Study Summary
This trial will compare two surgical treatments for pelvic organ prolapse: R-SCP, a new technique, and HUSLS, the current standard.
- Pelvic Organ Prolapse
- Rectocele
- Cystocele
- Enterocele
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 4 Secondary · Reporting Duration: 12 month post operative
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Sacrocolpopexy
1 of 2
HUSLS
1 of 2
Active Control
112 Total Participants · 2 Treatment Groups
Primary Treatment: Sacrocolpopexy · No Placebo Group · N/A
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 100 · Female Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Elliott, Daniel S., Amy E. Krambeck, and George K. Chow. 2006. “Long-term Results of Robotic Assisted Laparoscopic Sacrocolpopexy for the Treatment of High Grade Vaginal Vault Prolapse”. Journal of Urology. Ovid Technologies (Wolters Kluwer Health). doi:10.1016/j.juro.2006.03.040.
- Margulies, Rebecca U., Mary A.M. Rogers, and Daniel M. Morgan. 2010. “Outcomes of Transvaginal Uterosacral Ligament Suspension: Systematic Review and Metaanalysis”. American Journal of Obstetrics and Gynecology. Elsevier BV. doi:10.1016/j.ajog.2009.07.052.
- 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.
- 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.
- 2016. "SCP vs HUSLS for Pelvic Organ Prolapse Repair". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02800512.
Frequently Asked Questions
Are there any openings for enrollment in this trial at present?
"Affirmative. Per the information posted on clinicaltrials.gov, this trial is still in search of new patients since its initiation date of December 1st 2016. It requires 112 individuals to be recruited from a single location before September 19th 2022." - Anonymous Online Contributor
Who is qualified to join this scientific research endeavor?
"This clinical study is seeking 112 participants aged 18 to 100 with cystocele symptoms. To be eligible for this trial, individuals must possess the willingness and capacity to fulfil all visits associated with the experiment as well as suffer from symptomatic pelvic organ prolapse." - Anonymous Online Contributor
What is the highest possible number of participants in this clinical experiment?
"Affirmative. The information on clinicaltrials.gov demonstrates that this research is actively recruiting participants; the original post was made December 1st 2016, and it has most recently been edited September 19th 2022. Altogether 112 individuals must be recruited from one medical site for this project to succeed." - Anonymous Online Contributor
Is this investigation open to seniors aged 75 and above?
"The requirements for patient enrolment stipulate that individuals must fall between eighteen and one hundred years of age. Separately, 19 trials exist solely for those under 18 while 203 studies target patients above the age of 65." - Anonymous Online Contributor