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Outcomes Following Multidisciplinary Management of Women With Residual Pelvic Pain and Dyspareunia Following Synthetic Vaginal Mesh and/or Mesh Sling Removal

Abraham, Annie M. MD1; Scott, Kelly M. MD1; Christie, Alana BS, MS2; Morita-Nagai, Patricia PT1; Chhabra, Avneesh MD3; Zimmern, Philippe E. MD4

Author Information
Journal of Women’s Health Physical Therapy: October/December 2019 - Volume 43 - Issue 4 - p 171–179
doi: 10.1097/JWH.0000000000000140
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Abstract

INTRODUCTION

Chronic pelvic pain has an estimated prevalence of 5.7% to 26.6% among women worldwide.1 Women with persistent pelvic pain or dyspareunia present with a constellation of symptoms that can include unilateral or bilateral pelvic, labial, vaginal, or buttock pain. Chronic pelvic pain can create a functional disability and can negatively impact work activities, sitting tolerance, ability to exercise, sexual function, and overall quality of life.2 Even after a thorough evaluation, it is often difficult to identify the exact etiology of the pain. Possible etiologies may include pelvic floor dysfunction with pelvic floor myofascial pain; scar tissue; obturator, pudendal, or sciatic neuralgia; synthetic vaginal mesh or mesh sling contraction; and infection.3,4

Pelvic pain, among other adverse outcomes, can result from the placement of transvaginal mesh and mesh sling for the treatment of stress urinary incontinence and pelvic organ prolapse in a significant number of patients.5,6 A previous study demonstrated that, even after vaginal mesh or mesh slings were excised due to pain symptoms, chronic pelvic pain and dyspareunia persisted in 33% of vaginal mesh cases and 19% of synthetic mesh sling cases.7 There is a paucity of long-term data in the literature on the management of women experiencing chronic pain and dyspareunia after synthetic vaginal mesh and/or mesh sling excision once surgical removal has been optimized. Consequently, this lack of information leaves unanswered questions about optimal management for these patients.

Pelvic pain treatment by physical therapy and local injections can improve symptoms, but the long-term success rate of these interventions is not well established.8,9 In the case of pelvic neuropathies, advanced imaging, such as magnetic resonance neurography (MRN), can demonstrate pelvic nerve involvement that can be specifically targeted by perineural and/or intramuscular injections with variable degrees and duration of pain relief.10–13

Given the complexity of their presentations, women with painful mesh complications may be referred to multidisciplinary centers that offer a comprehensive approach including extensive diagnostic testing, surgical removal of as much synthetic material as possible, and nonsurgical therapies to manage residual symptomatology. This study aims to report on the evaluation of women with residual pain/dyspareunia after surgical removal of synthetic vaginal mesh and/or mesh sling, as well as the effectiveness of treatments received using a multidisciplinary approach toward improving their residual symptoms.

METHODS

The study was approved by the UT Southwestern Institutional Review Board prior to conducting a retrospective analysis of a prospectively maintained database of women treated jointly by a female pelvic medicine and reconstructive surgery specialist (P.Z.) and a physiatrist specializing in the management of pelvic pain (K.S.).

Subjects

Included were women who underwent surgery to remove vaginal synthetic mesh and/or a mesh sling. These women were evaluated by a physiatrist for continued pain and/or dyspareunia management and attended pelvic floor physical therapy. Exclusion criteria included women who were seen by the physiatrist for residual symptoms other than pain or those who were pending a subsequent resection procedure at the time of analysis.

Procedures

Each patient with chronic pelvic pain and/or dyspareunia was assessed by a physical medicine and rehabilitation (PM&R) physician specializing in pelvic floor rehabilitation medicine. A detailed history was obtained from each patient and a thorough physical examination was conducted, including neurological examination, musculoskeletal examination of the legs, hips, and pelvic girdle, abdominal examination, and a vaginal pelvic floor neuromuscular examination.

Pelvic floor dysfunction was characterized according to standard terminology.14 A patient was considered to have an overactive pelvic floor if the pelvic floor muscles did not relax fully when it was appropriate for them to do so. Meanwhile, an underactive pelvic floor described when the pelvic floor muscles could not contract or contracted weakly. The term “pelvic floor dyssynergia” indicated a situation when the pelvic floor muscles paradoxically contracted when they were supposed to relax (one example being during attempted defecation). It is possible for a patient to exhibit all 3 of these pelvic floor dysfunctions concurrently; they are not mutually exclusive. Finally, the presence of pelvic floor myofascial pain was determined, referring to tenderness elicited from the pelvic floor musculature and connecting fascia, often identified by the presence of myofascial trigger points.

