Sacrocolpopexy

Updated: Jan 28, 2021
Author: Wellman W Cheung, MD, FACS; Chief Editor: Kris Strohbehn, MD 

Overview

Practice essentials

Sacrocolpopexy (sacral colpopexy) is a surgical technique for repairing pelvic organ prolapse. Reconstruction is achieved with an open abdominal technique or with the use of minimally invasive techniques. The specific treatment approach is chosen in accordance with the type and degree of pelvic organ prolapse, as well as the severity of symptoms.

The image below illustrates the Pelvic Organ Prolapse Quantification staging system.

Prolapse staging according to the Pelvic Organ Pro Prolapse staging according to the Pelvic Organ Prolapse Quantification staging system.

Equipment

A basic exploratory laparotomy instrument set provides most of the needed surgical instruments. The following may be required:

  • Balfour, Turner-Warwick, or Bookwalter retractor

  • Vaginal instruments (eg, weighted speculum, Breisky retractors, a tenaculum, ring forceps, dilators, or an end-to-end anastomotic sizer)

  • Cystoscope

A graft is used to support the vaginal wall and suspend the apical vault to the sacral promontory. Material types include the following:

  • Autologous (patient’s own tissue)

  • Allograft (tissue obtained from members of the same species)

  • Xenograft (biologic material procured from other species)

  • Synthetic: The US Food and Drug Administration (FDA) notes that serious complications are not rare with the use of surgical mesh in transvaginal repair of pelvic organ prolapse (see FDA Safety Communication: Update on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse)

Technique

The key aspect of abdominal sacrocolpopexy is the suspension of the vaginal apex to the sacral promontory in a manner that recreates the natural anatomic support provided by the uterosacral and cardinal ligaments.

Steps in an abdominal sacrocolpopexy include the following:

  • Modified low lithotomy position

  • Intravenous prophylactic antibiotic (typically cefazolin)

  • Foley catheter

  • Pfannenstiel incision a few centimeters cranial to the pubic symphysis

  • Incision through the rectus fascia and separation of recti abdominis

  • Entry into the peritoneum and exposure of the surgical field, with bowel packed away from the field

  • Dissection of the bladder away from the anterior vagina along the vesicovaginal septum; continued posteriorly to separate the vagina from the rectum along the rectovaginal septum

  • Placement of an instrument in the vagina

  • Exposure of retroperitoneal space

  • Identification of the point for fixation of the graft: the sacral promontory

  • Selection of graft material and construction of graft

  • Positioning and fixation of graft in a tension-free manner

  • Closure of peritoneal reflection over the graft

Surgical concepts of the laparoscopic approach are similar. Additional points include the following:

  • Use of 4 or 5 trocar sites

  • Dissection with laparoscopic monopolar scissors and bipolar cautery

  • Fixation of mesh with nonabsorbable monofilament sutures and laparoscopic needle drivers; alternatively, bone anchoring devices are available

Robotic technology has also been employed.[1]

Alternative operations for apical (vaginal vault) prolapse repair include the following:

  • Sacrospinous ligament fixation

  • Uterosacral ligament suspension

  • Iliococcygeus suspension[2]

Background

Pelvic organ prolapse refers to the symptomatic descent of at least two parts of the vaginal wall—the anterior/posterior walls and the apex. Prolapse of these components of the wall can trigger subsequent prolapse of the cervix and/or uterus—or the vaginal cuff following hysterectomy. Similar to abdominal hernias, pelvic organ prolapse can be considered a herniation of either pelvic or abdominal contents through a structural weakness in the pelvic floor.

Symptoms of pelvic organ prolapse have been defined in a joint report from the International Urogynecological Association and International Continence Society as “a departure from normal sensation, structure, or function, experienced by the woman in reference to the position of her pelvic organs.”[3]

The Pelvic Organ Prolapse Quantification (POPQ) system and the Baden-Walker system are two systems that can be used to evaluate the degree of prolapse. DeLancey has graded these protrusions according to abnormalities in three different levels of anatomic support,[4] whereas the POPQ is an objective and ordinal classification system.[5] Prolapses are named based on the organ that has descended; for example, a defect in which the urinary bladder has herniated through the anterior vaginal wall is a cystocele. Uterovaginal prolapse and vaginal cuff prolapse are apical defects. Enteroceles are a hybrid of anterior and posterior defects, and refer to herniation of the intestines into the apical wall.

Staging

The International Urogynecological Association and International Continence Society have adopted a standardization of terminology for the evaluation and description of prolapse in the POPQ.[3, 6]  The hymen remnant is the fixed reference point in this system. Although the method of measurement and defined stages of prolapse remain under debate, the original description by Bump et al defines six points to compare in relation to the hymen, as shown in the image below.[6]

Six sites (Aa, Ba, C, D, Bp and Ap), genital hiatu Six sites (Aa, Ba, C, D, Bp and Ap), genital hiatus (gh), perineal body (pb), and total vaginal length (tvl) used for pelvic organ support quantification.

