Comparing effectiveness of combined transobturator tension-free vaginal mesh (Perigee) and transobturator tension-free vaginal tape (TVT-O) versus anterior colporrhaphy and TVT-O for associated cystocele and urodynamic stress incontinence

Objective

To evaluate the efficacy and safety of transobturator tension-free vaginal mesh (Perigee) and concomitant transobturator tension-free vaginal tape (TVT-O) for treating cystocele with urodynamic stress incontinence (UDSI).

Study design

A retrospective study of 115 patients with symptomatic stages 2-3 cystocele and UDSI who were treated with a Perigee system (Group I, n = 68) plus TVT-O procedure or traditional anterior colporrhaphy (Group II, n = 47) plus TVT-O procedure. All patients were followed up for more than one year. Objective and subjective symptoms were evaluated at one year postoperatively. Statistical analysis was performed using SPSS software.

Results

The objective cure rates for cystocele at one year were significantly higher in Group I than in Group II (98.5% and 86.9%, P = 0.018), respectively. The cure rates for UDSI in the two groups were 91.0% vs. 91.3% (P = 1.000). Symptomatic improvement of frequency was better in Group I than Group II (87.7% vs. 70.0%, P = 0.030). There were no significant differences with regard to intraoperative and postoperative complications between the two groups.

Conclusions

The combination of the Perigee system and TVT-O offers a safe and effective treatment for cystocele with UDSI and may be performed as first-line treatment.     

Anterior colporrhaphy versus repair with mesh for anterior vaginal wall prolapse: a comparative clinical study

Purpose

To compare the clinical effectiveness of anterior colporrhaphy versus mesh repair as surgical management of anterior vaginal prolapse.

Methods

Of 50 patients with ≥stage II anterior vaginal prolapse on Pelvic Organ Prolapse Quantification (POPQ) system who were initially approached, 44 consented and underwent surgery. They were randomly recruited into two groups. Group I (23 patients) received anterior colporrhaphy, while group II (21 patients) received soft polypropylene mesh (GYNEMESH*PS, Gynecare, Ethicon, France). Clinical assessment took place preoperatively and postoperatively at definite intervals. Functional and anatomical comparisons were based on comparison between preoperative and 24?months postoperative assessments of symptoms and POPQ stages, respectively. Four patients in total did not complete the follow-up assessments and were excluded.

Results

Both groups showed clinical improvement in their symptoms and POPQ staging at the end of the postoperative follow-up period. Improvement, however, was more significant in the repair with mesh group, as patients in this group reported better improvement of their prolapse symptoms, mainly vaginal bulge/pressure sensation (P?P?P?Conclusion Our data shows that repair with mesh is superior to anterior colporrhaphy with more satisfactory outcome to the patients. Due to the small size of our study and uncertainty of the long-term safety and resilience of the mesh, we recommend larger studies to confirm our preliminary results.     

Prolapso de la cúpula vaginal tratado mediante operación de Richter-Amreich asociada a colporrafia anterior

Objective

To study prospectively the succes rate of the sacrospinous vault suspension, using the vaginal approach associating an anterior colporrhaphy, in the cases of posthisterectomy vaginal vault prolapse.

Material and methods

Between January 1999-July 2005, 41 patients without urinary incontinence and vaginal vault prolapse were treated with the Richter-Amreich’s procedure associated with anterior colporrhaphy by the same surgeon. We have used the the Miya hook in all interventions and 2 sutures of Polyglactin 00. Every patient was 393 followed up a month after the operation and anually till now. We considered success as the lack of prolapse a month after the intervention, and relapse when another prolapse happened in a year or more after surgery. Patients were include in a database and Epi-info 3.3^TM was used to perform the statistical analysis.

Results

There were vaginal vault prolapse at 1- month follow-up in 4 of the 41 (success rate of 91.2%). Another 3 patients presented minor cystocele (grade 1), and one had a grade 2 cystocele without descent of vaginal apex (9.8%). There is no worsening of these cases till now in the annual follow-ups. The most common postoperatory complication was anemia, that was present in 13 patients (31,7%). The length of complete surgery was 102 ± 35 minutes. There is a clear correlation between operating time and surgeon experience.

