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NCT Number: NCT05707533

Vaginal Adventitia Reserved and Anatomical Implant Technique of Transvaginal Mesh Procedure for Pelvic Organ Prolapse

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:

* How to reduce the potential risk of mesh-related complications when performing TVM? * How effective is the use of the Vaginal Adventitia Reserved and Anatomical Implant Technique when performing TVM? Participants will be asked to fill the Pelvic Floor Distress Inventory (PFDI-20) at final follow-up, and the Prosthesis/Graft Complication Classification Code was used to record the mesh-related complications.

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Key information

Conditions

Pelvic Organ Prolapse Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

West China Hospital

Chengdu, Sichuan, 610041, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >18 yr
  • Clinical diagnosis of pelvic organ prolapse
  • Pelvic organ prolapse-quantification (POP-Q) > II stage
  • Patients underwent TVM using the Vaginal Adventitia Reserved and Anatomical Implant Technique

Exclusion criteria

  • Patients who refused to participate in the study.

Treatment and study plan

TVM using the Vaginal Adventitia Reserved and Anatomical Implant Technique

Procedure

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

Other names: Cefoxitin

Primary outcomes

  1. Pelvic Organ Prolapse-Quantification (POP-Q) scores

    Time frame: The time frame was from the date of surgery to the date of final follow-up, ranging from 9 to 156 months.

    The POP-Q system was used to assess the pelvic organ prolapse

  2. complication

    Time frame: The time frame was from the date of surgery to the date of final follow-up, ranging from 9 to 156 months.

    Prosthesis/Graft Complication Classification Code was used to record the mesh-related complications

  3. Pelvic Floor Distress Inventory (PFDI-20) scores

    Time frame: The time frame was from the date of surgery to the date of final follow-up, ranging from 9 to 156 months.

    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.

  4. Female Sexual Function Index (FSFI) scores

    Time frame: The time frame was from the date of surgery to the date of final follow-up, ranging from 9 to 156 months.

    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.

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Official study title

Vaginal Adventitia Reserved and Anatomical Implant Technique of Transvaginal Mesh Procedure for Pelvic Organ Prolapse: 13-year Surgical Results With 589 Cases

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 1, 2023
Registry last updated
Feb 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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