Clinical trial NCT03849157: RCT for Transvaginal Self-cut Mesh vs Mesh-kit for Severe POP
Official title: A Multicenter Randomized Controlled Non-inferiority Trial Comparing Transvaginal Self-tailored Titanium-coated Polypropylene Mesh Procedure With Mesh-kit Procedure.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pelvic Organ Prolapse
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Medstron Medical Co.Ltd
name: Chinese Academy of Medical Sciences
name: LinkDoc Technology (Beijing) Co. Ltd.
First posted: 2019-02-21
Enrollment: 312
Sex: FEMALE
Minimum age (years): 53
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: surgical "success"
timeFrame: up to 36 months after operation
Secondary outcomes:
measure: anatomic outcomes
timeFrame: up to 36 months after operation
measure: symptomatic improvement using validated instruments(PFIQ-7)
timeFrame: up to 36 months after operation
measure: symptomatic improvement using validated instruments(PFDI-20)
timeFrame: up to 36 months after operation
measure: symptomatic improvement using validated instruments(PISQ-12)
timeFrame: up to 36 months after operation
measure: symptomatic improvement using patient global impression of change (PGI-C)
timeFrame: up to 36 months after operation
measure: intraoperative and post operative complications
timeFrame: up to 36 months after operation
measure: post operative pain
timeFrame: within 3 days after operation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Foshan
country: China
facility: Fosha Maternal and Child Health Care Hospital
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical College
state: Guangdong
city: Changsha
country: China
facility: Changsha Maternal and Child Health Care Hospital
state: Hunan
city: Changsha
country: China
facility: The second Xiangya Hospital of Central South University
state: Hunan
city: Wuxi
country: China
facility: Wuxi Maternal and Child Health Care Hospital
state: Jiangsu
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Xi'an
country: China
facility: Shanxi Provincial People's Hospital
state: Shanxi
city: Chengdu
country: China
facility: Sichuan University West China Second University Hospital
state: Sichuan
city: Ürümqi
country: China
facility: the First Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
city: Ürümqi
country: China
facility: the People's Hospital of Xinjiang Uygur Autonomous Region
state: Xinjiang
Study officials:
affiliation: Peking Union Medical College Hospital
name: Lan Zhu
role: PRINCIPAL_INVESTIGATOR
References: