Transobturator four arms mesh in the surgical management of stress urinary incontinence with cystocele
Objective
This study aims to evaluate safety and efficacy of four arms polypropylene mesh in the long- term follow-up in the management of stress urinary incontinence (SUI) associated with cystocele.
Material and methods
This prospective study was conducted on 50 female patients with SUI associated with cystocele. Patients underwent placement of transobturator four-arms mesh implants. Stress incontinence was evaluated using cough stress test with and without prolapse reduction, Stamey’s grading of SUI, the validated Arabic version of the International Consultation on Incontinence Questionnaire-Short Form and King Health Questionnaire forms. Perioperative parameters evaluated included age, body mass index, grade of SUI, time of procedure, hospital stay after surgery, difference between pre-, and postoperative serum hemoglobin values, and need for blood transfusion. Follow- up visits were planned at 3, 9 and 18 months after surgery.
Results
The mean operative time was 37.4±10.2 (25–60) minutes. Blood transfusion was not required. The mean hospital stay was 30.5±10 (24–48) hrs. Five (10%) patients had fever and urinary tract infections were noticed in five (10%) patients. Two (4%) women had urine retention after catheter removal and vaginal mesh erosion was present in one (2%) patient. Forty (80%) patients were cured from SUI, 8 (16%) patients were improved and 2 (4%) patients failed to respond.
Conclusion
Cystocele associated with SUI can be repaired with transobturator four-arms mesh with promising results, improved quality of life, and tolerable side effects.
Introduction
Pelvic organ prolapse (POP) is a common condition for women. It affects 30–50% of parous women and it may be concomitantly present with stress urinary incontinence in some women.1,2] Cystocele [anterior vaginal wall prolapse (AVWP)] is the most common type of POP in women and is due to herniation of the bladder through anterior vaginal wall.3] It may be lateral or central due to loss of support or weakness of the pubocervical facia between bladder and vagina.4]
Female stress urinary incontinence (SUI) is a significant health problem which is considered to be a common condition for adult female with prevalence rates ranging from 12.8 to 46%.5] Popular techniques for repair of stress urinary incontinence are implantation of midurethral slings (MUS) by placing transvaginal or transobturator tape made of polypropylene.6] POP and SUI are most probably simultaneous conditions. Repair of the two conditions in the same operation has been a point of controversy.7] When the two procedures are performed in the same session a midurethral sling is implanted after repair of cystocele.8] One of the most popular procedures for the management of AVWP is anterior colporrhaphy (AC) which may be done alone or with sling operation.9] Traditional methods for the repair of anterior wall prolapse using native tissue have a high recurrence rate.10] Also, transabdominal or laparoscopic paravaginal repair have not yielded different results than anterior repair.11]
Recently synthetic mesh has been widely used and proved its efficacy in the management of SUI and POP due to high recurrence rates and failure of native tissue.2] Many procedures used polypropylene mesh on a large scale of patients suffered from SUI and POP with high success rates.12] Four-arms mesh is designed to fix the mesh at four points to the pelvic side wall by passing the needle through four anatomic routes which is relatively easier and safer.8] Double transobturator four arms polypropylene mesh was introduced for the management of SUI beside anterior compartment repair.13] Complications related to placement of mesh or passage of needle entrance such as visceral or vascular injury, also pelvic pain or mesh extrusion were reported.14]
This study aims to evaluate safety and efficacy of four arms polypropylene mesh in management of SUI associated with cystocele during the long term follow-up.
Material and methods
This prospective study was conducted on 50 female patients with SUI associated with cystocele who attended the outpatient clinic between June 2013 and September 2016. All procedures were approved by the local ethics committee. Informed written consent was obtained from all patients about operative details and purposes of research. Women suffered from SUI associated with cystocele were included in this study. Exclusion criteria included women with a history of previous transvaginal mesh surgeries, detrusor overactivity, malignancy of female genital system or urinary bladder, history of pelvic irradiation or presence of neurological disorders that caused voiding dysfunction.
