Sacrocolpopexy for Pelvic Organ Prolapse

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Loma Linda University URO/GYN, Loma Linda, CAPelvic Organ Prolapse+3 Morehigh uterosacral ligament suspension - Procedure
Eligibility
18 - 100
Female
What conditions do you have?
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Study Summary

This trial will compare two surgical treatments for pelvic organ prolapse: R-SCP, a new technique, and HUSLS, the current standard.

Eligible Conditions
  • Pelvic Organ Prolapse
  • Rectocele
  • Cystocele
  • Enterocele

Treatment Effectiveness

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: 12 month post operative

12 month post operative
Pelvic Organ Prolapse Quantification (pop-q) to asses change post operatively
questionnaires PFDI-7
questionnaires PFIQ-20
questionnaires PGI-I
questionnaires PISQ-12

Trial Safety

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

Sacrocolpopexy
Procedure
ActiveComparator Group · 1 Intervention: Robotic sacrocolpopexy · Intervention Types: Procedure
HUSLS
Procedure
ActiveComparator Group · 1 Intervention: high uterosacral ligament suspension · Intervention Types: Procedure

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 month post operative

Who is running the clinical trial?

Loma Linda UniversityLead Sponsor
286 Previous Clinical Trials
257,910 Total Patients Enrolled
Sam SiddighiPrincipal InvestigatorLoma Linda University Health Care

Eligibility Criteria

Age 18 - 100 · Female Participants · 4 Total Inclusion Criteria

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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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.