1271Vol. 11 | No. 01 | Jan-Feb 2014 |U R O LO G Y J O U R N A L Department of Urology, University of Istanbul, Cerrah- pasa Medical Faculty, Istanbul, Turkey. Sinharib Citgez, Oktay Demirkesen, Fatih Ozdemir, Fetullah Gevher, Cetin Demirdag, Bulent Onal, Bulent Cetinel Transvaginal Repair Using Acellular Col- lagen Biomesh for the Treatment of An- terior Prolapse Correspondence Author: Sinharib Citgez, MD Kartaltepe Mahaleesi, Ya- vuklular Sokak, Gul Apart- mani, No:1/3 Bakirkoy, Istanbul, Turkey. Tel: + 90 532 312 2377 Fax: + 90 212 571 3570 E-mail: drsinharib@yahoo.com Received January 2013 Accepted December 2013 Purpose: To determine the results and satisfaction of the patients underwent transvaginal repair of cystocele in our clinic. Materials and Methods: From January 2006 to October 2010, 15 patients with a mean age of 64 years (ranged 47-85 years) underwent transvaginal cystocele repair using acellular collagen biomesh. The patients were presented with vaginal mass in 10, dyspareunia and urge incontinence in 5 while 4 of them had both stress and urge incontinence. Grade 4 cystocele was determined in 2 patients, grade 3 in 9 and grade 2 in 4. Concomitant transobturator tape (TOT) was performed in 4 patients. Patient satisfactions were determined after the operation. Results: The mean follow-up time was 23.5 (12-60) months. There was no postoperative com- plication in early follow- up period. Cystocele was recurrent in 1 patient. The success rate was 93.4%. Urinary incontinence was continued in 1 patient after TOT. Nearly all of the patients (14/15) were satisfied from the operation. Conclusion: Transvaginal cystocele repair with using acellular collagen biomesh appears to be a safe and effective method. Further prospective and randomized controlled studies including large series of patients are needed. Keywords: urinary bladder diseases; surgery; cystocele; vagina; treatment outcome; urinary in- continence; surgical mesh. RECONSTRUCTIVE UROLOGY 1272 | INTRODUCTION Pelvic organ prolapse (POP) is accepted as the hernia-tion of the pelvic organs from the vagina. Internation-al Continence Society (ICS) describes this condition as downward displacement of the reproductive organs dur- ing Valsalva maneuver.(1) POP is a condition that can affect women at any age. According to epidemiological studies, life-long risk in women to be operated due to prolapse or uri- nary incontinence is between 7% to 19%.(2,3) In a study from the USA, the number of women having POP is expected to increase by 46% in 2050.(4) Treatment of POP aims to eliminate the symptoms, repair the anatomy, protect or improve the functions, prevent new problems related to the other compartments and to protect the quality of life in long term. Surgical treatment of POP can be made with methods performed through vaginal or abdominal routes. The studies demonstrated that vaginal route is pre- ferred more for treatment of POP.(2,5,6) In fact, recurrence rates are high following anterior colporrhaphy performed especially because of anterior vaginal POP, and this rate is given as 40% in a recent randomized controlled trial.(7) Thus, use of synthetic or biological grafts can be argued in order to strengthen POP repair. In fact, International Consultation on Incontinence (ICI) emphasizes as a first level of evidence that the repairs carried out by vaginal route using synthetic poly- propylene meshes yield more excellent anatomic outcomes in the first-year follow-ups than anterior colporrhaphy, while it reports an acceptable efficiency and lower risk of compli- cations in the repairs alternatively performed with biological grafts.(8) In this study, we investigated the success, complication rates and patients satisfaction in patients undergone cystocele re- pair by vaginal route using acellular collagen bio mesh. MATERIALS AND METHODS Between January 2006 and October 2010, 15 patients having anterior prolapse were investigated. Repair of anterior wall prolapse through vaginal route using acellular collagen bio mesh (PelviSoft BioMesh, CR Bard, Cranston, R.I., USA) was performed to all patients. Ten of the patients presented with a palpable mass and 5 with pain during sexual inter- course and urge urinary incontinence. The mean number of pregnancies was 4.5 (1-9), and the mean number of births was 2.8 (1-7) (Table 1). None of the patients had a history of prolapse surgery. Two of the patients had diabetes mel- litus while no any other comorbidity was detected in any of the patients preoperatively. The grade of prolapse was preop- eratively assessed according to Baden-Walker system and/or Pelvic Organ Prolapse Quantification System (POP-Q) clas- sification.