Please select the eligibility criteria that correspond to the clinical trial below.
Title: Prospective Randomized Trial on Laparoscopic Subtotal Hysterectomy During Sacral Colpopexy for the Treatment of Severe Pelvic Organ Prolapse (POP) With Bipolar Laparoscopic Loop/Bipolar Morcellator vs Conventional Monopolar Hook/Conventional Morcellator
Brief Summary: This prospective randomized pilot study is aimed to verify if the operative time of a standard laparoscopic sacral colpopexy associated to subtotal hysterectomy for the treatment of POP could be further reduced using PKS BILL: bipolar laparoscopic loop (a laparoscopic loop using advanced bipolar energy) (Olympus Medical Systems Corp, Tokyo) and PKS PlasmaSORD (Solid Organ Removal Device) vs. conventional monopolar hook and conventional mechanic morcellator.


Options:
A: Inclusion Criteria:

For patients

* Age ≤ 80 years
* Patient's informed consent
* American Society of Anesthesiologists: \< class III or IV
* Physiologic, surgical or iatrogenic menopause.
* No previous major abdominal surgical procedures

For diseases

* POP-Q stage III/IV for anterior and/or apical compartment; stage \<III for posterior compartment.
* No uterine cervix dysplasia or endometrial disorders.
* No uterine size larger than conform 10 weeks gestation
B: Inclusion Criteria:

* Female patients with vaginal apex prolapse that are eligible for repair by sacrocolpopexy.

Exclusion Criteria:

* Patients after previous hysterectomy.
* Patients after previous surgical procedures for prolapse repair.
C: 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.
D: Inclusion Criteria:

1. Completion of the Year 2 OPTIMAL in-person visit

Exclusion Criteria:

1. Inability to provide informed consent.
2. Subjects who are long-term residents of a skilled nursing facility (that is, residency is not limited to short-term rehabilitation) at the time of enrollment into E-OPTIMAL. Note: Subjects unable to return for annual visits are not excluded as they can participate in the telephone interview. However, every attempt will be made to encourage in-person participation.

Criteria for termination of participation:

(Due to evidence or likelihood that the subject can no longer consent for herself)

1. Subjects 75 years and older that fail the telephone mini-mental status examination. If the participant gets 5 or more of the 10 items "incorrect" the interviewer says "thank you very much for your time, that completes the interview for today." In other words, the interviewer in no way implies to the participant that they did not "pass" a test to continue. The interviewer contacts the appropriate site coordinator immediately after the interview to let them know of the outcome.
2. Subjects younger than 75 who appear to have cognitive deficits during the quality of life telephone interview will be administered the mini-mental status examination; those who fail will be excluded from further participation. (Proxy respondents will not be used.) Subjects who appear to have cognitive deficits during the in-person visit or site telephone interview will be withdrawn from the study by the study coordinator.
3. Subjects who become long-term residents of a skilled nursing facility.
4. Withdrawal of consent. Verbal assent will be obtained prior to each telephone interview and each in-person visit.

Note: Subjects that are unable to complete telephone interviews (for example, because of hearing loss) may complete the interview portion of the survey in person, either at the site or in the home.

Answer: A