RCT for Transvaginal Self-cut Mesh vs Mesh-kit for Severe POP

Peking Union Medical College Hospital312 enrolled

Overview

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 .

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

312

Conditions

Pelvic Organ Prolapse

Interventions

pelvic floor reconstructive surgeryPROCEDURE

transvaginal mesh implantation for pelvic organ prolapse

Eligibility

Sex: FEMALEMin age: 53 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 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

Locations (11)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

RECRUITING

Fosha Maternal and Child Health Care Hospital

Foshan, Guangdong, China

RECRUITING

Outcomes

Primary Outcomes

surgical "success"

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?