Fig. 4.1
As suggested by the hammock theory , the urethra is compressed against the pubocervical fascia of the anterior vaginal wall to provide continence. From DeLancey [9]; with permission
Fig. 4.2
As suggested by the integral theory , the urethra (U) is closed via muscle contraction/forces (arrows). Other structures represented in this figure include the vagina (V), bladder base (BB), anterior pubourethral ligament (1), midurethral part of pubourethral ligament (2), vaginal part of pubourethral ligament (3), uterosacral ligament (4), Hammock closure muscle (PC), Levator plate (LP), longitudinal muscle of the anus (LMA), sacrum (S), and pubic symphysis (PS). From Petros [10]; with permission
Petros and Ulstem’s integral theory suggests that pelvic floor disorders such as SUI, POP, urinary urgency, impaired bowel and bladder emptying, and some forms of pelvic pain are all related to laxity in the vagina or its supporting structures, such as its ligaments [12]. Pertaining to SUI, their theory suggests that urethral closing is under muscle control via ligamentous/connective tissue attachments to the urethra. Therefore, injury to the urethral ligaments/connective tissue can prevent appropriate transmission of the muscle activity required to close the urethra. Similar ligamentous/connective tissue injury may additionally contribute to the development of POP.
The hammock and integral theories have been pivotal to explaining the pathophysiology of SUI and its relationship to POP, although they do not describe the pathophysiology of ISD, which was introduced by McGuire [13]. SUI may be caused by inherent failure of the urethral sphincter to close, and this may occur in the presence or absence of urethral hypermobility. Among other factors, urethral sphincter competence is dependent upon intact neurologic control and appropriate watertight apposition of the urethral mucosa. Therefore, neural injury, as well as urethral mucosal deficiency (e.g., due to radiation, trauma, or ischemia), may lead to ISD and SUI. Clinically, ISD may be a potential reason for diminished SUI treatment efficacy [14]. In fact, it can be argued that, since most women develop urethral hypermobility after vaginal delivery yet have no SUI, some degree of ISD must be present for SUI to develop, regardless of the presence of urethral hypermobility.
While the underlying mechanism for SUI in women with POP may be urethral hypermobility, ISD, or both, advanced POP is well-known to potentially “mask” underlying SUI by displacing the bladder neck and “kinking” the urethra. In a study of 237 women with symptomatic POP, prolapse stage was inversely related to reported SUI [15], and in a urodynamic study of women with advanced prolapse, maximum urethral closure pressure decreased by 31% upon prolapse reduction [16]. Thus, underlying anatomic and physiologic deficiencies responsible for causing SUI may be obscured by POP and first become apparent postoperatively.
Incidence
Women with POP have a markedly elevated overall incidence of concomitant SUI versus women without POP, and studies have reported SUI occurring in as many as 80% of women with POP [17–19]. However, the exact overall rate of SUI in women with POP is unclear, owing to varying SUI definitions used in the literature and the dynamic nature of SUI in women with POP. While the natural history of POP progression (from low stages to high stages) is debatable [20], women with low-stage POP and SUI may potentially have continence restored by advancement of prolapse to a higher stage. Not uncommonly, women with POP who are presently continent can report a history of SUI that resolved without treatment. Therefore, the exact overall incidence of SUI in women with POP is difficult to determine. Nonetheless, it is clearly important for surgeons to appreciate the strong epidemiological relationship between POP and SUI.
Likewise, it is imperative for robotic pelvic surgeons to understand the general rates of SUI that can occur after pelvic floor reconstruction. Over the past decade, considerable research has been conducted to ascertain these rates and has provided a basis for performing an anti-incontinence procedure at the time of prolapse repair in some women (Table 4.1). While reported rates of postoperative SUI vary across studies, the data have generally suggested that the occurrence of postoperative SUI is dependent upon two factors: (1) the presence of preoperative SUI and (2) the performance of an anti-incontinence procedure at the time of surgery [21, 26–28].
