Dominic Lee1 and Philippe Zimmern1
Department of Urology, University of Texas Southwestern Medical Center, 5323 Harry Hines Boulevard, Dallas, TX 75390-9110, USA
Prolapse surgery is an art form that requires considerable understanding of the female pelvic anatomy, pathophysiology of the prolapse occurrence, an appreciation of previous historical techniques, astute clinical acumen, and most importantly a sound doctor–patient relationship based on trust and informed consent. This chapter aims to provide a brief overview of the factors considered in the surgical planning for pelvic organ prolapse repair. In addition, we explored the “controversies” encountered on a common basis by pelvic floor surgeons in the surgical decision-making process.
Back to Basics?
Time has not been kind to the management of pelvic organ prolapse (POP). In an era of vast progress in other fields, prolapse repair it seems has stood relatively still. Despite our intense efforts to improve outcomes and to benefit patients, we are still rooted in traditional approaches where the operative techniques have changed very little for the past 100 years, and the results have been underwhelming to say the very least or is it?
From the beginning, most of what has been done in prolapse repair is not evidence based and few have challenged the prevailing concepts. Over a century ago, the Manchester repair came into existence, and along with the anterior colporrhaphy, both became the surgical standard for prolapse repair for apical and anterior defects but where was the data to support its efficacy? Similarly the posterior repair came into being as a form of repair for episiotomy tears and quickly became the most prevalent surgery for posterior defect repair without any anatomical understanding. Gradually more elaborate concepts came to bear, and from the 1950s and 1960s we saw the emergence of vault suspension techniques including sacrospinous ligament fixation popularized by Randall and Nichols and later by Miyazaki, and abdominal sacrocolpopexy (SCP) by Lane, which restored vaginal axis and vaginal capacity but with the risk of bowel complications and bleeding.
Still there were issues. Prolapse recurrence was not uncommon and the anterior compartment was the most affected with failure rates of up to 70 % within the first postoperative year . DeLancey brought greater understanding of the pelvic anatomy highlighting the various levels of pelvic organ support . Basic research started to flourish and confirmed the intuition that connective tissue defects with reduction in collagen and proteoglycan synthesis may have a pivotal role in prolapse development . Translational research slowed but the race was on to find a suitable graft material to augment the repairs. Biologic grafts were advocated but the outcomes were disappointing . Encouraged by the utility of synthetic material in abdominal hernia repairs and inspired by the success of tension-free vaginal tape (TVT) sling, we entered into the era of transvaginal synthetic mesh, and momentarily it offered a glimpse of hope. Anatomical outcomes were superior in a few short-term studies, and before we knew it the die was cast [5, 6]. Transvaginal mesh and its various kit transformations were championed by the medical device industry and promoted extensively amongst physicians. Not surprisingly, the new surgical concept also led to new complications; viscus perforation not recognized at the time of surgery. Mesh erosions and contractions surfaced, presenting often at times beyond the duration of the trial protocols . The need for scientific reevaluation beckoned but regrettably, there was more effort spent marketing these devices rather than allowing for sufficient data to accumulate supporting their use. Clearly, there was inadequate understanding of the effects of synthetic material on delicate and atrophied vaginal tissues. The US Food and Drug Administration (FDA) intervened [8, 9], and as it stands we are entering the dominion of “meshology”; an evolving field of sub-specialization dedicated to a growing population of incapacitated women with scarred vaginas, extruded meshes, and chronic pain from vaginal mesh placement seeking relief and rallying for change.
To confuse matters further, outcome measures for success seem to be moving targets themselves. Previous successes were judged on anatomical correction, but now this seems inadequate, as 50 % of women were found asymptomatic despite recurring anatomical defects . Symptom relief and sexual satisfaction became incorporated into our reporting, and yet there is no consensus on the true definition of success in prolapse surgery.
As we stare into the eyes of our patients with limited evidence to guide our approaches, we ask ourselves: Where did it all go wrong? What can be done? The answer seems logical—we need a scientific pipeline in POP, from basic sciences to clinical trials; a cultivation of sound scientific and clinical data based on a systematic approach. It may be time to go back to basics.
Planning for Surgery
Vaginal prolapse is rarely a life threatening condition. Most prolapses will progress with time and can only be corrected with intravaginal pessary or restorative surgery. Indications for surgical management are largely directed by the patient’s presenting symptoms, and on rare occasions resultant complications associated with vaginal prolapse such as urinary retention or obstructive uropathy. Patient factors are important to consider as it can impact on the approach and outcome to management. As in other surgeries, the primary attempt at corrective surgery is the most likely to succeed, thus the most important. Therefore, a pelvic reconstructive surgeon should have expertise in several repair procedures for POP, including vaginal, laparoscopic/robotic, and open surgical techniques. The overall goal is to restore vaginal anatomy and improve symptoms and organ function.
