment for SUI since 1996.2
Thereafter many complications among which vaginal erosion, vaginal pain, bleeding, infections, lower urinary tract symptoms (LUTS), urinary retention and de novo incontinence have been reported.3,4
Besides, UI affects physical, emotional, psychological, social and sexual wellbeing, so resulting into a major impact on women's quality of life.5
SUI is the most frequent cause of urinary leakage, with a relevant social cost.6
It is characterized by the patient’s complaint of involuntary spillage following effort or physical exertion, sneezing or coughing.7
With current procedures approximately 85% of cases can be cured.8
Many tension-free sling kits are been used: SPARC, RetroArc, Align, Advantage, Lynx, Desara, Supris, Gynecare TVT,TOT, TUS,TICT and a number of synthetic materials have been employed with reductions in surgical morbidity. The use of meshes has reduced operative time and improved pelvic operations.9
The synthetic material resulting in a better tissue incorporation is considered the monofilament macroporous polypropylene mesh. Many different studies reported high cure rates using the retro-pubic approach, furthermore major complication including intestinal, vascular and bladder injuries have been referred.10-12
In an attempt to reduce retropubic complications, Delorme et al. developed a procedure by which the sling crossed obturator foramen.13
The pre-pubic route was introduced, once more, to make the anti-incontinence procedure easier .
Aim of this study was to evaluate the state of art of the three main anti-incontinence tension-free techniques: retro-pubic, trans-obturator and pre-pubic .
Material and Methods
A Medline bibliographical research of the most relevant reviews regarding retro-pubic, trans-obturator and pre-pubic mini-invasive anti-incontinence procedures between 1996 and 2015 was done
Surgical standard mini-invasive anti-incontinence procedures or Mid Urethral Slings (MUS) are as follows:
RETRO-PUBIC MINI-INVASIVE PROCEDURES
The retro-pubic TVT was introduced by Ulmsten in 1996 as a mini-invasive surgery for the treatment of SUI. Several other mini-invasive retro-pubic procedures have been following. In TVT the mesh wings cross the retro-pubic space; it was designed to replace functionally deficient pubo-urethral ligaments. With the patient in lithotomic position, 3 small incisions are made: 2 supra-pubic and one on the anterior vaginal wall at the mid-urethral level. The excess sling is trimmed. Cystoscopy is then performed to make sure no bladder perforations occurred. Direction of the wings is vertical, therefore intra operative stress test is indicated.
The pioneer of the trans-obturator sub-urethral procedure (TOT) was Delorme in 2001. The aim of TOT is to reduce the range of the retro-pubic complications. Three incisions are made: two small incisions in the groin lateral to the lower pubic ramus, and one vaginal incision in the mid-urethral area. The needles are inserted in the groin incision and passed into the mid-urethral incision (out-in) or vice versa (in-out). The direction of the wings is horizontal and intra-operative stress test is not necessary. Once the tape is well placed, it is adjusted to an appropriate tension. The sheath is then removed, the excess mesh trimmed from the surgical site and vaginal skin is sutured. Cystoscopy is optional.13
PRE-PUBIC TVT PROCEDURE
The pre-pubic mini-invasive procedure implies the use of a mid-urethral sling in which the tape crosses the space placed in front of the pubic bone. It was introduced to facilitate the anti-incontinence techniques through a less risky pathway.
With the woman in lithotomy position, three small incisions are made: two pre-pubic and one on the anterior vaginal wall crosswise the midurethra. The eye needles are then passed from the vagina to the supra-pubic area. The tape is adjusted following the stress test. Excess sling is then trimmed. Cystoscopic check-up is not necessary.
81 works were found.
According to Holly et al.14 the rates of objectively assessed treatment success were 80.8% in the retro-pubic-sling group and 77.7% in the trans-obturator-sling group. The rates of subjectively assessed success were 62.2% and 55.8%, respectively. The rates of voiding dysfunction requiring surgery were 2.7% in those who received retro-pubic slings and 0% in those who received trans-obturator slings. There were no significant differences between groups as far as postoperative urge incontinence, satisfaction with the results of the procedure or quality of life.
Liapis et al.15carried out a comparative study and concluded that the two routes are equally effective for surgical treatment of SUI, with cure rates of 90% and 89%, respectively.
Mellier et al.16conducted a similar study and observed cure rates of 90% for the retro-pubic approach and 95% for the trans-obturator approach. Similarly, Lee et al.17 reported a cure rate of 86.9% in both groups.
A randomized controlled trial of TOT versus TVT with a 12-month follow-up showed that TOT is as safe and effective as TVT in treating women with stress urinary incontinence.18 Objective cure rates were 71.4% for TVT and 77.3% for TOT.19,20
Palma et al.21 compared the efficacy of different surgical techniques, and did not detect any difference in terms of the cure rates, which were 92.1% using the supra-pubic vaginal approach and 94% using the trans-obturator approach. However, the trans-obturator technique was less time-consuming and the rate of complications such as bladder perforation (2.3% and 0%, respectively) and postoperative urgency (20.6% and 10%, respectively) was much lower. The sling became infected in 4.7% of the retro-pubic group and 1% of the trans-obturator group. None of the trans-obturator patients suffered from urine retention, which affected 3.1% of the retro-pubic patients. The sling was adjusted in 4.7% of the retro-pubic patients, (with a cure rate of 66.6%), and in 6% of trans-obturator patients (cure rate of 83.3%). There were no complications such as bleeding or vaginal or urethral perforation.