Table 4.1
Randomized clinical trials reporting rates of subjective and objective postoperative SUI
Study | Randomization arms | Rate of postoperative subjective SUI | Rate of postoperative objective SUI |
---|---|---|---|
Brubaker et al. [21] (CARE) [n = 322](women in the trial did not report preoperative SUI) | 1. Open sacrocolpopexy and Burch colposuspension | 1. 19% (at postoperative month-3) | 1. 4.7% (at postoperative month-3) |
2. Open sacrocolpopexy only | 2. 39.7% (at postoperative month-3) | 2. 8.6% (at postoperative month-3) | |
Liapis et al. [22] [n = 82](women in the trial had occult SUI) | 1. Vaginal POP repair and TVT-O | 1. 18.6% (at postoperative month-3) | 1. 9.3% (at postoperative month-3) |
2. Vaginal POP repair only | 2. 23% (at postoperative month-3) | 2. 28.1% (at postoperative month-3) | |
Schierlitz et al. [23] [n = 80](women in the trial had preoperative occult SUI or asymptomatic urodynamic SUI and the study included vaginal and abdominal POP repairs) | 1. POP repair and TVT | Rates not reported | 1. 15% (at postoperative month-6) |
2. POP repair only | No change in Median UDI-6 question 3 score in either group (at postoperative months- 6 and 24) | 2. 66% (at postoperative month-6) | |
van der Ploeg et al. [24] (CUPIDO-1) [n = 138](women in the trial had subjective SUI or objective SUI on non-reduced test) | 1. Vaginal POP repair and midurethral sling | 1. 22% (at postoperative month-12) | 1. 16% (at postoperative month-12) |
2. Vaginal POP repair only | 2. 61% (at postoperative month-12) | 2. 44% (at postoperative month-12) | |
van der Ploeg et al. [25] (CUPIDO-2) [n = 91](women in the trial had occult SUI) | 1. Vaginal POP repair and midurethral sling | 1. 14% (at postoperative month-12) | 1. 0% (at postoperative month-12) |
2. Vaginal POP repair only | 2. 52% (at postoperative month-12) | 2. 35% (at postoperative month-12) | |
Wei et al. [26] (OPUS) [n = 337](women in the trial did not report preoperative SUI and the postoperative incontinence outcome was not restricted to SUI, i.e., incuded stress, urgency, or mixed incontinence) | 1. Vaginal POP repair and midurethral sling | 1. 9.4% (at postoperative month-3) | 1. 6.3% (at postoperative month-3) |
2. Vaginal POP repair only | 2. 24.8% (at postoperative month-3) | 2. 34.4% (at postoperative month-3) |
Women with preoperative SUI (i.e., complain of SUI or demonstrate SUI on a non-reduced test) who do not undergo a concomitant anti-incontinence procedure appear to have the highest rate of postoperative SUI. The CUPIDO-1 study was a European multicenter randomized trial comparing vaginal prolapse repair with and without concomitant midurethral sling in women with POP and symptomatic or objective SUI (on non-reduced testing). Fifty-seven percent of women undergoing isolated prolapse repair reported bothersome SUI, had objective evidence of SUI, or were treated for SUI at 1 year postoperatively [24]. Another randomized trial, which compared prolapse repair with and without concomitant midurethral sling in women with POP and preoperative SUI (women with SUI upon prolapse reduction with a pessary were included), found that 71% of women undergoing isolated prolapse repair experienced SUI at postoperative month three [29].
Women with preoperative SUI who undergo a concomitant anti-incontinence procedure have a lower rate of postoperative SUI. In the CUPIDO-1 study, 78% of women undergoing concomitant midurethral sling placement experienced absence of SUI in comparison to 39% of women undergoing isolated prolapse repair [24]. Additionally, while 16% of women receiving a concomitant midurethral sling demonstrated SUI postoperatively, 44% of women who underwent an isolated prolapse repair had demonstrable SUI. The 16% objective failure rate of concomitant midurethral sling placement in this trial appears similar to the objective failure rate of midurethral slings in the Trial Of Mid-Urethral Slings (TOMUS) , a multicenter randomized trial comparing retropubic to transobturator midurethral slings [30]. Failure rates could be due to surgical technique, as prophylactic slings at the time of POP repair may potentially be tensioned to loosely and result in postoperative SUI.
