ESTEEM: Effects of Surgical Treatment Enhanced with Exercise for Mixed Urinary Incontinence
ESTEEM was a nine-site randomized superiority trial in women with bothersome stress and urgency incontinence that compared midurethral sling plus perioperative behavioral and pelvic floor muscle therapy with sling alone; the combined strategy produced a statistically significant but clinically small difference in 12-month urinary symptoms.[1]
- Design and population
- Multicenter randomized superiority trial. Women at least 21 years old with moderately or severely bothersome stress and urgency incontinence for at least 3 months and at least one episode of each type on a 3-day diary; anterior or apical prolapse at or beyond the hymen, planned anterior or apical repair, and prior sling were exclusions.
- Arms
- Midurethral sling plus perioperative behavioral and pelvic floor muscle therapy versus midurethral sling alone
- Report and follow-up
- 2019 · 12 months after sling surgery
| Endpoint | Results | Effect | Finding |
|---|---|---|---|
| Adjusted mean change from baseline at 12 months; effect is between-group mean difference in change, points | −128.1 points vs −114.7 points | difference -13.4; CI -25.9–-1; P 0.04 | Met |
Harms: Serious adverse events, related or unrelated: 8.7% vs 11.8%; Vaginal mesh exposure: 4/242 (1.7%) vs 1/238 (0.4%); Worsening urgency incontinence: 11/242 (4.5%) vs 5/238 (2.1%)
Design
Women at least 21 years old needed moderately or severely bothersome stress and urgency symptoms for at least 3 months and at least one episode of each type on a 3-day diary. Anterior or apical prolapse at or beyond the hymen, planned concomitant anterior or apical repair, and prior sling excluded enrollment. Women using overactive bladder medication could enter after a 3-week washout. Randomization was stratified by site and urgency severity; surgeons and outcome assessors were masked, while participants and interventionists were not.[1]
The primary endpoint was change in the patient-reported Urogenital Distress Inventory (UDI) long-form total score from baseline to 12 months; scores range from 0 to 300, with higher scores indicating worse symptoms. The trial tested a between-group difference at a two-sided alpha of 0.05 and prespecified 35 points as the minimal clinically important difference. UDI irritative and stress subscales were secondary outcomes. Outcomes recorded after additional urinary treatment were handled as missing in the primary model; the model accounted for retreatment rates.[1]
Results
Among 480 randomized women, 416 of 464 eligible women contributed postbaseline efficacy data. At 12 months, adjusted UDI total improvement was −128.1 points with combined treatment and −114.7 with sling alone: a between-group mean difference in change of −13.4 points (95% CI −25.9 to −1.0; P = .04). This met the prespecified statistical test for superiority but fell below the 35-point clinical-importance threshold.[1]
The adjusted UDI irritative-score changes were −45.0 and −38.9 points, a between-group mean difference of −6.1 points (95% CI −12.1 to −0.2; P = .04), below that subscale's 15-point clinical-importance threshold. In the prespecified exploratory diary analysis, daily urgency incontinence episodes changed by −1.1 and −0.4, a between-group mean difference of −0.7 episodes/day (95% CI −1.2 to −0.1; P = .02). Additional urinary treatment occurred in 20/235 (8.5%) and 36/229 (15.7%) eligible randomized women (adjusted OR 0.47, 95% CI 0.26–0.85). Secondary and exploratory comparisons were not adjusted for multiplicity.[1]
In a planned, corrected analysis of persistent symptoms, 112/379 women (29.6%) met a composite failure definition: less than a 26.1-point UDI improvement, less than a 70% reduction in daily leakage episodes, or additional urinary treatment. Prior overactive bladder medication (adjusted OR 1.96, 95% CI 1.17–3.31) and detrusor overactivity on cystometrogram (adjusted OR 2.82, 95% CI 1.60–4.97) were associated with failure. These were pooled-cohort associations, not randomized treatment effects.[2]
Surgery and treatment delivery
Surgeons could place either a retropubic or transobturator midurethral sling. The adjunct program, delivered by centrally trained interventionists, comprised one preoperative and five postoperative visits through 6 months. It taught pelvic floor muscle training, bladder training, voiding habits, and ways to control stress and urgency symptoms. Of the eligible randomized women, 198/235 in the combined arm and 204/229 in the sling-only arm were assessed at 12 months.[1]
Adverse events
Among all randomized women, serious adverse events, whether related to treatment or not, occurred in 8.7% with combined treatment and 11.8% with sling alone. Vaginal mesh exposure occurred in 4/242 (1.7%) and 1/238 (0.4%); worsening urgency incontinence in 11/242 (4.5%) and 5/238 (2.1%); and a new or worsening sensation of difficult bladder emptying in 32/242 (13.2%) and 31/238 (13.0%). Reoperation occurred in 3/242 (1.2%) and 4/238 (1.7%), for sling release, mesh excision, or cystotomy.[1]
Limitations
Participants and interventionists knew treatment assignment. The primary analysis excluded women found ineligible after randomization and required postbaseline outcome data. The combined intervention spanned both sides of surgery, so the trial could not isolate the preoperative and postoperative contributions. Its 12-month follow-up does not describe longer-term symptom or mesh outcomes.[1]
In conversation
- Confirmed by PORTRET (2013). Physiotherapy before sling added nothing at 12 years; ESTEEM likewise found perioperative pelvic floor therapy gave no clinically significant symptom benefit over sling alone.
