SCP vs HUSLS for Pelvic Organ Prolapse Repair

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the effectiveness of R-SCP versus HUSLS for treatment of pelvic organ prolapse.

Detailed Description
-----------------
To compare the effectiveness of Robotic Sacrocolpopexy versus vaginal High Uterosacral Ligament Suspension for treatment of pelvic organ prolapse. Both surgeries are standard of care and are equally and widely used throughout the country with well known safety and efficacy.

Official Title
-----------------
Robotic Sacrocolpopexy Versus High Uterosacral Ligament Suspension: A Randomized Trial

Conditions
-----------------
Pelvic Organ Prolapse, Cystocele, Rectocele, Enterocele

Intervention / Treatment
-----------------
* Procedure: Robotic sacrocolpopexy
* Procedure: high uterosacral ligament suspension


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 Years of age or older Signed Informed Consent Symptomatic pelvic organ prolapse, Willing and able to complete all study visit Exclusion Criteria: Non-High Uterosacral Ligament Suspension (unable to do HUSLS at time of surgery), Dementia or considered unable to complete questionnaires Hx of Alzheimer Disease Hx multiple strokes or other neurologic condition Caregiver states the subject is unable to complete MDs opinion Inability to complete follow up visits due to transportation issues No access to transportation (ie. does not have vehicle) Live > 2 hours from LLUH Does not have financial means Congenital anomalies Bladder Exstrophy Connective tissue disease Neovaginal prolapse Prolapse of sex change vagina Chronic pelvic pain > 6 months of pelvic pain of undetermined origin not cyclic pain (eg. period pain or dysmenorrhea) Patient has comorbidities of CPP Fibromyalgia Interstitial cystitis Vulvodynia Contraindications to Mesh, Opposition to the use mesh (ie. due to religious beliefs) History of mesh complications in past Pregnant or planning to become pregnant during the study period.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sacrocolpopexy<br>Robotic sacrocolpopexy | Procedure: Robotic sacrocolpopexy<br>* Sacrocolpopexy is a procedure to surgically correct vaginal vault prolapse where mesh is used to hold the vagina in the correct anatomical position. Robotic assistance is a minimally invasive method to perform this abdominal procedure.<br>* Other names: R-SCP;|
| Active Comparator: HUSLS<br>Vaginal high uterosacral ligament suspension | Procedure: high uterosacral ligament suspension<br>* Utilizing uterosacral ligaments to support the vaginal cuff can be performed vaginally-by passing sutures bilaterally through the uterosacral ligaments. near the level of the ischial spine. HUSLS is a vaginal minimally invasive procedure for POP.<br>* Other names: HUSLS;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pelvic Organ Prolapse Quantification (pop-q) to asses change post operatively | Pelvic organ prolapses are graded with the Pelvic Organ Prolapse Quantification (POP-Q) System. | 3 month post operative | 
| Pelvic Organ Prolapse Quantification (pop-q) to asses change post operatively | Pelvic organ prolapses are graded with the Pelvic Organ Prolapse Quantification (POP-Q) System. | 6 month post operative | 
| Pelvic Organ Prolapse Quantification (pop-q) to asses change post operatively | Pelvic organ prolapses are graded with the Pelvic Organ Prolapse Quantification (POP-Q) System. | 12 month post operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| questionnaires PFDI-7 | Subject will fill out the PFDI-7 questionnaire | 6 month post operative | 
| questionnaires PFDI-7 | Subject will fill out the PFDI-7 questionnaire | 12 month post operative | 
| questionnaires PFIQ-20 | Subject will fill out the PFIQ-20 questionnaire | 6 month post operative | 
| questionnaires PFIQ-20 | Subject will fill out the PFIQ-20 questionnaire | 12 month post operative | 
| questionnaires PISQ-12 | Subject will fill out the PISQ-12 questionnaire | 6 month post operative | 
| questionnaires PISQ-12 | Subject will fill out the PISQ-12 questionnaire | 12 month post operative | 
| questionnaires PGI-I | Subject will fill out the PGI-I | 6 month post operative | 
| questionnaires PGI-I | Subject will fill out the PGI-I | 12 month post operative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pelvic organ prolapse, cystocele, rectocele, enterocele