An observational study in Pelvic Organ Prolapse, sponsored by West China Hospital. Completed at 1 site in China. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-01.
Sponsored by West China Hospital · Observational
After obtaining an institutional ethics approval (#2021833), the investigators retrospectively reviewed patients with Pelvic organ prolapse (POP) who underwent Transvaginal Mesh (TVM) in their hospital during June 2008 and December 2020. The goal of this observational study is to introduce the Vaginal Adventitia Reserved and Anatomical Implant Technique in Transvaginal mesh surgery, and to report long term efficacy and safety results of this technique. The main questions it aims to answer are:
Patients and materials The investigators retrospective reviewed consecutive patients with stage II to IV Pelvic organ prolapse (POP) who underwent Transvaginal Mesh (TVM) at their center from June 2008 to December 2020. The Vaginal Adventitia Reserved and Anatomical Implant Technique was performed on all patients. Informed consent was obtained from all included patients. Approval was obtained from the institutional ethics committee of our hospital (West China Hospital, Sichuan University).
The pre-cut mesh kits including Gynecare Prolift® (Ethicon, Sommerville, NJ, USA), Perigee (AMS, Minnetonka, MN, USA), and Gynecare Prosima® (Ethicon, Sommerville, NJ, USA) and self-cut mesh Gynemesh (Ethicon, Sommerville, NJ, USA) were applied for transvaginal mesh repair in this study. Surgery was performed by an experienced surgeon (Dr. HS), utilizing the vaginal adventitia reserved and anatomical implant technique.
Outcome measures The effect of operation was assessed using both objective and subjective measures. The objective assessment (anatomic assessment) of success was that the nadir of prolapse never reached the point 0 (the level of hymen). The subjective assessment of success was the absence of prolapse symptoms. Chinese version of the Pelvic Floor Distress Inventory (PFDI-20) was also utilized for assessing the outcomes. Prosthesis/Graft Complication Classification Code was used to record the mesh-related complications.
Data analysis Statistical analysis was performed via the commercially available statistical package (SPSS) 22.0 for Windows (SPSS, Chicago, IL, USA). Categorical variables were represented using frequency and percentages and compared using the chi-square test. Continuous variables in accord with normal distribution were described using means and standard deviations (SDs) and analyzed using the Student's t-test. Statistical significance was defined at P \< 0.05.
516 studies on the registry are indexed under Pelvic Organ Prolapse; 80 are open to participants now.
This study's enrollment of 589 is above the median of 131 across 168 observational studies indexed under Pelvic Organ Prolapse.
Browse Pelvic Organ Prolapse studies →West China Hospital is the lead sponsor of 497 studies on the registry; 243 are open to participants now.
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Patients with POP who underwent TVM using the Vaginal Adventitia Reserved and Anatomical Implant Technique at the investigators' center from June 2008 to December 2020.
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Exclusion Criteria:
Patients with pelvic organ prolapse who underwent TVM using the Vaginal Adventitia Reserved and Anatomical Implant Technique between June 2008 and December 2020
Procedure: TVM using the Vaginal Adventitia Reserved and Anatomical Implant Technique
The Transvaginal mesh procedure with Vaginal Adventitia Reserved and Anatomical Implant Technique for the treatment of POP. The Cefoxitin Injection Solution was used for Prophylactic antibiotics
Also known as: Cefoxitin
Pelvic Organ Prolapse-Quantification (POP-Q) scores
The POP-Q system was used to assess the pelvic organ prolapse
Time frame: The time frame was from the date of surgery to the date of final follow-up, ranging from 9 to 156 months.
complication
Prosthesis/Graft Complication Classification Code was used to record the mesh-related complications
Time frame: The time frame was from the date of surgery to the date of final follow-up, ranging from 9 to 156 months.
Pelvic Floor Distress Inventory (PFDI-20) scores
The PFDI-20 was used to assess pelvic floor symptoms and associated bother and has 3 subscales: the pelvic organ prolapse distress inventory (POPDI)(0-300); the colorectal-anal distress inventory (CRADI)(0-400); and the urinary distress inventory (UDI)(0-300). Higher scores indicted greater symptom bother.
Time frame: The time frame was from the date of surgery to the date of final follow-up, ranging from 9 to 156 months.
Female Sexual Function Index (FSFI) scores
FSFI was used to assess the sexual function, which was a validated questionnaire comprised of 19 items. FSFI's total score ranged from 2 to 36; the higher the score, the severer the sexual dysfunction.
Time frame: The time frame was from the date of surgery to the date of final follow-up, ranging from 9 to 156 months.
Plan to share: Undecided
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Ran from Aug 2022 to primary completion in Nov 2022, 3 months.
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This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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