Anterior Elevate System for Treatment of Cystocele and Vault Prolapse via Single Incision Prolapse
Introduction / Background
Anterior vaginal wall relaxation (cystocele) is one of the most commonly diagnosed forms of pelvic organ prolapse in women. More than 200,000 cystocele repairs are completed yearly, however to date the procedures that are completed do not provide very high cure rates and/or poor anatomic outcomes. Successful treatment of anterior vaginal wall prolapse remains one of the most challenging aspects of pelvic reconstructive surgery we face. We have developed very good procedures that provide excellent support for the posterior wall (ie rectoceles) and the apex of the vagina (ie vaginal vault prolapse) and reproduce normal anatomy. We were one of the first centers in the country to utilize grafts in rectocele repairs and have seen improved cure rates to over 90% with minimal complications. It has been known for many years that abdominal sacralcolpopexy with placement of a mesh graft at the top of the vagina for vaginal vault prolapse is the most successful procedure in the literature. We have made advancements with this procedure as well in being able to offer our patients a laparoscopic minimally invasive approach for sacralcolpopexy, with the same excellent cure rates (>92%) and with hospital stays typically less than 24 hours and reduced complications. However the anterior wall has been one of the most difficult compartments in the vagina to get good anatomic results and high cure rates with traditional repairs and at the same time not cause sexual dysfunction, pain with intercourse, voiding dysfunction (ie incontinence or urgency/frequency syndrome), or a shortened or scarred down vagina. The transobturator approach was developed as a less invasive way to place an anterior wall graft (see below) however this still involved blind needle passes and the graft did not support the apex of the vagina, therefore the search for improvements in these procedures is ongoing.
Fig 1 - Normal anatomic support of the pelvis and the bladder. Note the layer of pubocervical fascia that supports under the bladder and keeps it in proper position.
Anterior vaginal wall reconstruction concentrates on the surgical repair of cystocele, which in essence is a hernia that occurs when the bladder bulges down into the vagina due to attenuation or site-specific defect of the pubocervical fascia. This fascia is the layer under the vaginal skin that provides support to the bladder and keeps it in its normal anatomic position in the pelvis (Fig 1). It stretches from one side of the pelvis to the other (from what is called the white line or the arcus) and provides a floor of support that the bladder sits on. If this fascia has a tear in the middle of it (midline defect), is torn away from the pelvic sidewalls (paravaginal defects) or is just generally stretched out or attenuated beyond its capacity to recover, the result is that the bladder sags down or bulges out of the vagina with a resultant cystocele (Fig 2).
Fig. 2 - Cystocele. Defect (hernia) in the supportive layer
(pubocervical fascia) causing the bladder to drop
into the vagina and creating a bulge (cystocele) that
may eventually protrude outside the vaginal opening.
Traditionally, the cystocele has been repaired with what is called an Anterior Colporhaphy (or simply Anterior Repair) which requires plication of the fascia from side to side from the bladder neck up to the top of the vagina. It is still today the most commonly performed procedure to treat cystoceles, despite failure rates in the literature typically in the range of 30-50%. It is one of the oldest procedures ever described for prolapse, and despite its poor cure rates, it continues to be performed by most gynecologists and urologists to treat cystoceles. In fact many patients are even told by their physicians to wait to get the procedure done until they are older as they will just have to get it done again at some point because eventually they will fail! In addition to having high failure rates, typically the anatomic outcomes are not optimal either as once the tissues are plicated together in the midline, the vagina can be constricted and then even further shortened as the surgeon cuts off what they call excess vaginal skin. This very commonly can cause pain with intercourse or the inability to have intercourse if the vagina is too constricted or shortened. It may reduce the bulge, however this is not a true repair, it is just a compensatory procedure that is plicating weakened tissue to weakened tissue that most likely will eventually tear or stretch out again, subjected to the same forces that caused the prolapse initially. Additionally, it is not uncommon to have voiding dysfunction following this tightening of tissue right under the bladder neck. Another theory of why these repairs fail is that if the patient actually has paravaginal defects (ie the tears are actually out laterally and the support has pulled away from the pelvic sidewalls), then the surgeon is actually pulling the good fascia farther from the sidewalls by plicating in the midline.
Traditional Anterior Repair. The tissue under the bladder is plicated and pulled together in the midline, thus reducing the bulge. Following the reduction, excess vaginal skin is then cut off which can create a shortened or constricted vagina.
Over the past 15-20 years, Richardson and others have popularized the paravaginal defect repair for cystoceles. The concept is that the floor of support (the anterior vaginal wall) under the bladder is intact in the midline, however it has torn away from its lateral attachments to the pelvic sidewall muscle and fascia. The repair involves locating the lateral tears of the pubocervical fascia away from the pelvic sidewalls and re-creating normal anatomy by actually repairing the tears, thus bringing the bladder up into its normal anatomic position in the pelvis. This procedure is most commonly completed abdominally, as even the experts in the vaginal approach for paravaginal repair admit inadequate cure rates and high complication rates with high rates of bleeding and technical difficulties in performing the procedure vaginally. The surgeon actually has to tear down any remaining support out to the sidewalls prior to the repair and then try to reconnect the lateral vaginal support tissue back up to the white line through the vagina. Visibility is very poor and most “experts” in this type of repair have abandoned the vaginal approach. We believe that the paravaginal repair completed abdominally, more specifically, laparoscopically, is the most anatomic repair of the anterior vaginal wall that is available (see our section on Laparoscopic Paravaginal Repair). Laparoscopically, we are able to visualize the defects very clearly and then actually repair the tears directly back out to the pelvic sidewall. Utilizing this approach, the vaginal wall is not incised at all (and no vaginal skin is removed) and therefore vaginal wall length and caliber are maintained, which we feel is very important for sexual function. Our laparoscopic approach offers patients a very minimally invasive approach to the repair, and in young sexually active patients is still our primary approach to cystocele repair (sometimes combined with mesh placed at the top of vagina for apical support—ie laparoscopic sacralcolpopexy). However, the laparoscopic approach is technically very difficult, requires advanced surgical skills and very few centers in the country are able to offer this approach, therefore an abdominal incision is required which makes the procedure much more invasive and less favorable among surgeons and patients. Additionally, although theoretically paravaginal repair would seem more effective (we feel it is certainly much more anatomic repair), it has never been proven to be more effective that traditional anterior repair. Again, even with paravaginal repair we are relying on suturing the patient’s native tissue back together, and this is the tissue that failed in the first place, therefore may be the cause of recurrence in the future.
Paravaginal Repair completed Laparoscopically. The fascia of the anterior vaginal wall that should be keeping the bladder in place up in the pelvis is torn away from the sidewalls causing the bladder to rotate and descend down creating the bulge of the cystocele. The tears are visualized and repaired from above as depicted in the diagrams.
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