Conclusions

This technique is an effective method, economic and safe to treat posthysterectomy prolapse of the apical vaginal compartment.     

Efficacy of inside-out transobturator vaginal tape (TVTO) at 4 years follow up

Objectives

To assess the efficacy and complications of TVTO with or without anterior colporrhaphy in women with urodynamic stress incontinence at 4 years follow up.

Study design

Seventy-four patients were subjected to TVTO operation and 41 patients to TVTO and anterior colporrhaphy. Subjective and objective cure and improvement rates and the incidence of complications were assessed.

Results

The objective cure rate based on the pad test findings for the TVTO-only patients was 82.4% and the improvement rate was 6.8%. The objective cure rate for the group undergoing TVTO and anterior colporrhaphy was 80.5% and the improvement rate was 7.4%.

Conclusions

At 4 years follow up TVTO procedure alone or with anterior colporrhaphy maintains a high cure and improvement rate with a very low complication rate and appears to be a promising technique, but long term results should be published for safer conclusions to be made.     

Optimal primary minimally invasive treatment for patients with stress urinary incontinence and symptomatic pelvic organ prolapse: Tension free slings with colporrhaphy,or Prolift with the tension free midurethral sling?

Objective

Comparison of procedures in patients with concomitant stress urinary incontinence (SUI) and pelvic organ prolapse (POP) was performed. Tension free vaginal tape (TVT) or transobturator tape (TOT) with colporrhaphy was compared with fixed mesh (Prolift™) applied with a tension free suburethral sling.

Study design

A total of 76 women with both SUI and POP were evaluated. TVT or TOT with colporrhaphy was performed in 39 patients and Prolift™ with the midurethral sling in 37 patients. Anatomy, symptoms and quality of life (QOL) were evaluated prior to, and at 1, 6 and 12 months after surgery.

Results

Continence was achieved in both groups equally (p = 0.57). The better anatomic outcome regarding the correction of POP was in the Prolift™ group but with a higher rate of additional procedures and complications. QOL was better in patients with grade III–IV POP corrected with Prolift™ (p = 0.05) and equal in both groups with grade I–II POP during the follow-up. Impairment of sexual life was present in both groups before surgery. After surgery, there was no improvement in sexual life regardless of correction of both anatomy and incontinence.

Conclusion

Both procedures are effective and safe. TVT or TOT performed with colporrhaphy looks a better primary choice for grade II POP and SUI. Results for grade III–IV POP and SUI are better with the Prolift™ with the sling. Sexual life could not be improved effectively with these types of surgery.     

Trans-vaginal cystocele repair using a tension-free polypropylene mesh: more than 5 years of follow-up

Objectives

Prospective randomized controlled trials, with 2 years’ follow-up, seem to lean in favour of anterior repair using synthetic mesh. The goal of this study was to report on long-term (>5 years) follow-up.

Study design

Polypropylene mesh was inserted in 63 women (in 1999-2001) from the retropubic space to under the bladder using a tension-free technique.

Results

At 79 months’ follow-up, 45 women were anatomically cured (76%). Four (7%) were lost to follow-up and 14 (24%) presented with stage 2 or 3 cystocele recurrences. None of them required surgery for cystocele recurrence. Vaginal extrusion was reported in 10 (16%) patients (in four cases after 4 years of follow-up) and all required partial surgical removal of the mesh (n = 10, 16%).

Conclusion

Cystocele repair using tension-free polypropylene mesh is associated with a low long-term rate of repeat surgery for cystocele recurrence.     

La colposacropexia laparoscópica en el tratamiento del cistocele

Objective

To study the results of sacrocolpopexy in our hospital for the treatment of cystoceles.

Material and methods

A total of 77 patients were treated by laparoscopic sacrocolpopexy. With a minimum mean follow-up of 6 moths, a clinical examination was performed to detect symptoms of prolapse or urinary, sexual and rectal symptoms. Objective cure was defined as < grade 2 prolapse in the Baden-Walker classification.