Preoperative workup was performed which included complete medical, surgical and gynecological history. Also, physical examination including full neurological examination, routine laboratory investigations and pelviabdominal ultrasound were performed. Urodynamic investigations included flowmetry, cystometry to assess the maximum cystometric capacity, presence of detrusor overactivity and the Valsalva leak point pressure (VLPP). We used vaginal gauze pack for reduction of severe prolapsus during urodynamic studies.15] Pelvic organ prolapse was described using pelvic organ prolapse quantification (POP-Q) system. Stress incontinence was evaluated using cough stress test with and without prolapse reduction, Stamey’s grading of SUI, the validated Arabic version of the International Consultation on Incontinence Questionnaire-Short Form and King Health Questionnaire (KHQ) forms.17]
Procedure
Patients subjected to transobturator four arms mesh implantation. We used monofilament polypropylene mesh of GYNECARE PROLIFT Pelvic Floor Repair System (Johnson and Johnson Co Somerville, New Jersey, USA) which included needle guide, cannula and retrieval device. Patients were placed in dorsal lithotomy position under spinal anesthesia and 16 Fr urethral catheter was inserted. Longitudinal midline incision was extended from bladder neck down to the cervix or vaginal cuff (Figure 1) then lateral right and left dissections were performed between bladder and vaginal wall in paravesical space to open the paravesical fossa reaching the ischial spine. Two right and left incisions were made in the genitofemoral crease at the level of clitoris just lateral to the ischiopubic ramus. Needle was passed with the cannula through the incised skin, and advanced up to the obturator muscle and membrane. Then it was inserted through obturator foramen around ischiopubic ramus till vaginal incision was approached under guidance of index finger (Figure 2). Then needle was removed leaving the cannula, in which the retrieval device was passed from the incised skin to the vaginal incision. Then the loops of the retrieval device were passed through the cannula and the upper arm of the mesh was fixed to it, and brought out through the cannula which then removed. The same procedure was repeated on the other side. The other two skin incisions were done 2 cm lateral and 3 cm inferior to the previous incisions then the procedure was repeated using the lower arms of the mesh as was performed with upper arms. Then the four arms of the mesh were used to adjust it in tension- free method to cover the prolapsed area (Figures 33–5). Finally, vaginal and groin incisions were closed with absorbable 2/0 sutures followed by vaginal pack placed for 24 hour and the catheter was removed after 24 hours. On discharge the patient was given oral ciprofloxacin at a dose of 500 mg at every 12 hours for 5 days, in addition to a non-steroidal anti-inflammatory drug (NSAID) and vaginal antiseptic. Patients were instructed to avoid sexual intercourse for 4 weeks postoperative.
Midline vaginal mucosa incision
Outside-in cannula
Cannulas through the obturator membrane
Mesh under the bladder
Four arms mesh
Follow-up
The following perioperative parameters were evaluated: age, body mass index (BMI), grading of SUI, time of procedure, hospital stay after surgery, difference between serum hemoglobin levels before and after surgery, and need for blood transfusion. Patients were seen 2 weeks postoperatively to be assessed for any complications. Follow-up visits were planned at postoperative 3, 9 and 18 months and, ICIQ-SF questionnaire, KHQ, Cough test, POP-Q system were administered, as well as severity assessment of SUI, visual analogue scale (VAS) for satisfaction, measurement of PVR were performed. Urodynamic studies were realized at postoperative 9 and 18 months.
Statistical analysis
The collected data were tabulated and analyzed using Statistical Package for the Social Sciences version 16 software (SPSS Inc.; Chicago, IL, USA) and Microstat W software (India, CNET Download.com). Categorical data were presented as number and percentages while quantitative data were expressed as mean±standard deviation, and range. Categorical variables were analyzed using “Z” test and Mc Nemer’s test. Quantitative data proved to be non-parametric were tested for normality using Shapiro-Wilks test, Friedman test was used to test the differences between matched variables considering p value of 0.05 as statistically significant. Friedman test was followed by post-hoc multiple comparison test using Wilcoxon test with Bonferroni correction to detect the significant pairs at adjusted p=0.008 if four variables, or 0.017 if 3 variables were compared.
Procedure
Patients subjected to transobturator four arms mesh implantation. We used monofilament polypropylene mesh of GYNECARE PROLIFT Pelvic Floor Repair System (Johnson and Johnson Co Somerville, New Jersey, USA) which included needle guide, cannula and retrieval device. Patients were placed in dorsal lithotomy position under spinal anesthesia and 16 Fr urethral catheter was inserted. Longitudinal midline incision was extended from bladder neck down to the cervix or vaginal cuff (Figure 1) then lateral right and left dissections were performed between bladder and vaginal wall in paravesical space to open the paravesical fossa reaching the ischial spine. Two right and left incisions were made in the genitofemoral crease at the level of clitoris just lateral to the ischiopubic ramus. Needle was passed with the cannula through the incised skin, and advanced up to the obturator muscle and membrane. Then it was inserted through obturator foramen around ischiopubic ramus till vaginal incision was approached under guidance of index finger (Figure 2). Then needle was removed leaving the cannula, in which the retrieval device was passed from the incised skin to the vaginal incision. Then the loops of the retrieval device were passed through the cannula and the upper arm of the mesh was fixed to it, and brought out through the cannula which then removed. The same procedure was repeated on the other side. The other two skin incisions were done 2 cm lateral and 3 cm inferior to the previous incisions then the procedure was repeated using the lower arms of the mesh as was performed with upper arms. Then the four arms of the mesh were used to adjust it in tension- free method to cover the prolapsed area (Figures 33–5). Finally, vaginal and groin incisions were closed with absorbable 2/0 sutures followed by vaginal pack placed for 24 hour and the catheter was removed after 24 hours. On discharge the patient was given oral ciprofloxacin at a dose of 500 mg at every 12 hours for 5 days, in addition to a non-steroidal anti-inflammatory drug (NSAID) and vaginal antiseptic. Patients were instructed to avoid sexual intercourse for 4 weeks postoperative.