The degree of prolapse is then stratified into an ordinal staging system[3] :

  • Stage 0: No prolapse

  • Stage I: Most distal point is greater than 1 cm proximal to the hymen

  • Stage II: Most distal point is between 1 cm proximal to the hymen and 1 cm distal to the hymen

  • Stage II: Most distal point is greater than 1 cm distal to the hymen

  • Stage IV: Complete eversion of the length of the lower genital tract

The image below shows the POPQ staging system.

Prolapse staging according to the Pelvic Organ Pro Prolapse staging according to the Pelvic Organ Prolapse Quantification staging system.

Such a classification system allows a standard method of exchanging information between physicians and allows better comparison of research data. Review of this system has shown good interobserver and intraobserver reproducibility.[5]

Etiology

Multiple factors contribute to the etiology of fascial or ligament weakness that ultimately result in pelvic organ prolapse. They can be related to or involve some combination of comorbidities, genetic, and environmental influences. Risk factors for pelvic organ prolapse include the following:

  • Increasing age

  • Increasing body mass index (obesity)

  • Increasing gravidity

  • Increasing parity

  • Number of vaginal deliveries

  • Macrosomic delivery

  • Chronic obstructive pulmonary disease

  • Constipation

  • Strenuous activity, weight bearing, or strenuous labor

Swift et al examined a cohort of 497 women older than 18 years who presented for routine gynecology evaluation in an outpatient setting.[7] Investigators identified a positive association between prolapse trend and parity, number of vaginal deliveries, and more specifically, number of vaginal deliveries of macrosomic infants. There was also a higher incidence of prolapse in postmenopausal women. A multicenter study consisting of 1004 women identified the following risk factors on univariate analysis: increasing age, body mass index (BMI), gravidity, parity, number of vaginal deliveries, and weight of the vaginally delivered infant.[8] Subsequent multivariate analysis revealed that only increasing age, Hispanic race, increasing BMI, and higher weight of the infant delivered vaginally were risk factors for prolapse.[8]

Nygaard et al studied participants of the Women's Health Initiative (WHI) Hormone Replacement Therapy trial and found that risk factors for prolapse differed based on the grade of the prolapse itself. For patients with stage II prolapse and above, education level, number of vaginal deliveries, and infant birth weight were risk factors that distinguished affected patients from those at earlier stages.[9]

Chronic obstructive pulmonary disease (COPD), constipation, and a history of strenuous exercise or manual labor have also been associated with pelvic organ prolapse.[10, 11, 12] Though prior studies have identified race as having a potential connection with prolapse, the correlation has appeared to vary based on the selection bias. Further studies are needed to clarify the association.

Surgical treatment

Sacrocolpopexy is a surgical technique used in cases of pelvic organ prolapse—in particular, apical and vaginal vault prolapses in females. Reconstruction involves attaching the apical portion of the vagina—or for women who have undergone hysterectomy, the vaginal cuff—to the sacral promontory. The procedure is meant to mimic the suspension normally provided by the uterosacral and cardinal ligaments, and can be attained with open technique or with laparoscopic or robotic surgery. Patients who also present with uterine prolapse can undergo hysterectomy at the time of reconstruction, or choose from a number of uterine-sparing options.

Preoperative assessment is paramount to the success of the reconstruction, as the type of surgery is predicated on the type and grade of organ prolapse, in addition to presenting symptoms. For instance, there may be concomitant herniation of other aspects of the vaginal wall also requiring repair. These patients may be better served with a transvaginal approach.

Epidemiology

Pelvic organ prolapse has a prevalence of 31-41% among menopausal women, according to large multicenter observational studies.[10, 13]  One such study examined women at an outpatient gynecology clinic and reported the following distribution according to the POPQ assessment: 24% stage 0, 38% stage I, 35% stage II, 2% stage III, and 0% stage IV.[8]

Nygaard et al studied a smaller population that was a subset of those enrolled in the WHI Hormone Replacement Therapy trial. They found 2.3% with stage 0 prolapse, 33% with stage I, 62.9% with stage II, 1.9% with stage III, and 0% with stage IV.[9] They found that the lifetime risk of undergoing an operation for pelvic organ prolapse is reported to be 11-19%.[11, 14]

The discrepancy between prevalence of pelvic organ prolapse and the lifetime risk of operation points to the fact that some organ herniation may indicate a normal finding, or present asymptomatically in a subset of women. Swift et al investigated the symptoms and the level at which organ prolapse affected patients’ lives and did find a statistically significant association with POPQ stage. There was a significant correlation of the leading edge of the organ descent as it increased from -3cm to +7cm in association with reporting of symptoms.[15]

Indications

Consideration for surgical repair of apical (vaginal vault) or uterine prolapse is based on adequate assessment of the patient's symptoms and degree of bother, as well as a standard method to quantify prolapse. It is important to note that symptom severity may not correlate with the degree of prolapse. Some degrees of prolapse may be found without symptoms and could represent a normal physical finding.[15, 16]

