NCT03283124

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 .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
312

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

11 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2017

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 14, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

January 12, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2020

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2022

Completed
Last Updated

March 5, 2019

Status Verified

February 1, 2019

Enrollment Period

2 years

First QC Date

May 7, 2017

Last Update Submit

March 4, 2019

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (1)

  • 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?

    up to 36 months after operation

Secondary Outcomes (8)

  • anatomic outcomes

    up to 36 months after operation

  • symptomatic improvement using validated instruments(PFIQ-7)

    up to 36 months after operation

  • symptomatic improvement using validated instruments(PFDI-20)

    up to 36 months after operation

  • symptomatic improvement using validated instruments(PISQ-12)

    up to 36 months after operation

  • symptomatic improvement using patient global impression of change (PGI-C)

    up to 36 months after operation

  • +3 more secondary outcomes

Study Arms (2)

self-cut mesh procedure

ACTIVE COMPARATOR

This procedure is transvaginal mesh implantation surgery for POP patients. Self-cut mesh procedure is an economic pelvic reconstructive surgical operation with use of specially designed puncture needles and self-cut mesh, which mainly provide anterior and apical compartments support, with posterior compartment reinforced by bridge technique repair. The mesh pieces used in this surgery was cut from a single piece of mesh material(TiLOOP 10\*15cm) which is much cheaper and readily available. Patients could have transvaginal hysterectomy concomitantly.

Procedure: pelvic floor reconstructive surgery

mesh-kit procedure

ACTIVE COMPARATOR

This procedure is transvaginal mesh implantation surgery for POP patients.Mesh-kit procedure is refered to pelvic floor reconstructive surgery with titanium-coated meshes kit(TiLOOP TOTAL6).Patients could have transvaginal hysterectomy concomitantly.

Procedure: pelvic floor reconstructive surgery

Interventions

pelvic floor reconstructive surgeryPROCEDURE

transvaginal mesh implantation for pelvic organ prolapse

mesh-kit procedureself-cut mesh procedure

Eligibility Criteria

Age50 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

RECRUITING

Fosha Maternal and Child Health Care Hospital

Foshan, Guangdong, China

RECRUITING

The First Affiliated Hospital of Guangzhou Medical College

Guangzhou, Guangdong, China

RECRUITING

Changsha Maternal and Child Health Care Hospital

Changsha, Hunan, China

RECRUITING

The second Xiangya Hospital of Central South University

Changsha, Hunan, China

RECRUITING

Wuxi Maternal and Child Health Care Hospital

Wuxi, Jiangsu, China

RECRUITING

Qilu Hospital of Shandong University

Jinan, Shandong, China

RECRUITING

Shanxi Provincial People's Hospital

Xi’an, Shanxi, China

RECRUITING

Sichuan University West China Second University Hospital

Chengdu, Sichuan, China

RECRUITING

the First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

RECRUITING

the People's Hospital of Xinjiang Uygur Autonomous Region

Ürümqi, Xinjiang, China

RECRUITING

Related Publications (2)

  • Chen J, Yu J, Morse A, Tao G, Gong J, Wang B, Wang Y, Ababaikeli G, Jiang X, Liu P, Zhang X, Nisier H, Wang P, Funfgeld C, Huang K, Zhang H, Sun X, Zhu L. Effectiveness of Self-cut vs Mesh-Kit Titanium-Coated Polypropylene Mesh for Transvaginal Treatment of Severe Pelvic Organ Prolapse: A Multicenter Randomized Noninferiority Clinical Trial. JAMA Netw Open. 2022 Sep 1;5(9):e2231869. doi: 10.1001/jamanetworkopen.2022.31869.

    PMID: 36112377DERIVED

  • Chen J, Yu J, Morse A, Funfgeld C, Huang K, Gong J, Tao G, Wang B, Wang Y, Jiang X, Ababaikeli G, Liu P, Nisier H, Zhang X, Wang P, Sun X, Zhu L. Self-cut titanium-coated polypropylene mesh versus pre-cut mesh-kit for transvaginal treatment of severe pelvic organ prolapse: study protocol for a multicenter non-inferiority trial. Trials. 2020 Feb 26;21(1):226. doi: 10.1186/s13063-019-3966-3.

    PMID: 32102687DERIVED

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Lan Zhu

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lan Zhu

CONTACT

86-10-69155749zhu_julie@sina.com

Juan Chen

CONTACT

86-10-69155749pumchcj@sina.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
participant and investigator are not blinded. outcome assessor who are in charge of follow-up assement is masked.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2017

First Posted

September 14, 2017

Study Start

January 12, 2018

Primary Completion

January 12, 2020

Study Completion

January 12, 2022

Last Updated

March 5, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(11)