For this chapter, we will take for granted that the patient has been fully worked up and a diagnosis has been reached confirming the presence of a bothersome prolapse condition for which surgery is indicated. The patient expectation can be simple (correction of a bothersome bulge) or more complex involving other domains such as restoration of sexual function, or correction of associated urinary or bowel symptoms. This needs to be addressed thoroughly to prevent postoperative disappointments but the setting of realistic expectations is beyond the reach of this chapter and is limited at present by few available tools to explore this important domain. For clarification, this chapter will exclude patients unfit for surgery, unwilling to undergo surgery, or those preferring a nonsurgical alternative such as a pessary. We will also exclude from our discussion patients who are not sexually active and can only undergo a short obliterative procedure such as a colpocleisis because of age and anesthesia risks for example. So, in summary, we will discuss the index patient who has a bothersome POP, wishes surgical repair (indication), and can be amenable to all currently available surgical approaches (decision).
Indications for Surgery
Vaginal prolapse can affect several compartments and demands astute clinical judgement from the surgeon in balancing between the patient’s operative risks and chances for success. Consideration needs to be given to the following when deciding on surgical repair: (1) thorough assessment of prolapse symptom(s) and organ dysfunction(s), (2) the absence or presence of urinary incontinence, (3) patient comorbidities, (4) examination findings, (5) additional testing, (6) patient expectations, and (7) surgeon expertise.
Patients that are at high risk for recurrence including those who had failed previous surgical repairs and those with predisposing comorbidities for poor healing should be identified. Overall medical condition such as patients with diabetes mellitus or on chemotherapy and/or steroids should seek medical clearance prior to proceeding with repair. Patient with chronic cough inducing respiratory conditions such as COPD and asthma should be medically optimized. Poorly estrogenized tissues should be treated with hormone cream for a minimum of 3 months if possible prior to procedure. Bowel evaluation may be needed in case of chronic constipation to avoid the risk of tearing a native tissue repair.
Lifestyle activities may be an issue and heavy physical duties may have to be curtailed in the perioperative period to ensure adequate healing and not jeopardizing repair. Sexual function is important in the indication as it sometimes eliminates a vaginal approach by fear of inducing vaginal pain, narrowing, and/or shortening. The presence or absence of uterus, and patient’s interest to retain or remove this organ may need to be explored; and post-hysterectomy patients will need their ovarian status reviewed if they had elected to keep their ovaries thus far. Transvaginal mesh may be beneficial when used in the appropriate setting with “at risk for recurrence” individuals following thorough patient counseling by an adequately trained surgeon.
Finally patients with one compartment defect may need a different surgery than those with dual prolapse (anterior and apex, or apex and posterior, including enterocele and/or rectocele) or triple compartment prolapse. Furthermore, the presence of occult or urodynamic stress urinary incontinence (SUI) on testing needs to be factored into the final operative management.
Aside from surgical repertoire and training issues, several factors may persuade the surgeon either to adopt an abdominal approach or to consider minimally invasive techniques such as laparoscopy/robotic-assisted laparoscopy or a vaginal approach. Overweight patients are not well suited for open, robotic, or laparoscopic techniques due to higher rates of perioperative complications. Patients with prior abdominal surgeries, hernia repairs (inguinal or midline), and colon issues (diverticulitis) need specific attention. Similarly, the need for an adjunct procedure such as a concomitant oophorectomy can affect the approach undertaken.
Decisions for Surgery
We will highlight three cases that illustrate our treatment choices and decision process taken in recent patients. In each case of prolapse the treatment should be individualized to the patient with considerations given to symptoms of bother, primary versus secondary presentation, associated comorbidities, sexual function, and past surgical history. In addition, the impact of prolapse on quality of life (QOL) as well as a thorough physical assessment documenting the anatomic defects in tandem with radiological or functional testing should be defined. Full disclosure of risks and benefits of operative approach to patient based on a comprehensive evaluation ensues, i.e., vaginal versus abdominal approach (laparoscopic/robotic or open), uterine conservation or not, mesh or no mesh, and with or without concomitant anti-incontinence procedure.
A 53-year-old woman presents with a symptomatic cystocele following total vaginal hysterectomy 3 years ago for uterine prolapse. She reports mixed urinary incontinence (stress greater than urge) and wears two pads per day. She denies dyspareunia and reports no sexual activity secondary to partner’s erectile dysfunction. Previous surgical history includes laparoscopic cholecystectomy and an appendectomy. Exam shows stage 2 cystocele and stage 1 vault prolapse. POP-Q Staging: Aa −2, Ba +1, C point −4, Ap −3, Bp −2. She desires treatment.