Symptoms may include the following[3, 17] :

  • Vaginal bulge

  • Pelvic pressure

  • Bleeding

  • Infection

  • Splinting or digitation (the need to manually assist in reducing prolapse, often to void or defecate)

  • Back pain

Concomitant symptoms may include the following[3, 17] :

  • Urinary incontinence symptoms, such as stress, urgency, or postural incontinence

  • Bladder storage symptoms, such as frequency, urgency, or overactive bladder syndrome

  • Voiding symptoms, such as hesitancy, slow stream, straining, incomplete emptying, or position-dependent voiding

  • Sexual dysfunction symptoms, such as dyspareunia or obstructed intercourse

  • Anorectal dysfunction, such as fecal incontinence, flatal incontinence, fecal urgency, straining to defecate, constipation, and incomplete evacuation

Contraindications

Many of the general contraindications to sacral colpopexy are the same for any surgical procedure. These may include the following:

  • Anemia

  • Bleeding diathesis or the need for anticoagulation

  • Significant cardiac or pulmonary comorbidities

  • Active infection such as cystitis, bacterial or fungal vaginal infection, pelvic inflammatory disease, or active sexually transmitted disease

  • Active venous thromboembolism

  • Uncontrolled hyperglycemia

Other contraindications specific to sacral colpopexy include the following:

  • Vaginal cancer, cervical cancer, or uterine cancer that is untreated or cannot be adequately treated due to advanced stage

  • Fistulas such as vesicovaginal, rectovaginal, vesico-utero, or urethral fistulas

  • Previous pelvic prolapse repairs with infected or exposed foreign material and erosions

Relative contraindications include the following:

  • Pelvic irradiation

  • Previous pelvic surgery or prolapse repair, depending on the nature of the operation and the subsequent pathology, side effects, or complications (the existence of such may warrant additional diagnostic evaluation and may require additional surgical intervention or change of approach to prolapse repair)

  • Concomitant cystocele, rectocele, or urinary incontinence (the existence of such pathology may require additional surgery, a vaginal approach, or a combined approach)

 

Periprocedural Care

Pre-procedure planning

History and physical examination

A thorough history and physical examination to assess the degree of prolapse symptoms, in addition to urinary, bowel, and sexual symptoms, are necessary for proper preoperative workup. Symptoms and the degree to which they interfere in patients’ lives can be assessed with validated surveys or quesionnaires that have shown to give accurate and reliable results with regard to quality of life. These are the Pelvic Floor Distress Inventory, the Pelvic Floor Impact Questionnaire, and the Pelvic Organ Prolapse/ Urinary Incontinence Sexual Questionnaire, for which accurate short forms also exist.[18]

Urinary symptoms can be evaluated with the Incontinence Impact Questionnaire-7, a quality of life assessment. Patients should also submit a 24-hour diary that includes urinary volume and frequency.

Information to be collected on history taking includes the following: first menarche, gravidity, parity, number of vaginal deliveries, menstruation cycles, age at menopause if applicable, any history of infections including sexually transmitted diseases, a sexual history, comorbidities, and a thorough surgical history. Women should also undergo cervical cytology screening with subsequent workup of any discovered abnormalities.

Physical examination, while centered on the pelvis, includes an abdominal examination, most importantly to evaluate prior surgical sites, hernias, or masses. While in dorsal lithotomy, the introitus and urethral meatus can be examined for any masses or protrusions. A Graves speculum should then be used to isolate each individual component of the vaginal wall (using the posterior blade). When the blade is rested against the anterior wall, any posterior wall abnormalities can be visualized on their own, such as enterocele or rectocele. The rectal wall can be pushed upward with the examiner’s finger to discern between enterocele and high rectocele. The process is repeated for possible anterior and lateral prolapses.

Other examination maneuvers to consider are the following:

  • Vaginal mucosa examination: to assess the degree of atrophy, which is characterized by rugae loss
  • Q-tip test: to evaluate stress incontinence and urethral hypermobility
  • Bimanual examination: to evaluate the uterus and adnexa
  • Rectal examination: to examine rectal tone and integrity of the rectovaginal septum
  • Examination of the patient in different positions: to assess the effect of gravity

Based on the history and physical examination, the surgeon may recommend additional laboratory studies, imaging, or procedures. Urinalysis should be part of the preoperative workup, with subsequent investigation of infection or microhematuria, if present. Further evaluation would include cystoscopy, a study used to visualize the interior of the bladder with an endoscope. This study becomes important in cases of hematuria to rule out bladder tumors. Vasavada et al have suggested preoperative or intraoperative cystoscopy as an additional tool to distinguish aspects of the prolapse.[19]

It is important to assess for urinary incontinence, as this condition can present concomitantly with pelvic organ prolapse. Prolapse can cause secondary obstruction, such as urethral kinking, and as a result may hide ongoing stress incontinence. On physical examination, the examiner may wish to reduce the prolapse with a pessary, gauze roll, or manually to reveal urinary continence if suspected.