The incidence rates of bladder perforation range from 0.8% to 21% among patients treated using the retro-pubic technique.22-25 On the other hand, few cases of bladder or urethra perforation are reported during trans-obturator surgery.
Rechberger et al. concluded that both approaches are effective for the treatment of stress urinary incontinence. Nevertheless, the retro-pubic technique was found to be more effective for Intrinsic Sphincter Deficiency (ISD).26 Kuuva et al.27 observed 0.8% of infection of the surgical wound. Rarer infectious complications that have also been observed include infected hematoma and necrotizing fasciitis.28 Complications observed after trans-obturator surgery include inguinal and obturator abscesses, as well as perineal cellulites.29,30
Tanuri et al.31 compared TVT and TOT techniques; they found out that the rate of bladder perforation was of 3.3% in the retro-pubic group without any other complications. Improvement in the quality of life was similar for both groups.
In both groups, subjective and objective cure rates were 90%.
They observed a 25% failure rate among patients with ISD (pressure at leakage below 60 cm H2O) after TOT procedure.
No significant differences were detected between the groups in terms of postoperative complications. All urinary tract infections were solved by antibiotic therapy. Urine retention in the retro-pubic group was reported, while in TOT group a persistent mild sporadic pain in the medial surface of the left thigh was found. 6 months after surgery both subjective and objective cure rates were 90% in both groups and at 12 month follow-up, the subjective cure rate was 90% in the TOT and 88.8% in the retro-pubic group.
Hammad et al.32 referred a 1.2% rate of vaginal erosion after retro-pubic TVT.
A higher risk of vaginal erosion with the TOT rather than with the TVT approach was reported. Groin abscesses have been found using TOT and they are more common with certain types of sling material.33,35
Juma and Brito36 found lower rates of persistent urge incontinence (21/130 [16%]) and de novo urge incontinence (1/130 [2%]).
No significant differences10 after comparing the classic retro-pubic TVT with the trans-obturator TVT (TVT-O) were observed.
Silvia (2007) reported no difference in cure rates or complications among the in-out and out-in TOT. The short-term efficacy of TOT mid-urethral slings was comparable with the retro-pubic slings; however, evidence confirmed that TOT slings have a lower success rate compared with retro-pubic slings for the treatment of ISD. 37
There is now a significant body of Literature showing the success of TVT for the treatment of severe SUI. A number of prospective observational trials have been conducted to evaluate the effectiveness of the TVT procedures. 38-42
Trans-obturator tape and retro-pubic tension-free vaginal tapes are comparable in terms of efficacy.43 For patients with recurrent incontinence, the results are similar to those achieved with a primary procedure; for those with a fixed urethrovesical junction, the outcome is poor, as it is with any other surgical procedures.44-46 Holmgren conducted a long-term study, published in 2005, concluding that initial cure rates of TVT were good for mixed incontinence but did not persist after four years.47
Concerns about the safety of retro-pubic mid-urethral slings have been prompted by a growing number of case reports of complications, including injury to the bowel, major vessels, and bladder, and urethral perforation. Complications with retro-pubic slings also include bleeding, hematoma, erosion of the mesh into the urethra or vagina, bladder perforation, de novo urge symptoms, voiding dysfunction and infection. 48-51 Rarer case reports include delayed bowel erosion, bowel injury, bowel obstruction, urethral diverticulum, vesical calculi, paraurethral abscess, necrotizing fasciitis, fistulas, urethral erosions, and nerve damage. 52-57 However, Ammendrup et al. noted that TVT procedure complication rates are low, with very few serious complications. 58
Giberti et al. carried out a two-year follow-up study on women with stress urinary incontinence treated with TOT and found an objective cure rate of 80%.59 whereas Cindolo et al. observed a cure rate of 92%.60
De Leval et al.61 found neither vesical nor urethral injuries and stated that the trans-obturator approach is a safe procedure not requiring intra-operative cystoscopy.
Postoperative groin pains were reported and they decreased in two months follow-up. 62 Although trans-obturator approaches avoid the retro-pubic area, a higher risk of damage obturator vessels is not to be understimated.63,64
Recently, Köktürk et al.65 assessed the indication-related safety, feasibility, and efficacy of midurethral sling (MUS), retropubic vaginal tape (TVT), transobturator vaginal tape (TOT) procedures in comparison with abdominal and laparoscopic techniques for surgical treatment of female stress urinary incontinence (SUI). They found LBC (laparoscopic Burch Colposuspension) having one (0.8 %) intra-operative complication (bladder injury) and a mean operation time of 56.5 min. The objective and subjective cure rate associated with LBC was 90.3 and 71 %, respectively. The Open Burch had 13 % intra-operative complications and a mean procedure time of 44.6 min. The objective and subjective cure rate was 69.2 and 61.5 %, respectively. Regarding Mid-Urethral-Sling (MUS) 5.4 % of procedure-related complications ware reported while the mean operative was 19.8 min. The objective and subjective efficacy rate for MUS was 84.5 and 62 %, respectively.
