Clinical trial NCT02800512: SCP vs HUSLS for Pelvic Organ Prolapse Repair
Official title: Robotic Sacrocolpopexy Versus High Uterosacral Ligament Suspension: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pelvic Organ Prolapse
Cystocele
Rectocele
Enterocele
Keywords: pelvic organ prolapse
cystocele
rectocele
enterocele
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2016-06-15
Enrollment: 112
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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

  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.

Primary outcomes:
measure: Pelvic Organ Prolapse Quantification (pop-q) to asses change post operatively
timeFrame: 3 month post operative
measure: Pelvic Organ Prolapse Quantification (pop-q) to asses change post operatively
timeFrame: 6 month post operative
measure: Pelvic Organ Prolapse Quantification (pop-q) to asses change post operatively
timeFrame: 12 month post operative
Secondary outcomes:
measure: questionnaires PFDI-7
timeFrame: 6 month post operative
measure: questionnaires PFDI-7
timeFrame: 12 month post operative
measure: questionnaires PFIQ-20
timeFrame: 6 month post operative
measure: questionnaires PFIQ-20
timeFrame: 12 month post operative
measure: questionnaires PISQ-12
timeFrame: 6 month post operative
measure: questionnaires PISQ-12
timeFrame: 12 month post operative
measure: questionnaires PGI-I
timeFrame: 6 month post operative
measure: questionnaires PGI-I
timeFrame: 12 month post operative
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University URO/GYN
state: California
Study officials:
affiliation: Loma Linda University Health Care
name: Sam Siddighi
role: PRINCIPAL_INVESTIGATOR
References:
citation: Elliott DS, Krambeck AE, Chow GK. Long-term results of robotic assisted laparoscopic sacrocolpopexy for the treatment of high grade vaginal vault prolapse. J Urol. 2006 Aug;176(2):655-9. doi: 10.1016/j.juro.2006.03.040.
citation: Margulies RU, Rogers MA, Morgan DM. Outcomes of transvaginal uterosacral ligament suspension: systematic review and metaanalysis. Am J Obstet Gynecol. 2010 Feb;202(2):124-34. doi: 10.1016/j.ajog.2009.07.052.