After examination, patients were referred for pelvic floor physical therapy. All of the pelvic floor physical therapists who treated patients in this study were certified through the Certificate of Achievement in Pelvic Physical Therapy program offered by the Section on Women's Health of the American Physical Therapy Association,15 and 3 out of the 5 therapists were certified by the American Board of Physical Therapy Specialties as Women's Health specialists. The overall goal of the therapy was to relax overactive pelvic floor muscles and improve scar tissue restrictions, although each program was individually catered to each patient. Each patient was provided a prescription for lidocaine 2% jelly to allow for enhanced tolerance of intravaginal myofascial release during internal physical therapy.

The physical therapy program consisted of 2 main components—education and treatment (with instruction in a long-term management plan).16 The educational component prepared the patient for rehabilitation by providing a clear and simple explanation of the relationship between anatomy and physiology of the pelvic floor and symptom development. The therapists endeavored to heighten awareness of maladjusted patterns of movement and faulty behaviors, substituting an appropriate response to a stimulus. These methods are derived from experimental psychology—aversion therapy, modeling, operant conditioning, and systematic desensitization.17 The ultimate aim of education was to assist the patients in the development of self-efficacy and intervene to develop healthy coping strategies, gain a sense of control over symptoms, and adjust their lifestyle to enable a positive approach to symptom management.17

The rehabilitative treatment component of the program focused on improving pelvic floor overactivity via a variety of different techniques to teach the patient to relax their pelvic floor muscles and restore optimal muscle length. These techniques are collectively described as “downtraining” of the pelvic floor muscles.18 General relaxation techniques were encouraged through practices such as meditation, mindfulness, physiologic quieting, restorative yoga, and surface electromyography biofeedback monitoring of various body regions including the pelvic floor, gluteal, and abdominal wall muscles. Muscle flexibility was addressed via the teaching of stretches, particularly for the adductors, obturator internus, piriformis, hamstring, and iliopsoas muscles. Patients were instructed in the use of vaginal dilator therapy using conical-shaped devices with the intent of increasing flexibility or elasticity of soft tissues.17 Individuals were also instructed to perform diaphragmatic breathing to influence the physiologic stress response.19 Eccentric lengthening of pelvic floor muscles using the verbal cue to “bulge” the perineum gently was coordinated with diaphragmatic breathing (an exercise also termed “reverse Kegels”). Physical therapists performed myofascial release to improve trigger points and restore connective tissue pliability. Myofascial release was performed externally to the abdominal wall, adductor muscles, gluteal muscles, and superficial pelvic floor muscles as well as internally via intravaginal and/or intrarectal palpation on the deep pelvic floor muscles. Select patients were also taught self-treatment of trigger points within the pelvic floor via the use of a small dilator or other specialized tool for internal myofascial release.

Patients were also taught a home exercise program to be performed between visits and after completion of therapy, which consisted of relaxation exercises, stretching, and other measures tailored to their individual situation, such as the use of vaginal dilators or the practice of restorative or Hatha yoga. The patients were not instructed to do pelvic floor muscle-strengthening exercises commonly known as Kegels, and vaginal electrical stimulation was not used as a treatment modality.

MRN was performed on select patients to assess for relevant nerve-related diagnoses, specifically pudendal, sciatic, obturator, and genitofemoral neuropathies. The physiatrist ordered MRN either when neuropathy was clinically suspected based on patient history and examination or when the patient did not respond well to physical therapy, necessitating further work-up for nonmyofascial pain etiologies. All studies were performed on 3-T MR scanners (Achieva, Ingenia, Philips; Amstelplein 2, 1096 BC Amsterdam, the Netherlands) employing a combination of 2D (dimensional) and 3D nerve selective techniques including diffusion tensor imaging and the SHINKEI protocol.20 For all cases, the radiologist read the images blinded, without knowledge of the clinical presentation (A.C.).

Patients who either were unable to tolerate the pelvic physical therapy due to severe pain or were not exhibiting expected improvement with PT alone were considered for various injections or medications. Injections included botulinum toxin injections, steroid trigger point injections, greater trochanteric bursa injections, epidural steroid injections, and CT-guided perineural and/or intramuscular piriformis injections. Medications generally fell within the categories of psychotherapeutic medications (sertraline, buspirone, duloxetine, etc), muscle relaxants (baclofen, cyclobenzaprine, diazepam, etc), and neuropathic pain medications (gabapentin, pregabalin, duloxetine, etc). Patients with a prior diagnosis of anxiety disorder or depression were encouraged to continue with previous medication treatment or counseling.