The Colpopoexy and Urinary Reduction (CARE) trial was a prospective study of pelvic organ prolapse patients.[20] Participants were all to undergo sacral colpopexy, but were randomized to a group that would or would not receive Burch colposuspension. Those receiving the additional procedure had a significant reduction in postoperative stress incontinence. This superior outcome was sustained at 2 years postoperatively. The advantage conferred by the colposuspension lends additional evidence to concomitant pelvic organ prolapse and underlying incontinence and points to the importance of working up surgical candidates for both conditions.

Urodynamics before surgery is a topic of debate. The goal would be to identify patients with outlet obstruction, detrusor overactivity, and stress incontinence before repair. Urodynamic evaluation has identified significant numbers of women with stress incontinence and detrusor overactivity who presented with severe prolapse.

A study of 68 women with prolapse evaluated participants with urodynamics: 58% of patients with grade 3/4 cystocele had bladder outlet obstruction, compared with only 4% among the grade 1/2 cystocele group. For women with the more advanced cystocele, normal free flow could be elicited in 94% of the group with vaginal pessary placement. Patients with grade 3 cystocele or higher had detrusor overactivity at a rate of 52%, compared to 20% in grades 1 and 2.[21]

On analysis of the CARE trial data, urodynamic stress incontinence identification depended on how the prolapses were reduced: 27% of women in CARE demonstrated incontinence upon prolapse reduction; 3.7% had leakage without reduction. Among all study participants, even those slated to the Burch colposuspension, patients with preoperative stress incontinence that could be detected by urodynamic study were more likely to experience postoperative stress incontinence.[22]

Roovers et al retrospectively analyzed 76 patients following surgery for vaginal prolapse without simultaneous surgery for incontinence. All patients were evaluated with preoperative urodynamic study. Investigators did not find positive urodynamic study to be predictive of postoperative incontinence.[23]

Technical considerations

Complication prevention

Perioperative complications are bowel obstruction, peritonitis, urine leak in the event of existing cystotomy, dehiscence, and infection. These immediate complications are rare but must be considered, in addition to delayed bleeding in the case of hemodynamic instability.

There are risks involved with anesthesia, positioning, technique, implants, and infection. Complications may be mitigated by carefully considering each of these factors. Proper positioning and cushioning of pressure points can prevent neurapraxia. Special attention should be paid to retractor placement and not to hyperextend the hip to avoid injury to the femoral nerve in modified lithotomy, while the stirrup needs appropriate cushioning to prevent perineal nerve injury. A short intraoperative duration reduces the time the patient spends in a position that makes her more injury prone.

General anesthesia, positioning for the procedure, and compression of great vessels by the procedure or retractor are necessary conditions that favor venous thromboembolism. In a study of Medicare patients having simultaneous prolapse repair with urethral sling versus urethral sling alone, multivariate analysis revealed that postoperative thromboembolic events were three times as probable.[24] As with other surgeries, risk of these complications can be minimized with compression devices, compression stockings, early ambulation following surgery, and prophylactic heparin or LMWH for patients whose risk profile favors coagulation.

Mesh erosion occurs with abdominal sacral colpopexy at a rate of 3-7.6% on average 5-14 months post-operatively, with patients presenting with a constellation of symptoms: dyspareunia, vaginal discharge and bleeding. Studies indicate mixed results with regard to concurrent hysterectomy affecting erosion rates.[25, 26, 27]  The use of monofilament polypropylene mesh has been associated with lower erosion rates. Treating this complication involves transvaginal excision with either partial or complete graft removal. Management can also be accomplished with laparotomy with complete graft removal. Less radical options such as mesh tripping, antibiotics, and estrogen cream are not recommended. In the event of suture erosions into vaginal mucosa, excision of the suture and mucosa cauterization, with intravaginal estrogen and oral antibitiocs has been successful.[28, 29]

The FDA has issued a statement indicating that the use of surgical mesh in transvaginal pelvic organ prolapse repair is not without serious complications. As discussed, the most frequently observed postoperative event is mesh erosion, which takes surgery to repair, though mesh contraction, which causes vaginal tightening and pain, also occurs. These complications can have debilitating, long-term effects in some women. The International Urogynecological Association and the International Continence Society developed guidelines by which to describe mesh-related complications.[30] The system depends on assessing three variables: category, time, site. Each variable is given an alphanumerical code based on the degree of the complication evalued. An interactive classification tool is available based on the report put forward by these organizations.

