Pelvic organ prolapse (POP) is a significant health issue in females worldwide [
Graft use in prolapse surgery is somewhat controversial, however it has been proven to be very effective and has become a standard of care in the treatment of severe apical prolapse. Abdominal Y-mesh sacralcolpopexy has the highest cure rates in literature for vault prolapsed, and the benefit of utilizing mesh in the repair seems to outweigh the risks [
The transobturator space has been shown to be a very safe space for the placement of tension-free tape slings for the treatment of stress urinary incontinence and has simplified the technique of this procedure [
This study is a descriptive retrospective case series of 77 consecutive women with symptomatic Stage 2 or greater anterior wall prolapse (cystocele) that underwent anterior repair with mesh graft augmentation with needles passed through the transobturator space utilizing the Perigee procedure over a 2-year period at our center. Comprehensive preoperative urogynecologic exams were completed including prolapse quantification utilizing the International Continence Society Pelvic Organ Prolapse Quantification (POP-Q) staging system. Additional testing included complex urodynamic testing to evaluate for the presence of concomitant stress urinary incontinence (or detrusor instability) with and without the patient’s prolapse reduced. If SUI was documented on urodynamic testing, with or without the prolapse reduced, the patient was scheduled for a tension-free sling procedure at the time of surgery. A sling was not placed prophylactically in any patient if SUI was not seen on testing. All procedures were performed by the authors.
After signing informed consent, the patients were taken to the operating room and prepped and draped in the dorsal lithotomy position using adjustable Allen stirrups. Typically, the anterior compartment was addressed first if other repairs or incontinence procedures were completed. A weighted speculum and/or a self-retaining retractor was utilized to obtain exposure. The anterior wall of the vagina was infiltrated subcutaneously with a solution of 1/4% lidocaine and
The vaginal epithelium was then grasped and then dissected off of the bladder and out laterally to the pelvic sidewalls up to the level of the ischial spines bilaterally. Apically and in the midline, the bladder was dissected all the way up and off the cuff of the vagina or the cervix if the uterus was in place. This dissection is essentially the same as we would complete for an anterior repair. We tried to make our dissection slightly deeper than we would for standard anterior repair and leave some of the endopelvic fascia on the vaginal epithelium in order to reduce the risk of mesh complications. This dissection leaves a thicker vaginal epithelium over the mesh once closed. After the dissection was completed, 4 small stab incisions are made in the groins. The superior incisions were made in the genitofemoral crease below the adductor longus tendon at the approximate level of the clitoral hood. The inferior incisions were made 3 cm inferior and 2 cm lateral to the superior incisions bilaterally. The needles are passed through the groin incisions and the obturator space (Figure
Inferior or “apical” needle being passed through the obturator space to attach the more apical arm of the mesh graft to the pelvic sidewall at the level of the ischial spine.
Once all the needles were removed, the tail of the mesh was cut according to the patients vaginal length and the apical aspect of the graft was attached to the pericervical ring or the cuff of the vagina with absorbable sutures. The arms were then adusted and tightened in a tension-free fashion which created a hammock-effect under the bladder and elevated the bladder back into its normal anatomic position. The final positioning placed the mesh under the bladder and attached laterally to the arcus tendineus from the bladder neck up to the ischial spine bilaterally (Figure
Final positioning of the mesh providing support under the bladder.
If an incontinence procedure was completed concomitantly, a separate suburethral incision was made, and the tension-free sling was placed utilizing standard technique. Remaining prolapse procedures were then completed as necessary. Postoperatively, vaginal packing and foley catheter were left in for 24 hours. If stable, patients were discharged home on postoperative day one and antibiotics were given for 5 days postoperatively. Vaginal estrogen cream was started one week postoperatively and used every other day.
Patients were evaluated in the office at 4 weeks, 3 months, 6 months, and then every 6 months thereafter. ICS POP-Q staging was completed as well as subjective assessment of prolapse (feeling or seeing a bulge), incontinence and urinary urgency, and frequency symptoms. Objective cure was defined if the midline anterior vaginal wall (point Ba) was
Patient demographics are presented in Table
Demographics.
Age (years) | 70.5 |
Parity | 2.8 |
Previous hysterectomy | 68.8 % |
Menopausal | 87.2 % |
Estrogen use | 27.4 % |
Previous repair | 40.2% |
7.8% |
Concomitant procedures.