Results

The mean age was 53.8 + 8.9 years. The mean operating time was 193.6 + 44 minutes. Intra-operative and post-operative complications rates were 11.6% and 19.4%, respectively. The mean length of hospital stay was 2.7 (1-8) days. With a mean follow-up of 15.3 + 12.8 months, the subjective cure rate was 89.6% and the improvement rate was 6.4%. The rate of anatomical recurrence of cystocele was 11.6%. Seventy-five patients reported they were satisfied or moderately satisfied (97.7%)

Conclusion

Laparoscopy sacrocolpopexy appears to be an effective method for the treatment of cystocele.     

Urodynamic and clinical effects of transvaginal mesh repair for severe cystocele with and without urinary incontinence

Objective

To demonstrate the urodynamic and clinical effects of transvaginal polypropylene mesh repair (TVM) for severe cystocele with or without stress urinary incontinence (SUI).

Methods

One hundred women with severe cystocele who underwent transvaginal cystocele repair using a tension-free polypropylene mesh were included in a retrospective study. A simultaneous transobturator tape (TOT) procedure was performed in 24 patients with concurrent urodynamic stress incontinence (USI). Postoperative follow-up examinations included urodynamic testing, pelvic organ prolapse quantification, and urogynecologic questionnaire.

Results

Mean follow-up was 35 months (range, 13-68 months). At 3-6 months after surgery, 2 (8.3%) of the 24 patients with USI who had undergone TVM and TOT had persistent SUI. Of the 30 women with occult USI who had undergone TVM alone, 6 (20%) developed symptomatic SUI and 9 (30%) had asymptomatic SUI. Thirteen (28.3%) of the 46 patients without USI developed postoperative SUI. The 1-year results showed de novo SUI in 10 (10%) women, recurrent cystocele in 6 (6%), and mesh erosions in 5 (5%). Four (13.3%) of the 30 patients engaging in sexual activity had dyspareunia.

Conclusion

TVM is effective and safe in patients with severe cystocele, but may have an impact on voiding and sexual activity.     

Does pelvic mesh treated with phosphorylcholine improve outcomes? An early experience

Objectives

Implantable devices treated with phosphorylcholine (PC) have been successfully used in cardiac, ophthalmic, and other applications. This surface modification has resulted in a reduction in the host inflammatory responses. This pilot study tested the safety and efficacy of PC treated polypropylene mesh grafts implanted for the treatment of pelvic organ prolapse.

Study design

Surgeons from five U.S. sites collected data on subjects implanted with Perigee IntePro Lite + PC. Pre-procedure data collected included demographics and prolapse severity. At follow-up, subjects were assessed for anatomical outcomes (success ≤ stage I POPQ or Baden Walker), symptomatic improvement, and complications, particularly mesh exposure.

Results

A total of 40 subjects were enrolled with 80% (32/40) of them completing at least 5–7 months of follow-up. Mean patient age was 60 years (range 36–78 years) and the mean BMI was 28 (range 20–40). There were no cases of mesh exposure/extrusion or granuloma formation. The anatomical success rate was 100% at 5–7 months (32/32).

Conclusions

This is the first publication on pelvic mesh treated with PC. There were no adverse events attributed to this surface modification. However, as the numbers are small, the results are not statistically significant. PC surface modification of pelvic mesh shows promise in its application for the reduction of mesh related complications.     

Does the method of dissecting in anterior colporraphy lead to a difference in thickness of removed vaginal tissue?

Objective

To evaluate the difference in thickness of the anterior vaginal wall removed after different surgical dissecting techniques of anterior colporrhaphy.

Study design

In patients undergoing primary anterior colporrhaphy, trimmed vaginal tissue was taken following different surgical techniques of vaginal wall dissection. Tissues were preserved in formalin and stained with hematoxylin-eosin and elastica-van Giesen stains. The examiner was an experienced pathologist blinded to the surgical technique. The specimens were examined for the epithelial thickness (ET), lamina propria thickness (LPT), muscular layer thickness (MT) and total thickness (TT).

Results

Tissue was analysed in 93 women who underwent anterior compartment pelvic organ prolapse surgery. There was no difference between the different surgical techniques in thickness measured in the three histological layers and for the total thickness. The use of hydrodissection was the only independent factor leading to thicker removed vaginal tissue.

