SCP vs HUSLS for Pelvic Organ Prolapse Repair

Loma Linda University (LLU)

Status: Active, not recruiting

Conditions: Enterocele; Cystocele; Pelvic Organ Prolapse; Rectocele

Treatments: Procedure: high uterosacral ligament suspension; Procedure: Robotic sacrocolpopexy

Study type: Interventional

Funder types: Other

Identifiers

NCT02800512

5160158

Details and patient eligibility

About

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

Full 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.

Enrollment: 112 estimated patients

Sex: Female

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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112 participants in 2 patient groups

Sacrocolpopexy

Active Comparator group

Description:

Robotic sacrocolpopexy

Treatment:

Procedure: Robotic sacrocolpopexy

HUSLS

Active Comparator group

Description:

Vaginal high uterosacral ligament suspension

Treatment:

Procedure: high uterosacral ligament suspension