CARE Trial.

In stress continent pts undergoing abdominal sacrocolpopexy for stage II to IV prolapse, adding a Burch colposuspension roughly halves postop SUI at 3 months without increasing urge symptoms or urinary retention.

Question

In women without symptomatic SUI undergoing abdominal sacrocolpopexy for pelvic organ prolapse, does adding a prophylactic Burch colposuspension reduce postoperative stress urinary incontinence compared with sacrocolpopexy alone?

DESIGN

• Population: N=322, mean age ~61yo, with stage II to IV pelvic organ prolapse planning open abdominal sacrocolpopexy, stress continent by MESA screening, and without a fixed urethra or contraindication to Burch.

• Intervention: Open abdominal sacrocolpopexy + standardized open Burch colposuspension through the same laparotomy incision, with optional paravaginal repair per surgeon.

• Comparison: Open abdominal sacrocolpopexy alone (no Burch), with other aspects of prolapse repair and paravaginal repair performed per protocol and surgeon preference.

Outcomes

Primary composite SUI outcome at 3 months (Symptomatic SUI on PFDI, +stress test, or treatment for SUI)
(Abd SCP+Burch vs. Abd SCP alone)

• *Composite stress incontinence: 33.6% vs 57.4% (p<0.001)

Components of the SUI outcome (Abd SCP+Burch vs. Abd SCP alone)

• *Symptomatic SUI (PFDI stress items): 19% vs 39.7% (p<0.001)

• *Positive stress test at max capacity or 300 ml (supine or standing): 20/8% vs 40.6% (p<0.001)

• *Any treatment for SUI by 3 months: 5.1% vs 11.5% (p=0.05)

• *Bothersome SUI (moderately or quite a bit on PFDI): 6.1% vs 24.5% (p<0.001)

• Burch remained protective after adjustment for surgeon and paravaginal repair.

  • AOR for SUI with Burch: 0.40 (95% CI 0.24-0.66).

Urge and other lower urinary tract symptoms (Abd SCP+Burch vs. Abd SCP alone)

• Composite urge outcome (bothersome urgency, UUI, freq, nocturia, enuresis, or tx): 32.7% vs 38.4% (p=0.48)

• Any urge symptoms regardless of bother at 3 months: 79.7% vs 80.9% (p=0.94)

• Bothersome nocturia: 15.7% vs 13.8% (p=0.53)

• Treatment for urge symptoms: 3.2% vs 5.5% (p=0.45)

Operative outcomes and adverse events (Abd SCP+Burch vs. Abd SCP alone)

• *Operative time (incision to closure): 190 ± 55 mins vs 170 ± 60 mins (p=0.002)

• *Estimated blood loss: 265 ± 242 ml vs 192 ± 125 ml (p=0.001)

• Serious adverse events within 3 months (all causes): 14.6% vs 14.5% (p=0.79)

• Serious urologic or gynecologic events: 3.2% vs 3% (p=0.70)

• Events plausibly related to Burch: 4.5% vs 3% (p=0.24)

• Urinary retention at 3 months: 1 patient in each group.

Key subgroup finding

• *Even in pts without demonstrable leakage on preoperative urodynamics with prolapse reduction, Burch reduced postoperative SUI: 22.9% vs 47.9% (p<0.001)

Quiz

1. Which mechanism best explains how a Burch colposuspension improves stress urinary continence in pts with urethral hypermobility?
A) Increases urethral sphincter resting tone via direct muscular plication
B) Elevates and stabilizes the urethrovesical junction, restoring a backstop under increased intraabdominal pressure
C) Reduces detrusor overactivity by interrupting parasympathetic afferent pathways
D) Narrows the bladder neck by circumferentially constricting the proximal urethra

2. Why can advanced apical and anterior prolapse mask underlying stress urinary incontinence that becomes clinically apparent after sacrocolpopexy?
A) Prolapse compresses the urethra, permanently increasing intrinsic sphincter tone
B) Prolapse stretches the detrusor, decreasing bladder capacity and urgency symptoms
C) Prolapse kinks and mechanically obstructs the urethra, reducing leakage until normal anatomy is restored
D) Prolapse increases ureteral peristalsis, lowering bladder filling pressure.