Midline vaginal mucosa incision
Outside-in cannula
Cannulas through the obturator membrane
Mesh under the bladder
Four arms mesh
Follow-up
The following perioperative parameters were evaluated: age, body mass index (BMI), grading of SUI, time of procedure, hospital stay after surgery, difference between serum hemoglobin levels before and after surgery, and need for blood transfusion. Patients were seen 2 weeks postoperatively to be assessed for any complications. Follow-up visits were planned at postoperative 3, 9 and 18 months and, ICIQ-SF questionnaire, KHQ, Cough test, POP-Q system were administered, as well as severity assessment of SUI, visual analogue scale (VAS) for satisfaction, measurement of PVR were performed. Urodynamic studies were realized at postoperative 9 and 18 months.
Statistical analysis
The collected data were tabulated and analyzed using Statistical Package for the Social Sciences version 16 software (SPSS Inc.; Chicago, IL, USA) and Microstat W software (India, CNET Download.com). Categorical data were presented as number and percentages while quantitative data were expressed as mean±standard deviation, and range. Categorical variables were analyzed using “Z” test and Mc Nemer’s test. Quantitative data proved to be non-parametric were tested for normality using Shapiro-Wilks test, Friedman test was used to test the differences between matched variables considering p value of 0.05 as statistically significant. Friedman test was followed by post-hoc multiple comparison test using Wilcoxon test with Bonferroni correction to detect the significant pairs at adjusted p=0.008 if four variables, or 0.017 if 3 variables were compared.
Results
Fifty women were included in this study and their demographic data are shown in Table 1. Preoperative data of the patients are shown in Table 2. Two patients at postoperative 9, and another two patients at postoperative 18 month were lost to follow-up.
Table 1
Sociodemographic characteristics of the patients
| Variable | Mean±SD | Range | |
|---|---|---|---|
| Age (years) | 47.6±6.4 | 35–65 | |
| BMI (kg/m) | 26.2±4.1 | 20–36 | |
| Parity | 3.7±1.1 | 2–7 | |
| Mode & number of delivery | NVD | 3.2±1.1 | 1–7 |
| CS | 0.5±0.6 | 0–2 | |
| No. | % | ||
| Menopause | No | 15 | 30.0 |
| Yes | 35 | 70.0 | |
BMI: body mass index; NVD: normal vaginal delivery; CS: cesarean section
Table 2
Preoperative data of the patients
| Variable | n=50 (%) | |
|---|---|---|
| Cough test | Negative | 0 (0) |
| Positive | 50 (100) | |
| Stamey’s grading | Grade I | 24 (48) |
| Grade II | 20 (40) | |
| Grade III | 6 (12) | |
| PVRU (mL) | Mean±SD (Range) | 18.4±23.1 (0–95) |
| VLLP (cm H2O) | ≥90 | 12 (24) |
| 60–90 | 34 (68) | |
| <60 | 4 (8) | |
| Q-max (mü/sec) | Mean±SD (Range) | 24.8±2.5 (20–30) |
| ICIQ-SF | Slight | 0 (0) |
| Moderate | 12 (24) | |
| Severe | 28 (56) | |
| Very severe | 10 (20) | |
| Mean±SD (Range) | 14.8±4.1 (6–21) | |
| POP-Q | Grade II | 21 (42) |
| Grade III | 26 (52) | |
| Grade IV | 3 (6) | |
| Mean±SD (Range) | 2.6±0.6 (2–4) |
PVRU: Post-void Residual Urine; VLLP:Valsalva leak point pressure; Q-max: Maximum urine flow rate; ICIQ-SF: Arabic version of the International Consultation on Incontinence Questionnaire-Short Form; POP-Q: Pelvic Organ Prolapse-Questionnaire
The mean operative time was 37.4±10.2 (25–60) minutes. Blood transfusion was not required by any patient as mean blood loss was 83.6±62.7 (50–400) mL. The mean hospital stay was 30.5±10 (24–48) hrs. Intraoperatively, no patient had bladder or urethral injury. Five (10%) patients had fever and urinary tract infections (UTIs) were noticed in five (10%) patients during early postoperative period who were improved using antibiotics and antipyretics.
Two of the 50 (4%) women had urine retention after catheter removal. They were treated by indwelling catheter for two weeks. One of them improved but the other retained urine again and treated by clean intermittent catheterization for another 2 weeks. Four (8%) patients developed groin and thigh pain that were relieved with analgesics.
