Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized Trial of Vaginal Surgery for Uterovaginal Prolapse: Vaginal Hysterectomy With Native Tissue Vault Suspension vs. Mesh Hysteropexy Suspension
Brief Summary: The primary purpose of this randomized clinical trial is to compare the effectiveness and safety of two transvaginal apical suspension strategies for uterovaginal prolapse: a mesh augmented hysteropexy versus vaginal hysterectomy and uterosacral ligament suspension (USLS). The primary aim is to determine whether treatment success in women who undergo the above strategies differ at time points through 3 years.

A supplemental study investigates anterior vaginal wall movement resulting from descent or rotation of the vaginal apex and/or anterior vaginal elongation, in women in both of the study arms of SUPeR.


Options:
A: INCLUSION CRITERIA

* \>18 years old
* Undergoing RALSC with or without other procedures for pelvic organ prolapse or incontinence
* Willing to return for follow-up visits
* Written informed consent obtained from each subject
* Must be having a robotic assisted laparoscopic sacrocolpopexy

Exclusion Criteria:

* Decline to participate
* Pregnant or contemplating future pregnancy
* Unable to participate in the informed consent process
B: 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. \[Both ULS and SLS include removal of the uterus, if not previously removed\]
C: Inclusion Criteria:

* Greater than 18 years of age

Exclusion Criteria:

* Prior sacral colpopexy or rectopexy

Contraindication to surgery based on co-existent medical condition

Desire for expectant management or pessary use

Pregnancy or the desire for pregnancy within 24 months of the sacral colpopexy procedure
D: Inclusion Criteria:

1. Women aged 21 or older who have completed child -bearing
2. Prolapse beyond the hymen (defined as Ba, Bp, or C \> 0 cm)
3. Uterine descent into at least the lower half of the vagina (defined as point C\> -TVL/2) )
4. Bothersome bulge symptoms as indicated on question 3 of the PFDI-20 form relating to 'sensation of bulging' or 'something falling out'
5. Desires vaginal surgical treatment for uterovaginal prolapse
6. Available for up to 60 month follow-up
7. Amenorrhea for the past 12 months from either menopause or endometrial ablation
8. Not pregnant, not at risk for pregnancy or agree to contraception if at risk for pregnancy (only applicable to the rare endometrial ablation patient)
9. Eligible for no cervical cancer screening for at least 3 years

Exclusion Criteria:

1. Previous synthetic material (placed vaginally or abdominally) to augment POP repair
2. Known previous uterosacral or sacrospinous uterine suspension
3. Known adverse reaction to synthetic mesh or biological grafts; these complications include but are not limited to erosion, fistula, or abscess
4. Chronic pelvic pain
5. Pelvic radiation
6. Cervical elongation- defined as an expectation that the C point would be Stage 2 or greater postoperatively if a hysteropexy was performed. (Note: cervical shortening or trachelectomy is not an allowed intraoperative procedure within the hysteropexy treatment group).
7. Women at increased risk of cervical dysplasia requiring cervical cancer screening more often than every 3 years (e.g. HIV+ status, immunosuppression because of transplant related medications, Diethylstilbestrol (DES) exposure in utero, or previous treatment for cervical intraepithelial neoplasia (CIN)2, CIN3, or cancer)
8. Uterine abnormalities (symptomatic uterine fibroids, polyps, endometrial hyperplasia, endometrial cancer, or any uterine disease that precluded prolapse repair with uterine preservation in the opinion of the surgeon
9. Indication for ovarian removal (adnexal mass, BRCA 1/2 positivity, family history of ovarian cancer)
10. Current condition of amenorrhea caused by exogenous sex steroids or hypothalamic conditions.

Answer: D