This lady presents interesting diagnostic and therapeutic considerations with dual complaints of symptomatic prolapse and urinary incontinence. Validated questionnaires are recommended to quantify these complaints and to establish baseline as a comparison for treatment success. Further testing was obtained to address her leakage mechanism and degree of urethral mobility with multichannel urodynamic studies (UDS) incorporating prolapse reduction with vaginal packing  and a standing voiding cystourethrogram (VCUG) with lateral views at rest and with straining. Prolapse evaluation with magnetic resonance imaging (MRI) defecography was suggested to evaluate apical support and assess for the presence of an enterocele that could impact on surgical approach.
Her evaluation returned with the following testing information:
VCUG: maximum cystometric capacity (MCC) at 450 mL. Grade 3 cystocele with the lower part of the bladder at 6 cm below the lower edge of the pubic symphysis on straining views. Low-lying urethra at a 90° angle, with normal urethral views during voiding, and a moderate post-void residual confirming her clinical impression of incomplete bladder emptying (Fig. 16.1).
Lateral view on VCUG showing a Grade 3 cystocele and a poorly supported, low-lying urethra
MRI revealed a minimal vault descent and no posterior compartment defect, specifically no enterocele or rectocele (Fig. 16.2). No SUI with or without packing, or detrusor overactivity (DO) was evidenced during UDS. During pressure-flow study, a prolonged flow curve with low maximum flow at 10 mL/s along with Valsalva efforts was noted, with normal range voiding pressures.
MR defecography (T2) confirming anterior compartment defect
Given the predominant cystocele defect on VCUG and MRI with minimal apical involvement, we planned for a transvaginal repair of her cystocele with an anterior vaginal wall suspension technique to repair the cystocele defect and provide support to the bladder neck area at the same setting . A concurrent anti-incontinence procedure was not offered (see controversies), as patient had no demonstrable occult SUI (OSUI) on clinical exam or on UDS. Secondary incontinence (sphincteric deficiency and/or bladder overactivity) may occur, but is unlikely given her current findings. In the absence of vaginal vault weakness and/or posterior compartment defect, a mesh repair with an abdominal SCP was not recommended but could be considered if despite this thorough evaluation, her vault support fails secondarily.
A 65-year-old woman presents with a 1-year history of symptomatic recurrent prolapse following failed trial of pessary. She is status post laparoscopic-assisted vaginal hysterectomy (LAVH) for uterine prolapse and a cystocele repair performed 2 years ago. She reports no SUI. She denies any pain or bowel symptoms. She is G4P3 with all vaginal deliveries. Patient is sexually active and intends to remain active. Examination confirms no leak with cough or strain. No anterior vaginal wall compartment defect is noted (Fig. 16.3), but a large posterior compartment defect is appreciated with POP-Q: Aa −3, TVL −9, C +1, Ap at +1. Vaginal trophicity is adequate with no evidence of ulcerations.
Well supported urethra and bladder base during straining on lateral standing VCUG
The impression was that she had a secondary vault prolapse with an associated rectocele and suspicion of enterocele. MR defecography, ordered to determine if this was a large rectocele alone or with an associated enterocele, demonstrated widening of the levator hiatus and anorectal junction with descent of the anorectal junction during defecation. Aside from a large distal rectocele during defecation, a small enterocele was noted (Fig. 16.4a, b).
(a) MR defecography T2 sagittal view with distal rectocele and no apical defect. (b) Further exaggeration with dynamic gel defecation with minimal apical descent
In counseling this patient we took into consideration her previous surgical history and her desire for maintenance of sexual activity. We discussed the risk and benefits of a transvaginal posterior repair with a potential 15–20 % rate of dyspareunia versus a laparoscopic/robotic-assisted abdominal mesh SCP (RA-SCP) with restoration of vaginal capacity and axis at the expense of mesh erosion risks around 5 %, mesh infection (<2 %), and secondary bowel obstruction (<5 %). Finally the patient opted for a robotic repair to preserve vaginal size and length. The intraoperative findings revealed a larger enterocele defect than estimated on MR defecography (Fig. 16.5).
Intraoperative view of large enterocele defect at robotic surgery
This is a case in point that imaging in supine position has a degree of false negative rate and clinical suspicion is still paramount, as it would have impacted on intraoperative management and outcome if a posterior repair had been pursued.
A 64-year-old presents with symptomatic uterine and bladder prolapse. She denies any urinary incontinence or bowel symptoms. Patient is still sexually active but denies dyspareunia. She gives a history of negative Pap smears. Previous surgical history includes a laparoscopic cholecystectomy but no other abdominal surgeries. Pelvic exam revealed a large cystocele and uterine prolapse with POP-Q: Ba +1, C −1, and D −3.
Given her symptoms and the presence of her reproductive organs, she was investigated with: (1) a pelvic ultrasound to evaluate for uterine size and to exclude a uterine or ovarian pathology, (2) standing cystogram to document the extent of her cystocele and degree of urethral hypermobility, and (3) a UDS with pack reduction of prolapse to unmask incontinence. Completed evaluation confirmed the following:
· Pelvic ultrasound: small uterus and normal ovaries.