Vaginal mesh erosion presented in one (2%) patient who required local estrogen cream for improvement without any need for operative intervention. Dyspareunia was reported in 4 (8%) patients who required topical estrogen cream for relief. Two (4%) patients had recurrent cystoceles which were discovered during local examination at 3 months follow-up in the form of grade II and III cystoceles according to POP-Q, but the patients refused any further surgical intervention.
The outcomes of the procedures were as follows: 40 (80%) patients were cured from SUI, 8 (16%) patients were improved and 2 (4%) patients with recurrent cystoceles failed to respond to the treatment. In 40 patients with ICIQ-SF=0 subjective cure was achieved. Subjective improvement with ICIQ-SF ≤12 was realized in 8 patients. Forty-eight patients achieved objective cure with negative cough stress test results, while in two patients objective cure could not be attained.
Anatomical success: In 48 patients POPQ was ≤1 at 3 month of postoperative follow-up period. Anatomical failure was observed in 2 patients with POPQ II and III. Comparative grades of pelvic organ prolapsus over the period of the study are shown in Table 3. Table 4 does not demonstrate any significant difference regarding PVRU and maximum flow rates during follow-up period, while there was a significant improvement in the mean values of ICIQ-SF and POP-Q scale scores. Table 5 shows changes in KHQ that assess quality of life which reveals significant improvements at postoperative 3, 9 and 18 months in comparison to baseline data.
Table 3
Comparing the grades of pelvic organ prolapsus occurred during the study period
| Before intervention | Postoperative 3. month | Postoperative 9, month | Postoperative 18. month | |
|---|---|---|---|---|
| (n=50) | (n=50) | (n=48) | (n=46) | |
| POP1 | n (%) | n (%) | n (%) | n (%) |
| None | 0 (0) | 28 (56) | 26 (54.2) | 25 (54.3) |
| Grade I | 0 (0) | 20 (40) | 20 (41.7) | 19 (41.3) |
| Grade II | 21 (42) | 1 (2) | 1 (2.1) | 1 (2.15) |
| Grade III | 26 (52) | 1 (2) | 1 (2.1) | 1 (2.15) |
| Grade IV | 3 (6) | 0 (0) | 0 (0) | 0 (0) |
| p | Ref | <0.001 (S) | <0.001(S) | <0.001(S) |
| Ref | 0.32 (NS) | 0.32 (NS) | ||
| Ref | 1.0 (NS) | |||
Table 4
Pre-and postoperative PVRU, Q-Max, ICIQ-SF and POPQ values
| Variable | Before intervention | Postoperative 3. month | Postoperative 9. month | Postoperative 18. month |
|---|---|---|---|---|
| Mean±SD | Mean±SD | Mean±SD | Mean±SD | |
| PVRU (mL) | 18.4±23.1 | 18.0±18.03 | 18.0±18.01 | 16.3±15.51 |
| Q-max (mL/sec) | 22.8±2.52 | --- | 21.3±2.23 | 20.4±1.73 |
| ICIQ-SF | 14.8±4.1 | 3.9±4.34* | 3.1±3.99,† | 2.9±4.14,† |
| POP-Q score | 2.6±0.6 | 0.50±0.64* | 0.54±0.71* | 0.56±0.72* |
PVRU: Post-void Residual Urine; Q-max: Maximum urine flow rate; ICIQ-SF: Arabic version of the International Consultation on Incontinence Questionnaire-Short Form; POP-Q score: Pelvic Organ Prolapse-Questionnaire Score
Table 5
Assessments using King Health Questionnaire (KHQ) forms over the study period
| Variable | Before intervention | Postoperative 3. month | Postoperative 9. month | Postoperative 18. month |
|---|---|---|---|---|
| Mean±SD | Mean±SD | Mean±SD | Mean±SD | |
| General health perception | 52.1±28.29 | 28.8±18.97* | 11.4 ± 12.59† | 8.1±1189† |
| Incontinence impact score | 52.8±22.85 | 27.5±20.23* | 6.5±13.35† | 4.3±11.33† |
| Role limitations | 60.8±17.63 | 45.6±17.72* | 18.5±17.27† | 18.4±17.29† |
| Physical limitations | 60.4±20.59 | 39.4±19.35* | 19.8±10.89† | 18.0±12.57† |
| Social limitations score | 60.4±20.59 | 21.7±15.26* | 7.2±10.89† | 5.4±10.55† |
| Personal relationships score | 16.2±19.71 | 7.5±12.50* | 2.5±6.02† | 0.00±0.00†‡ |
| Emotions score | 25.8±17.36 | 14.9±14.84* | 4.1±5.41† | 4.1±5.41† |
| Sleep/energy score | 3.6±6.92 | 1.4±4.72 | 0.0±0.00* | 0.0±0.00* |
| Severity measures | 58.8±25.18 | 28.0±17.07* | 9.7±10.29† | 7.3±6.82†‡ |
| Symptom scale | 17.5±3.75 | 5.8±2.33* | 2.0±1.16† | 1.4±1.27†‡ |
Bonferroni adjusted Wilcoxon test was used.