(1) Grade 4 cystocele was found in 2, grade 3 in 9 and grade 2 in 4 patients. Four of the patients complained of mixed (stress + urge) incontinence. These patients were asked to fill Turkish validated International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF).(9) Patients scheduled for concurrent surgery for stress urinary incontinence had undergone urodynamic study. Transobtura- tor midurethral sling (Transobturator tape, TOT) was planned for patients who defined to have urodynamic stress urinary incontinence (USUI). The operation was performed at lithotomy position under general anesthesia. All the patients were administered 1 g cefazolin preoperatively. Following insertion of the urethral catheter, an incision was made in the anterior vaginal wall from the level of the bladder neck towards to the vaginal apex. The incision was expanded to the sideways from infe- rior and superior, providing a horizontal ‘H’ shape (Figure). Thus, a wider area of dissection was obtained. The dissec- tion plane was defined with the bright, white pubocervical fascia and expanded until infralevator obturator fascia was palpated. Two anchoring sutures were placed through the fas- cia as to be at 1 and 11 o’clock positions, and the other two sutures were inserted through the cardinal ligament as to be at 5 and 7 o’clock positions. In the meantime, acellular col- lagen biomesh of 4 × 7 cm in size was cropped and tailored to the size of the defect, and the sutures were crossed from the proper pore openings in the mesh and tied. After the mesh was inserted, excess of the vaginal wall was properly cut and the process was ended by closure of the anterior wall. In 4 pa- tients who were found to have USUI, a separate suburethral and longitudinal incision was made, and TOT was properly placed. The urethral catheters were withdrawn immediately after or at the night of the operation. Postoperative follow-up of the patients were carried out in the first, 3rd and 6th weeks of the operation and then annu- Reconstructive Urology 1273Vol. 11 | No. 01 | Jan-Feb 2014 |U R O LO G Y J O U R N A L Acellular Collagen Biomesh for Anterior Prolapse | Citgez et al ally. The follow-up procedure was planned as questioning in terms of urinary incontinence (ICIQ-SF) and prolapse recur- rence (palpable mass), full urine test, vaginal examination and determination of post void residual urine. In the follow- up, patients having not complaints of prolapse or those with anterior wall prolapse under grade 2 at the vaginal examina- tion were considered as cure, while patients with complaints or those having a recurrence of grade 2 and above were con- sidered as failed. Patient to be dry was accepted as success for the treatment of stress urinary incontinence. In addition, patient satisfaction was evaluated by asking them whether they would recommend this operation to a relative, and if they would want to be operated again if it is necessary, in order to learn their reviews for the operation. RESULTS Mean age of the patients was 64 years (ranged 47-85 years). Body mass index (BMI) was calculated as 26.5 (range, 24.2- 28.4) for the patients. There was no any obese patient ac- cording to BMI while 5 of them were overweight. Mean op- eration time was 57.2 minutes (range, 30-75), while mean hospitalization stay was 18.4 hours (range, 12-36) (Table 2). There were no postoperative complications for the patients in early period. Mean follow up time was 23.5 months (range, 12-60). In one patient the palpable mass observed to persist. In this patient the examination revealed recurrence of grade 2 anterior prolapse. The patient did not want to be re-operated and was taken to follow-up. The success rate for repair of prolapse was found as 93.4%. None of the patients devel- oped de novo dyspareunia or SUI. Two of the 4 patients who had urgency at the preoperative period were improved after the operation. De novo urgency was detected in 2 patients. A total of 4 patients, including those having urge urinary incontinence preoperatively and continued postoperatively, responded to anticholinergic therapy. Combination treatment (prolapse repair + anti-incontinence surgery) was performed in 4 of our patients. Although de- creasing, urinary incontinence was observed to continue in one of 4 patients in whom TOT was inserted and the rate of success for stress urinary incontinence was 75%. In pa- tients with urinary incontinence, the mean preoperative and postoperative ICIQ-SF values were 14.33 (8-21) and 2.3 (0-11) respectively. Of 15 patients evaluated for satisfaction, 14 (93.4%) stated that they were completely well; they could be re-operated if necessary and would recommend the opera- tion to their relatives. In one patient the palpable mass ob- served to persist and dissatisfaction was observed because of the failure and unnecessary anesthesia. DISCUSSION Rates of recurrence are reported between 3% and 70% fol- lowing anterior colporrhaphy and between 5% and 50% after paravaginal repair by vaginal route in the treatment of ante- rior wall prolapse.