Conclusions

Dissecting the vaginal wall as thin as possible does not result in a thinner vaginal layer than dissecting in the most optimal surgical plane. The use of hydrodissection provides a thicker trimmed tissue.     

A long-term cohort study of surgery for recurrent prolapse comparing mesh augmented anterior repairs to anterior colporrhaphy

Background

There are safety concerns regarding the use of mesh in vaginal surgery with a call for long-term follow-up data. This study was designed to evaluate the long-term safety and efficacy of vaginal repairs performed for recurrent cystocele using Perigee (non-absorbable trans-obturator) mesh.

Methods

A retrospective consecutive cohort of 48 women who underwent surgery for recurrent prolapse between March 2007 and December 2011 in a single centre was reviewed. Satisfaction was assessed using the patient global impression of improvement (PGI-I). Symptoms were assessed with the pelvic floor distress inventory (PFDI). Women were questioned regarding pain, sexual activity and pelvic floor surgery performed since the original procedure and examined for erosion. Women were compared to 25 controls from a consecutive cohort of repeat anterior colporrhapies.

Results

The mean length of follow-up was 6.5 years (78 months; range 48–106). Significantly more women in the mesh group reported that they were “much better” or “very much better” (69 vs 40% p?=?0.02). The rate of mesh erosion at follow-up was 11.6%. Two women in the mesh group required surgical excision of eroded mesh in the operating room (4%). The reoperation rate for a combination of de novo stress incontinence, recurrent prolapse and mesh exposure was similar in each group (33% mesh vs 32% native tissue).

Conclusions

A vaginal mesh repair using a non-absorbable trans-obturator mesh has improved satisfaction compared to an anterior colporrhaphy.

     

Transvaginal cystocele repair using tension-free polypropylene mesh at the time of sacrospinous colpopexy for advanced uterovaginal prolapse: a prospective randomised study

The management of an advanced multi-compartment prolapse requires a combination of techniques. The objective of this study was to report the anatomical outcomes of a prospective randomised trial comparing tension-free polypropylene mesh-reinforced anterior vaginal prolapse with anterior colporrhaphy at the time sacrospinous colpopexy and posterior fascial plication for the management of massive uterovaginal prolapse. A total of 116 patients with a stage III or IV (Pelvic Organ Prolapse Quantification System/International Continence Society) uterovaginal prolapse were randomised into two groups. The mesh group includes transvaginal cystocele repair using a tension-free polypropylene mesh, while the non-mesh group includes anterior colporrhaphy. All patients in the two groups underwent a sacrospinous colpopexy and posterior fascial plication. The primary outcome was objective success < stage 2 prolapse. The secondary outcomes were reoperation for recurrent prolapse, subjective success rates, patient satisfaction with the surgery and complications. The overall objective success rates (in all compartments) were 79 % (42/53) in the mesh group and 62 % (39/63) in the non-mesh group (p?=?0.043). The objective success rates in the anterior compartment were 85 % (45/53) in the mesh group and 62 % (39/63) in the non-mesh group (p?=?0.006). Three (6 %) patients in the mesh group and 12 (19 %) in the non-mesh group underwent repeat surgery for recurrent pelvic organ prolapse (p?=?0.03). The subjective success rates were 89 % (47/53) in the mesh group and 76 % (48/63) in the non-mesh group (p value?=?0.08). The mean patient satisfaction rates with the surgery were 84 % in the mesh group and 76 % in the non-mesh group (p?=?0.08). The development of a urinary tract infection, right-sided buttock pain (temporary sciatic neuralgia) and new-onset stress urinary incontinence were not significantly different between the two groups. The mesh exposure rate was 8 %. Transvaginal cystocele repair using tension-free polypropylene mesh at the time of sacrospinous colpopexy and posterior fascial plication offers lower anatomic recurrence and less need for further prolapse surgery to correct recurrent pelvic floor defects than anterior colporrhaphy, sacrospinous colpopexy and posterior fascial plication.     