Procedure | % | |
---|---|---|
Hysterectomy | 2 | 2.5 |
Vaginal Vault | ||
15 | 19.5 | |
6 | 7.8 | |
8 | 10.4 | |
Posterior repair | ||
17 | 22.1 | |
12 | 15.6 | |
3 | 3.9 | |
Tension free slings | 32 | 41.2 |
Average blood loss was 77cc (range 10–400cc). There were 2 intraoperative bleeds that formed hematomas under the anterior wall after initial closure that required opening up the anterior wall incision after finishing other repairs (patients were still in the operating room). The hematomas were evacuated and bleeding was controlled with sutures. One of these patients required a postop blood transfusion of 2 units of PRBCs on postoperative day 1. This was the only patient in the series that required transfusion. There were no postoperative bleeds or hematomas and no patient had to be taken back to the O.R. for bleeding or pain. There was one midline cystotomy, above the trigone, that occurred during the dissection of the anterior wall. This was closed in a 2-layer fashion with absorbable sutures and the mesh was still placed. There were no bladder injuries passing any of the needles. The average hospital stay was 1.2 days (range 1 to 4 days). Average time to void was 2.4 days (range 1–10 days). Foley catheters were taken out on postoperative day one and voiding trial attempted. If patient did not pass the voiding trial, she was sent home with an indwelling catheter and voiding trial was reattempted on postop day 3. The patient that had the complication of cystotomy had her catheter in for 10 days and had no sequelae from the injury.
Average followup was 18.1 mos (range 3–36 mos ). Objective cure rate was 93.5%, using a definition of Ba
Preoperative versus postop POP-Q measurements (mean).
Preoperative | Postoperative | ||
---|---|---|---|
Mean POP-Q measurements | |||
Total Vaginal Length (cm) | NS |
Fifty-three patients (68%) complained of urge leakage and urge symptoms preoperatively and 39 of these patients (73%) had resolution of these symptoms postoperatively following their surgery. Three patients (3.8%) developed denovo urge symptoms postoperatively requiring treatment with anticholinergic agents. Two patients (2.5%) have had problems with recurrent UTI’s since surgery.
Seven patients suffered from SUI postop. Three (4%) had concomitant tension-free slings (2 TVT, 1 TOT) at time of surgery that failed. One of these patients had repeat TVT sling and was cured, one patient had periurethral collagen and was cured, and the 3rd patient opted for no treatment. Two patients (2.7%) early in the series suffered from preop SUI; however no sling was placed as it was thought that the Perigee may be able to be used to treat SUI as well. This was found not be successful as both patients suffered from persistent SUI postop. One underwent TVT sling at 2 months postop and was cured, and the other opted for no treatment as she had very mild SUI. The last two patients (2.7%) did not have SUI preop neither subjectively nor objectively with their prolapse reduced; however they developed it postop. One had subsequent TVT sling and was cured, and the other opted for no treatment as she had very mild symptoms.
There were no postoperative infections of the mesh and no mesh had to be removed secondary to infection or pain. No patients had to be taken back to the operating room for revision of the mesh or release of the lateral mesh arms due to pain. Five patients (6.4%) suffered from mesh extrusion due to healing defects (4 discovered
Repair of anterior wall prolapse has been one of the most challenging aspects of the pelvic reconstructive surgeon for many years and continues to be the compartment that plagues the surgeon with recurrences after repair. The search for a permanent cure of the cystocele has been going on for more than a century and continues into present day. Traditional vaginal repair of cystocele utilizing the patient’s own tissue is a compensatory procedure that does not restore normal anatomy and has very high failure rates. The traditional anterior colporrhaphy plicates weakened tissue together, under tension which most likely leads to its high failure rates. Richardson identified that a large percentage of cystoceles were actually caused by tears of the pubocervical fascia away from the arcus tendineus pelvi and this caused rotational descent of the anterior wall leading to cystocele [
General surgeons have been utilizing synthetic mesh in the repair of hernias for many years and have seen the benefit of increased cure compared to repair with native tissue under tension. Graft use in pelvic surgery has been reported on for many years; however it is only recently that its use seems to be more widespread. Although its use vaginally has been somewhat controversial, most seem to agree that grafts may be necessary to try to achieve more anatomic repairs with higher cure rates. The management of using a mesh graft in the anterior compartment is also supported by a recent Cochrane review that reported a higher rate of recurrent prolapse after anterior colporrhaphy than after mesh repair [
With the success of apical graft use, more recently, graft augmentation of prolapse repair has been utilized via the vaginal route. A review of the series that have utilized synthetic meshes for vaginal cystocele repair can be seen in Table
Review of literature of mesh use in cystocele repair.
