The future of treating pelvic organ prolapse

August 15, 2016

Demand for prolapse surgery is increasing and techniques are evolving.

 

Dr Ninivaggio is a fellow in the Division of Female Pelvic Medicine & Reconstructive Surgery, Department of Obstetrics and Gynecology, University of New Mexico, Albuquerque.

 

Dr Dunivan is an Associate Professor and Fellowship Program Director in the Division of Female Pelvic Medicine & Reconstructive Surgery, Department of Obstetrics and Gynecology, University of New Mexico, Albuquerque.

 

 

 

Approximately one quarter of women in the United States have at least one pelvic floor disorder such as urinary incontinence (UI), fecal incontinence, or pelvic organ prolapse (POP).1 POP-vaginal descent of the bladder, uterus, or bowel-results in symptomatic pelvic pressure, or a bulge that women can feel and/or see. Depending on the definition used, the prevalence of bothersome POP ranges from 3% to 8%.1,2 By age 80, approximately 20% of women will undergo surgery for treatment of urinary incontinence or POP.3

The demand for POP surgery is expected to increase by nearly 50% over the next 40 years.2 As our understanding of POP has evolved, surgical techniques and outcomes have evolved as well, with a diverse number of treatment options. These range from expectant management and nonsurgical approaches (such as physical therapy and removable devices) to surgery. Surgical approaches vary widely from vaginal reconstruction with or without graft materials to abdominal or vaginal approaches.

Here we review treatment options for POP and discuss the importance of a patient-centered approach to decision making.

Patient counseling

A discussion of prolapse treatment options must begin with patient education, articulation of patient goals, and shared decision-making to reach the best individualized option for a patient. Traditionally, surgeons have focused on anatomic success or correction of the prolapse into a high pelvic position. But anatomic correction does not always result in a satisfied patient. For example, a woman who no longer has bulge symptoms following prolapse repair, but continues to have urinary incontinence, may be dissatisfied with her surgical repair despite surgical “anatomic” success. Indeed, goal achievement for prolapse repair is highly influenced by resolution of incontinence symptoms.4 Thus, the definition of successful prolapse repair has evolved to include composite outcomes that also incorporate patient perception of an array of pelvic floor symptoms, function, and satisfaction.

Given the elective nature of POP repair, an upfront discussion is needed regarding the patient’s goals and expectations, and adequate time should be allowed for patient education about what prolapse treatment and repair can and cannot achieve. POP treatment discussion lends itself well to shared decision-making, which is defined as “a collaborative process that allows patients and their providers to make healthcare decisions together, taking into account the best scientific evidence available, as well as the patient’s values and preferences.”5

A paternalistic physician-patient model of counseling no longer aligns with the changing medical field in which patient choice is crucial, particularly for elective procedures. Patient autonomy and increased access to information has led to adoption of an interpretive model of medical counseling. The role of the physician is to help the patient clarify and integrate priorities, preferences, and values into the decision-making process while acting as an information source.6

 

Nonsurgical management of POP

Conservative measures are appropriate in patients who do not want surgery, those who are poor surgical candidates due to medical comorbidities, or patients who are pregnant or have not completed childbearing.7

Expectant management

If prolapse is asymptomatic, patient education, reassurance, and expectant management can be offered. In patients with advanced prolapse, experts recommend renal ultrasound and creatinine measurement annually to evaluate for urinary retention, hydronephrosis, or compromise of the upper tracts.8 Many women interested in expectant management are often concerned about the risk of POP worsening. Data are limited with which to guide patients; in a small percentage of cases, POP may spontaneously regress, although that is infrequent when the condition is bothersome and extends to or beyond the hymen.9,10

Vaginal pessaries

Vaginal pessaries are silicone devices available in a variety of shapes and sizes. Patients may be taught to perform self-care but if they are unable to do so, a pessary should be removed and cleaned every 2 to 3 months. Pessaries can be used in women of any age and can be successful for multiple stages of prolapse.11,12 Commonly thought of as a temporizing measure, pessaries can be successfully used long term in the right patients,13 but independent predictors for pessary discontinuation include age <65, stage >3 posterior wall prolapse, and desire for surgery.

Sexual activity status has not been found to be associated with pessary discontinuation.14 In a study of pessary users, approximately half of the women reported sexual activity and pessary use did not change sexual function.15

Pelvic floor muscle training

Burgeoning evidence favors pelvic floor muscle training (PFMT) in conservative management of POP. PFMT has demonstrated subjective improvement in women’s prolapse symptoms and bother. Those who received PFMT had reduced frequency and bother of prolapse symptoms, with anatomic improvement by one POPQ stage compared to controls. Adherence with home exercises and PT sessions was >80%.16,17 A systematic review concluded that women who received PFMT had subjective and objective improvement in Stage 1-2 POP symptoms and severity.18 Although its use for stage 3 prolapse remains questionable,19 greater standardization of PFMT intervention could potentially improve clinical outcomes.