· UDS: SUI with pack reduction.
· VCUG: 600 mL bladder capacity with large cystocele Grade 3 and urethral hypermobility. No residual (Fig. 16.6).
Lateral VCUG showing bottleneck appearance of a Grade 3 cystocele on straining with poorly supported urethra represented by the axis of the urethral Foley catheter
This patient has significant dual compartment prolapses with occult SUI on UDS testing. The approach will depend on her decision regarding uterine preservation versus hysterectomy in addition to whether a concomitant anti-incontinence procedure should be undertaken (see discussion on controversies). If she desires uterine preservation, counseling with regard to an approach with laparoscopic or open abdominal mesh sacrohysteropexy with an anterior mesh segment to correct her cystocele and a Burch urethropexy or suburethral tape would be a reasonable option. If she decided on a hysterectomy, then a total vaginal approach could be a logical option including a vaginal hysterectomy with possible bilateral salpingo-oophorectomy (BSO), an enterocele repair with a Moschowitz-type purse-string closure of the peritoneal defect, a vault fixation procedure, and a cystocele repair with bladder neck suspension at the same setting. If she opted for an open repair, a supracervical hysterectomy would be considered to minimize the risks of mesh erosion at the vaginal cuff (see controversies).
Mesh Versus No Mesh for Transvaginal Prolapse Repair
Anterior compartment defects are the commonest and also the most prone to recurrence following repair . The definition of recurrence has changed over time further complicating the debate in this field. Data from a control group of women examined for non-prolapse symptomatology highlighted a natural tendency for anterior vaginal descent with ageing. Therefore, reconsideration of prior published studies with modified criteria for failure has led to a change in the rate of anatomic recurrence noted after native tissue cystocele repairs . The assessment of postoperative outcomes following POP surgery lacks standardization leading to variable successes quoted in the literature for native tissue repairs. The initial emphasis on anatomical correction as the dominant outcome may have been too stringent as there may be less correlation with the patient’s overall assessment of improvement. A study by Barber et al. using the colpopexy and urinary reduction efforts (CARE) trial data reevaluated their outcomes based on 18 definitions of surgical success. Treatment success varied widely depending on definitions used (19.2–97.2 %). Definition of surgical success correlated most with both treatment success and overall improvement when the following was utilized: (1) the absence of prolapse beyond the hymen (94 %), (2) the absence of bulge (92.1 %), and (3) the absence of re-treatment (97.2 %). Importantly, subjective cure was associated with significant improvements in the patient’s assessment of both treatment success and overall improvement, more so than any other definition considered (p < 0. 001 and p < 0. 001, respectively) . The original data of a landmark RCT by Weber et al., often cited and quoted for lack of anatomical success (30–46 %) with native repair, was reanalyzed using more clinically relevant definitions of success based on the NICHD Pelvic Floor Disorders Network’s recommendation. Of the 114 subjects randomized to the three treatment arms, 88 % were successful based on the new definitions with no difference between the three groups. No reoperations were reported for complications or recurrence at 12 months .
Nonetheless, a legitimate approach to diminish these rates of anatomic failure included the interposition of a mesh material or net beneath the bladder base through a minimally invasive, transvaginal approach . Fed by initial reports of anatomical success with short-term follow-up and byway of the US FDA 510 K-approval process, a plethora of mesh kits became rapidly available on the market . However, a series of reports on “unique” mesh-related complications (mesh extrusion, erosion, and/or retraction, as well as pain and infection), some of which were found to be irreversible and crippling, prompted the US FDA to issue two consecutive notifications in 2008 and 2011. The second notification, based on a continued increase in complications reported on the MAUDE database, was directed to all involved, including patients for whom a list of 14 questions to ask their repair surgeon was recommended. Several other measures were activated including the process of reclassifying vaginal mesh products from a class II to class III device, which will mandate elaborate pre- and post-market investigations . Just recently, Johnson and Johnson Ethicon Women’s Health & Urology decided to remove the following meshes from the market: Prosima™, Prolift, and Prolift +M™ .
What Is the Current Evidence to Favor Transvaginal Mesh Use?
Most of the evidence base related to mesh use is at level 2–3 and there is only a handful of level 1 evidence to date. De Landsheere et al. reported on 3 % failure rate and 3.6 % mesh reoperation rate (2.7 % for mesh exposure) in their retrospective series of 524 patients with transvaginal Prolift™ mesh repair at a median follow-up of 38 months (range: 15–63). They concluded that the rate of prolapse recurrence and re-intervention for mesh-related complications was low in experienced hands . In a large randomized trial by Altman et al. comparing anterior colporrhaphy versus trocar-guided mesh kit repairs in 389 women with stage ≥2 cystocele with composite (objective and subjective) outcomes, mesh kits performed better than native repair at 12 months: 60.8 % versus 34.1 %. The sexual function domains were not significantly different between the two groups (p = 0.99) and the reoperation rate for mesh complications was 3.2 % . Withagen et al. randomized 190 women with recurrent prolapse to trocar-guided mesh repair versus conventional repair and reported a lower anatomical failure rate for mesh repair compared to conventional repair; 9.6 % versus 45.2 % at 12 months follow-up .