Discussion
This study assessed the results of transobturator four-arms mesh technique in the management of cystocele associated with SUI. Early reports were controversial regarding the repair of pelvic organ prolapse that may affect bladder neck mobility, results of SUI or obstructive complications, while others reported no effect.18] Sergent et al.18] reported 97% and 81% (69% cure and 12% improvement) success rates for the treatment of cystocele and SUI, respectively. Also, Önol et al.19] noticed a cure rate of 86.4% and improvement rate of 9% for SUI. These data matched with our results as we had cure rate of 96% based on SUI sum, according to ICIQ-SF. Also, the anatomical success rate in our study was 96%, according to POP classification similar to that found in the study by Yonguc et al.20] which was 96% in medium term follow-up with double sling procedure. This outcome was better than that was found in another study13] in which anatomical and subjective success rates were 87.5% and 92.1%, respectively.
Only 2 patients showed recurrent cystoceles at follow- up visits in this study which were associated with SUI but the patients refused to undergo any further intervention. Likewise, Eboue et al.21] reported a 2.4% symptomatic cystocele recurrence after transobturator 4-arms mesh repair in 123 patients. Also, Stanford et al.22] reported an overall 2.6% failure rate at a minimum 2 years’ follow-up in a cohort of 154 women treated with transvaginal and abdominal custom-shaped polypropylene mesh for POP.
In our study, there was no intraoperative complications as bladder or urethral injury. Likewise, no patient required blood transfusion as the mean blood loss was (83.6±62.7) mL which was in concordance with the study by Moez and Fethi.23] In other studies performed by Moore et al.24] and Yonguc et al.20] one case in each study required blood transfusions. On the other hand, in a study by Sharifiaghdas et al.13] two patients had required one unit of blood postoperatively. Blood transfusions during POP repair were required due to lateral vaginal wall dissection not related to the passage of the needle.24]
Vaginal mesh erosion is one of the most common complications after POP repair whose incidence rtates ranged from 4% to 30%13,21,22,25–29] while in the study done by Yonguc et al.20] any mesh erosion had not been observed. In our study, vaginal mesh erosion was observed in one patient (2%) that was improved on local estrogen cream without operative intervention. Size and location of vaginal incision, depth of dissection, sexually active and younger aged women are seen as prognostic factors for mesh erosion.30] Also limited experience may be a factor in the high incidence of mesh erosion.27]
In that respect, an important controversy exists concerning the anterior vaginal wall repair, and its relation to sexual activity. In recent studies any difference between mesh repair, and traditional methods for the repair of anterior vaginal wall prolapse with respect to sexual activities.31,32] At follow-up visits 4 (8%) patients developed dyspareunia that was improved on local estrogen cream which was in accordance with the results of Palma et al.29] who used the Nazca-Tc mesh kit and the rate of dyspareunia in their study was reportedly 2.7%. In a study by Sharifiaghdas et al.13] 68.9% of the patients who were sexually active reported improvement in their sexual function after surgery and only 6.8% of them complained of worsening of dyspareunia, similarly Yonguc et al.20] reported that their 2 patients developed dyspareunia.
Urologists have believed that dyspareunia is not related to the mesh itself, but may be due to some points in the technique. Many studies have demonstrated that vaginal mesh does not seem to cause a negative impact on sexual function, and prospective comparative studies assessing mesh and traditional repair for the anterior compartment defects have not demonstrated any substantial deviation in the rate of dyspareunia.31,32] To cut down the risk of dyspareunia after the operation, the surgeon must sure that mesh is tension free and the mesh arms haven’t pulled tight to get sexual activity improved after repair of POP.32]
In our study 4 (8%) patients developed groin and thigh pain that improved on analgesics in parallel with results of Moore et al.24] where 4.4% of their patients had postoperative vaginal, groin, buttock or leg pain. Vaiyapuri et al.33] reported that 10.4% of their patients had vaginal and groin pain and 22.6% of their patients had pain in the inner side of the thigh which they attributed this pain to inadvertent passage of needle through adductor muscle. For decreasing postoperative groin or thigh pain some steps should ber followed in passing the needle, as passing it from outside-in, below the tendon of adductor longus and as medially as possible to the ischiopubic ramus.34]
Infection may be considered as an additional complication in vaginal repair either using mesh or another traditional method.35] In our study 5 patients developed UTI and treated by antibiotics. Two patients had urinary retention after catheter removal and were treated by indwelling catheter for 2 weeks. One of them improved, but the other retained urine again and treated with clean intermittent catheterization for another 2 weeks. This was also similar to other studies which had the same ratio19,24] reportedly only one case of urinary retention. In other studies13,23] 11 and 6 patients had postoperative urine retention, respectively. Yonguc et al. 36], reported postoperative urinary retention in nine women (11.3%) in Group 1 (repairing cystocele through one incision), which required an indwelling catheterization for 7–14 days. There was no UR in Group 2 (cystocele repaired through two incisions). This problem was not reported by Sergent et al.18] in his work.