Outcome Measures

For the purpose of evaluation, patients were categorized as compliant or noncompliant with treatment recommendations. Patients were considered compliant with the rehabilitation program if they followed treatment recommendations of the supervising physician and physical therapist, including attending physical therapy sessions with minimal gaps in attendance and performing their home exercise program faithfully. Compliant patients were grouped into 2 categories for statistical analysis—the “improvement” group, containing those who experienced symptom relief, and the “nonimprovement” group, which included those who experienced a lack of progress with symptom relief despite dedication to the program.

Primary outcome was pelvic pain severity score assessed by a Numeric Pain Rating Scale recorded at baseline at the initial evaluation visit with the physiatrist and then similarly recorded at each subsequent visit with the physiatrist or physical therapist. A successful outcome was considered to be a 50% reduction in pain score from the initial to the final visit, given that a minimal clinically important difference can be estimated at a change of 2 points or 33% change in pain score.21,22 Data extracted by a third party not involved in the care of these women included pain scores, appointment dates, treatment type (physical therapy, medications, and injections), MRN findings, type of synthetic material (vaginal mesh or mesh sling), and other demographic and historical data as reported in Table 1. Final pain scores were obtained from either the final physiatry visit or the final physical therapy visit to more accurately represent the effect of treatment if therapy continued past the final physician appointment. As a measure to encourage compliance, patients received standard reminder phone calls before appointments as well as personalized calls from their physical therapist if they missed multiple sessions.

Table 1
Table 1:
Baseline Sample Characteristics

For statistical analysis, descriptive statistics were provided as frequencies and percentages for categorical variables and given the evidence of nonnormality in the data, medians and interquartile ranges were reported for continuous measures. The Fisher exact test was used to test for association between categorical variables, while the Kruskal-Wallis test was used to determine whether there were differences in continuous measures among groups. All analyses were completed at the .05 significance level using SAS 9.4 (SAS Institute Inc, Cary, North Carolina).

RESULTS

From 2010 to 2015, 41 women were evaluated by the PM&R specialist for residual pelvic pain after having vaginal mesh or mesh sling resection by the female pelvic medicine and reconstructive surgery specialist. Of these, 37 women were included in the study; the 4 excluded were lost to follow-up after the initial PM&R visit and did not participate in any treatment. The women in this study had a mean age of 54 years (range 28-69) as well as various associated conditions at the time of evaluation, including urinary incontinence (78%) and voiding dysfunction (100%), as noted in Table 1. On physical examination, all of these patients exhibited pelvic floor overactivity and pelvic floor myofascial pain, while 68% also demonstrated pelvic floor underactivity and 27% had pelvic floor dyssynergia.

Of the 37 patients, 33 had chronic pelvic pain, of which 31 also had dyspareunia. There were 4 patients who had isolated dyspareunia and experienced no pain apart from vaginal penetration. All of these patients had a total pain duration (months from implantation to pain specialist referral) of a median of 51 months, or 4.25 years. The majority of this period occurred between implantation and removal, which accounted for a median of 44 months, while the time from implant removal to referral approximated 7 months.

Patients were categorized according to 4 treatment programs. All patients underwent pelvic physical therapy, of which 17 were treated with pelvic physical therapy alone. Five patients were treated with medication in addition to pelvic physical therapy and 3 patients were treated with therapeutic injections in addition to pelvic physical therapy. There were 12 patients who received pelvic physical therapy, medication management, and injections.

Among the patients with chronic pelvic pain, the median initial pain score was 6 with a final pain score of 4, amounting to a median reduction of 16.7% in pain score (Table 1). Eight (24%) of these 33 patients experienced a good outcome of 50% or greater reduction in pain score. Overall, 18 (55%) patients demonstrated at least some reduction in their pain score, while the remaining 15 experienced no change or heightened pain scores. When only these 18 patients with improved pain scores are considered, the average percent reduction in pain score was 49.7%. There were no statistically significant differences regarding change in pain score across the 4 treatment programs. In addition, the comparison of PT alone versus PT with any intervention (medications and/or injections) also did not demonstrate a difference in change in pain score. Interestingly, patients who had previously been administered muscle relaxants were more likely to require medications or injections in addition to physical therapy. Meanwhile, a history of narcotic use or psychiatric conditions did not demonstrate a higher likelihood of these interventions.