Factors influencing success of pelvic organ prolapse repair using porcine dermal implant Pelvicol

Objective

To evaluate factors influencing pelvic organ prolapse (POP) recurrence after repair surgery with a porcine dermal collagen implant (Pelvicol^®).

Study design

From December 2003 to August 2005, 78 patients with mainly stage 3 pelvic organ prolapse by the Pelvic Organ Prolapse Quantification (POP-Q) system underwent vaginal repair using porcine dermal implant. Assessments were made preoperatively and at 6 weeks and one year follow-up. These included physical examination with POP-Q, Incontinence Impact Questionnaire, Urogenital Distress Inventory and the Defaecatory Distress Inventory and questions from the Patient Global Impression of Improvement. Data were recorded on changes in functional status, mesh erosion and adverse events. Procedural success was defined as POP-Q stage 0/1.

Results

71 patients returned for one year follow-up. The overall cure rate was 74.6%. The chance of a successful operation in the younger group was significantly higher than in the older group (OR: 7.5; 95% CI 1.38, 40.69), but this effect is lower and no longer significant after adjusting for compartment (post, anterior, post + anterior) (adjusted OR: 5.5; 95% CI 0.92, 32.6).

Conclusions

A low complication rate and satisfactory overall results were observed in a group of women after POP repair surgery with Pelvicol^®. Whether these results are better or worse than with conventional surgery or non-resorbable mesh implantation is unclear and can only be determined in a randomized controlled trial. There was a strong tendency towards better results in the younger women than in the older women, but the reason for this phenomenon is unclear.     

Factors affecting transient urinary retention after transobturator tape mid-urethral sling surgery for female patients with stress urinary incontinence: a single center experience

Objective

To identify the incidence and potential risk factors affecting postoperative transient urinary retention (TR) with transobturator tape (TOT) mid-urethral sling surgery for female patients with stress urinary incontinence (SUI).

Study design

We reviewed the medical records of 305 patients with SUI who underwent the TOT procedure. Postoperative TR was defined as follows: (1) patients had still voiding difficulty after removing the Foley catheter postoperatively and (2) straining pattern of postoperative voiding with the post-void residual urine volume (PVR) larger than 100 mL during 1st or 2nd trial of self-voiding and (3) these voiding problems are resolved within 48 h without any special treatment. The Foley catheter was removed routinely on the first postoperative day. Age, previous pelvic surgery history, co-existence of cystocele, number of vaginal deliveries and all urodynamic parameters were analyzed and compared between the TR group and control group.

Results

The incidence of TR was 9.5%. Comparative analysis revealed concomitant prolapse surgery including anterior and posterior repair, Valsalva leak point pressure and preoperative PVR. In multivariate analysis, preoperative PVR proved to be a potential risk factor for TR.

Conclusion

TR was not a rare postoperative complication after TOT procedures. Potential risk factors for transient retention include preoperative PVR.     

Estudio prospectivo sobre la efectividad de una minibanda suburetral en el tratamiento de la incontinencia urinaria de esfuerzo

Objectives

To assess the efficacy of the tension-free vaginal tape mini-sling (TVT-S) to treat stress urinary incontinence (SUI) in women.

Material and method

We performed a prospective study of 170 patients who underwent TVT-S insertion and who were followed-up for at least 24 months. Both the objective and subjective cure rate were evaluated using clinical examination and the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF).

Results

The final number of assessed women was 137. The objective cure rate was 84% and the subjective cure rate was 91.2%. There were 7 complications during the surgery and 5 cases of mesh exposure (3.6%) during the follow-up period.

Conclusions

In our experience, the TVT-S cure rate for SUI is acceptable but is lower than the published cure rate for tension-free transvaginal tape (TVT) and tension-free transvaginal tape obturator (TVT-O).     

Combined anterior vaginal wall mesh with sacrospinous ligament fixation or with posterior intravaginal slingplasty for uterovaginal or vaginal vault prolapse

Objective

To evaluate outcomes of anterior vaginal wall mesh augmentation with concomitant sacrospinous ligament fixation (SSLF) or with concomitant posterior intravaginal slingplasty (IVS) for uterovaginal or vaginal vault prolapse.