Many questionnaires were used to assess quality of life, improvement and satisfaction after cystocele repair.24] In our study, all the scores of KHO which is used to assess quality of life, improvement and the overall satisfaction was 88.4%, according to VAS in agreement with others23,36] in which improvement, and overall satisfaction scores of VAS were 71.4% and 86.4%, respectively. Leanza et al.37] found a significant difference in VAS scores and in the majority of the main domains in the King’s health questionnaire when compared pre- and post-operative data (p<0.001). On the other hand, other questionnaires used as Pelvic Floor Distress Inventory short form (PFDI-20), the Pelvic Floor Impact Questionnaire short form (PFIQ-7), Pelvic Organ Prolapse Urinary Incontinence, Sexual Questionnaire (PISQ-12), Pelvic Floor Distress Inventory (PFDI) indicated significant improvements.1,13,19] Also, there was a significant improvement in all domains of prolapse quality of life (P-QOL) questionnaire.19]
Main limitation of our study is, it is a single arm, single-centered study with small number of patients and midterm follow up. However, our findings contributed to current literature with detailed examination and validated questionnaire based assessment. Nevertheless, cystocele associated with SUI can be repaired with transobturator four-arms mesh giving better results with improved quality of life and tolerable complications. To further improve the outcomes and reduce associated complications related to mesh use in pelvic floor reconstruction, more randomized and multicentered studies using standardised techniques and validated instruments are needed.
Abstract
Objective
This study aims to evaluate safety and efficacy of four arms polypropylene mesh in the long- term follow-up in the management of stress urinary incontinence (SUI) associated with cystocele.
Material and methods
This prospective study was conducted on 50 female patients with SUI associated with cystocele. Patients underwent placement of transobturator four-arms mesh implants. Stress incontinence was evaluated using cough stress test with and without prolapse reduction, Stamey’s grading of SUI, the validated Arabic version of the International Consultation on Incontinence Questionnaire-Short Form and King Health Questionnaire forms. Perioperative parameters evaluated included age, body mass index, grade of SUI, time of procedure, hospital stay after surgery, difference between pre-, and postoperative serum hemoglobin values, and need for blood transfusion. Follow- up visits were planned at 3, 9 and 18 months after surgery.
Results
The mean operative time was 37.4±10.2 (25–60) minutes. Blood transfusion was not required. The mean hospital stay was 30.5±10 (24–48) hrs. Five (10%) patients had fever and urinary tract infections were noticed in five (10%) patients. Two (4%) women had urine retention after catheter removal and vaginal mesh erosion was present in one (2%) patient. Forty (80%) patients were cured from SUI, 8 (16%) patients were improved and 2 (4%) patients failed to respond.
Conclusion
Cystocele associated with SUI can be repaired with transobturator four-arms mesh with promising results, improved quality of life, and tolerable side effects.
Footnotes
Ethics Committee Approval: Ethics committee approval was received for this study from the ethics committee of Benha University.
Informed Consent: Written informed consent was obtained from patients who participated in this study.
Peer-review: Externally peer-reviewed.
Author Contributions: Concept – H.S., T.S.O.; Design – H.S.; Supervision – H.S.; Data Collection and/or Processing – H.S., T.S.O.; Analysis and/or Interpretation – T.S.O.; Literature Search – A.E.; Writing Manuscript – H.E.; Other – A.E.
Conflict of Interest: No conflict of interest was declared by the authors.
Financial Disclosure: The authors declared that this study has received no financial support.