What About Those Who Object to the Use of Transvaginal Mesh Placement?
Withagen et al., in the same study mentioned above, reported subjective improvement as equivocal between the two groups at 80 %, despite higher anatomical recurrence in the non-mesh group . Similarly, Neiminen et al. at 3 years follow-up on their randomized trial of anterior colporrhaphy with mesh reinforcement versus traditional repair reported a lower recurrence rate in the mesh versus non-mesh arm: 13 % versus 41 % (p < 0.001). Interestingly, no difference in symptomatic recurrence was noted between the two groups, and the mesh erosion rate was high at 19 % . This debate can be summarized by reviewing the recent Cochrane publication issued in 2010 on 3,773 patients which reported that although mesh repairs showed superior anatomical outcomes, with a higher native repair failure risk (RR 3.55, 95 % CI 2.29–5.51), the current data sets were extracted from conference abstracts and should be interpreted with caution. Furthermore, it appears that there is insufficient evidence to support a clinically significant difference in subjective outcomes, QOL data, and reoperation rate for recurrent prolapse compared to traditional repairs . Finally the FDA notification of 2011 emphasized the Cochrane review by stating that the anatomical outcome may be favorable for mesh, but there is no evidence that this finding changes functional outcomes or patient satisfaction, and can cause grief through mesh-related complications. “In particular, the literature review revealed that: while transvaginal surgical repair to correct weakened tissue between the bladder and vagina (anterior repair) with mesh augmentation may provide an anatomic benefit compared to traditional POP repair without mesh, this anatomic benefit may not result in better symptomatic results” .
How Safe Is Vaginal Mesh?
Data abstracted from a recent systematic review conducted by the Society of Obstetrics and Gynecology of Canada (SOGC) in 2010 reported that although mesh repairs had an anatomical success rate of 79–100 %, the mesh erosion rate was 5–19 % and the reoperation rate 3.2–22 % . These numbers, derived from high volume and experienced centers, have implications for less well trained pelvic surgeons, although caseload and experience levels have not been officially quantitated to date. In recognition of the increased frequency and complexity of vaginal mesh-associated complications, the International Urogynecological Association (IUGA) and the International Continence Society (ICS) issued a joint terminology and classification system to standardize the reporting of mesh complications . In addition, the FDA has proposed 13 points a mesh surgeon should discuss with suitable patients, which has become the core consensus requirement at present (Table 16.1) .
Thirteen core discussion points with potential mesh patients as part of FDA 2011 notification
• Are you planning to use mesh in my surgery?
• Why do you think I am a good candidate for surgical mesh?
• Why is surgical mesh being chosen for my repair?
• What are the alternatives to transvaginal surgical mesh repair for POP, including nonsurgical options?
• What are the pros and cons of using surgical mesh in my particular case?
• How likely is it that my repair could be successfully performed without using surgical mesh?
• Will my partner be able to feel the surgical mesh during sexual intercourse?
• What if the surgical mesh erodes through my vaginal wall?
• If surgical mesh is to be used, how often have you implanted this particular product?
• What results have your other patients had with this product?
• What can I expect to feel after surgery and for how long?
• Which specific side effects should I report to you after the surgery?
• If I develop a complication, will you treat it or will I be referred to a specialist experienced with surgical mesh complications?
• What if the mesh surgery doesn’t correct my problem?
• If I have a complication related to the surgical mesh, how likely is it that the surgical mesh could be removed and what could be the consequences?
• If a surgical mesh is to be used, is there patient information that comes with the product, and can I have a copy?
Falling short of a bipartisan divide between mesh supporters and mesh sceptics in “meshology,” and leaving aside for a moment the patients’ internet networks  and our volatile medicolegal environment regarding mesh use, we should debate the question of whether the time has come to reconsider the concept of vaginally placed mesh in the management of prolapse. First, a better understanding of mesh performance in tissues may be needed before human implantation. This could be obtained from animal studies allowing access to valuable information of in vivo mesh behaviors based on their properties (weight, porosity, fibrosis process, and composition) . Second, once a mesh has been selected and tested in phase I studies , a process of gradual dissemination with surgeon mentors has to take place to try to reduce the effects of a learning curve. For now, transvaginal mesh may remain an option in well-selected cases, for example, a nonsexually active woman, with a symptomatic recurrent cystocele, in a high volume center and following thorough informed consent as recommended in the FDA notification of 2011. In this unique situation, the critical factor may well be the role of the surgeon experience as highlighted by Vaiyapuri et al. who reported on outcomes of Prolift™ mesh placement in Grade 4 POP by a single surgeon in 254 cases with 209 evaluated patients at 12 months. They noted improvements in both objective (Grade ≤ 1 POP: 92.4, 100, and 97 %) and subjective cure rates (absence of symptomatic bulge: 92.1, 92.1, and 97 %) for the consecutive 3 years of evaluation, respectively .
