Please select the eligibility criteria that correspond to the clinical trial below.
Title: Long-term Effectiveness of Abdominal Sacrocolpopexy for the Treatment of Pelvic Organ Prolapse: The Extended Colpopexy and Urinary Reduction Efforts (E-CARE) Study
Brief Summary: The Colpopexy and Urinary Reduction Effort (CARE) trial is a research study designed to evaluate whether the addition of a second surgical procedure in addition to a procedure for female pelvic organ prolapse (POP) affects the rates of urinary incontinence. This study will follow women in the CARE study for 10 years from the time of the surgery to compare success and complication rates in the two groups. Recruitment into this study is open only to women that already participated in CARE. Recruitment into CARE is closed.


Options:
A: Inclusion Criteria:

* Female
* Stress urinary incontinence (SUI) as evidenced by all of the following:
* Self-reported stress-type urinary incontinence symptoms, of duration ≥ 3 months
* Medical, Epidemiological and Social Aspects of Aging (MESA) stress symptom score (percent of total possible stress score) greater than MESA urge symptom score (percent of total possible urge score)
* Observation of leakage by provocative stress test at a bladder volume ≤ 300ml
* Bladder capacity ≥ 200ml by stress test
* Post-void residual (PVR) ≤ 100cc with pelvic organ prolapse (POP) Stage I or lower. If POP is Stage II-IV, PVR \>100cc but ≤ 500cc is allowed
* Eligible for both retropubic and transobturator procedures
* No medical contraindications, e.g., current urinary tract infection (UTI), history of pelvic irradiation, history of lower urinary tract cancer
* American Society of Anesthesiologists (ASA) class I, II, or III
* No current intermittent catheterization
* Available for 24-months of follow-up and able to complete study assessments, per clinician judgment
* Signed consent form

Exclusion Criteria:

* Age \<21 years
* Non-ambulatory (ambulatory with assistive devices does not exclude the patient)
* Pregnancy by self-report or positive pregnancy test, or self-reported intention to ever become pregnant
* Current chemotherapy or current or history of pelvic radiation therapy
* Systemic disease known to affect bladder function (i.e., Parkinson's disease, multiple sclerosis, spina bifida, spinal cord injury or trauma)
* Urethral diverticulum, current or previous (i.e. repaired)
* Prior augmentation cystoplasty or artificial sphincter
* Implanted nerve stimulators for urinary symptoms
* History of synthetic sling for stress urinary incontinence
* \<12 months post-partum
* Laparoscopic or open pelvic surgery \<3 months\*
* Current evaluation or treatment for chronic pelvic pain (painful bladder syndrome)
* Participation in another treatment intervention trial that might influence the results of this trial
* Need for concomitant surgery requiring an abdominal incision, use of graft material in the anterior compartment, or any use of synthetic graft material
* Enrollment in other urinary incontinence trials including SISTEr/E-SISTEr or BE-DRI/E-BE-DRI
B: * Predominant stress urinary incontinence by self-report,examination and test;
* Urethral hypermobility;
* Eligible for both surgical procedures;
* Ambulatory;
* Not pregnant;
* \>12 months post-partum;
* No systemic disease known to affect bladder function;
* No current chemotherapy or radiation therapy;
* No urethral diverticulum, augmentation cytoplasty, or artificial sphincter;
* No recent pelvic surgery;
* Available for follow-up and able to complete study assessments;
* Signed informed consent.
C: Inclusion Criteria:

* Women enrolled in CARE

Exclusion Criteria:

* Inability to provide informed consent.
* Subjects who, at the time of enrollment into E-CARE, are long-term residents of a skilled nursing facility (that is, residency is not limited to short-term rehabilitation).
D: Inclusion Criteria

1. Eligibility for primary procedure (sacrocolpopexy)
2. Eligibility for secondary procedure (Burch colposuspension)
3. Stage II-IV anterior vaginal prolapse, defined as POP-Q Point Aa at -1, 0, +1, +2, or +3 cm.
4. Negative stress incontinence screen
5. Negative stress incontinence screen (MESA questionnaire)

Exclusion Criteria

1. Contraindication for sacrocolpopexy or Burch colposuspension.

   * Anatomic contraindication for Burch colposuspension (i.e., Point Aa fixed at -2 or -3 cm).
   * Surgeon judgment that a contraindication to Burch colposuspension exists.
2. Anticipated geographic relocation within the first three months after surgery (e.g., within approximately 6 months of screening).
3. Inability to provide informed consent or to complete testing or data collection.
4. Currently pregnant.

Answer: C