Please select the eligibility criteria that correspond to the clinical trial below.
Title: N/A
Brief Summary: This research protocol is a randomized controlled trial. It is being done to compare and find out the relative differences between the materials, (Pelivisoft) "natural organic mesh" to poly propylene mesh (Pelvitex) "manmade mesh" after a surgery known as sacral colpopexy. This surgery involves supporting the prolapsed vaginal wall with a piece of material (known as a graft) attached to a ligament along your backbone (or sacrum). These materials are both FDA approved and widely used. The following objectives: anatomic outcomes, graft-related complications between the two materials, changes in pelvic organ prolapse-related quality of life, subjective changes in sexual function,changes in bowel function and the prolapse related pain present after sacral colpopexy will be evaluated.

The study visits are all under standard of care. Study questionnaires are unique to the study and will be completed at the enrollment in hospital, 2, 6,12 weeks, 6 months and one year visits The questionnaires are related to bowel function, bladder function, prolapse and sexual activity.

Permission will be requested to contact the patient again 5 years after surgery. Contact in the future will in no way obligate the patient to participate.

There may or may not be direct medical benefits to the participant. Decreased risk of erosion may be a possible benefit if placed in the organic "natural" arm of the study. The information learned from this study may benefit other patients in the future


Options:
A: INCLUSION CRITERIA

* \>18 years old
* Undergoing LSC 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

* \>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
C: Inclusion Criteria:

* Age ≥18
* Subject must have apical with anterior or posterior vaginal prolapse with leading edge of prolapse to or beyond the hymen. This is defined as stage 2-4 pelvic organ prolapse ( C \> - (TVL / 2) AND Ba or Bp ≥ 0 by the POP)
* Subject reports a bothersome bulge they can see or feel per PFDI-20, question 3, response of 2 or higher (i.e., responses of "somewhat", "moderately", or "quite a bit")
* Eligible for robotic or laparoscopic sacral colpopexy
* Desires surgical treatment for primary, symptomatic uterovaginal prolapse
* English speaking
* Willing to undergo hysterectomy

Exclusion Criteria:

* Patients who had prior hysterectomy
* Patients who are not surgical candidates due to medical comorbidities
* Current foreign body complications (including but not limited to erosion, fistula, abscess). This covers foreign bodies of any type (e.g. synthetic and biologic including allograft, xenograft).
* Desires uterine conservation
* Inability to give informed consent or to complete the testing or data collection
* Anticipated circumstances resulting in an inability to follow up (geographic relocation, etc).
* Pregnant or intends to become pregnant
* Active/chronic systemic infection including any gynecologic infection, untreated UTI or tissue necrosis
* History of pelvic organ cancer (e.g. uterine, ovarian, bladder, or cervical)
* Prior or currently undergoing radiation, laser therapy, or chemotherapy in the pelvic area
* Subject has taken systemic steroids (within the last month), or immunosuppressive or immunomodulatory treatment (within the last 3 months)
* Systemic connective tissue disease (e.g. scleroderma, Marfan's syndrome, Ehlers Danhlos, collagenosis, polymyositis or polymyalgia rheumatica)
* Chronic systemic pain that includes the pelvic area or chronic focal pain that involves the pelvis
* Poorly controlled diabetes mellitus (DM), as indicated by Hemoglobin A1c \> 9
* Those requiring concomitant rectopexy
* Subject is not able to conform to steep trendelenburg position
* Known sensitivity to polypropylene
D: 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

Answer: D