Pelvic Floor Disorders: Surgical Approach

26. Management of Concomitant Pelvic Disorders: The Urologic Perspective

Giulio Del Popolo , Stefania Musco and Vincenzo Li Marzi

(1)

Department of Neuro-Urology, Careggi University Hospital, Florence, Italy

Giulio Del Popolo

Email: gdelpopolo@alice.it

Abstract

The pelvic floor is a crossover of various complex functions, and can be considered from three aspects: urological, gynaecological, and coloproctological. The pelvic floor is at risk of damage in females because of its anatomy, since the pelvic organs are positioned in dynamic tensile structures that are subject to weakness over time. There are many factors to be considered, both intrinsic and extrinsic. Intrinsic factors induce the reduction of collagen production, which might lead to deterioration of the fibroelastic support. Extrinsic factors (i.e., constipation, cough, and physical activities) induce an increase in abdominal pressure. Two critical moments in the life of a woman are pregnancy and delivery, which can result in injury. Birth trauma may lead to muscle and neurological lesions, and damage due to stretching. Further alterations are brought about by hormonal changes in the menopause. Symptoms of damage are voiding dysfunction, incontinence, urinary retention, gynecological disorders (such as dyspareunia or vaginal prolapse), and coloproctology dysfunctions (such as constipation and fecal incontinence). An overactive pelvic floor is frequently associated with voiding difficulties of the bladder, and constipation, dyspareunia, and chronic pelvic pain. A reduced tone of the pelvic floor is associated with urinary stress incontinence and/or fecal incontinence, vaginal prolapse, and sexual problems. The most frequent urological symptom in females is stress urinary incontinence (SUI) due to sphincter deficiency, with involuntary loss of urine during activities requiring effort.

26.1 Introduction

The pelvic floor is a crossover of various complex functions, and can be considered from three aspects: urological, gynaecological, and coloproctological. The pelvic floor is at risk of damage in females because of its anatomy, since the pelvic organs are positioned in dynamic tensile structures that are subject to weakness over time. There are many factors to be considered, both intrinsic and extrinsic. Intrinsic factors induce the reduction of collagen production, which might lead to deterioration of the fibroelastic support. Extrinsic factors (i.e., constipation, cough, and physical activities) induce an increase in abdominal pressure. Two critical moments in the life of a woman are pregnancy and delivery, which can result in injury. Birth trauma may lead to muscle and neurological lesions, and damage due to stretching. Further alterations are brought about by hormonal changes in the menopause. Symptoms of damage are voiding dysfunction, incontinence, urinary retention, gynecological disorders (such as dyspareunia or vaginal prolapse), and coloproctology dysfunctions (such as constipation and fecal incontinence). An overactive pelvic floor is frequently associated with voiding difficulties of the bladder, and constipation, dyspareunia, and chronic pelvic pain. A reduced tone of the pelvic floor is associated with urinary stress incontinence and/or fecal incontinence, vaginal prolapse, and sexual problems. The most frequent urological symptom in females is stress urinary incontinence (SUI) due to sphincter deficiency, with involuntary loss of urine during activities requiring effort. If this condition is not treated, it evolves over time into mixed urinary incontinence (MUI). MUI is a combination of SUI with urinary urge incontinence (UUI). Urge incontinence is caused by an abnormal bladder filling function secondary to detrusor overactivity. A clinical definition of overactive bladder (OAB) syndrome is dry, urinary urgency and frequency, or wet, if patients also refer urge incontinence. In cases of pelvic organs prolapse (POP), all symptoms and dysfunctions must be identified before surgery since they are not always correlated with POP and can be cured with conservative or mini-invasive treatment. It is also necessary to perform effective patient counseling on the outcomes after surgery. The urological approach provides for the clinical assessment of the sacral area. In addition to the presence of POP, the integrity of innervation in terms of sensitivity and muscle contractile activity should be investigated. The assessment consists of a specific and general history, physical examination, and neuro-urological and examinations with instruments (such as renal pelvic ultrasound and urodynamics). First-line therapy treatments are conservative. They include perineal rehabilitation and medical treatment. In cases where these fail, percutaneous tibial neurostimulation (PTNS) and sacral neuromodulation should be considered. A more recent option is the injection of botulinum toxin (BoNT-A) into the detrusor muscle or the submucosa of the bladder wall in patients with OAB syndrome. BoNT-A injection is still under investigation; however, it is included in the International Consensus on Incontinence algorithm.

