20 January 2020:
The ESTEEM trial (Effects of Surgical Treatment Enhanced with Exercise for Mixed Urinary Incontinence) was published in JAMA earlier this year . This is a randomized controlled trial of women with moderate to severe mixed urinary incontinence (both stress and urge) who underwent mid-urethral sling surgery. One group was given behavioral and pelvic floor muscle therapy for 1 session pre-operatively and five sessions post-operatively. The second group just underwent surgery with no other specific intervention. The primary outcome measure was a change in Urinary Incontinence (UI) symptoms at 12 months as assessed by the Uro-genital Distress Inventory (UDI) score (maximum 300), which is a validated tool for this type of analysis. Four hundred eighty women were randomized across nine sites in the US. In the combined group, the UDI score fell from 178 to 30.7 (mean change - 128 points), and in the surgery only group, the score dropped from 176.8 to 34.5 (mean change -114.7 points). Both groups significantly reduced the UDI score. The difference between the two groups just reached significance (p = 0.04), but this did not meet the pre-specified threshold for clinical importance (35 points). The difference between the two groups was noted primarily in the irritative component of the UDI score, whereas there was little difference in the stress component. Episodes of urge incontinence were reduced in the combined group, and this group was significantly less likely to need additional treatment for lower urinary tract symptoms (8.5% vs. 15.7% OR 0.47 95% CI 0.26-0.85). Adverse events occurred in 10.2% of participants. The authors concluded that amongst women with moderate to severe mixed urinary incontinence combined behavioral and pelvic floor muscle therapy resulted in a reduction in urinary incontinence symptoms, which may not be of clinical importance.
The existing management pathways for managing women with stress urinary incontinence or irritative bladder symptoms are clear and distinct. However, those women with both types of symptoms (mixed urinary incontinence) can be a much more difficult group to manage and can account for up to half of women with urinary incontinence. This well-conducted randomized trial focuses on the management of women with mixed urinary incontinence (both stress and urge incontinence) and provides useful clinical information for those clinicians managing women with urinary incontinence. Standard teaching and guidelines recommend conservative and behavioral therapy should be first line in women with all types of urinary incontinence and that any urgency symptoms should be treated medically before surgery [2,3]. There are additional concerns that surgery for stress incontinence may exacerbate urgency symptoms . Previous studies in other conditions such as hip arthroplasty and prostatectomy have shown that combining physical muscle therapy with surgery is effective. Still, the results with pelvic floor disorders have not demonstrated a clear advantage . This study showed a significant reduction in urgency symptoms in both groups, which was more pronounced in the combined group. This has two important clinical implications. Firstly current guidelines recommend treating irritative symptoms before surgery for women with stress incontinence, but this paper suggests that may not be necessary as surgery with or without combined pelvic floor muscle therapy led to a significant reduction in urgency and urge incontinence. Thus current management strategies may result in delayed surgery and, also, expose the patients to the increased side-effects and risks of anticholinergic medication such as cognitive decline . Secondly, the study demonstrates that for women with mixed symptoms, a comprehensive package of care including behavioral and pelvic muscle training around the time of surgery is likely to reduce the requirements for subsequent intervention or medication. One of the strengths of this study is that it chose patient-reported outcomes (PRO) as the primary outcome. These were based on a wide range of urinary symptoms, which were assessed on a 3-day bladder diary and had to include moderate to severe stress and urge UI. While demonstrating urinary incontinence can be done objectively, it's difficult to assess its severity. Using the patient's perspective is far more effective and clinically meaningful. The study employed a validated pre-determined clinically significant difference (MCID) of 35 points as a statistical marker for a difference between the two groups. Although this difference was not reached, that does not mean to say that lower changes in the score were not beneficial to individual women. The overall adverse event rate in the study rate was 10.2% at 12 months, of which only 2.3% were deemed to related to the procedure with a mesh exposure rate of 1%, which is consistent with the published literature . This study reaffirms that despite all the adverse publicity around the mid-urethral sling procedures for SUI, they remain a very effective treatment option with a relatively low complication rate. The challenge remains to identify in advance those women who are more likely to develop a complication from surgery and how these could be minimized. While this study does not report any specific advantage of combined therapy in this regard, the additional input around surgery inherent in the combined approach could potentially aid in patient decision making around surgery and subsequent early identification of problems post-operatively both of which have been identified as particular issues behind the concerns raised about mesh usage . In summary, this trial shows that combining behavioral and pelvic muscle training with mid-urethral sling surgery has potential advantages for women with moderate to severe mixed urinary incontinence.
Tim Hillard, DM FRCOG
Consultant Gynaecologist & Urogynaecologist, Poole Hospital NHS Trust, Poole, Dorset, UK
- Sung VW, Borello-France D, Newman DK, Richter HE, Lukacz ES, Moalli P, Weidner AC, Smith AL, Dunivan G, Ridgeway B, Nguyen JN, Mazloomdoost D, Carper B, Gantz MG; NICHD Pelvic Floor Disorders Network. Effect of Behavioral and Pelvic Floor Muscle Therapy Combined With Surgery vs Surgery Alone on Incontinence Symptoms Among Women With Mixed Urinary Incontinence: The ESTEEM Randomized Clinical Trial. JAMA. 2019 Sep 17;322(11):1066-1076.
- NICE Clinical Guideline (NG123). Urinary Incontinence and Pelvic Organ Prolapse in women: management. April 2019
- Syan R, Brucker BM. Guideline of Guidelines: urinary Incontinence. BJUI 2016;117:20-33.
- Barber MD, Brubaker L, Burgio KL, Richter HE, Nygaard I, Weidner AC, Menefee SA, Lukacz ES, Norton P, Schaffer J, Nguyen JN, Borello-France D, Goode PS, Jakus-Waldman S, Spino C, Warren LK, Gantz MG, Meikle SF; Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network. Comparison of 2 transvaginal surgical approaches and perioperative behavioral therapy for apical vaginal prolapse: the OPTIMAL randomized trial. JAMA. 2014 Mar 12;311(10):1023-34. doi: 10.1001/jama.2014.1719.
- Ayeleke RO, Hay-Smith EJ, Omar MI. Pelvic floor muscle training added to another active treatment versus the same active treatment alone for urinary incontinence in women. Cochrane Database Syst Rev. 2015 Nov 3;(11):CD010551.
- Kammerer-Doak D, Rizk DE, Sorinola O, Agur W, Ismail S, Bazi T.Mixed urinary incontinence: international urogynecological association research and development committee opinion. Int Urogynecol J. 2014 Oct;25(10):1303-12.
- Imamura M, Hudson J, Wallace SA, MacLennan G, Shimonovich M, Omar MI, Javanbakht M, Moloney E, Becker F, Ternent L, Montgomery I, Mackie P, Saraswat L, Monga A, Vale L, Craig D, Brazzelli M. Surgical interventions for women with stress urinary incontinence: systematic review and network meta-analysis of randomised controlled trials. BMJ. 2019 Jun 5;365:l1842.
- Toozs-Hobson P, Cardozo L, Hillard T.Managing pain after synthetic mesh implants in pelvic surgery. Eur J Obstet Gynecol Reprod Biol. 2019 Mar;234:49-52.