SCP vs HUSLS for Pelvic Organ Prolapse Repair

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2025-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Pelvic Organ Prolapse Cystocele Rectocele Enterocele

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Sacrocolpopexy

Robotic sacrocolpopexy

Group Type ACTIVE_COMPARATOR

Robotic sacrocolpopexy

Intervention Type PROCEDURE

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.

HUSLS

Vaginal high uterosacral ligament suspension

Group Type ACTIVE_COMPARATOR

high uterosacral ligament suspension

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Other Intervention Names

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R-SCP HUSLS

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No