Patient outcomes were also analyzed after dividing the patients into groups based on compliance with treatment recommendations (see Table 2). Nine patients were deemed non-compliant (failing to attend required PT sessions or follow through with their home exercise program), while 28 patients were compliant. Noncompliant patients underwent a median of 4 physical therapy sessions, while compliant patients underwent 7.5 sessions. There were no statistically significant factors associated with compliance versus noncompliance, including demographics, preexisting conditions, therapy programs, or implant types. In addition, the difference in percent change in pain score between the noncompliant and compliant groups was not statistically significant. Overall, patients in the noncompliance group did not worsen, although none of them achieved more than 50% reduction in pain score. Meanwhile, 8 (29%) of the 28 compliant patients achieved a good outcome of more than 50% improvement. Compliant patients treated for isolated dyspareunia (2 of 4) achieved more than 80% improvement.

Table 2
Table 2:
Association Between Clinical Parameters and Outcome Groups

When examining success rates of more than 50% improvement in pain score by the treatment program among the group of compliant patients (Figure), there were 5 (38%) out of the 13 who underwent physical therapy alone, 1 (33%) out of 3 who had physical therapy and medications only, 1 (33%) out of 3 who had physical therapy and injections only, and lastly 1 (11%) out of 9 who underwent physical therapy with a combination of medications and injections.

Figure
Figure:
Flowchart demonstrating a breakdown of outcomes based on therapy variations.

The group of 28 compliant patients was further divided into 2 categories: “improvement” (n = 14) and “nonimprovement” (n = 14), as shown in Table 2. Half of the compliant patients experienced improvement with their treatment program, with a median pain score change from 5.5 to 1.5, representing a 63.4% decrease in pain. Thus, for 38% of all patients, the treatment program yielded clinically significant pain reduction. While 50% of compliant patients saw improvement in pain scores, there are equal numbers who continued at the same level of pain or slightly worsened (median initial pain score of 5.5 to final pain score of 5.8 with 0% change in pain score). There were no statistically significant correlations found between demographics or preexisting conditions and patient improvement. Clinical parameters that were trending toward significance included a higher rate of depression (P = .16), underactive pelvic floor (P = .13), and urinary incontinence (P = .07) in the nonimprovement group compared with the improvement group.

MRN was obtained in 15 patients (41%). All 8 patients with MRN-positive studies were compliant, with 4 in the nonimprovement group and 4 in the improvement group. Of these, 8 (53%) demonstrated evidence of nerve involvement on imaging: 3 showed pudendal neuropathy while the remaining 5 showed both pudendal and sciatic neuropathies as demonstrated by increased signal and/or size of the nerves. These patients were more likely to have injections incorporated into their treatment plan, as 6 (75%) of the 8 received injections, whereas only 31% (9 of 29) of all other patients underwent injections. Out of the 5 patients with both pudendal and sciatic neuropathies, 4 experienced no improvement or worsened pain with treatment, while 1 showed improvement. Among the 3 patients with isolated pudendal neuropathy, all improved with treatment.

DISCUSSION

Interventions focused on the treatment of pelvic pain and dyspareunia, including pelvic floor physical therapy, medication management, and therapeutic injections, are a reasonable recommendation for patients experiencing pelvic pain following vaginal mesh or mesh sling removal. Fifty percent of patients who are compliant with treatment (38% of all patients in this study) will experience at least some improvement, and 24% of patients with pelvic pain will achieve greater than 50% improvement in their pain score. There were no clear factors identified in this study to pinpoint which patients will improve with this treatment approach. Conversely, then, all patients are candidates for potential improvement, even in the face of a significant psychiatric history, prior narcotic use, resection of multiple types of mesh, or a longer pain duration.

The patients in this study all received pelvic physical therapy, and select patients also received further diagnostic testing with MRN, medication management, or therapeutic injections. It is interesting to note that there was no clear added benefit to pursuing these physician-directed treatments, although this determination is limited by small sample size. The most likely explanation for the lack of clear additional benefit in these cases is that the patients who were selected to receive intervention beyond physical therapy tended to be the patients with higher pain scores and poor tolerance of physical therapy alone.