Mesh Placement, with or Without Hysterectomy
Mesh abdominal SCP is the current gold standard for the management of vault prolapse with well-established level 1 evidence in its favor . The median mesh erosion rate from a large systemic review was reported at 3.4 % . Most case series report an increased risk of mesh erosion when ASC was performed concurrent with total hysterectomy (TH) although RCTs are lacking. Culligan et al. reported an increase in mesh erosion in women who underwent a concurrent TH compared to those who did not: 27 % versus 1.3 % (p < 0.001) . As part of the CARE trial, Cundiff et al. reported similar trends in 26 % of women who had concurrent TAH. The mesh erosion rate was 14 % in women with concomitant TAH compared to 4 % with SCP alone, which represented a fivefold increased risk. The increased risk was attributed to the direct contact between the mesh and the vaginal cuff suture line, in addition to possible mesh contamination from vaginal bacteria . Bensinger et al. reported on a retrospective analysis of 121 women who were stratified into 3 groups: (1) SCH with SCP (n = 37), (2) TH with SCP (n = 49), and (3) SCP alone (n = 35). The overall reported mesh erosion rate was 3.3 % and adjusted to 8.2 % (p < 0.039) in Group 2 with all cases occurring exclusively within that group. Patients undergoing SCP at the time of TH had a sevenfold increase in erosion rate risk compared to SCH and ASC or SCP group alone . A recent publication by Kim et al. explored the risk of mesh erosion with minimally invasive sacrocolpopexy (MISC), both robotic and laparoscopic-assisted SCP, in 188 women. They reported an overall 10 % mesh erosion rate, which is higher than most series. Women with concurrent transvaginal hysterectomy (TVH) had higher erosion rate (23 % versus 5 %, p = 0.109) compared to SCH (5 %) or SCP alone (5 %). The odds of mesh erosion for concomitant TVH was 5.67 (95 % CI: 1.88–17.10) compared to SCP alone .
Over the last decade there has been a trend to perform uterine sparing surgery instead of the standard option of a total hysterectomy. Purported advantages of this approach include perioperative and psychosexual benefits in addition to preserving fertility in women who are still within child bearing age. Surgical treatment options for uterine prolapse include open, laparoscopic, or vaginal approaches. Uterine preservation techniques include the Manchester procedure and its variants, sacrospinous hysteropexy (SSH), laparoscopic sacral hysteropexy, and laparoscopic uterosacral vault suspension. Deciding on which operative approach is difficult as there is a paucity of head-to-head comparison trials.
SSH is the most studied vaginal technique with favorable outcomes. Most retrospective studies reported anatomical success rates between 74 and 93 % with short- to intermediate-term follow-up . A recent multicenter randomized control trial by Dietz et al. compared TVH (n = 31) with unilateral SSH (n = 35) for stage 2–4 uterine prolapse with an intention to treat analysis. These authors reported a higher proportion of recurrent apical prolapse in the SSH group compared to TVH at 1 year: 27 % versus 3 %, which they attributed to a higher stage of POP. No statistical significance was detected for QOL or functional outcomes between the two groups although the time to return to work for SSH group was shorter .
Abdominal and laparoscopic sacrohysteropexy provide similar outcomes to TH and SCP with the advantage of shorter operative time, blood loss, and length of stay. Failure rates are estimated between 0 and 22 % and mesh erosion between 0 and 4.1 % . However, most of the data for subjective and objective outcomes for these prolapse procedures are from uncontrolled retrospective case series. Costantini et al. reported on a prospective non-randomized series of 72 women comparing abdominal sacrohysteropexy (n = 34) and SCP (n = 38) alone. They reported shorter operating time in the uterine sparing group and although the rate of cystocele recurrence was higher in this group, 14.7 % versus 2.6 %, it did not reach statistical significance and no reoperations were performed for failures in either group .
The drawback with any uterine preservation technique is the requirement for lifelong surveillance for gynecological cancer. With a lack of definitive gold standard in uterine prolapse treatment, the operative approach will be dependent on multiple factors including compartments affected, patient’s age, comorbidities and performance status, desire for future fertility, patient preference, family genetics, and the surgeon’s skills set.