(7,10-12) This is because the classical ante- rior colporrhaphy primarily focuses on central defects, while paravaginal repair targets lateral defects.(12) Since the central defects alone are rare,(13) the dissection should be expanded toward the lateral to provide adequate support both for lat- eral and central defects in all anterior prolapse repairs. By the technique and incision form we used and by expanding the dissection area toward the lateral, we aimed to realize an anterior wall repair supporting not only central but also lat- eral defects and to reduce the rates of recurrence. Besides the surgical method, use of support material is proposed in the literature in order to achieve a higher anatomic success compared to traditional anterior colporrhaphy.(8) Indeed, in- creased rates of anatomic success were demonstrated in the repair of central and lateral defects using additional support material.(14) Govier and colleagues also suggested a method similar to above mentioned using mesh.(15) Polypropylene Figure 2. A) Type of incision, B) appearance after dissection, C) insertion of the prepared biomesh, and D) appearance after operation. 1274 | type 1 synthetic meshes have priority as support material, while despite their low rate of success, biological grafts are also reported and can be preferred due to their lower risk of complications.(8,15) In addition to repair of the anterior wall through vaginal route with synthetic meshes,(16,17) there are several studies in the literature about posterior wall,(18) vaginal stump(19) and to- tal genital prolapse treatment.(20) However, as it is reported by ICI, there is no sufficient scientific evidence showing that support material in the posterior wall repair or use of any specific technique in apical wall repair through vaginal route is superior to native tissues.(8) In a study by Flood and colleagues, in the mean follow-up duration of 3.2 years fol- lowing use of synthetic meshes for treatment of anterior wall prolapse, none of 142 patients developed recurrent prolapse and, only in 3 patients meshes had to be removed due to vagi- nal erosion.(21) In a prospective, randomized controlled trial with 161 women recurrence rates of anterior wall prolapse was found to be statistically significantly decreased with use of mesh.(22) In a study by Sand and colleagues, a higher rate of success was reported in the patients undergone repair of anterior wall prolapse using mesh compared to the traditional colporrhaphy methods.(22) In this study, rate of success was found as 75% in mesh group and 57% in the anterior colpor- rhaphy group. According to the Cochrane database regarding to the treatment of anterior wall prolapse, the anatomic fail- ure rate is reported to be lower in the repair of anterior wall prolapse through vaginal route using mesh.(23,24) Biomesh is another support material described in the litera- ture and the rates of success using biomesh for the treatment of anterior wall prolapse are reported between 81%-93%. (25,26) ICI reports that, there is only one randomized con- trolled study with a high level of evidence demonstrating an- terior repair using porcine dermis to be superior to traditional vaginal plication,(27) but although with low level of evidence, there are also several studies giving conflicting results, thus use of biomesh in anterior repair can be recommended at the level of C.(8) Although it is not recommended by ICS, high efficiency was found in a study with 35 patients undergone surgery for posterior wall prolapse surgery using acellular collagen biomesh.(28) In our study we also found the rate of success and patients satisfaction very high (93.4%) with acel- lular collagen biomesh we used for the repair of anterior wall prolapse through vaginal route. However, as mentioned ear- lier, since use of biological mesh is recommended by ICI at the level of C,(8) better designed studies with extensive series should be conducted in order to define its efficiency and to obtain higher levels of recommendations.(15) On the other hand, it should be noted that the anatomic suc- cess is not always compatible with subjective results.(29) In fact, before the surgery to be performed using mesh, the pa- tients should be informed in details about functional results such as sexual function, continence, detrusor over activity and about the operation. De novo dyspareunia was reported between 2% and 15% in patients undergone repair of the an- terior wall with recently described transobturator four arms mesh which is inserted using trocar.(30-33) In this method, dyspareunia may be both due to the mesh,(34) and the tool used to insert the mesh.