Author | Year | Mesh | Followup (months) | Anatomical success rate (%) | Vaginal infection (%) | Vaginal erosion (%) | |
---|---|---|---|---|---|---|---|
Julian [ | 1996 | Marlex | 12 | 24 | 100 | 0 | 8.3 |
Nicita [ | 1998 | Marlex | 44 | 3 | 93.2 | 0 | 2.3 |
Flood et al. [ | 1998 | Marlex | 142 | 36 | 94.4 | 3.5 | 2.1 |
Mage [ | 1999 | Mersuture | 46 | 26 | 100 | 0 | 2.2 |
Migliari et al. [ | 2000 | Prolene | 12 | 20 | 75 | 0 | 0 |
Hardiman et al. [ | 2000 | GyneMesh | 18 | 1 | 100 | 0 | 11.1 |
Adhoute et al. [ | 2004 | GyneMesh | 52 | 27 | 95 | 0 | 3.8 |
Shah et al. [ | 2004 | Prolene | 29 | 25 | 93.3 | 0 | 6.7 |
Dwyer and O’Reilly [ | 2004 | Atrium | 47 | 29 | 94 | 0 | 7 |
Milani et al. [ | 2004 | Prolene | 63 | 17 | 94 | 0 | 13 |
de Tayrac et al. [ | 2006 | GyneMesh | 63 | 37 | 89.1 | 0 | 9.1 |
de Tayrac et al. [ | 2007 | Sofradim Soft poly-propylene | 132 | 13 | 92.3%. | 0 | 6.3 |
*Hiltunen et al., [ | 2007 | Low-weight polypropylene | 104 | 12 | 93.3% versus 61.5% ant repair | 0 | 17 |
*Sivaslioglu et al. [ | 2008 | Polypropylene (Sofradim) | 90 | 12 | 91% versus 72% (ant repair) | 0 | 6.9 |
*Nieminen, et al. [ | 2008 | Low-weight polypropylene | 105 | 24 | 89% versus 59% (ant repair) | 0 | 8.0 |
*denotes prospective randomized trial.
de Tayrac et al., in an attempt to simplify the technique of graft placement and attachment, were one of the first to utilize the transobturator route for partial attachment of a mesh graft in the anterior compartment; however, they only utilized the space to attach the graft laterally at the level of the bladder neck [
In 2004, Rane began devising a technique to utilize the obturator space to attach the graft not only at the bladder neck but also more apically through the white line near the ischial spine utilizing needles passed through the obturator space. He felt that a strong four-point fixation of the mesh to the lateral pelvic sidewalls will lead to higher long-term cure rates. The Perigee procedure was developed based on these ideas and utilizes two different shaped helical needles passed through the obturator space to attach a mesh graft to the pelvic sidewall at the level of the bladder neck and higher up in the vagina near the ischial spine. Anatomic studies completed on cadavers have shown the needle passages to be a safe distance from the critical vessels and nerves in the space including the obturator and pudendal vessels and nerves. The dissection is the same that is utilized for anterior repair and does not require dissection into the retropubic space nor to the sacrospinous ligament therefore keeping the dissection simplified and minimizing risks of bleeding. The result of the procedure is an anterior wall mesh that supports the bladder from the bladder neck up to the ischial spine and from sidewall to sidewall.
The current study is one of the first reports in the US literature on a series of patients that underwent the transobturator Perigee procedure for anterior wall prolapse with followup greater than a year. We found the surgical procedure a minimally invasive, safe, and time-efficient method to place an anterior wall mesh for treatment of cystocele. We have previously attempted other techniques of graft placement in the anterior compartment and found them to be very time-consuming and difficult with extensive dissections and high risk of bleeding and abandoned them for these reasons. The Perigee procedure has the advantage of simplicity and standardization as it comes in a kit with a prefabricated graft and accompanying needles.
