An interventional study of pelvic floor reconstructive surgery in Pelvic Organ Prolapse, sponsored by Peking Union Medical College Hospital. Status unknown at 11 sites in China. Open to female participants aged 50 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-03-05.
Sponsored by Peking Union Medical College Hospital · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
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
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
transvaginal mesh implantation for pelvic organ prolapse
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?
Time frame: up to 36 months after operation
anatomic outcomes
anatomic outcome of each vaginal segment( anterior, posterior and apical) using POP-Q score.
Time frame: up to 36 months after operation
symptomatic improvement using validated instruments(PFIQ-7)
Relief of symptoms using validated instruments(PFIQ-7) .
Time frame: up to 36 months after operation
symptomatic improvement using validated instruments(PFDI-20)
Relief of symptoms using validated instruments(PFDI-20) .
Time frame: up to 36 months after operation
symptomatic improvement using validated instruments(PISQ-12)
Relief of symptoms using validated instruments(PISQ-12)
Time frame: up to 36 months after operation
symptomatic improvement using patient global impression of change (PGI-C)
Relief of symptoms using patient global impression of change (PGI-C)
Time frame: up to 36 months after operation
intraoperative and post operative complications
using IUGA/ICS joint terminology CTS coding system and dingo system
Time frame: up to 36 months after operation
post operative pain
visual analogue scales (VAS) were used to evaluate the degree of pain.
Time frame: within 3 days after operation
Hospital costs
hospitlization expenses
Time frame: up to 4 weeks after operation
Plan to share: No
This study is status unknown, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Peking Union Medical College Hospital