- Parallel to OPTIMAL (2014). Both Pelvic Floor Disorders Network trials randomized perioperative behavioral therapy alongside pelvic surgery, in different patient populations.
Same setting ATLAS (2010)
ESTEEM and OPTIMAL came from the Pelvic Floor Disorders Network and tested behavioral therapy around pelvic surgery in different populations: mixed incontinence undergoing sling surgery here, and prolapse undergoing vaginal repair in OPTIMAL.[1]
Report history
| Published | Report | Cutoff | Headline results | Citation |
|---|---|---|---|---|
| 2019-09-17 | Primary 12-month report · primary | — | Adjusted mean change from baseline at 12 months; effect is between-group mean difference in change, points: −128.1 points vs −114.7 points; difference -13.4; CI -25.9–-1; P 0.04 Met Adjusted mean change from baseline at 12 months; effect is between-group mean difference in change, points: −45.0 points vs −38.9 points; difference -6.1; CI -12.1–-0.2; P 0.04 Adjusted mean change in daily episodes at 12 months; effect is between-group mean difference in change, episodes/day: −1.1/day vs −0.4/day; difference -0.7; CI -1.2–-0.1; P 0.02 Any additional treatment for lower urinary tract symptoms by 12 months: 20/235 (8.5%) vs 36/229 (15.7%); OR 0.47; CI 0.26–0.85; P 0.01 | Sung VW, Borello-France D, Newman DK, et al. "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;322(11):1066-1076. doi:10.1001/jama.2019.12467 DOI |
| 2021-08-01 | Corrected treatment-failure analysis · secondary | — | Subjective failure, objective diary failure, or additional urinary treatment at 12 months: 112/379 (29.6%) met the composite; this was a planned pooled-cohort analysis, not an arm comparison. Subjective failure used a 26.1-point UDI minimal clinically important difference; objective diary failure meant less than 70% improvement in daily episodes.; — Descriptive Any additional urinary treatment at 12 months: 56/379 needed additional treatment; only 2 were treated for persistent stress incontinence. The abstract gives 14.7% for 56/379; ordinary one-decimal rounding gives 14.8%, so the percentage is omitted here.; — Descriptive Adjusted odds ratio for overall failure, prior OAB medication versus none: Association from corrected multivariable analysis, not a randomized contrast.; OR 1.96; CI 1.17–3.31 Descriptive Adjusted odds ratio for overall failure, detrusor overactivity on cystometrogram versus none: Association from corrected multivariable analysis, not a randomized contrast.; OR 2.82; CI 1.6–4.97 Descriptive | Sung VW, Richter HE, Moalli P, et al. "Characteristics Associated With Treatment Failure 1 Year After Midurethral Sling in Women With Mixed Urinary Incontinence." *Obstet Gynecol.* 2021;138(2):199-207. doi:10.1097/AOG.0000000000004444 DOI |
References
1. Sung VW, Borello-France D, Newman DK, et al. "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;322(11):1066-1076. doi:10.1001/jama.2019.12467
2. Sung VW, Richter HE, Moalli P, et al. "Characteristics Associated With Treatment Failure 1 Year After Midurethral Sling in Women With Mixed Urinary Incontinence." Obstet Gynecol. 2021;138(2):199-207. doi:10.1097/AOG.0000000000004444