Our series showed excellent anatomic results and an objective cure rate of 93.5% (Ba
Concerning the safety of the procedure, bleeding was minimal in most cases with average blood loss at 77cc. Two patients did develop intraoperative hematomas under the anterior wall during completion of other procedures; however the bleeding was found to be secondary to the dissection and not the needle passes through the sidewall. One of these patients had a blood loss of 400cc and did require blood transfusion postoperatively; however our threshold for transfusion in her was lower secondary to her suffering from mild anemia preop as well as sarcoidosis with diminished lung capacity. She recovered well without any further sequelae. No patient had any postop bleeding nor required reoperation for bleeding. One patient suffered a midline cystotomy during the procedure; however this was during the dissection of the anterior wall and was not related to the mesh or needle passes. We repaired the cystotomy with a double layered closure, still placed the mesh, and she recovered without sequelae.
Recently, concerns over complications with vaginal mesh and vaginal mesh kits have been raised [
There has also been concern of groin-pain following transobturator procedures; however we did not have any patients that suffered from long-term pain in the groin region. We feel that this is secondary to the needles being passed from the outside-in and being careful to stay below the adductor longus tendon with the superior pass as well as staying as medial as possible to the ishiopubic ramus during both needle passes. One patient did suffer from short-term groin pain and periurethral pain unilaterally; however this resolved spontaneously by 2 weeks postop. We also feel that it is very important to avoid any tension on the lateral mesh arms as this can also lead to not only potential groin pain but also vaginal pain or dyspareunia. We did have two patients that suffered from vaginal pain postoperatively and were found to have levator myalgia and pelvic floor spasm on exam. They were placed on a muscle relaxant, and both patients pain, resolved by the fourth week postoperatively. This type of pain may be secondary to the mesh arms traversing the levator muscles; however we have also seen this type of pain with traditional uterosacral vault suspension, which typically also resolves with time and muscle relaxants. We did not have any patient present with delayed groin or vaginal pain and saw no evidence of the mesh arms “tightening” or the mesh shrinking over time, which could potentially cause pain to develop further out from surgery.
There has also been significant concern over the thought that the use of mesh or mesh kits causes an increased risk of dyspareunia compared to traditional repair [
The complication of vaginal mesh extrusion has made many surgeons very hesitant to utilize synthetic mesh vaginally. In the current series, our overall rate of mesh extrusion was 6.4% (5/77), which is consistent with other reports in literature. All extrusions but one were seen prior to 12 weeks postoperatively. One patient healed spontaneously with vaginal estrogen treatment alone, and the other four required minor revision in the O.R. under local anesthesia and mild sedation (5.1% overall revision rate). We have found that when an extrusion occurs, it is typically a very small defect that can be treated easily with small excision and closure of the epithelium that does not result in long-term sequelae. No patient suffered from infection of the mesh or required removal of the entire graft secondary to infection or pain. We feel the low extrusion rate, and minimal morbidity is secondary to the mesh being a soft macroporous monofilament polypropylene (Type I) mesh, which seems to be the best tolerated graft material available today for vaginal surgery. We also feel that, by keeping the vaginal incision as small as possible, making a slightly deeper dissection, excising minimal vaginal epithelium, and utilizing pre- and postoperative vaginal estrogen help keep mesh extrusion rates as low as possible. Vaginal erosion of synthetic mesh is a common, but seemingly accepted, complication of abdominal sacralcolpopexy with an overall rate of 3.4%; however typically these erosions occur at the apex of the vagina [
In conclusion, we have found that the vaginal repair of anterior wall prolapse utilizing an anterior wall mesh placed with needles passed through the transobturator space, a safe minimally invasive and effective procedure for the treatment of anterior wall prolapse in this subset of mostly postmenopausal patients. We feel that the role of mesh in vaginal repairs is in its infancy, and much study still needs to be done to determine the ideal material to be utilized and the optimal way to place and attach the graft vaginally and the proper patient to utilize it in. A limitation of any surgical trial that also has to be considered is surgeon experience, expertise, and skills with the particular procedure and anatomy. Complications in the current trial may have been kept to a minimal secondary to this variable (i.e., a higher level of expertise) and therefore the translation of the results to general ob/gyns and/or urologists must be considered. The current study is limited by its retrospective nature and medium-term followup and we do recommend further prospective studies with longer term followup prior to recommending its general use in clinical practice.