(35) On the other hand, a randomized controlled study comparing porcine dermis with standard re- pair anterior colporrhaphy without using graft reported that insertion of biomesh does not increase the risk for dyspareu- nia.(27) In another randomized, controlled study, synthetic Table 1. Patients characteristics. Number of patients 15 Mean age, years (range) 64 (47-85) Body mass index (mean) 26.5 (24.2-28.4) Underweight (< 18.5) 0 Normal weight (18.5-24.9) 10 (66.7%) Overweight (25-29.9) 5 (33.3%) Obesity (≥ 30) 0 Mean pregnancy, no. (range) 4.5 (1-9) Mean delivery, no. (range) 2.8 (1-7) Sexual activity, no. (%) Yes 9 (60.0) No 6 (40.0) Presentation of the patient Palpable mass 10 (66.7) Dyspareunia, urinary incontinence 5 (33.3) POP-Q classification (no.) Grade 2 4 Grade 3 9 Grade 4 2 Key: POP-Q, Pelvic Organ Prolapse Quantification. Reconstructive Urology 1275Vol. 11 | No. 01 | Jan-Feb 2014 |U R O LO G Y J O U R N A L polypropylene mesh Gynemesh PS (Ethicon, INC, Somer- ville, NJ,USA) and Pelvicol (C.R. Bard, Mol, Belgium) were compared, and sexual functions were found to be better in biomesh group, and this was attributed to propylene mesh to impair vaginal flexibility.(36) In accordance with the litera- ture, in this study with biomesh, none of the sexually active patients developed dyspareunia. Development of de novo SUI in anterior repairs through vaginal route using mesh is reported between 12% and 17% in the literature.(33,37,38) In a randomized controlled trial, this rate was stated as 12.3% following insertion of mesh using trocar, and it was reported to be statistically more frequent than anterior colporrhaphy.(37) In another randomized con- trolled study, no statistically significant difference was found between the mesh group and standard methods.(39) In our study, de novo SUI was not found in any patient. In addition, following the repairs with biological mesh, rate of detrusor overactivity was found as 17.4%, but this was not found sta- tistically significant compared to the standard techniques. (36) In the present study, 13% of the patients developed com- plaints of de novo urgency, and responded to anticholinergic therapy. In the reviews of Cochrane's database, conflicting data are mentioned about the prophylactic surgery for concurrent in- continence during the repair of anterior wall prolapse.(23,24) In our study, we simultaneously inserted TOT in 4 patients who was found to have USUI. None of these patients de- veloped per- or postoperative additional complications. TOT was failed in one patient, although the patient was satisfied with the operation. The mean ICIQ-SF value was declined to 2.3 (0-11) postoperatively which was 14.33 (8-21) preop- eratively. Use of mesh leads to additional complications re- quiring special treatment. The most common ones are mesh exposition or extrusion, and the complications related to the mesh shrinkage.(40) In fact, rates of vaginal exposition or ex- trusion may show an increase up to 11.9% according to the type of mesh used.(41) However, these types of complications are rare when using biological mesh because of the lower tissue rejection and less risk of infection.(27) Nevertheless, these complications should be considered in follow-up in the patients with complaints such as vaginal bleeding, vaginal discharge, vaginal or pelvic pain and dyspareunia. In this study, none of the patients developed such a biomesh spe- cific complication. In addition, it should be remembered that despite they are prepared with aseptic techniques, all the al- lografts like biomeshes are under the risk for transmission of diseases such as human immunodeficiency virus (HIV) and hepatitis B. There are several limitations to our study. One weakness of our study is that our data were collected retrospectively. Sec- ond, our series is small and not a long term study. Although it was not a randomized controlled study, this technique seems to be an alternative treatment in POP surgery. Further pro- spective, randomized and comparative studies with a high level of evidence are needed. In conclusion, in this study out- comes and complication rates seem to be acceptable in the anterior repair through vaginal route using acellular collagen biomesh. CONFLICT OF INTEREST None declared. Table 2. Results and complications after surgery. Mean follow up, month (range) 23.5 (12-60) Mean operation time, min (range) 57.2 (30-75) Mean hospitalization stay, hour (range) 18.4 (12-36) Success rate, no. (%) 14/15 (93.4) Complications, no. (%) Major (bleeding, organ injury) 0 de novo dyspareunia 0 de novo SUI 0 de novo urgency 2 (13.3) Key: SUI, stress urinary incontinence. REFERENCES 1. Bump RC, Mattiason A, Bo K et al. 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