Outcomes

Objective outcomes are assessed via POPQ or Baden-Walker ordinal classification anatomic measurements. Subjective outcomes are reported by patients on questionnaires. Patient satisfaction is between 85% and 100%.[31] The cure rate (lack of apical postoperatively) is 78-100%. When expanded to include all postoperative prolapse, the rate is 58-100%. Most studies have shown lower success rates in postoperative hernia once the criteria are expanded beyond just apical prolapse.[27, 32]

The rate of reoperation following surgery for prolapse or incontience was 13% in a study of 376 women, measured at 71 months postoperatively.[33] The rate was 17% for women with previous surgery for prolapse or incontinence. A second study reported a reoperation rate up to 29.2%.[11]

Patient education

Each patient should be sent home with specific discharge instructions detailing avoidance of strenuous exercise or heavy lifting within 6-8 weeks postoperatively. This precaution is to allow scar tissue to form to prevent recurrent prolapse. Anything that leads to perineal strain or trauma should be avoided early in the postoperative course. Sexual intercourse and tampon use are also prohibited during the early healing period.

Imaging

The role of medical imaging in evaluating women with pelvic organ prolapse is not standardized. Abnormalities identified on history and physical examination or on other ancillary tests (eg, hematuria on urinalysis) may require further evaluation with abdominal imaging. Empiric upper tract imaging is not mandated. However, an overall 7.7% prevalence of hydronephrosis has been identified in women undergoing prolapse surgery.[34] The prevalence was higher in those with worsening prolapse.[34] In patients with severe pelvic organ prolapse, a preoperative renal ultrasound may identify patients who may require additional assessment or changes in management.

Imaging modalities have been studied for the diagnosis and quantification of pelvic organ prolapse. Pelvic ultrasound can be used to diagnosis prolapse and determine which compartment or organ is responsible for the symptomatic prolapse.[35] Three-dimensional ultrasound has been used to correlate the degree of descent with symptoms.[35] Dynamic magnetic resonance imaging has shown correlation with clinical staging and allows for the measurement of the descent of pelvic organs.[36, 37] Further studies are warranted to assess whether such imaging changes clinical outcomes.

Staging

The International Urogynecological Association and International Continence Society have adopted a standardization of terminology for the evaluation and description of prolapse in the POPQ.[3, 6]  The hymen remnant is the fixed reference point in this system. Although the method of measurement and defined stages of prolapse remain under debate, the original description by Bump et al defines six points to compare in relation to the hymen, as shown in the image below.[6]

Six sites (Aa, Ba, C, D, Bp and Ap), genital hiatu Six sites (Aa, Ba, C, D, Bp and Ap), genital hiatus (gh), perineal body (pb), and total vaginal length (tvl) used for pelvic organ support quantification.

Equipment

A basic exploratory laparotomy instrument set provides most of the needed surgical instruments. A Balfour, Turner-Warwick, or Bookwalter type retractor is used for exposure. Vaginal instruments such as a weighted speculum, Breisky retractors, a tenaculum, ring forceps, dilators, or an end-to-end anastomotic sizer should be available. Intraoperative cystoscopy may be required.

The key aspect of sacral colpopexy is the use of a graft to support the vaginal wall and suspend the apical vault to the sacral promontory. The types of materials can be categorized into autologous, allograft, xenograft, and synthetic. The mesh should be biologically compatible and not generate an allergic response. However, inflammatory response cascades allow fibroblast infiltration for the deposition of collagen and elastin. Autologous graft use in such repairs draws questions about the structural integrity of the patient's own tissue. Because there are likely defects within the structural components of the patient's own fascia (hence the development of a hernia in the first place) its use may not be best suited for repair of a prolapse.

Allografts are made from tissue obtained from members of the same species, such as harvested cadaveric fascia lata. In a randomized study comparing cadaveric fascia lata to polypropylene mesh grafts for abdominal sacral colpopexy, there was a higher cure rate in those with polypropylene mesh, 91% compared to 68%.[38] Xenografts are biologic material procured from other species, such as porcine dermis or small intestine submucosa, or bovine pericardium. These grafts are acellular and have often been modified by cross-linking to prevent degrading. Paraiso et al studied the use of porcine small intestine submucosa grafts to augment rectocele repair and found that those in the group randomized to receive the graft had a greater failure rate at 1 year.[39]

Synthetic mesh is commonly used and should have sufficient tensile strength to provide support but still be flexible enough for proper placement and to limit erosions or extrusion. The mesh should have large interstitial spaces, greater than 75 µm, to allow leukocytes and macrophages to penetrate.[40] If the pore size is too small, bacteria will pass or be trapped in the interstitial spaces of the mesh, but the leukocytes and macrophages will not traverse.[40] This predisposes the graft to infection. Thus monofilament grafts with larger pore sizes are preferred. Polypropylene monofilament mesh is often used and has a low erosion rate reported in the literature.[26]

On July 13, 2011, the FDA issued a statement that serious complications are not rare with the use of surgical mesh in transvaginal repair of pelvic organ prolapse. Their statement separates out mesh placed via an abdominal approach such as via laparotomy or laparoscopy from transvaginal repairs. The FDA reviewed the literature from 1996-2011 to evaluate safety and effectiveness and found surgical mesh in the transvaginal repair of pelvic organ prolapse does not improve symptoms or quality of life more than nonmesh repair. The review found that the most common complication was erosion of the mesh through the vagina, which can take multiple surgeries to repair and can be debilitating in some women. Mesh contraction was also reported, which causes vaginal shortening, tightening, and pain.

