Dr. Amanda Yunker
At the end of January, Vanderbilt’s Evidence-based Practice Center (EPC) published a comparative effectiveness review for the Agency for Healthcare Research and Quality (AHRQ) on noncyclic chronic pelvic pain.
Vanderbilt Fellowship in Female Pelvic Medicine
In March 2011, the American Board of Medical Specialties (ABMS) voted to officially recognize the field of Female Pelvic Medicine and Reconstructive Surgery (FPMRS) as a medical subspecialty in the same way Maternal Fetal Medicine or Gynecologic Oncology is recognized. The formal designation allows women with prolapse, bladder control issues, nonspecific pelvic pain, incontinence and other pelvic issues to receive care from a fellowship-trained physician.
Vanderbilt was prepared … and in fact already on ‘go’ … when the word came down from ABMS. In anticipation of approval, the medical school had been working for years to create a collaborative program. The new subspecialty integrates two previously separate training programs in gynecologic urology and female urologic surgery.
A fellowship has been in existence at Vanderbilt for nine years with a specific urology track and for four years on the OB/GYN side. Now, the two tracks have been combined. Vanderbilt was one of the first three academic medical centers in the nation to roll out the collaborative approach to training fellows to achieve the new certification in both urologic and gynecologic disciplines at once. Roger Dmochowski, MD, professor of Urologic Surgery, is the director of the new FPMRS Fellowship at Vanderbilt.
“One in three women will experience either prolapse or incontinence in her lifetime, plus there is a broad range of women who experience a complicated disorder like damage from prior radiation, a failed surgery or other complicated co-morbidities,” Dmochowski told the Vanderbilt Reporter last summer.
Two FPMRS specialists, one each from urology and from OB/GYN, will complete training each year, and Vanderbilt has already seen the first two complete training. Physicians who have been practicing under the original separate tracks will be able to apply for subspecialty certification through ABMS. www.effectivehealthcare.ahrq.gov/ehc/products/195/808/CER41-Pelvic-Pain_20120112.pdf
Noncyclic Chronic Pelvic Pain, CPP, Amanda Yunker, Agency for Healthcare Research and Quality, AHRQ, Effective Health Care Program, Vanderbilt’s Evidence-based Practice Center, Endometriosis
Vanderbilt is one of 14 North American EPCs that undertake systemic reviews of the available evidence on a given topic as part of AHRQ’s Effective Health Care Program. The information gathered for the reports is intended to assist healthcare decision-makers and can be used to develop clinical practice guidelines. Investigators focus attention on the strengths and limits of the available evidence from research studies regarding the effectiveness and safety of a clinical intervention. Sometimes, as was true in this case, the available evidence points to a clear need for additional research.
For this particular women’s health report, Vanderbilt investigators reviewed evidence on therapies for women 18 and older with noncyclic chronic pelvic pain (CPP). The interventions reviewed included surgical approaches, such as hysterectomy and laparoscopy, medical management, and integrative interventions.
Ultimately, the review included 36 studies published between January 1990 and May 2011. Of these studies, 18 were randomized controlled trials, of which two were deemed ‘good,’ three ‘fair’ and 13 were found to be of poor quality. There were also three cohort studies (all considered poor quality) and 15 cross-sectional studies of varying quality addressing the prevalence of comorbidities.
Amanda Yunker, DO, MSCR, assistant professor in the Department of Obstetrics/Gynecology at Vanderbilt, said protocols for noncyclic CPP were important to review since about 10 percent of referrals to gynecologists are for this type of chronic pain, which is typically defined as pain not associated with the menstrual cycle that is located in the pelvis and is significant enough or frequent enough to affect a person’s quality of life. Furthermore, it is a condition that is still poorly understood by physicians.
“It tends to be lumped together as a syndrome,” Yunker said of CPP. “The problem is that most studies treat it based on the symptoms first without looking to see where the pain is coming from. We need to make a better effort in treating the etiology of the pain and not just the pain itself.”
Yunker, whose clinical specialty is pelvic pain, noted too often the automatic assumption is the pain is associated with endometriosis. The problem with jumping to that conclusion, she said, is that it “can lead to people receiving treatments that aren’t effective or can actually cause harm.”
While noncyclic CPP certainly could stem from endometriosis, Yunker noted a 2003 article by noted researcher Fred Howard, MD, in the American Journal of Obstetrics & Gynecology found more than 60 possible causes for a CPP diagnosis including disorders of the reproductive tract, gastrointestinal system, urological organs, musculoskeletal system or neuropsychological system.
One of the stumbling blocks to effectively treating this confounding condition, Yunker said, is that so many of the published studies available today are of poor quality. Even in the studies that were well set up, most compared an active treatment to another active treatment.
“Very few compared active treatment to placebo treatment,” Yunker noted. “The problem with that is when you compare two active treatments without first comparing to a placebo, then you have no way of knowing if you are just getting the placebo effect in both.”
The placebo effect, she continued, is not insignificant since it can have as much as 30-40 percent efficacy. “The studies overall are poor, and we need more studies,” Yunker said was a key conclusion of the Vanderbilt EPC.
The problem, she continued, is that all the available drugs or surgical options to treat CPP carry a risk. Additional quality research might better outline which treatments are most effective depending on the pain’s etiology.
While AHRQ doesn’t ask the investigators to make recommendations of one therapy over another, Yunker did say, “We can tell one of the best quality studies showed not to use raloxifene. Patients on that actually had a faster return to pain than those without it.”
The frustration, Yunker said, is that well-meaning physicians might be choosing a course of therapy, notably hysterectomy, based on a poorly crafted study. “I see a lot of women who have had hysterectomies in their ‘20s, and they still hurt,” she said. “And now, they’ve lost any reproductive capability.”
Before jumping to any conclusions, Yunker said, “Physicians should really take a very thorough history and perform a standardized physical exam.” Oftentimes, she added, noncyclic CPP is difficult to diagnose, difficult to manage and takes a lot of office time. “For a really busy OB/GYN who is seeing 30-40 patients a day, this can throw a significant wrench in their schedule.”
Effectively managing CPP and its comorbidities can be difficult. “When women have had pain for a long period of time, they might have started with one specific cause, such as endometriosis or chronic urinary tract infection; and then after time, the pain starts to involve other systems,” she explained.
Because of the complexity, Yunker said physicians who don’t specialize in the condition might want to refer to a specialist. The International Pelvic Pain Society (www.pelvicpain.org) has a “find a provider” search engine to help physicians find specialists in their geographic area.
“There’s no Band-Aid for this condition,” Yunker concluded. “We need to work harder to help these women.”
To read the complete report, go online to www.effectivehealthcare.ahrq.gov and enter “Effectiveness Review No. 41” in the search engine.