SCP vs HUSLS for Pelvic Organ Prolapse Repair

N/AActive Not RecruitingNCT02800512

Loma Linda University112 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

112

Conditions

Pelvic Organ Prolapse Cystocele Rectocele Enterocele

Interventions

Robotic sacrocolpopexyPROCEDURE

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.

high uterosacral ligament suspensionPROCEDURE

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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.

Locations (1)

Loma Linda University URO/GYN

Loma Linda, California, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 12 month post operative

Secondary Outcomes

questionnaires PFDI-7

Subject will fill out the PFDI-7 questionnaire

Time frame: 6 month post operative

questionnaires PFDI-7

Subject will fill out the PFDI-7 questionnaire

Time frame: 12 month post operative

questionnaires PFIQ-20

Subject will fill out the PFIQ-20 questionnaire

Time frame: 6 month post operative

questionnaires PFIQ-20

Subject will fill out the PFIQ-20 questionnaire

Time frame: 12 month post operative

questionnaires PISQ-12

Subject will fill out the PISQ-12 questionnaire

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.