 

 

Surgical management

Patient-centered care and patient involvement in medical decision-making is critically important when a woman is considering elective surgery. Clinicians must recognize that patients’ values are rooted in personal and cultural beliefs that are not always captured in traditional medical guidelines.20

Surgical reconstructive procedures

The surgical route for pelvic organ prolapse can be vaginal, laparoscopic/robot-assisted, or abdominal. Addressing the vaginal apex is a key component of successful prolapse repair.21 Experts recommend that whenever a surgeon performs a hysterectomy, especially for prolapse, the apex must be supported or the repair is doomed to fail. Despite adequate support of the apex, all prolapse procedures carry with them a risk of failure.

Native tissue repair

Native tissue repair refers to correction of prolapse using the patient’s own tissue and suture material without mesh augmentation. These procedures typically include apical repairs, such as uterosacral ligament suspension (USLS) or sacrospinous ligament suspension (SSLS). Such procedures can be performed immediately after a vaginal hysterectomy or with vaginal vault prolapse. A large randomized controlled trial (RCT) comparing USLS to SSLS reported no difference in surgical success rate (composite of subjective and objective measures) or adverse events between the 2 surgical techniques at 2 years. USLS success rate was 64.5% vs 63.1% for SSLS, P=0.84.22

Mesh-augmented repairs

Sacrocolpopexy utilizes a non-absorbable polypropylene mesh that is affixed to the anterior and posterior vagina and secured to the anterior longitudinal ligament of the sacrum. Although it is traditionally performed abdominally, over the past 10 years, more surgeons have adopted a minimally invasive technique.23

The clinical benefit for a robot-assisted laparoscopic sacrocolpopexy (RALSC) over a laparoscopic sacrocolpopexy (LSC) has yet to be established. A recent meta-analysis and systematic review comparing LSC and RALSC found that the mean operative time for the RALSC was significantly longer than for the LSC (245.9 minutes vs 205.9 minutes, P < 0.001), estimated blood loss and complications were similar, but costs were significantly higher with the RASLS.24

SCP has long been considered the “gold standard” surgery for POP as it had higher and longer-lasting rates of success compared to vaginal procedures.25 However, 7-year follow up from a RCT of women undergoing abdominal SCP with or without a urethropexy demonstrated higher failure rates for colpopexy than previously believed. Composite treatment failure was reported in approximately one-third of all subjects and the rate of mesh erosion was 10.5%.26

Importantly, 95% of the patients had no retreatment for POP, similar to low rates of retreatment for native tissue and vaginal mesh repairs.22,26,27 The findings from this trial have called into question the true durability of all surgical treatments for POP.

Colpocleisis

Colpocleisis is an obliterative vaginal procedure with a shorter operative time and decreased perioperative morbidity compared to other reconstructive procedures.28 It carries a very low risk of prolapse recurrence with success rates reported as high as 90% to 100%.21,29,30 Colpocleisis results in a shortened vagina and narrower genital hiatus, preventing vaginal intercourse. For that reason, it is more commonly offered to patients who are older, medically frail, or who have more complicated conditions and who are no longer interested in sexual activity.21,29,31,32

Because patients undergoing the procedure are typically sicker, it may still carry significant morbidity. Patient and physician must discuss both the morbidity of the procedure depending on the health of the individual as well as the high success rates. It is key that a patient’s sexual preferences/activities be considered.

The majority of patients (86% to 94%) report high levels of satisfaction with colpocleisis. Fewer than 10% of women reported dissatisfaction and no patients cited loss of sexual function as a reason for regret in a study of 152 women undergoing colpocleisis.33 Nonetheless, if a patient desires future vaginal intercourse, colpocleisis is not a viable option regardless of age and medical comorbidities.

Special considerations

Vaginal mesh procedures

Transvaginal mesh (TVM) has been used in an effort to improve upon the success of native tissue repairs. The introduction of TVM kits resulted in a dramatic increase in their use for POP repair until 2008, followed by a decrease in their use beginning in 2011.34 In 2008 the US Food and Drug Administration released a public health notification related to complications associated with vaginal mesh for the treatment of POP. In 2011 that was expanded to a Safety Communication. The key message was that serious complications from TVM for the repair of POP were “not rare.”35 Given this controversy and concern for complications, many TVM kits were removed from the market and have been replaced with more lightweight mesh and trocar-free placement.

