SCP vs HUSLS for Pelvic Organ Prolapse Repair

Pelvic Organ Prolapse Clinical Trial

Official title:

Robotic Sacrocolpopexy Versus High Uterosacral Ligament Suspension: A Randomized Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02800512
• Other study ID #: 5160158
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 2016
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 112
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cystocele
• Enterocele
• Hernia
• Pelvic Organ Prolapse
• Prolapse
• Rectocele

Intervention

Procedure:
• Robotic 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.
• high 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.

Locations

Country	Name	City	State
United States	Loma Linda University URO/GYN	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 month post operative
Primary	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.	6 month post operative
Primary	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.	12 month post operative
Secondary	questionnaires PFDI-7	Subject will fill out the PFDI-7 questionnaire	6 month post operative
Secondary	questionnaires PFDI-7	Subject will fill out the PFDI-7 questionnaire	12 month post operative
Secondary	questionnaires PFIQ-20	Subject will fill out the PFIQ-20 questionnaire	6 month post operative
Secondary	questionnaires PFIQ-20	Subject will fill out the PFIQ-20 questionnaire	12 month post operative
Secondary	questionnaires PISQ-12	Subject will fill out the PISQ-12 questionnaire	6 month post operative
Secondary	questionnaires PISQ-12	Subject will fill out the PISQ-12 questionnaire	12 month post operative
Secondary	questionnaires PGI-I	Subject will fill out the PGI-I	6 month post operative
Secondary	questionnaires PGI-I	Subject will fill out the PGI-I	12 month post operative