Substantial failure rates have been reported for conservative management of chronic pelvic pain related to pelvic mesh complications.2,23,24 This study, which is the first to our knowledge that examines the effectiveness of pelvic physical therapy in patients with pelvic pain related to mesh complications, has findings, which help to support this assessment for conservative interventions that include physical therapy, medications, and injections. Similar treatment programs with an emphasis on pelvic physical therapy have been reported to be far more efficacious for other pelvic pain populations, such as those with dyspareunia, levator ani syndrome, interstitial cystitis, vulvodynia, and coccydynia related to overactive pelvic floor dysfunction.25–30 More research is needed to identify the reason for this discrepancy. Possible factors may include the presence of residual mesh or mesh anchors, which may cause tissue restrictions and serve as a nidus for infection, scar tissue, pelvic neuropathies due to multiple prior surgical procedures, severity of psychological comorbidities, and secondary gain influences related to pending lawsuits against mesh manufacturing companies.23

One quarter of the patients in this study were noncompliant with treatment recommendations, including attending recommended pelvic physical therapy sessions and following through with physician recommendations. This high percentage is consistent with what has been reported in the literature for other studies involving pelvic physical therapy.30,31 It can be speculated that reasons for this noncompliance may have included worsening pain, perceived ineffectiveness, depression/anxiety, or medical or logistical complications, which made further treatment impossible. Being a tertiary care center, many of our patients needed to travel more than an hour to reach our facility, which may have been a factor in worsening pain scores or noncompliance. It may also be that pelvic physical therapy seemed too expensive, invasive, intimate, time-consuming, or embarrassing for some patients to fully commit.31,32

The retrospective nature of this study did not allow for diagnostic MRN imaging on every patient, which would have been helpful to determine the prevalence of pelvic neuropathies in this patient population. Even so, 53% of patients who underwent imaging had evidence of at least one pelvic neuropathy, resulting in an overall study prevalence of a minimum of 22% (8 out of 37 patients). The treatment of pelvic neuropathic pain needs further investigation; it may be that these patients would benefit from targeted nerve blocks, radiofrequency ablations or pulsed radiofrequency treatments, and neuropathic pain medications in addition to pelvic physical therapy.3,10,33

An important aspect to consider is that many of these patients may have also experienced pelvic floor dysfunction and/or pelvic neuropathies before removal of their implant(s). There was no way to evaluate that aspect in this study given the limited data available on chart review, as these patients were only referred to a pelvic pain specialist for evaluation after mesh resection. Nevertheless, urologists, urogynecologists, and gynecologists should consider referral to a pelvic pain specialist or pelvic physical therapy for assessment both prior to and after vaginal mesh or mesh sling resection surgery in cases of chronic pelvic pain or dyspareunia. While cases of exposed vaginal mesh or vaginal scar tissue may demand further removal, it may be possible to treat milder cases more conservatively with a combination of physical therapy, medications, and/or injections, thereby sparing the patient the risk of further surgical complications.

Limitations

This study contains various limitations. As a retrospective chart review, it holds a risk for selection bias. As with any pain study, pain scores are subjective and the patient's reporting of them can be inconsistent depending on many factors, which might influence the situation at the time. A small sample size makes it difficult to determine significant trends in the data and thereby assess clinical importance of findings, and the fact that 25% of the patients were not compliant with treatment recommendations further complicates data interpretation.

Various conditions and factors can complicate patient progress, including psychological conditions, geographic location, and pending lawsuit cases against vaginal mesh and mesh sling manufacturers. Notably, more than 100 000 lawsuits have been filed against vaginal mesh and mesh sling manufacturers; in addition, in 2013 alone there were more than 40 000 medical device complication accounts submitted to a reporting database of the Food and Drug Administration.34 Although these factors may play a large role in patient progress, it is difficult to pinpoint the effects of these variables.

In addition, it would have been helpful to have had an appropriate, validated, functional outcome assessment specific to patients with pelvic pain and a validated pain outcome assessment; however, as a retrospective review, these were not available. While many patients reported functional improvements after completion of treatment (such as improved sitting tolerance, improved urinary incontinence, and improvement in dyspareunia), these questions were not routinely asked of every patient; therefore, this study is unable to address the functional impact of this treatment.

CONCLUSION

Further investigation into the treatment of chronic pelvic pain and dyspareunia associated with vaginal mesh and mesh sling complications and resection surgical procedures is warranted; a randomized, controlled trial of pelvic floor physical therapy versus classic treatment with external physical therapy, injections, or medications would be helpful in determining correlation versus causation. A prospective study would also allow for evaluation of the patients at multiple time points after completion of the program to determine whether the results of the treatment program can be maintained long-term.

Pelvic pain-focused interventions, including pelvic floor physical therapy, medication management, and injections, may be helpful for women with refractory pelvic pain after vaginal mesh or mesh sling removal, provided they maintain compliance with treatment recommendations.

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Keywords:

pelvic floor; pelvic floor physical therapy; pelvic rehabilitation; synthetic mesh

Copyright © 2019 by the Section on Women's Health, American Physical Therapy Association.