References
- 1. Moore RD, Beyer RD, Jacoby K, Freedman SJ, McCammon KA, Gambla MTProspective multicenter trial assessing type I, polypropylene mesh placed via transobturator route for the treatment of anterior vaginal prolapse with 2-year follow-up. Int Urogynecol J. 2010;21:545–52.. [[PubMed][Google Scholar]
- 2. Patel BN, Smith JJ, Badlani GHMinimizing the cost of surgical correction of stress urinary incontinence and prolapse. Urology. 2009;74:762–4.. [[PubMed][Google Scholar]
- 3. Rane A, Iyer J, Kannan K, Corstiaans AProspective study of the Perigee™ system for treatment of cystocele - our five-year experience. Aust N Z J Obstet Gynaecol. 2012;52:28–33.. [[PubMed][Google Scholar]
- 4. Safir MH, Gousse AE, Rovner ES, Ginsberg DA, Raz S4-Defect repair of grade 4 cystocele. J Urol. 1999;161:587–94.. [[PubMed][Google Scholar]
- 5. Botlero R, Urquhart DM, Davis SR, Bell RJPrevalence and incidence of urinary incontinence in women: review of the literature and investigation of methodological issues. Int J Urol. 2008;15:230–4.. [[PubMed][Google Scholar]
- 6. Serati M, Salvatore S, Uccella S, Artibani W, Novara G, Cardozo L, et al Surgical treatment for female stress urinary incontinence: what is the gold standard procedure? Int Urogynecol J Pelvic Floor Dysfunct. 2009;20:619–21.[PubMed][Google Scholar]
- 7. Murray S, Haverkorn RM, Lotan Y, Lemack GEMesh kits for anterior prolapse are not cost effective. Int Urogynecol J. 2011;22:447–52.. [[PubMed][Google Scholar]
- 8. Borstad E, Kulseng HS, Moghimi K, Sandved M, Maji-da M, Western KlAn incontinence procedure performed at the time of prolapse repair might be unnecessary surgery. Neuroulogy and Urodynamics. 2006;25:551–2.[PubMed][Google Scholar]
- 9. Maher C, Feiner B, Baessler K, Schmid CSurgical management of pelvic organ prolapse in women. Cochrane Database Syst Rev. 2013;30:CD004014.[PubMed][Google Scholar]
- 10. Hiltunen R, Nieminen K, Takala T, Heiskanen E, Merikari M, Niemi K, et al Low-weight polypropylene mesh for anterior vaginal wall prolapse: a randomized controlled trial. Obstet Gynecol. 2007;110:455–62.. [[PubMed][Google Scholar]
- 11. Maher C, Baessler KSurgical management of anterior vaginal wall prolapse: an evidence based literature review. Int Urogynecol J Pelvic Floor Dysfunct. 2006;17:195–201.. [[PubMed][Google Scholar]
- 12. Park HK, Paick SH, Lee BK, Kang MB, Jun KK, Kim HGInitial experience with concomitant prolift™ system and tension-free vaginal tape procedures in patients with stress urinary incontinence and cystocele. Int Neurourol J. 2010;14:43–7.. [PubMed][Google Scholar]
- 13. Sharifiaghdas F, Daneshpajooh A, Mirzae MSimultaneous treatment of anterior vaginal wall prolapse and stress urinary incontinence by using transobturator four arms polypropylene mesh. Korean J Urol. 2015;56:811–6.. [PubMed][Google Scholar]
- 14. Iglesia CB, Sokol AL, Sokol ER, Kudish BI, Gutman RE, Peterson JL, et al Vaginal mesh for prolapse: a randomized controlled trial. Obstet Gynecol. 2010;116:293–303.. [[PubMed][Google Scholar]
- 15. Gilleran JP, Lemack GE, Zimmern PEreduction of moderate to large cystocele during urodynamic evaluation using a vaginal gauze pack:8-year experience. BJU Int. 2006;97:292–5.. [[PubMed][Google Scholar]
- 16. Tamanini JT, Dambros M, D’Ancona CA, Palma PC, Rodrigues Netto N., Jr Validation of the international consultation on incontinence questuionnaire-short form (ICIQ-SF) for portuguese. Rev Saude Publica. 2004;38:438–44.. [[PubMed]
- 17. Shripad H, Harshita P, Arun CHUnderstanding King’s Health Questionnaire (KHQ) in assessment of female urinary incontinence. International Journal of Research in Medical Sciences. 2015;3:531–8.. [PubMed][Google Scholar]
- 18. Sergent F, Sentilhes L, Resch B, Verspyck E, Medeiros R, Descamps P, et al Treatment of concomitant prolapse and stress urinary incontinence via a transobturator subvesical mesh without independent suburethral tape. Acta Obstet Gynecol Scand. 2010;89:223–9.. [[PubMed][Google Scholar]
- 19. Önol FF, Tosun F, Güzel R, Boylu U, Küçük EV, Gümüş EMinimum 1.5-Year Results of “Surgeon-Tailored” Transvaginal Mesh Repair for Female Stress Urinary Incontinence and Pelvic Organ Prolapse. Urology. 2012;80:273–9.. [[PubMed][Google Scholar]
