Status:
UNKNOWN
RCT for Transvaginal Self-cut Mesh vs Mesh-kit for Severe POP
Lead Sponsor:
Peking Union Medical College Hospital
Collaborating Sponsors:
Shanghai Medstron Medical Co.Ltd
Chinese Academy of Medical Sciences
Conditions:
Pelvic Organ Prolapse
Eligibility:
FEMALE
53-75 years
Phase:
NA
Brief Summary
Pelvic organ prolapse(POP) is a common health problem and has significant negative effects on woman's quality of life. Transvaginal mesh procedure is a durable reconstructive surgery, but the mesh kit...
Detailed Description
The trial is a randomized controlled multi-center non-inferiority trial. The primary outcome measure is success rate at 1-year follow-up. The second outcomes are subjective improvement of quality of l...
Eligibility Criteria
Inclusion
- Age:More than 50 year with more than 3 years after menopause, or more than 55 years old, but less than 75 years old.
- Subject must have severe apical or anterior vaginal prolapse (stage III-IV), with moderate posterior vaginal prolapse(stage I-II). This is defined as ( C \> +1cm OR Ba \> +1cm, with Bp ≤+1cm by the POP-Q). This is the most common modality of multiple compartment POP in clinic.
- Subject reports a bothersome bulge they can see or feel per PFDI-20, question 3, response of 2 or higher (i.e., responses of "somewhat", "moderately", or "quite a bit").
- Desires transvaginal mesh treatment for primary or recurrent, symptomatic uterovaginal prolapse.
- Concomitant hysterectomy when indicated. But concomitant anti-incontinence surgeries will not be enrolled.
- Subject is willing and able to comply with the follow-up regimen.
Exclusion
- Subject is pregnant or intends to become pregnant in the future
- Subject has an active or chronic systemic infection including any gynecologic infection, untreated urinary tract infection (UTI) or tissue necrosis
- Subject has history of pelvic organ cancer (e.g. uterine, ovarian, bladder, colo-rectal or cervical)
- Subject has had prior or is currently undergoing radiation, laser therapy, or chemotherapy in the pelvic area
- Subject has taken systemic steroids (within the last month), or immunosuppressive or immunomodulatory treatment (within the last 3 months)
- Subject has systemic connective tissue disease (e.g. scleroderma, systemic lupus erythematosus (SLE), Marfan syndrome, Ehlers Danlos, collagenosis, polymyositis, polymyalgia rheumatica)
- Subject has chronic systemic pain that includes the pelvic area or chronic focal pain that involves the pelvis
- Subject has uncontrolled diabetes mellitus (DM)
- Subject has a known neurologic or medical condition affecting bladder function (e.g., multiple sclerosis, spinal cord injury or stroke with residual neurologic deficit)
- Subject has had previous prolapse repair with mesh in the target compartment
Key Trial Info
Start Date :
January 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 12 2022
Estimated Enrollment :
312 Patients enrolled
Trial Details
Trial ID
NCT03849157
Start Date
January 12 2018
End Date
January 12 2022
Last Update
February 21 2019
Active Locations (11)
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1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
2
Fosha Maternal and Child Health Care Hospital
Foshan, Guangdong, China
3
The First Affiliated Hospital of Guangzhou Medical College
Guangzhou, Guangdong, China
4
Changsha Maternal and Child Health Care Hospital
Changsha, Hunan, China