Global Versus Site-Specific Repair for Rectocele
Rectocele is a common clinical finding, often in association with other vaginal compartment defects with a prevalence of 50 % as reported by Olsen et al. Rectocele in isolation is less common with an estimated prevalence of 7 % . Most rectoceles remain largely asymptomatic and conservative treatments with dietary modifications, stool softeners, vaginal pessaries, and/or pelvic floor therapy should be considered first. Symptoms related to a pronounced rectocele may include the presence of bulge, defecatory dysfunction requiring digital manipulation (vaginal splinting), and/or sexual dysfunction. The existence of a “rectovaginal septum” is controversial. Cadaveric studies by Richardson have demonstrated specific breaks within the “septum” resulting in site-specific defects . On the contrary, histological studies by Farrell et al. on “fascia” biopsies at the time of colporrhaphy demonstrated a layer that consists of moderately dense connective tissue with smooth muscle similar to the deep aspects of the vaginal wall with a conclusion that the surgical “fascia” was an artifact of the surgical dissection . Kleeman et al. reported similar findings on cadaveric studies with no evidence of a distinct septum identified .
Surgical management for rectocele is highly successful. Posterior colporrhaphy (PC) (with or without levator plication) is the most commonly used technique for repair with anatomical cure rates of 76–96 % [43, 44]. If surgical repair is to be considered, the impact on bowel and sexual dysfunction should be appropriately evaluated and the patient counseled accordingly, as rates of bowel dysfunction may not differ following surgery and postoperative dypareunia rates of 5–26 % have been reported [45, 46]. Levator plication should be reserved for nonsexually active women, as dyspareunia rates as high as 30 % have been reported . For this reason, some pelvic floor surgeons have advocated for a more directed approach based on Richardson’s “septum” theorem with site-specific repairs (SSR) on the premise of better functional outcomes. Anatomical cure rates for SSR have ranged between 56 and 100 %. Abramov et al. from a large retrospective series reported that SSR (n = 124) is associated with higher anatomic recurrence rate and lower subjective outcome (symptomatic bulge) compared to traditional PC (n = 183): (11 % versus 4 %, p = 0.02) and (11 % versus 4 %, p = 0.02), respectively. Rate of postoperative dyspareunia (16 % versus 17 %) was not significantly different between the two study groups . Paraiso et al. reported on 106 women with stage ≥ II rectocele randomly assigned to PR (n = 37), SSR (n = 37), or SSR augmented with biologic graft. At 1 year, anatomical outcomes for PC (4/28; 14 %) and SSR (6/27; 22 %) were similar whereas those who received graft augmentation had a significantly greater anatomic failure rate (12/26; 46 %, p = 0.02). There was no significant change in the rate of dyspareunia and overall sexual function improved significantly in all groups postoperatively at 1-year follow-up (p < 0.001), with no differences between groups . From the current literature, native tissue repair with PC remains the gold standard and SSR is an acceptable alternative .
Sling and POP Repair
To sling or not to sling? That is the question. But the answer is not so apparent. It is well known that a certain population of women will have postoperative stress urinary incontinence (POSUI) associated with prolapse repair. Multiple publications have attested to this problem but there is no easy solution. The estimated incidence of POSUI in women without preoperative SUI is estimated between 11 and 37 % [49, 50]. In patients with OSUI, especially in women with high-grade POP (stage ≥ 3), the risk may be as high as 80 % . The intervention rate due to obstruction following mid-urethral sling in one study with POSUI was 8.5 % . How does one justify an additional procedure that will offer benefit and yet not over-treat those that do not require the surgery to begin with and expose such individuals to material risks and complications? This frequent situation presents a particular conundrum to all treating clinicians. There are three proposed approaches: (1) concomitant prophylactic anti-incontinence procedure for all patients undergoing POP surgery, (2) staged approach, and (3) selective approach based on clinical and urodynamic parameters. For those who are in favor of prophylactic slings, we have level 1 evidence with the CARE trial. Women without significant symptoms of SUI on clinical evaluation who were randomized to receiving Burch urethropexy at the time of open abdominal SCP performed better than those without with respect to postoperative de novo SUI (6.1 % versus 24.5 %, p < 0.001), without attracting additional risks at 3 months follow-up . The same authors reported their 2-year data with a similar trend (32 % (Burch) versus 45.2 % (control), p = 0.026) . As cautioned by the authors, it is still a matter of debate as to whether these findings can be generalized to transvaginal route of prolapse repair and other associated anti-incontinence procedures. The OPUS trial aims to address this debate with a controlled study of planned accrual of 350 women, randomized to transvaginal prolapse repair with or without mid-urethra TVT sling . Wei et al. reported on this recent data and concluded that prophylactic TVT during POP surgery resulted in superior continence rates at 3 and 12 months. Number needed to treat was six patients to prevent one urinary incontinence at 12 months, but benefits were tempered by higher rate of postoperative complications . The counterpoint advocating for a staged approach favors the argument that there is scant high-level evidence evaluating clinical predictors that determine which women may require and ultimately benefit from a concomitant anti-incontinence procedure. A study by Borstad et al. gave further credence to this approach within a multicenter randomized trial between evident SUI women managed with concomitant prolapse repair and sling and delayed retropubic sling surgery at 3 months following repair. Of the women in the delayed group, 44 % did not proceed to sling surgery as they either were cured of their SUI (29 %) or improved (15 %) following POP repair alone at 3 months and at 1 year . And finally the principles of first do no harm-“primum non nocere” needs to be factored into any surgical decision planning process. Anti-incontinence surgeries are not risk-free and a recent review by Daneshgari et al. reported on overall complication rates on synthetic mid-urethral slings (MUS) ranging from 4.3 % to 75.1 % for retropubic and 10.5 % to 31.3 % for transobturator MUS, respectively. De novo dyspareunia rate was 1.3–7.3 % and mesh extrusion rates were 0–10.9 % . Furthermore, Deng et al. utilizing data from the MAUDE (manufacturer and user facility device experience) website concluded that MUS complications may be underreported .