26.2 Conservative Management

Conservative management should be considered as a first-line treatment for uncomplicated lower urinary tract symptoms in women. This includes lifestyle interventions, and physical and pharmacological therapy.

26.2.1 Behavioral Techniques

Changes of lifestyle can be helpful especially in the early stages of disease, and these are generally combined with rehabilitation programs consisting of bladder re-education and pelvic floor muscle training (PFMT). Behavioral modifications include, for example, loss of weight, maintenance of regular bowel habits, quitting smoking, adjusting daily fluid intake, and even reducing or stopping the consumption of alcohol, coffee, and/or tea [12].

Strategies of scheduled voiding regimens are mainly distinguished on the basis of adjustment of urinary symptoms. Bladder retraining includes a program of scheduled voiding that gradually increases over time, in order to improve OAB symptoms such as frequency, urgency, and UUI. Timed voiding consists of a fixed interval between micturition during the day (every 3–4 h). This program is usually recommended in cases of SUI or voiding dysfunction (e.g., incomplete bladder emptying) to prevent urinary leakage or retention [3].

26.2.2 Physical Therapy

Pelvic floor rehabilitation programs should be the first attempt to resolve mild or moderate urinary incontinence [34]. The rationale of PFMT is to improve the quality and control of the striated pelviperineal muscles, which maintain continence by means of abdominoperineal reflexes. Furthermore, the voluntary contraction of pubococcygeous muscles provides a supplementary action for urethral sphincter function. Therefore, PFMT can be recommended not only for stress incontinence, but also as an adjunct to other treatments for mixed and UUI.

PFMT is often combined with biofeedback and functional electrical stimulation (FES) [5]. Biofeedback is usually indicated in the first stage of a rehabilitation program, to make the patient aware of the pelvic floor muscles and be able to eliminate synergies or correct dysfunctions; an example is the reverse perineal command.

The FES provides two different effects resulting from stimulation of the pudendal nerve: a trophic action by passive contraction of the pelvic floor muscles, and a reflex inhibition of detrusor contractions (pelvic-pudendal reflex). Therefore, FES should not be used in patients with urinary retention.

A more recently introduced, alternative form of electrical stimulation is percutaneous tibial nerve stimulation (PTNS) [6]. It consists of an acupuncture needle inserted few centimeters above the medial malleolus, while a surface electrode is placed on the medial calcaneus of the same leg. The needle electrode is then connected to an external pulse generator that delivers an adjustable electrical pulse that travels to the sacral plexus via the tibial nerve. This treatment is considered to be the least invasive form of neuromodulation, and it has been proven to be effective and safe in OAB syndrome. Furthermore, PTNS can be used as an option for chronic pelvic pain or nonobstructive urinary retention, to be used concomitantly with other conservative therapy [7].

26.2.3 Pharmacological Treatment

26.2.3.1 Overactive Bladder Syndrome and Urinary Urge Incontinence

Currently, muscarinic receptor antagonists are the first choice for pharmacological treatment of OAB syndrome and UUI. The rationale of these medications is based on the fact that detrusor contractions are primarily mediated via muscarinic receptors, particularly subtypes M2 and M3. Several antimuscarinic receptor antagonists have been investigated (Table 26.1). All have been documented to be efficacious in OAB syndrome, but none has been proven to be the ideal treatment when compared with the others available. It is still unclear which drugs should be chosen as first-, second-, and third-line therapy. Profiles of each drug and dosage differ, and these should be considered when making treatment choices [810]. Particular caution should be used when treating elderly patients, who should be put on lower dosages in order to avoid cognitive impairment [11]. Close-angle glaucoma is the main contraindication for antimuscarinic drugs.