- 20. Yonguc T, Bozkurt I, Sen V, Aydogdu O, Yonguc G, Gunlusoy BDouble sling procedure for the surgical management of stress urinary incontinence with concomitant anterior vaginal wall prolapse. Int Urol Nephrol. 2015;47:1611–7.. [[PubMed][Google Scholar]
- 21. Eboue C, Marcus-Braun N, von Theobald PCystocele repair by transobturator four arms mesh: monocentric experience of first 123 patients. Int Urogynecol J. 2010;21:85–93.. [[PubMed][Google Scholar]
- 22. Stanford EJ, Mattox TF, Pugh CJOutcomes and complications of transvaginal and abdominal custom-shaped light-weight polypropylene mesh used in repair of pelvic organ prolapse. J Minim Invasive Gynecol. 2011;18:64–7.. [[PubMed][Google Scholar]
- 23. Moez K, Fethi Z3 year results of transvaginal cystocele repair with transobturator four-arm mesh: A prospective study of 105 patients. Arab J Urol. 2014;12:275–84.. [PubMed][Google Scholar]
- 24. Moore RD, Miklos JRVaginal repair of cystocele with anterior wall mesh via transobturator rout: efficacy and complications with up to 3-years follow up. Adv Urol. 2009:743831.[Google Scholar]
- 25. Finamore PS, Echols KT, Hunter K, Goldstein HB, Holzberg AS, Vakili B. Risk factors for mesh erosion 3 months following vaginal reconstructive surgery using commercial kits vs. fashioned mesh-augmented vaginal repairs. Int Urogynecol J. 2010;21:285–91.. [[PubMed]
- 26. Kaufman Y, Singh SS, Alturki H, Lam AAge and sexual activity are risk factors for mesh exposure following transvaginal mesh repair. Int Urogynecol J. 2011;22:307–13.. [[PubMed][Google Scholar]
- 27. Elgamasy AKH, Elashry OM, Elenin MA, Eltatawy HH, Elsharaby MDThe use of polypropylene mesh as a transobturator sling for the treatment of stress urinary incontinence (early experience with 40 cases) Int Urogynecol J Pelvic Floor Dysfunct. 2008;19:828–33.. [[PubMed][Google Scholar]
- 28. Abed H, Rahn DD, Lowenstein L, Balk EM, Clemons JL, Rogers RG. Systematic Review Group of the Society of Gynecologic Surgeons. Incidence and management of graft erosion wound granulation, and dyspareunia following vaginal prolapse repair with graft materials: a systematic review. Int Urogynecol J. 2011;22:789–98.. [[PubMed]
- 29. Palma P, Riccetto C, Muller V, Rogerio F, Sarsotti C, Ortiz C, et al A monoprosthesis for the simultaneous correction of cystocele and urinary stress incontinence - a multicentric trial. Urology. 2007;70(Suppl 3A):193–4.[PubMed][Google Scholar]
- 30. Lucente V, Murphy M, Saiz CVaginal prolapse repair: suture repair versus mesh augmentation: a urogynecology perspective. Urol Clin North Am. 2012;39:325–33.. [[PubMed][Google Scholar]
- 31. Nieminen K, Hiltunen R, Heiskanen E, Takala T, Niemi K, Merikari M, et al Symptom resolution and sexual function after anterior vaginal wall repair with or without polypropylene mesh. Int Urogyn J. 2008;19:1611–6.. [[PubMed][Google Scholar]
- 32. Gauruder-Burmester A, Koutouzidou P, Tunn REffect of vaginal polypropylene mesh implants on sexual function. Eur J Obstet Gynecol Reprod Biol. 2009;142:76–80.. [[PubMed][Google Scholar]
- 33. Vaiyapuri GR, Han HC, Lee LC, Tseng LA, Wong HFUse of the gynecare prolift system in surgery for pelvic organ prolapse: 1- year outcome. Int Urogynecol J. 2011;22:869–77.. [[PubMed][Google Scholar]
- 34. Margulies RU, Lewicky-Gaupp C, Fenner DE, McGuire EJ, Clemens JQ, Delancey JComplications requiring reoperation following vaginal mesh kit procedures for prolapse. Am J Obstet Gynecol. 2008;199:678.e1–4.[PubMed][Google Scholar]
- 35. Ridgeway B, Walters MD, Paraiso MF, Barber MD, McAchran SE, Goldman HB, et al Early experience with mesh excision for adverse outcomes after transvaginal mesh placement using prolapse kits. Am J Obstet Gynecol. 2008;199:703.e1–7.[PubMed][Google Scholar]
- 36. Yonguc T, Bozkurt I, Arslan B, Kozacioglu Z, Gulden I, Gunlusoy B, et al Outcomes of two different incision techniques for surgical treatment of stress urinary incontinence with concomitant anterior vaginal wall prolapse. World J Urol. 2015;33:1045–9.[PubMed][Google Scholar]
- 37. Leanza V, Zanghi G, Vecchio R, Leanza GHow to prevent mesh erosion in transobturator Tension-Free Incontinence Cystocoele Treatment (TICT): a comparative survey. G Chir. 2015;36:21–5.. [PubMed][Google Scholar]