Women with occult SUI prior to prolapse repair appear to be at elevated risk of postoperative SUI (i.e., de novo SUI) compared to stress continent women, and performing a concomitant anti-incontinence procedure decreases their risk of postoperative incontinence [27, 28, 31]. The Colpopexy and Urinary Reduction Efforts (CARE) study was a large multicenter trial investigating the effects of performing a concomitant Burch colposuspension at the time of sacrocolpopexy in women without SUI symptoms [21]. Participants in the study were randomized to sacrocolpopexy versus sacrocolpopexy with concomitant Burch colposuspension, and participants underwent urodynamic testing preoperatively (with and without prolapse reduction). The rate of occult SUI in the study was 27%, and women with preoperative occult incontinence more frequently reported SUI postoperatively whether or not they underwent concomitant Burch colposuspension [31]. Among women who did not undergo a Burch colposuspension , 58% with preoperative occult SUI reported SUI postoperatively compared to 38% who did not demonstrate occult SUI preoperatively. Among women undergoing concomitant Burch colposuspension, 32% with preoperative occult SUI reported SUI postoperatively, compared to 21% who did not demonstrate occult SUI preoperatively.
Another multicenter randomized trial (Outcomes Following Vaginal Prolapse Repair and Midurethral Sling, OPUS), which investigated the effects of concomitantly placing a midurethral sling at the time of vaginal prolapse repair, confirmed an elevated rate of postoperative SUI in women with preoperative occult SUI [26]. This trial also substantiated a role for concomitant SUI treatment. In the OPUS trial , 34% of women demonstrated SUI on preoperative prolapse reduction testing, and there was a clear reduction in postoperative urinary incontinence in these women by placement of a concomitant midurethral sling (at postoperative month three, 30% of women receiving a concomitant midurethral sling experienced urinary incontinence compared to 72% of women who did not).
Women who are stress continent before surgery (i.e., no subjective/objective SUI, including no occult SUI) appear to have the lowest risk of postoperative SUI [26, 31]. However, the rate of postoperative SUI is also decreased in these women by performing an anti-incontinence procedure at the time of POP repair [26, 31]. As previously mentioned, the rates of postoperative SUI in women who did not have occult incontinence in the CARE trial were 38% (no Burch group) and 21% (Burch group) [21, 31]. In the OPUS trial, the rates of postoperative urinary incontinence in women who did not have occult SUI were 38% (no midurethral sling group) and 21% (midurethral sling group) [26]. These results were similar to the findings in the CUPIDO-2 study, which also compared postoperative SUI rates among women with and without occult SUI [25]. Thus, although stress continent women may have a lower rate of postoperative SUI, they still remain at risk.
Other factors, such as type of prolapse repair, may potentially influence the incidence of postoperative SUI . While large randomized trials have established the safety and efficacy of robotic pelvic floor repair, there is no high-quality evidence at this time that assesses if using robotic technology in pelvic floor reconstruction affects postoperative SUI rates [32]. However, findings from a meta-analysis suggested that between 10 and 25% of women undergoing isolated robotic sacrocolpopexy need subsequent anti-incontinence surgery [32]. The excellent support of the anterior vaginal wall with sacrocolpopexy (either open, laparoscopic, or robotic) is likely to result in higher rates of postoperative SUI than other POP procedures that have less of a “straightening” effect on the bladder neck.
Preoperative Decision Making
Deciding whether or not to perform an anti-incontinence procedure at the time of robotic pelvic floor reconstruction can be challenging. As discussed in the previous section (Incidence), women with POP have a high rate of SUI preoperatively and a considerable risk of experiencing persistent SUI or developing de novo SUI after prolapse repair. On the other hand, concomitantly treating SUI during prolapse repair poses additional surgical risks and not all women undergoing isolated prolapse repair experience SUI postoperatively. Therefore, pelvic surgeons are faced with a clear dilemma during reconstructive surgical planning. Adding another layer of complexity to this dilemma is the fact that opposing conclusions can be drawn from examining the same data on the topic [33, 34]. For example, data from the CARE trial can be used to support one of three strategies: (1) always perform an anti-incontinence procedure during POP repair, (2) never perform an anti-incontinence procedure during POP repair, and (3) selectively perform an anti-incontinence procedure during POP repair.
Multiple strategies for managing SUI at the time of pelvic floor reconstruction have been adapted, and there is no gold standard method of management [35]. While SUI can be markedly bothersome to women, it is rarely life-threatening, and treatment is considered elective. Therefore, the decision to perform an anti-incontinence procedure at the time of robotic pelvic floor reconstruction should be handled on an individual basis and reflect the patient’s risk of postoperative SUI and treatment goals [36, 37]. The risks and benefits of performing a concomitant anti-incontinence procedure should always be discussed with the patient during counseling and the informed consent process. Understanding the advantages and disadvantages of concomitantly performing an anti-incontinence procedure provides the foundation for counseling.