The FDA’s update states, “Both mesh erosion and mesh contraction may lead to severe pelvic pain, painful sexual intercourse or an inability to engage in sexual intercourse. Also, men may experience irritation and pain to the penis during sexual intercourse when the mesh is exposed in mesh erosion.” The FDA is continuing to review the literature regarding surgical mesh in the treatment of stress urinary incontinence and will issue a report at a later date. The full update on FDA Safety Communication: Update on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse can be viewed online.

In April 2019, the FDA mandated that all manufacturers of surgical mesh intended for transvaginal repair of anterior compartment prolapse (cystocele) stop selling and distributing their products. The FDA has determined that the vaginal mesh kit manufacturers have not demonstrated reasonable assurance of safety and effectiveness for these devices, which is the premarket standard that now applies to them since the FDA reclassified them into class III (high risk) in 2016.[41]

Patient preparation

Prior to surgical intervention, comorbid conditions should be medically optimized. Evaluation by an internist or medical specialist may be warranted. Voided urine should not show evidence of bacteriuria or infection. Antiplatelet or anticoagulant medications should be discontinued, if medically safe, within adequate time to allow reversal of the medication effects.

Bowel preparation is advised, with the specific regimen at the discretion of the surgeon. The use of intravaginal estrogen cream before surgery has been recommended to improve the integrity of the vaginal mucosa, which is often atrophied in postmenopausal women. A meta-analysis has shown benefit from intravaginal estrogen for both symptom reduction and measurable urogenital atrophy.[42] The safety and tolerability has also been well documented.[43] A 6-week preoperative course of intravaginal estrogen has been proposed to ameliorate vaginal atrophy.[44] An outcomes benefit from preoperative intravaginal estrogen has not been clearly established.[45]

Anesthesia

Either general or regional (spinal) anesthesia can be used for abdominal sacral colpopexy. Adequate abdominal wall relaxation facilitates retractor placement and allows the bowel to be packed out of the operative field. Decompression of the stomach with an orogastric or nasogastric tube reduces bowel distention during surgery. Laparoscopic or robotic-assisted sacral colpopexy requires general endotracheal anesthesia due to the technical requirements of pneumoperitoneum and steep Trendelenburg position.

Positioning

The patient is placed in modified lithotomy position with both legs secured in stirrups, allowing for both abdominal and vaginal exposure. All pressure points should be properly padded to prevent neurapraxia. The patient’s abdomen as well as perineum and vaginal mucosa are prepped for sterile draping.

Monitoring and follow-up

Following surgery, the patient should be discharged with a comprehensive set of postoperative care instructions. Any strenuous activity or heavy lifting should be avoided in the immediate postoperative period, usually 6-8 weeks, to allow adequate time for scar tissue formation. Activities that generate perineal strain or trauma, such as bicycle riding, should be prohibited. The patient must refrain from any sexual intercourse during healing. Additionally, the patient should be instructed to not insert tampons or applicators into the vagina. A course of antibiotics is often prescribed at discharge, but level I evidence supporting its use is limited.

 

Technique

Approach considerations

The key aspect of abdominal sacrocolpopexy is the suspension of the vaginal apex to the sacral promontory in a manner that recreates the natural anatomic support provided by the uterosacral and cardinal ligaments. This is accomplished by dissecting the vagina from the bladder and rectum followed by interposition of a graft attaching the vagina to the sacral promontory.

Abdominal sacrocolpopexy

After positioning in a modified low lithotomy position, the patient is draped using sterile technique. An intravenous prophylactic antibiotic is administered, typically cefazolin, unless the patient is allergic. A Foley catheter is inserted on the field under sterile condition.

A Pfannenstiel incision is made a few centimeters cranial to the pubic symphysis. A horizontal laparotomy incision is made through the rectus fascia and the rectus abdominus muscles are separated midline. The fascia of the transversus abdominis is incised, the peritoneum is entered, and the bowel is inspected. An abdominal wall retractor, such as a Balfour, is placed to expose the surgical field. At this time, the bowel is packed away from the surgical field to expose the peritoneal surface of the bladder, the uterus and ovaries (if present), the vaginal apex, and the rectosigmoid segment of the colon.

