Pelvic Organ Prolapse
Conditions
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 kits are expensive for underdeveloped countries. Our preliminary trial showed that the use of self-tailored mesh had good success rate (91.8% at 1-year follow-up) and low complication rate. The trial is designed to compare self-tailored titanium-coated polypropylene mesh procedure with mesh-kit in the treatment of POP stage III-IV in terms of efficacy, safety and cost-effective .
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 life, complications and costs. Analysis will be performed according to the intention to treat principle. Based on comparable success rate of 90% and 10% as the margin(beta 0.2 and one sided alpha 0.025), about 312 patients in total from 11 centers will be recruited per group including 10% drop-out. The aims of the research are to demonstrate whether self-tailored mesh is non-inferior to the mesh-kit. The finding of this research might influence the treatment selection for POP in China.
Interventions
PROCEDUREpelvic floor reconstructive surgery
transvaginal mesh implantation for pelvic organ prolapse
Sponsors
Shanghai Medstron Medical Co.Ltd
LinkDoc Technology (Beijing) Co. Ltd.
Chinese Academy of Medical Sciences
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
participant and investigator are not blinded. outcome assessor who are in charge of follow-up assement is masked.
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age:More than 50 years old with 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| surgical success | up to 36 months after operation | Subjects will be considered a success if they meet the definitions of anatomic cure and deny vaginal bulging symptoms, and no additional treatment for prolapse(surgical or pessary use). Anatomic cure is defined as leading edge above the hymen (i.e Ba, C, Bp\<0 cm) Symptomatic cure is defined as the absence of vaginal bulge symptoms as indicated by a negative response question 3 of the pelvic floor distress inventory- 20 (PFDI-20): Do you usually have a bulge or something falling out that you can see or feel in your vaginal area? |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| symptomatic improvement using validated instruments(PFIQ-7) | up to 36 months after operation | Relief of symptoms using validated instruments(PFIQ-7) . |
| symptomatic improvement using validated instruments(PFDI-20) | up to 36 months after operation | Relief of symptoms using validated instruments(PFDI-20) . |
| symptomatic improvement using validated instruments(PISQ-12) | up to 36 months after operation | Relief of symptoms using validated instruments(PISQ-12) |
| anatomic outcomes | up to 36 months after operation | anatomic outcome of each vaginal segment( anterior, posterior and apical) using POP-Q score. |
| intraoperative and post operative complications | up to 36 months after operation | using IUGA/ICS joint terminology CTS coding system and dingo system |
| post operative pain | within 3 days after operation | visual analogue scales (VAS) were used to evaluate the degree of pain. |
| Hospital costs | up to 4 weeks after operation | hospitlization expenses |
| symptomatic improvement using patient global impression of change (PGI-C) | up to 36 months after operation | Relief of symptoms using patient global impression of change (PGI-C) |
Countries
China
Contacts
Primary ContactLan Zhu
Backup ContactJuan Chen
Outcome results
None listed