Advantages of Performing a Concomitant Anti-incontinence Procedure
There are multiple benefits of performing a concomitant anti-incontinence procedure at the time of prolapse repair. In many clinical trials, concomitant anti-incontinence procedures led to a reduction in the rate of postoperative SUI [27, 28]. Thus, for many women, performing an anti-incontinence procedure at the time of prolapse repair can obviate the need for further SUI therapy. As many as 56% of women with preoperative SUI undergoing isolated prolapse repair may proceed to subsequent anti-incontinence surgery [29]. Needless to say, those women undergoing subsequent anti-incontinence surgery are then exposed to the risks of an initial anti-incontinence operation (e.g., voiding dysfunction, mesh exposure, pain), plus the additional risks of undergoing a second operative intervention, including anesthetic risks. Therefore, performing a concomitant anti-incontinence procedure during prolapse repair may potentially prevent the need for a future operative intervention.
After an isolated prolapse repair, some women with postoperative SUI may elect to not undergo subsequent incontinence surgery and may experience continued bother from SUI. While as many as 56% of women undergoing isolated prolapse repair proceeded to subsequent anti-incontinence surgery, 21% of women with postoperative SUI elected not to return to the operating room for treatment [29]. Furthermore, in a retrospective study of 100 women who underwent isolated POP repair, 32% of women with postoperative SUI reported their incontinence to be bothersome [38]. Therefore, these women may have potentially benefitted from the performance of a concomitant anti-incontinence procedure; granted, the relationship between SUI bother and the decision to undergo anti-incontinence surgery is unclear. However, aside from operative intervention, women undergoing isolated prolapse repair more frequently undergo additional non-operative SUI treatment, such as physiotherapy, compared to women undergoing concomitant anti-incontinence surgery [24].
Thus, the overall advantages of performing anti-incontinence surgery at the time of prolapse repair are: (1) decreased occurrence of postoperative SUI, (2) decreased need for future SUI surgical therapy, (3) decreased need for further non-operative SUI therapy, and (4) empiric treatment of women who may experience bothersome postoperative SUI, yet wish to avoid a second operative intervention.
Disadvantages of Performing a Concomitant Anti-incontinence Procedure
There are also disadvantages of performing concomitant anti-incontinence surgery at the time of prolapse repair. While anti-incontinence surgery decreases the rate of postoperative SUI, many women undergoing isolated prolapse repair do not experience bothersome SUI postoperatively. In women without preexisting SUI, data from the CARE trial demonstrated that only 25% reported bothersome SUI after isolated prolapse repair [21]. Thus, performing an anti-incontinence procedure in women without preexisting SUI may be unnecessary. Furthermore, approximately 39% of women with preexisting SUI reported resolution of SUI after isolated prolapse repair [39]. Thus, prolapse repair alone may, perhaps, lead to SUI resolution in some women [40].
Women who experience postoperative SUI may not be significantly bothered by their incontinence, and women with postoperative SUI still frequently report surgical satisfaction [41, 42]. In the CUPIDO-1 study, although 61% of women undergoing isolated prolapse repair reported SUI, only 17% underwent subsequent anti-incontinence surgery [24]. Additionally, 7 year CARE data found that only 13 women who underwent isolated prolapse repair underwent subsequent SUI surgery (including injection therapy) [43]. Therefore, it may be unnecessary to perform an anti-incontinence procedure in women at the time of prolapse repair, as postoperative SUI may not always be bothersome or result in further treatment.
Undergoing concomitant anti-incontinence surgery at the time of prolapse repair exposes women to additional adverse events. Women undergoing concomitant midurethral sling placement in the OPUS trial had more urinary tract infections (31% vs. 18%; p = 0.008), more episodes of major bleeding or vascular complications (3% vs. 0%; p = 0.03), incomplete bladder emptying (at multiple time points), and the need for urethrolysis (2.4% vs. 0%; p = 0.06) [26]. Furthermore, women undergoing concomitant midurethral sling had longer operative times and larger operative blood loss, albeit only by 11 min (p = 0.05) and 24 mL (p = 0.03), respectively. Notably, in a different study of women undergoing transvaginal POP repair, the rate of surgical intervention to correct obstruction after concomitant midurethral sling placement was equal to the rate of subsequent surgical intervention for SUI (8.5% vs. 8.3%) [44].
