SCP vs HUSLS for Pelvic Organ Prolapse Repair

Not Applicable

Active, not recruiting

• Conditions: Pelvic Organ Prolapse; Cystocele; Enterocele; Rectocele
• Interventions: Procedure: Robotic sacrocolpopexy; Procedure: high uterosacral ligament suspension

• Registration Number: NCT02800512
• Lead Sponsor: Loma Linda University

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.

Study Timeline

• Study First Submitted: 2016-04-26
• Study First Submitted QC: 2016-06-14
• Study First Posted: 2016-06-15
• Study Start: 2016-12
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-02
• Last Update Posted: 2025-01-03
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 112

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sacrocolpopexy	Robotic sacrocolpopexy	Robotic sacrocolpopexy
HUSLS	high uterosacral ligament suspension	Vaginal high uterosacral ligament suspension

Primary Outcome Measures

Name	Time	Method
Pelvic Organ Prolapse Quantification (pop-q) to asses change post operatively	12 month post operative	Pelvic organ prolapses are graded with the Pelvic Organ Prolapse Quantification (POP-Q) System.

Secondary Outcome Measures

Name	Time	Method
questionnaires PISQ-12	12 month post operative	Subject will fill out the PISQ-12 questionnaire
questionnaires PFIQ-20	12 month post operative	Subject will fill out the PFIQ-20 questionnaire
questionnaires PGI-I	12 month post operative	Subject will fill out the PGI-I
questionnaires PFDI-7	12 month post operative	Subject will fill out the PFDI-7 questionnaire

Trial Locations

Locations (1)

Loma Linda University URO/GYN; 🇺🇸 Loma Linda, California, United States