Arrabal-Polo MA et al.66 reported more complications with patients treated by retro-pubic procedures (26%) when compared with patients using the trans-obturator surgical procedure(12%).
There are few Literature works showing the outcomes of pre-pubic route for the treatment of stress urinary incontinence. Some trials have been conducted to evaluate the effectiveness of this procedure.67-75 Daher et al.67 reported a 87,2% subjective cure, 4.3-7 % improvement and 6-13,4% failures.
No significant intra- and post-operative complications occurred. In a Multicenter Randomized Trial, Leanza et al. compared the pre-pubic with the retro-pubic procedure.68 In the pre-pubic, subjectively, incontinence was cured in 177(87.2%). Objectively, S.U.I. was cured in 175 cases (86.2%). The cystocele was cured 173 (85.2%) patients. Postoperative complications included neither cases of “de novo” instability nor obstruction, whereas 13 (6.4%) patients suffered from urge-incontinence, 14 (6.9%) patients from urgency and 9 (4.4%) patients from pollakiuria. 5 cases (2.5%) of erosion were observed: they had been treated by the excision of protruding mesh without suturing the vaginal skin and the pelvic floor was not compromised. During follow-up, two other pelvic procedures were requested. Postoperative Q tip test average was 27 degrees (range 12-51). A significant difference in VAS scores and in the majority of the main domains was found in King's Health Questionnaire regarding preoperative and postoperative data (p<0.001), whereas the results of the pre-pubic procedure were comparable to the retro-pubic one. Besides, subject satisfaction was not significantly different between retro and pre-pubic TICT: 88 versus 89%.69
In another study70 both procedures (pre-pubic and retro-pubic) for the treatment of Recurrent Stress Incontinence (RSI) were compared. The retro-pubic was found to be more effective to solve RSI (83.3% versus 76.7%); yet, the retro-pubic procedure had a higher rate of complications (7.4% of voiding difficulties). Trans-obturator technique late complications such as severe troubles when walking have never been reported with the retro-pubic and pre-pubic procedures71-79
Leanza et al.36 (2015) compared two trans-obturator samples differing in that vaginal skin was (A-group) or not (B-group) sutured beneath the mesh. A-group: subjectively SUI was cured in 87/102 (85.3%); cystocoele in 87/102 (85.3%). B-group: subjectively SUI was cured in 86/98 (87.7%) of patients; cystocoele was solved in 86/98 (87.7%). Between the two groups both anti-incontinence end cystocoele treatment was superimposable (p value > 0.05). Nevertheless regarding mesh erosion, a percentage of 5.1% (5/98) was found among B-group while none among A-group patients where integrity of vaginal skin beneath the mesh was preserved. The conclusion was that, when vaginal skin is neither incised nor sutured beneath the mesh, erosion is avoided.80
Long CY et al (2013) compared the efficacy and safety of the modified prepubic tension-free vaginal tape-obturator (PTVT-O) system procedure with the original TVT-O methods. One hundred and ninety women with urodynamic stress incontinence (USI) were included in this study (93 cases in the TVT-O group and 97 in the PTVT-O group). They found the efficacy of surgery (cure and improvement) in the PTVT-O group was significantly higher than that in the TVT-O group (P=0.038). Complication rates and visual analog scale (VAS) scores were similar (P>0.05). Overactive bladder symptoms decreased significantly after surgery in both groups (P<0.05) although all urodynamic parameters revealed no significant difference after both procedures (P>0.05). 81
The various types of MUS (retro-pubic, the trans-obturator and the pre-pubic procedures) are minimally invasive and effective for SUI cure. They reduce many risks reported in major procedures, even if some of them persist and can be severe. There was no statistical difference between the three approaches in terms of clinical results, quality of life assessment, pad test or number of complications. Considering solution of severity of incontinence the retropubic approach appears the most advantageous, however many authors actually prefer the transobturator route due to a reduction of intra and early postoperative complications.
Intra-operative vascular and perforating risks prevail in the retro-pubic because of the anatomic danger of the retro-pubic space; whereas late infective complications are higher in the trans-obturator procedure owing to the site of the mesh tip that may interfere with thigh movements. Mesh erosion is found in all main tension-free techniques with overlapping percentages, however, some opportune precautions are able to prevent its onset.
Severe complications in the pre-pubic were not reported, but this kind of surgery is rarely performed. Pre-pubic mini-invasive procedure is a simple technique with very low risks and the preliminary results are consistent with those of other published techniques.
When compared with the retro-pubic, the pre-pubic one is not obstructive but less stable.
Finally, in the severe cases of SUI, RSI and in ISD the retro-pubic tension-free route remains the favourite; when obstructive symptoms prevail, the prepubic technique is the most appropriate; whereas for all other cases the trans-obturator route is the most suitable and, besides, according to Literature, it represents the most popular anti-incontinence mini-invasive procedure of the last decade.