Pelvic Organ Prolapse, The Mesh Controversy and Integrative Health

May 14, 2019   |   Evidence in Integrative Healthcare

Integrative healthcare clinicians (IH) may frequently encounter female patients with troubling symptoms of Pelvic Organ Prolapse (POP). POP is very common, more frequent among older women, but often without significant difficulty. Population based studies suggest that from 15% to 35% of women however do have symptoms, especially of stress urinary incontinence. Women often are reluctant to volunteer a medical history of POP symptoms, so sensitive and respectful inquiry about POP-related disorders may identify patients who can benefit from evidence-based treatment recommendations. Many of these treatments are non-drug/non-surgical and are within the scope of practice of IH providers.

While (POP) occurs in both women and men, it is primarily a problem for women[note]Nygaard I, Barber MD, Burgio KL, et al. Prevalence of symptomatic pelvic floor disorders in US women. JAMA. 2008;300(11):1311–1316. doi:10.1001/jama.300.11.1311[/note]. POP occurs when the ligaments and muscles that normally support the organs in the lower abdomen and pelvis weaken. The pelvic organs descend into the lower pelvis where they can put pressure on the bladder, ureters, and lower bowel and produce troubling symptoms. Not all patients who exhibit POP have significant symptoms, but POP often produces pelvic and low back pain, bladder incontinence, urinary leakage, pain with sexual activity, and other problems that, while usually not life threatening, do impair a patient’s quality of life.

The primary goal of any treatment for POP is relief of symptoms and delaying the progression of prolapse. Treatment options range from “watchful waiting;” to various physical methods such as pelvic floor muscle training, physical and massage therapy, yoga, and behavioral changes; the use of a pessary; and on through to a variety of surgical procedures.

Watchful waiting is certainly appropriate for women who may have some degree of POP but few troublesome symptoms. This is an ideal time to implement preventive approaches involving education and exercises for self-management and to prevent development of advancing POP.

When symptoms of POP manifest, evidence based recommendations are for non-surgical interventions to be considered as first-line treatment. Clinical research on Kegel exercises has shown these to be helpful.[note]Dumoulin C, Hay-Smith EJ, Mac Habée-Séguin G. Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women. Cochrane Database Syst Rev. 2014;(5): CD005654.[/note]  Individualized exercise regimens have been shown to improve symptoms.[note]Hagen S. et al. Individualised pelvic floor muscle training in women with pelvic organ prolapse (POPPY): a multicentre randomised controlled trial. The Lancet. VOLUME 383, ISSUE 9919, P796-806, MARCH 01, 2014.[\note]Other exercise regimens such as yoga, Pilates, and Tai Chi have been advocated. Traditions in Chinese medicine, Tai Chi and yoga have spoken to exercises and breathing techniques to control symptoms of urinary incontinence. There is a great deal of anecdotal evidence for these approaches; however none have been studied in randomized controlled trials[note][/note].

Exercise interventions are generally of low risk and are recommended by most clinical practice guidelines as a first-line treatment. This approach can enhance a woman’s sense of self-efficacy and control over troublesome and embarrassing symptoms and therefore should be considered first. Other self-management approaches include managing fluid intake, bladder “training,” and scheduled bathroom visits[note][/note]. These recommendations are largely based on clinical consensus since none of these interventions have been investigated in clinical trials[note]Imamura  M, Williams  K, Wells  M, McGrother  C. Lifestyle interventions for the treatment of urinary incontinence in adults. Cochrane Database of Systematic Reviews 2015, Issue 12. Art. No.: CD003505. DOI: 10.1002/14651858.CD003505.pub5.[/note].

Mechanical support devices, pessaries, have been in use for generations. Ancient Egyptian, Greek, and Latin medical texts describe a variety of mechanical methods intended to support pelvic organs. Contemporary use continues with a variety of devices, usually made of silicone and inserted vaginally[note]Lewicky-Gaupp, C, Glob. libr. women’s med.,(ISSN: 1756-2228) 2010; DOI 10.3843/GLOWM.10025 [/note]. Proper fitting is key to successful treatment. In one small trial (n=113) use of a pessary helped 72% of women avoid surgery.[note]Coolen AWM, Troost S, Mol BWJ, Roovers JPWR, Bongers MY. Primary treatment of pelvic organ prolapse: pessary use versus prolapse surgery. Int Urogynecol J. 2017;29(1):99–107. doi:10.1007/s00192-017-3372-x[/note] A 2013 Cochrane review found only one randomized trial comparing just one pessary type to another. This very weak level of evidence prompted the reviewers to conclude that there is, “No good quality evidence from randomised controlled trials …on which to base the management by pessaries of women with pelvic organ prolapse..”

Surgery for POP is common. 300,000 procedures occur annually in the US. Various surgical techniques include the use of “native” connective tissue grafts and over the past several years has involved the use of a “mesh” which is surgically inserted into the pelvis to suspend the prolapsing organs in their normal positions. The surgical fixes fail frequently depending on the patient, the surgeon and the technique used. One recent retrospective cohort study (n=112) found recurrence of POP symptoms in 18% of patients after about 2.6 years .

Post-surgical complications with mesh procedures are frequent and sometimes serious. Recent research across the globe however has called into the question the effectiveness and safety of this procedure. One large study in the UK found nearly 10% of surgical mesh cases had complications[note]Keltie K, et al. Complications following vaginal mesh procedures for stress urinary incontinence: an 8 year study of 92,246 women. Scientific Reports volume 7, Article number: 12015 (2017).[/note]. On April 16, 2019, the FDA ordered all manufacturers of surgical mesh intended for transvaginal repair of anterior compartment prolapse (cystocele) to stop selling and distributing their products immediately[note]FDA.[/note].

Despite the frequency of occurrence and the numbers of women affected by POP, good medical evidence about which treatments are safe and effective is scarce. Treatments available in IH clinician offices have supportive clinical evidence on the same level as that which supports conventional medicine.