Please select the eligibility criteria that correspond to the clinical trial below.
Title: Operations and Pelvic Muscle Training in the Management of Apical Support Loss: The OPTIMAL Trial: A Randomized Trial of Sacrospinous Ligament Fixation (SSLF) Versus Uterosacral Ligament Suspension (ULS) With and Without Perioperative Behavioral Therapy/Pelvic Muscle Training
Brief Summary: Pelvic organ prolapse is common among women with a prevalence that has been estimated to be as high as 30%. Pelvic organ prolapse often involves a combination of support defects involving the anterior, posterior and/or apical vaginal segments. While the anterior vaginal wall is the segment most likely to demonstrate recurrent prolapse after reconstructive surgery, reoperations are highest among those who require apical suspension procedures with or without repair of other vaginal segments (12%-33%). Despite the substantial health impact, there is a paucity of high quality evidence to support different practices in the management of prolapse, particularly surgery. Thus, the objectives of the Operations and Pelvic Muscle Training in the Management of Apical Support Loss (OPTIMAL) Trial are:

1. to compare sacrospinous ligament fixation (SSLF) to uterosacral vaginal vault ligament suspension (ULS); and
2. to assess the role of perioperative behavioral therapy/pelvic muscle training (PMT) in women undergoing vaginal surgery for apical or uterine prolapse and stress urinary incontinence.


Options:
A: Inclusion Criteria:

* women with stage II of pelvic organ prolapse, preferably symptomatic and not to be submitted to surgery to correct pelvic organ prolapse during the study

Exclusion Criteria:

* Neuromuscular diseases and use of hormonal therapy
B: Inclusion Criteria:

* Undergoing urogynecologic surgery
* Receive postoperative catheterization

Exclusion Criteria:

* Age less than 21 years old
* Pregnancy
* Allergy, contraindication or intolerance to Nitrofurantoin
* Do not speak English
* Dependent on trans-urethral catheter to accomplish voiding preoperatively
* Undergoing interstim device placement, urethral diverticulum surgery or fistula surgery
* Sustain intraoperative urinary tract injury requiring postoperative catheterization
C: Inclusion Criteria:

* Stage 2 to 4 prolapse
* Prolapse of the vaginal apex or cervix to at least half way into the vaginal canal (POPQ Point C \> -TVL/2) \[TVL stands for total vaginal length\]
* Vaginal bulge symptoms as indicated by an affirmative response to either questions on the Pelvic Floor Distress Inventory (PFDI)
* Vaginal surgery for prolapse is planned, including a vaginal apical suspension procedure.
* Stress incontinence symptoms as indicated by an affirmative response to the PFDI Stress incontinence subscale
* Documentation of transurethral stress leakage on an office stress test or urodynamics with or without prolapse reduction within the previous 12 months
* A tension free vaginal tape (TVT) is planned to treat stress urinary incontinence.
* A pelvic muscle training (PMT) visit can be performed at least 2 weeks and not more than 4 weeks before surgery.
* Available for 24-months of follow-up.
* Able to complete study assessments, per clinician judgment
* Able and willing to provide written informed consent

Exclusion Criteria:

* Contraindication to sacrospinous ligament fixation (SSLF), uterosacral vaginal vault ligament suspension (ULS), or TVT in the opinion of the treating surgeon.
* History of previous surgery that included a SSLF or ULS. (Previous vaginal vault suspensions using other techniques or in which the previous technique is unknown are eligible.)
* Pelvic pain or dyspareunia due to levator ani spasm that would preclude a PMT program.
* History of previous synthetic sling procedure for stress incontinence.
* Previous adverse reaction to synthetic mesh.
* Urethral diverticulum, current or previous (i.e., repaired)
* History of femoral to femoral bypass.
* Current cytotoxic chemotherapy or current or history of pelvic radiation therapy.
* History of two inpatient hospitalizations for medical comorbidities in the previous 12 months.
* Subject wishes to retain her uterus. \[Both ULS and SLS include removal of the uterus, if not previously removed\]
D: Inclusion Criteria:

* Age ≥ 19
* Female
* Undergoing transvaginal reconstructive surgical intervention for vaginal prolapse (apical suspension and posterior compartment repair required, other concurrent surgery allowed)

Exclusion Criteria:

* Male
* Pregnant, planning pregnancy, or less than 1 year from delivery
* History of total colectomy or prior ileostomy
* Inflammatory bowel disorder (Crohn's disease and ulcerative colitis) formally diagnosed
* Inability to understand written study material (including non-English speaking)
* Inability to give consent
* Presently diagnosed colorectal cancer
* Undergoing chemotherapy and/or radiation
* Chronic constipation suggestive of colonic inertia defined as fewer that 3 stools per week (Rome III guidelines)
* Severe neurological diseases (such as Multiple Sclerosis)

Answer: C