TVM has since been reclassified as a class III device and requires post-market studies, several of which are currently under way. A systematic review found evidence that TVM is successful in improving apical support in the short term but with increased risk of reoperation for mesh complications (4.6%–10.7%). TVM decreased reoperation for recurrent POP but had higher rates of repeat surgery for combined outcomes of POP, stress urinary incontinence, and mesh exposure.27,36 Societies such as the American Urogynecologic Society have subsequently released “Guidelines for Providing Privileges and Credentials to Physicians for Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse,” an informed consent toolkit, and created the Pelvic Floor Disorders Registry (PFDR). The PFDR is a national patient registry created for both patients and providers to track outcomes from prolapse surgery.37 The future role of TVM in POP treatment is uncertain; comparative long-term studies are needed to help guide clinicians and patients.

 

 

Uterus-sparing procedures

A hysterectomy is traditionally performed at the time of POP repair in the United States, and more than 100,000 hysterectomies are performed annually in this country for POP.38 Uterus-sparing techniques date back to the late 1800s but fell out of favor in the United States in the twentieth century with improvement in surgical morbidity and mortality and due to efforts to reduce the risk of cervical and endometrial cancers.

With the renewed interest and importance of patient preferences in POP procedures, the role of uterine-sparing prolapse procedures has resurged.39 Women report that a doctor’s opinion, surgical risk, and cancer risk were leading considerations. On a non-validated questionnaire that was mailed before they were seen for POP at a large academic urogynecology group, 60% of 100 women reported that they preferred to avoid hysterectomy at the time of surgery.40

Geography may influence patient preference as well. The highest proportion of women preferring uterine preservation lived in the west (62%) and the lowest in the south (27%). In addition, women with at least some college education and those who believe that the uterus is important for their sense of self prefer uterine preservation.41

Sacrospinous hysteropexy is a common uterine-sparing vaginal approach.39 The first non-randomized trial by Maher et al. compared sacrospinous hysteropexy and vaginal hysterectomy with SSLS.42 Operative time and estimated blood loss were lower in sacrospinous hysteropexy compared to hysterectomy with SSLS with no difference in short-term (26–33 months), subjective (86% vs 78%), or objective success rates (72% vs 74%) in the hysterectomy versus hysteropexy groups, respectively.42 However, data are mixed. In a RCT comparing sacrospinous hysteropexy to vaginal hysterectomy with suspension, the rate of objective success was higher in the hysterectomy group; 11% in the hysterectomy group versus 27% in the hysteropexy group had stage 2 or greater recurrent prolapse at 1-year follow up.43 Recent data have demonstrated that sacrospinous hysteropexy is not inferior to a vaginal hysterectomy with USLS at 1 year.44

Mesh kits also are available that can be used for uterine-sparing POP repairs. Limited data regarding TVM hysteropexy report > 95% composite outcome success rates at 1 year using one of these kits, the Uphold (Boston Scientific). The mesh extrusion and reoperation rates were 6.52% and 7.53%, respectively.45

Other uterine-preserving options include abdominal uterosacral hysteropexy or mesh-augmented sacrohysteropexy. A small comparative trial of abdominal sacrohysteropexy versus hysterectomy with sacrocolpopexy found no difference in anatomic outcomes at 51 months but mean operating times, intraoperative blood loss, and hospital stay were significantly less after hysteropexy.46 Additionally, Maher et al. reported on the largest prospective trial to date of laparoscopic uterosacral ligament hysteropexy.47 One-year success rates for laparoscopic uterosacral ligament hysteropexy were reported to be 81% for subjective and 79% for objective success rates; 16% of participants underwent additional surgery for symptomatic uterine prolapse.47 Hence, it appears that laparoscopic uterosacral ligament hysteropexy is relatively safe and effective, although more data are needed.39

Although long-term comparative data are largely lacking, there is evidence that uterine-preserving prolapse surgeries can be successful and in alignment with patient preference, because uterine preservation is important to some women. These procedures may play an increasingly important role in the future of prolapse repair.

 

 

Summary

Ob/gyns are often the first providers to identify and initiate treatment for POP. It is incumbent upon residency training programs to ensure that training in pelvic floor disorders continues to meet the high standards expected by patients. It is critically important for clinicians to understand and offer an array of treatment options to women with POP, taking into consideration a thorough review of each patient’s goals and expectations. The choice of treatment should be arrived at in consultation with a patient.

Patient education, guidance from the provider, and an understanding of patient goals represents the future of treatment for POP.

Dr Ninivagggio has no conflict of interest to report in respect to the content of this article. Dr Dunivan reports performing contracted research for Pelvalon.

 

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