Cystocele, Enterocele, Pelvic Organ Prolapse, Rectocele
Conditions
Keywords
pelvic organ prolapse, cystocele, rectocele, enterocele
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.
Interventions
PROCEDURERobotic sacrocolpopexy
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.
PROCEDUREhigh uterosacral ligament suspension
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.
Sponsors
Loma Linda University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 100 Years
Healthy volunteers
No
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 1. Hx of Alzheimer Disease 2. Hx multiple strokes or other neurologic condition 3. Caregiver states the subject is unable to complete 4. MDs opinion * Inability to complete follow up visits due to transportation issues 1. No access to transportation (ie. does not have vehicle) 2. Live \> 2 hours from LLUH 3. Does not have financial means * Congenital anomalies 1. Bladder Exstrophy 2. Connective tissue disease 3. Neovaginal prolapse 4. Prolapse of sex change vagina * Chronic pelvic pain 1. \> 6 months of pelvic pain of undetermined origin 2. not cyclic pain (eg. period pain or dysmenorrhea) 3. Patient has comorbidities of CPP 4. Fibromyalgia 5. Interstitial cystitis 6. Vulvodynia * Contraindications to Mesh, 1. Opposition to the use mesh (ie. due to religious beliefs) 2. History of mesh complications in past * Pregnant or planning to become pregnant during the study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pelvic Organ Prolapse Quantification (pop-q) to asses change post operatively | 3 month post operative | Pelvic organ prolapses are graded with the Pelvic Organ Prolapse Quantification (POP-Q) System. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| questionnaires PFDI-7 | 6 month post operative | Subject will fill out the PFDI-7 questionnaire |
| questionnaires PFIQ-20 | 6 month post operative | Subject will fill out the PFIQ-20 questionnaire |
| questionnaires PISQ-12 | 6 month post operative | Subject will fill out the PISQ-12 questionnaire |
| questionnaires PGI-I | 6 month post operative | Subject will fill out the PGI-I |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSam Siddighi
Loma Linda University Health Care
Outcome results
None listed