SCP vs HUSLS for Pelvic Organ Prolapse Repair



Status:Recruiting
Conditions:Women's Studies, Gastrointestinal
Therapuetic Areas:Gastroenterology, Reproductive
Healthy:No
Age Range:18 - 100
Updated:3/2/2019
Start Date:December 2016
End Date:August 2021
Contact:Sam Siddighi, MD
Email:ssiddighi@llu.edu
Phone:9095582782

Use our guide to learn which trials are right for you!

Robotic Sacrocolpopexy Versus High Uterosacral Ligament Suspension: A Randomized Trial

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

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.

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.
We found this trial at
1
site
Loma Linda, California 92354
Principal Investigator: Sam Siddighi
Phone: 909-558-2782
?
mi
from
Loma Linda, CA
Click here to add this to my saved trials