Table 26.1

Formulation and dosage of muscarinic receptor antagonists

Drug

Dose

Frequency

Tolterodine

1–2 mg

TID

Tolderodine LA

2–4 mg

Once daily

Oxybutynin

2.5–5 mg

BID or TID

Oxybutynin XL

5–15 mg

Once daily

Oxybutynin transdermal patch

3.9 mg/dL

One patch BIW

Oxybutynin gel (10%)

1 mL

Once daily

Trospium

20 mg

BID or TID

Trospium XL

60 mg

Once daily or BID

Solifenacin

5–10 mg

Once daily

Fesoterodine

4–8 mg

Once daily

Darifenacin

7.5–15 mg

Once daily

Propiverine

15 mg

BID or TID

XL 30 mg

Once daily

BID, twice daily; TID, three times daily; BIW, twice weekly.

More recently, the US Food and Drug Administration approved a new drug for OAB treatment. Mirabegron is a β-3 adrenergic receptor agonist, and the first of a new class of treatments with a different mechanism of action compared with antimuscarinic drugs. Mirabegron acts by relaxing the detrusor smooth muscle during the storage phase by activation of β-3 receptors, but with no negative effects on the voiding phase [12]. Promising Phase II studies have also been recently completed on Solabegron, a highly selective high-affinity β-3 receptor agonist, for the treatment of OAB and irritable bowel syndrome. It has been shown to produce visceral analgesia by releasing somatostatin from adipocytes. Phase II studies indicated a tolerability profile for Solabegron that was similar to placebo. Phase III trials are still underway [1314].

26.2.3.2 Female Stress Urinary Incontinence

Several pharmacologic therapies have been proposed for the treatment of SUI in women. These have shown varying success rates, but they rarely bring about total dryness in cases of severe or even moderate SUI.

Duloxetin, an antidepressant acting on the reuptake of serotonin, is the only drug approved in Europe for treatment of SUI. It is approved in the USA for other conditions, but not for SUI. It has weak effects on the bladder and urethral sphincter activities under normal conditions; however, under conditions of “bladder irritation” it suppresses bladder activity through central serotonin receptor mechanisms and enhances urethral sphincter activity through serotonergic and α1-adrenergic mechanisms. Despite a reported significant improvement when compared with placebo, many patients discontinue therapy because of side-effects [15].

Local estrogen treatment for incontinence may improve SUI, but there is no evidence about long-term effects. There have been a few studies on the choice of estrogen type and dose, but there is no direct evidence regarding the best route of administration. The risk of cancer related to long-term treatment with estrogen (breast, endometrial) suggests that estrogens should be used for limited periods only [16].

26.3 Surgical Treatments

26.3.1 Midurethral Sling

26.3.1.1 Midurethral Sling and Stress Urinary Incontinence

Surgical treatment is the standard approach for women with SUI who have failed conservative management strategies such as lifestyle changes, physical therapies, scheduled voiding regimens, and behavioral therapies. Minimally invasive midurethral slings are now considered the first-line surgical treatment for female SUI. In just a few years, midurethral sling (MUS) surgery has revolutionized this urologic field [17] because of a very short learning curve for the procedure, combined with high clinical efficacy and safety [1820]. This new concept of tension-free midurethral support was introduced in the 1990s by Ulmsten and Petros [17].

The use of tension-free vaginal tape (TVT) has been shown to produce significantly higher continence rates compared with Burch colposuspension [21]. Furthermore, the TVT procedure has been shown to outperform other retropubic slings (intravaginal sling, SPARCTM) (Table 26.2). As regards the long-term data, Nilsson et al. reported an objective cure rate for TVT of 84–90% with a follow-up ranging from 5 to 11 years [22].