Thus, the overall disadvantages of performing anti-incontinence surgery at the time of prolapse repair are: (1) unnecessarily treating women for SUI (i.e., overtreatment) and (2) potentially exposing women to adverse events.
De Novo Storage Symptoms
Developing new urinary urgency and/or urge incontinence is a well-known phenomenon that can occur after isolated anti-incontinence surgery [45]. While women who undergo concomitant anti-incontinence surgery at the time of prolapse repair may theoretically be at increased risk of experiencing de novo storage symptoms , the data suggests otherwise. In the CARE and OPUS trials, women who underwent concomitant anti-incontinence procedures did not have worse storage symptoms, and a meta-analysis found that the development of postoperative urge urinary incontinence was unrelated to whether an anti-incontinence procedure at the time of prolapse repair [21, 26, 28, 46]. Notably, storage symptoms can often improve after isolated prolapse repair [47], and whether anti-incontinence surgery diminishes or augments this improvement is unclear. Therefore, in regard to storage symptoms, there is no clear advantage or disadvantage to performing concomitant anti-incontinence surgery at the time of prolapse repair.
Approach to Treatment
Ideally, an anti-incontinence procedure would only be performed in women who would experience postoperative SUI, be bothered by SUI, and be at low risk of having complications. Unfortunately, accurately identifying women with these exact characteristics is challenging. Therefore, three common strategies to manage SUI at the time of prolapse repair have been adopted: the universal approach, the staged approach, and the selective approach (Fig. 4.3).
Fig. 4.3
Example of a selective approach to managing SUI at the time of POP repair. PFDN pelvic floor disorders network
In the universal approach , surgeons perform an anti-incontinence procedure in all women undergoing prolapse repair, irrespective of preoperative testing and SUI risk factors (women who have already undergone midurethral sling placement may be excluded from this approach). While this approach minimizes undertreatment, it exposes women to overtreatment and additional surgical complications. In the staged approach , surgeons never perform a concomitant anti-incontinence procedure, irrespective of preoperative testing and SUI risk factors, and subsequently offer anti-incontinence surgery to only those women with bothersome SUI postoperatively. While this approach minimizes overtreatment, it exposes women to undertreatment, as some women will have to undergo a subsequent anti-incontinence intervention. Additionally, with this approach, women with postoperative SUI who elect to not undergo a second operative intervention may experience persistent bother from their incontinence. In the selective approach , surgeons incorporate preoperative testing and SUI risk factors in their decision to perform a concomitant SUI procedure. This approach has the benefits of balancing overtreatment and undertreatment and is predicated on identifying those women who will be at the highest risk of postoperative SUI [35].
Understanding the number of women who need to be treated (i.e., number needed to treat [NNT]) with anti-incontinence surgery to prevent a case of postoperative SUI highlights the benefit of using a selective approach . In women with preoperative coexisting SUI (i.e., not occult SUI), data from a meta-analysis suggested that two women would need to be treated with anti-incontinence surgery to prevent a case of postoperative SUI [28]. Therefore, pelvic surgeons may elect to perform concomitant anti-incontinence surgery in women with preexisting symptomatic SUI. On the other hand, in women without symptomatic SUI preoperatively, the number of anti-incontinence procedures that would need to be performed to reduce a case of postoperative SUI is considerably higher and is markedly dependent upon the presence of occult SUI preoperatively. According to the CARE data, 5.4 Burch colposuspensions would have to be performed to prevent one case of postoperative SUI, and according to the OPUS data, 3.9 midurethral slings would have to be placed to reduce one case of postoperative SUI [21, 26, 48]. However, results of preoperative occult stress testing significantly alter the NNT. In the CARE trial, the NNT among women with occult incontinence was 3.8 as opposed to 5.7 in women without occult SUI, and the NNT among women with occult incontinence in the OPUS trial was 2.4 versus 5.7 in women without occult SUI. Therefore, preoperatively testing for occult SUI provides a key data point for surgeons using the selective approach.