On balance, most clinicians will prefer to exercise a balanced approach based on selective identification of women who may be at risk of POSUI and offer these women concomitant surgeries. Chaikin et al. reported from a small prospective study of 24 women that in 10 women with negative preoperative testing for SUI, none developed de novo SUI; and in the 14 women who tested positive for SUI on prolapse reduction and underwent sling surgery, 12 were cured and 2 were failures . Ballert et al. in a prospective study evaluated 105 patients who were treated with a sling based on objective evidence of OSUI on UDS criteria. They reported an 8.3 % complication rate for obstruction in the sling group compared to an 8.5 % rate in those who required re-intervention for POSUI who had negative testing. Interestingly they also reported 30 % risk for POSUI in women with a history of SUI but negative urodynamics, suggesting that a remote history of SUI in the absence of clinical signs may also be a reason to consider an associated anti-incontinence procedure . Liang et al. also reported similar trends when using OSUI on UDS with pessary reduction of high-grade prolapse as a predictor for POSUI. All women who tested negative did not develop POSUI and interestingly, of those that did and declined a TVT, 65 % developed POSUI . From the various publications, performing anti-incontinence procedures with evident SUI is a reasonable approach. This is congruent with the recently published AUA adult urodynamics guidelines .
While there may be many facets on both sides of the argument, ultimately the overriding clinical principle is a thorough preoperative counseling that offers the patient a balanced perspective on risk to benefit ratio based on clinical and investigative predictors such as urodynamic findings.
Sexual Function and POP
Sexual dysfunction is common in women with POP but evidence on outcomes of sexual function following pelvic reconstructive surgery is limited. A prospective study by Dua et al. evaluated postoperative sexual function in 123 sexually active women undergoing prolapse repair stratified into four groups: posterior repair, anterior repair, anterior repair with vaginal hysterectomy, and combined anterior and posterior repair. The electronic personal assessment questionnaire-pelvic floor (ePAQ-PF) was used to assess symptoms and the authors reported that sexual function improved overall following pelvic reconstructive surgery, but greater improvement was seen following anterior repair either alone or in combination with a vaginal hysterectomy when compared with posterior repair .
Pain following pelvic floor reconstruction surgery is inherent to both native tissue and mesh prolapse repairs. Anterior colporrhaphy has a 5–9 % risk of dypareunia . Posterior repair with levator plication is associated with dyspareunia rate as high as 30 % . However, the advent of synthetic mesh and “mesh kits” with synthetic arm extensions into the ischiorectal fossa, transobturator foramen, and sacrospinous ligament for prolapse repair has given way to a new set of pain syndromes. De novo dyspareunia rate of up to 38 % has been reported following transvaginal mesh placement . Withagen et al. attempted to identify risk factors for mesh complications and prospectively studied 294 women treated with tension-free trocar-guided mesh kits for POP. They reported a postoperative dypareunia and de novo dypareunia rate of 45 % and 26 %, respectively, and predictors for both were preexisting pain preoperatively . The exact mechanism leading to pain is unknown. A combination of nerve damage/entrapment and tension on vaginal or perivaginal structures as a result of scarring seems probable. Feiner et al. defined the biomechanical characteristic of “mesh contraction” and reported on a case series of 17 women surgically managed with mesh excision. All subjects presented with intractable pelvic pain, global dyspareunia, and tenderness on pelvic examination associated with vaginal scarring. The reduction of pain postoperatively for pelvic pain and dypareunia was 88 % and 64 %, respectively, with 12 % reporting persistent pain symptoms . Groin pain is a recognized complication of trocar-based mesh systems in up to 4 % with transobturator mesh placement. Most pain occurs transiently but can be intractable requiring extensive obturator dissection and mesh excision with variable success . This is congruent with the FDA warnings that some complications are life altering and intervention “may or may not correct the complication.”
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