Table 26.2

Type, approach, and manufacturer of commercially manufactured midurethral slings

Midurethral sling

Approach

Manufacturer

TVT™

RP: bottom to top

Ethicon

Advantage®

RP: bottom to top

Boston Scientific

SPARC™

RP: top to bottom

AMS

Lynx®

RP: top to bottom

Boston Scientific

Prefix PPS™

Pre-pubic: bottom to top

Boston Scientific

Monarc™

TOT: out to in

AMS

Obtryx®

TOT: out to in

Boston Scientific

Aris®

TOT: out to in

Coloplast

TVT-O™

TOT: in to out

Ethicon

MiniArc™

Single incision

AMS

TVT SECUR™

Single incision

Ethicon

AJUST™

Single incision

Bard

Solyx™

Single incision

Boston Scientific

Altis®

Single incision

Coloplast

Ophira®

Single incision

Promedon

RP, retropubic; TOT, transobturator.

In 2001, Delorme proposed a new device with a transobturator route of midurethral tape insertion (TOT) to reduce the risk of pelvic complications (particularly bladder injury) [23]. In controlled trials comparing MUS devices, patients randomized to retropubic or transobturator tapes yielded similar objective and subjective postoperative continence outcomes [21]. In the opinion of O’Connor, the retropubic sling is more effective among patients with intrinsic sphincter deficiency [24]. Rechberger et al. reported that the effectiveness of transobturator tape is significantly lower with Valsalva leak point pressure (VLPP) ≤ 60 cm H2O, while the retropubic technique is effective with VLPP ≤ 60 cm H2O [25]. Therefore, as reported in the literature, the TOT approach should be suggested in SUI patients with VLPP > 60 cm H2O, while in patients with VLPP ≤ 60 cm H2O, the retrobubic approach should be considered [24].

Furthermore, regarding the two different TOT techniques, ‘inside-out’ and üoutside-in’, it has been reported in a prospective study that both have shown similar cure rates (86% versus 92%, respectively) [26]. Moreover, fewer postsurgical complications were seen after TOT than after the retropubic approach [2728].

In addition to the low risks of TOT, a much less invasive MUS (placed without use of any needles, and passed either retropubically or through the groin) has been developed. Gynecare TVT SECUR™, the first mini-sling manufactured by Ethicon, Inc., a Johnson and Johnson company, was released in the USA in 2006. More recently, the MiniArc® single-incision sling has been developed by AMS, Inc. In Tables 26.3 and 26.4, the outcomes of using mini-slings compared with TOT procedures are described [2930]. However, due to poor efficacy, TVT SECUR has been out of production since 2012.

Table 26.3

Cure and improvement rates for mini-slings

Mini-sling [29]

Cure rate (%)

Improvement rate (%)

TVT-O™

83

10

TVT SECUR™

67

13

MiniArc™

87

7

Table 26.4

Objective and subjective cure rates for TOT and TVT SECUR™

Procedure [30]

Cure rate (%)

Objective

Subjective

TOT

97.6

92

TVT SECUR™

83.5

76

26.3.1.2 Midurethral Sling and Mixed Urinary Incontinence

There is conflicting evidence on the effectiveness of the MUS in MUI. While the cure rate for the urge component seems to be variable, there is good evidence that the MUS improves the stress component.

However, a few studies have reported positive results in UUI after the TVT procedure. Rezapour and Ulmsten reported that not only SUI, but also UUI, was cured in 85% of patients and significantly improved in 4% [31].

Paick et al. evaluated the outcome after TVT, SPARC, and TOT procedures in women with MUI. The cure rates in women with MUI were similar following the TVT, SPARC, and TOT approaches (for SUI: TVT 95.8%, SPARC 90.0%, TOT 94.0%; and for UUI: TVT 81.9%, SPARC 86.4%, and TOT 82.0%) [32].

However, a recent systematic review underlines the fact that specific randomized controlled trials of tapes with a long-term follow-up are needed in order to demonstrate the efficacy of retropubic and TOT techniques in women with urodynamically proven and symptomatic MUI [33].

26.3.1.3 Midurethral Sling and Voiding Dysfunction

Voiding dysfunction after sling procedures can be caused by urethral obstruction from hyperelevation of the bladder neck or an exaggerated kinking of urethra. Further voiding symptoms (e.g., hesitancy, slow stream, intermittency, incomplete bladder emptying) and obstruction can also lead to other urinary symptoms, such as pain or OAB syndrome. Voiding dysfunctions, transient or persistent, have been reported in about 3–38% of patients after MUS procedures [34]. Although there is neither an established cut-off point between normal and abnormal postvoid residual (PVR), nor evidence of a correlation between PVR and voiding symptoms, almost 90% of patients report a PVR of < 100 mL after MUS surgery [3536].