Study design

Women with symptomatic uterovaginal or vaginal vault prolapse were randomly allocated to SSLF or IVS. All underwent concomitant anterior repair augmented with self-tailored multifilament polypropylene and polyglactin composite mesh. Before and 2, 12, 24 and 36 months after surgery, the outcome was assessed by examination and standard questions. The primary endpoint was anatomic recurrence of pelvic organ prolapse at stage II or beyond (−1 cm or greater) at any site of the vaginal wall. Secondary outcomes included perioperative and postoperative complications, symptom resolution, reoperation and mesh exposure.

Results

Twenty-two women were recruited from March 2003 to December 2005. At 3-year follow-up3 (2 posterior and 1 apical) out of 14 (21%) in the IVS group had anatomic recurrences of pelvic organ prolapse, and 1 anterior out of 8 (13%) in the SSLF group. Severe operative complications or reoperations did not occur. The proportions of symptomatic patients, including those with dyspareunia, did not differ between the groups. Erosion of the anterior multifilament mesh was found in 2 out of 22 cases (9%; 95% CI 3-28%).

Conclusion

At 3-year follow-up anterior repair reinforced with a composite mesh with concomitant sacrospinous ligament fixation or with concomitant posterior intravaginal slingplasty allowed feasible support in patients with severe pelvic organ prolapse.     

Transvaginal Prolift mesh surgery due to advanced pelvic organ prolapse does not impair female sexual function: a prospective study

Objectives

To evaluate sexual function among women with advanced pelvic organ prolapse (POP) before and after Prolift^® vaginal reconstructive mesh surgery.

Study design

Assessments were performed preoperatively and 12–18 months after the surgery, including physical examination using the Pelvic Organ Prolapse Quantification (POP-Q) scale as well as the Female Sexual Function Index (FSFI) questionnaire.

Results

Fifty-nine sexually active patients who underwent vaginal reconstructive surgery due to advanced POP between June 2008 and January 2010 were included in the study. Analysis of the FSFI questionnaire showed no statistically significant differences after surgery, despite proper anatomical results. When comparing the group of women who underwent additional surgical restoration of the perineal body with patients without this procedure we also did not observe any differences in FSFI scores.

Conclusions

Surgical treatment of advanced POP with the Prolift^® system does not negatively influence sexual function, but patients should not expect a significant improvement after this type of operation. Additionally performed surgical restoration of perineal body does not reduce sexual function, either.     

Outcome after anterior vaginal prolapse repair: a randomized controlled trial

OBJECTIVES: To report 1-year outcomes of a randomized controlled trial comparing polypropylene mesh-reinforced anterior vaginal prolapse repair with anterior colporrhaphy. METHODS: Seventy-six patients with stage II or greater anterior vaginal prolapse were randomly assigned to either colporrhaphy or polypropylene mesh repair. The primary outcome was recurrent stage II anterior vaginal prolapse, and secondary outcomes were effects on quality of life and sexual symptom scores, operative time, blood loss, length of hospitalization, and adverse events. RESULTS: Thirty-eight women had anterior colporrhaphy, and 37 had polypropylene mesh repair. One patient allocated to mesh repair withdrew from the study before surgery. Clinical and demographic data did not differ significantly between the two treatment groups. One year after surgery, optimal and satisfactory anterior vaginal support were obtained in 21 of 38 (55%) of the colporrhaphy group and 33 of 38 (87%) of the mesh group (P=.005). Patients in both groups reported less bother after surgery in both prolapse and urinary symptoms. The rates of de novo dyspareunia were 4 of 26 (16%) and 2 of 23 (9%) in the colporrhaphy and mesh groups, respectively. Two of 37 (5%) patients had vaginal mesh extrusion. Nine anterior colporrhaphy patients would have to have recurrent anterior vaginal prolapse to prevent one vaginal mesh extrusion. Neither serious adverse events nor deaths occurred in either group. CONCLUSION: Anterior vaginal prolapse repair with polypropylene mesh reinforcement offers lower anatomic recurrence than anterior colporrhaphy at one year. However, quality of life and sexual symptoms scores improved in both groups.