The peritoneal reflection over the bladder is incised at the vesicouterine angle, or at the junction of the vaginal vault in patients who have had a hysterectomy. Sharp dissection is used to dissect the bladder away from the anterior vagina along the vesicovaginal septum. As the space is opened, care must be used to avoid cystotomy and injury to the ureters, which insert posteriorly at the trigone. Dissection is continued posteriorly to separate the vagina from the rectum along the rectovaginal septum. An instrument can be placed in the vagina, such as an anastomotic sizer, dilator, or ring forceps, to identify the proximal extent of the apical vault and facilitate dissection.

The retroperitoneal space is then exposed by incising the posterior peritoneum from the level of the rectovaginal septum cranially to the sacral promontory. Avoidance of the middle sacral vessels prevents hemorrhage that can be difficult to control. The sacral venous plexus and middle sacral veins, if injured, can be controlled with applied pressure, suture ligatures, or application of sterilized tacks into the bone. The selected point for fixation of the graft is the sacral promontory, a location chosen as a result of increased hemorrhagic complications that occurred when using other sacral segments.[46] The initial concern regarding changing the normal vaginal axis through fixation to the promontory has not been shown to be a problem.[47]

A graft material is selected (eg, polypropylene mesh) and trimmed to size. A Y-shaped graft is fashioned from two pieces; a long arm placed anteriorly and a shorter posterior arm. The arms are fixed to each other using 2-0 nonabsorbable monofilament suture. The anterior arm is fixed using four nonabsorbable 2-0 monofilament sutures through the pores of the mesh and into the vaginal muscularis. Two are placed at the most distal aspect of the graft and two at the most distal aspect of the anterior vaginal cuff. The sutures are placed deep through the muscularis but should not penetrate through the vaginal mucosa itself. Four sutures are placed posteriorly in a similar fashion.

The graft is positioned along the retroperitoneal space cranial to the sacral promontory. It should be sized to create a tension-free approximation (see image below).

Tension-free placement of Y-shaped mesh from the v Tension-free placement of Y-shaped mesh from the vaginal apex to the sacral promontory.

The graft is fixed to the anterior longitudinal ligament close to the sacral promontory using two 2-0 nonabsorbable monofilament sutures, with care to avoid any presacral vessels. The peritoneal reflection is closed over the graft using absorbable sutur es, thus maintaining the graft in a retroperitoneal location. Such a maneuver is proposed to reduce any risk of erosion into the bowel.

Please see the FDA Safety Update (discussed further in Equipment) regarding surgical mesh in pelvic organ prolapse.

Minimally invasive sacral colpopexy

Laparoscopic techniques emerged in the 1990s and large series with comparison to the standard abdominal approach have since been published.[48, 49, 50] In a retrospective review comparing consecutive open abdominal sacral colpopexy and laparoscopic techniques at a single center, Paraiso et al found no difference in the reoperation rates for pelvic floor dysfunction.[50]

Surgical concepts of the laparoscopic approach are similar in that a Y-shaped graft is used to suspend the anterior and posterior vaginal wall to the sacral promontory. The patient is placed in low lithotomy position either in stirrups or with spreader bars. As with open surgery, all pressure points are properly padded. The patient is carefully secured to the table for positioning in steep Trendelenburg. Four to five trocar sites are used.

A 10-mm trocar is placed at the level of the umbilicus for the telescope. Equipment is available to assist in holding the telescope, such as the Aesop or Laparostat.[51] An additional 10-mm trocar is placed on the right side, slightly caudal, and approximately 6 to 8 cm lateral to the umbilical port.[51] This will be used for the introduction of needles and the mesh.

A 5-mm trocar is placed on the left side, mirroring the 10-mm port. An additional 5-mm port is placed on the right side approximately 5 cm superior and medial to the anterior superior iliac spine, allowing enough space for movement of the trocar. A fifth port can be placed on the left side in the same fashion if needed for retraction. Typically, the surgeon stands on the patient’s left.

Dissection is completed with laparoscopic monopolar scissors and bipolar cautery. The mesh can be fixed using the same 2-0 nonabsorbable monofilament sutures and laparoscopic needle drivers. Alternatively, bone anchoring devices are available to fix the mesh to the sacral promontory.[27]

A study by Chaudhry et al indicated that in patients undergoing minimally invasive sacrocolpopexy, older age does not increase the risk of urinary tract infection, hospital readmission, or return to the operating room, nor does it increase patients’ chances for an abnormally long hospital stay (3 days or more, as defined in the study).[52]

In recent years, there has been an expanding use of robot technology. Since its introduction in 1999, the da Vinci® surgical system has gained popularity. The basic principles of laparoscopic surgery apply and the setup is similar. Trocar placement must meet the technical requirements of the da Vinci® itself. Newer models have three working surgical arms and a fourth arm for the telescope.

The 12-mm telescope port is placed midline just superior to the umbilicus at a distance 15 cm from the pubic symphysis. Two 8-mm working arms are placed bilaterally along an imaginary line from the camera port to the anterior superior iliac spine. These ports are placed caudally and should be approximately 8 cm away from the camera trocar to prevent the da Vinci® working arms from colliding.