There is no consensus on appropriate surgical revision techniques. Tape release, urethrolysis, and sling incision can be considered options for use in voiding dysfunction after MUS.

26.3.1.4 Midurethral Sling and Recurrent/Persistent Stress Urinary Incontinence

The choice of treatment in cases of recurrent or persistent SUI after a first surgical approach is the subject of much debate. After a MUS procedure, the rate of patients re-treated for recurrent or persistent SUI is from 5% to 20% [37].

When failure occurs after a sling procedure, several treatments have been proposed for further management such as the injection of bulking agents, retropubic suspension, pubovaginal sling procedure, shortening of the preimplanted tape, artificial urethral sphincter, adjustable continence therapy or repeat MUS [3738]. The latter seems to be the most attractive choice in cases of early MUS failure. Recently, Stav et al. reported encouraging results in two groups of female patients who had undergone primary and repeat MUS procedures. The preoperative incidence of intrinsic sphincter deficiency was higher in patients who had had a repeat MUS (31% vs. 13%). The subjective SUI cure rate was 86% and 62% in the primary and repeat group, respectively. Repeating the retropubic approach was significantly more successful than a repetaing the transobturator approach (71% vs. 48%). De novo urgency (30% vs. 14%) and de novo urgency urinary incontinence (22% vs. 5%) were more frequent in the group undergoing a second surgery than in the primary group. In authors’ opinion, although a repeat MUS procedure has a significantly lower cure rate rather than primary MUS, the retropubic approach seems to have a higher success rate compared with TOT, whether or not repeat surgery is needed [39].

26.3.2 Anterior Vaginal Wall Prolapse Surgery

Normal pelvic organ support depends on the integrity of the endopelvic fascia, i.e. connective tissue, the pelvic floor muscles, and an adequate nerve supply. Theoretically, if one of these factors fails, the others might be able to compensate to a certain degree. Epidemiological studies have also emphasized the contributing effects of aging, genetic predisposition, obesity, constipation, and hormone therapy. A single anterior defect of the vaginal wall accounts for 33.8% of the total number of POP cases; these data were published by Hendrix et al. in 2002, and include results from 27,342 women [40]. “Bladder outlet obstruction” and occult SUI may coexist and be associated with POP. Detrusor overactivity and urethral hypermobility can be correlated with the degree of POP, while detrusor underactivity and intrinsic sphincter deficiency do not appear to have any correlation with the degree of POP. In female patient with severe POP during urodynamic evaluation reduction of prolapse could be useful to determine asymptomatic and/or hidden conditions [41] (e.g. occult stress incontinence).

Vaginal or abdominal (retropubic, laparoscopic) surgical approaches have been considered as options for treatment of anterior POP. Surgical techniques result in pelvic floor reconstruction or suspension of the involved organs. Traditional surgery comprises anterior repair and paravaginal repair.

Anterior repair is recommended for central defects [42].The recurrence rate varies from 3% to 40% [4344]. Paravaginal repair is recommended for lateral defects. Retropubic and vaginal access show a recurrence rate of 3–14% and 7–20%, respectively. In both accesses a persistent SUI is reported in 57% of cases [45].

POP repair with absorbable and biological mesh improves the anatomical outcome as compared with traditional repair alone, and with no increase in the rate of complications. The literature reports better anatomical outcome for polypropylene mesh as compared with biological mesh. In the polypropylene mesh group, prosthesis exposure rate was significantly higher than in the biological mesh group [46]. A polypropylene prosthesis showed better anatomical and subjective results compared with traditional surgery. Apical or posterior compartment prolapse was significantly more common following use of a polypropylene mesh, and the mesh extrusion rate was 10.4%, with 6.3% undergoing surgical correction [47].

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