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

Pelvic Organ Prolapse Clinical Trial

Official title:

A Multicenter Randomized Controlled Non-inferiority Trial Comparing Transvaginal Self-tailored Titanium-coated Polypropylene Mesh Procedure With Mesh-kit Procedure.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03849157
• Other study ID #: protocol for TVM
• Status: Recruiting
• Phase: N/A
• Start date: January 12, 2018
• Est. completion date: January 12, 2022

Study information

• Verified date: February 2019
• Source: Peking Union Medical College Hospital
• Contact: Lan Zhu
• Phone: 86-10-69155749
• Email: zhu_julie[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 312
• Est. completion date: January 12, 2022
• Est. primary completion date: January 12, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 53 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Procedure:
• pelvic floor reconstructive surgery
transvaginal mesh implantation for pelvic organ prolapse

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing
China	Changsha Maternal and Child Health Care Hospital	Changsha	Hunan
China	The second Xiangya Hospital of Central South University	Changsha	Hunan
China	Sichuan University West China Second University Hospital	Chengdu	Sichuan
China	Fosha Maternal and Child Health Care Hospital	Foshan	Guangdong
China	The First Affiliated Hospital of Guangzhou Medical College	Guangzhou	Guangdong
China	Qilu Hospital of Shandong University	Jinan	Shandong
China	the First Affiliated Hospital of Xinjiang Medical University	Ürümqi	Xinjiang
China	the People's Hospital of Xinjiang Uygur Autonomous Region	Ürümqi	Xinjiang
China	Wuxi Maternal and Child Health Care Hospital	Wuxi	Jiangsu
China	Shanxi Provincial People's Hospital	Xi'an	Shanxi

Sponsors (4)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital	Chinese Academy of Medical Science, LinkDoc Technology (Beijing) Co. Ltd., Shanghai Medstron Medical Co.Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	anatomic outcomes	anatomic outcome of each vaginal segment( anterior, posterior and apical) using POP-Q score.	up to 36 months after operation
Secondary	symptomatic improvement using validated instruments(PFIQ-7)	Relief of symptoms using validated instruments(PFIQ-7) .	up to 36 months after operation
Secondary	symptomatic improvement using validated instruments(PFDI-20)	Relief of symptoms using validated instruments(PFDI-20) .	up to 36 months after operation
Secondary	symptomatic improvement using validated instruments(PISQ-12)	Relief of symptoms using validated instruments(PISQ-12)	up to 36 months after operation
Secondary	symptomatic improvement using patient global impression of change (PGI-C)	Relief of symptoms using patient global impression of change (PGI-C)	up to 36 months after operation
Secondary	intraoperative and post operative complications	using IUGA/ICS joint terminology CTS coding system and dingo system	up to 36 months after operation
Secondary	post operative pain	visual analogue scales (VAS) were used to evaluate the degree of pain.	within 3 days after operation