The third working arm can be set up on the left side and placed approximately 8-9 cm away from the other working port. It should be 5 cm cranial and medial to the anterior superior iliac spine. The assistant port is a 10-mm trocar mirroring the third robot arm and is used for insertion of the mesh, needles, and retraction. An additional 5-mm port used for irrigation and aspiration is placed on the right side, cranial to and bisecting the distance between the camera trocar and the left-side working arm. Variations in technique have been described.[53, 54]

Port placement sites for the da Vinci® robot are shown in the image below.

Port placement sites for laparoscopic sacrocolpope Port placement sites for laparoscopic sacrocolpopexy. This setup is more suited for use with the da Vinci® robot. Yellow represents the 12-mm trocar for the telescope. Blue represents the three 8-mm working ports for the surgical arms. Green represents an additional 12-mm trocar for passing needles and the mesh. An additional 5-mm port site is marked in red and can be used for irrigation and aspiration. Variations in setup have been described.

Outcomes for robot-assisted sacrocolpopexy have been limited to small series without direct comparison to other techniques. In a retrospective study, Geller et al reported short-term outcomes confirming improvement in measurable POPQ following robot-assisted sacrocolpopexy in 73 patients, comparable to abdominal sacrocolpopexy at 6 weeks.[55] A smaller series demonstrated successful repair in 95% of patients at a minimum of 12 months follow-up.[53] Two of the 30 patients in their series developed a recurrence that required reoperation.[53] Looking at secondary outcomes measurements, operating time is generally longer in most reported series, but blood loss and length of hospital stay are reported to be less.[53, 54, 55] Surgical complication rates differ between series. Prospective randomized studies are needed to delineate differences in outcomes and complications.

Alternative surgical techniques

Numerous vaginal operations for apical (vaginal vault) prolapse repair have been described. They most commonly include sacrospinous ligament fixation, uterosacral ligament suspension, and iliococcygeus suspension.

Vaginal sacrospinous ligament fixation has been compared to abdominal sacral colpopexy in two randomized trials.[56, 57] Benson and colleagues randomized 88 women to receive either vaginal sacrospinous ligament fixation or abdominal sacrocolpopexy and terminated the study at the interim analysis due to a disparity in outcome favoring the abdominal approach.[56] Reoperation for cystocele was necessary in 29% of those in the vaginal group versus 10.5% of those in the abdominal group. Vaginal vault prolapse recurred in 12% of the vaginal group versus 2.6% of the abdominal group.[56]

In a study of 95 women randomized to either approach, Maher et al found a subjective success rate of 94% in the abdominal group versus 91% in the vaginal group after a median of 2 years.[57] The objective success rate was 76% in the abdominal group and 69% in the vaginal group.[57] These differences, however, did not reach statistical significance.[57]

In a Cochrane review of 22 randomized controlled trials, abdominal sacral colpopexy was found to have a lower rate of recurrent vault prolapse and less dyspareunia.[58] The trend for a lower reoperation rate after abdominal sacral colpopexy was not statistically significant.[58] There was a longer operating time, longer recovery period, and higher cost associated with the abdominal approach.[58]

For women who are not sexually active, additional surgical options exist. Colpocleisis is a method of approximating and closing the vaginal wall after excising the mucosa to prevent apical or vaginal vault eversion. Total colpocleisis is performed in sexually inactive women for complete vaginal eversion after hysterectomy. A circumferential incision is made in the vaginal mucosa near the hymenal ring and the mucosa is undermined and sharply dissected from the underlying fascia.[59] The anterior and posterior walls of fascia are approximated using absorbable suture in a purse string or interrupted fashion, thus obliterating the vaginal lumen.[59]

If stress incontinence exists, simultaneous procedures for stress incontinence, such as a transvaginal or transobturator sling, can be performed. The dense tissue over the levator ani muscles and perineal membrane near the location of the hymen is approximated to firmly close the pelvic floor. Lastly, the anterior and posterior leafs of the remaining vaginal mucosa are closed.[59] In women with procidentia, the LeFort colpocleisis approximates the anterior and posterior vaginal wall, allowing for uterine or vaginal secretions to drain through open side channels.

 

Devices

Device summary

Pessaries are ring-shaped devices placed vaginally to reduce pelvic organ prolapse. They are fitted to the largest size that is comfortable and reduces the prolapse. Their use requires instructional training for cleaning and replacement. In a study of 73 women fitted for vaginal pessaries for prolapse, significant improvement in prolapse symptoms, specifically bulge and pelvic pressure, was seen at 2 months. Stress incontinence improved in 45% of this cohort, urge incontinence improved in 46%, and voiding difficulty improved in 53%.[60] Discontinuation of use occurred in 8% of this cohort due to side effects. These side effects can include de novo voiding difficulty, unmasking of occult stress incontinence, defecatory symptoms, and difficulties with sexual intercourse. Vaginal erosion can occur from pessary use and must be monitored.