The Clinical Outcome of TVM or LSC Mesh Suspension for POP

Completed

• Conditions: Pelvic Organ Prolapse
• Interventions: Procedure: TVM; Procedure: LSC mesh suspension

• Registration Number: NCT04139083
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

Brief Summary

The investigators aim to assess the surgical outcomes of transvaginal mesh (TVM) and laparoscopic (LSC) mesh suspension. During the study period, all women with main uterine prolapse stage II or greater defined by the POP quantification staging system receiving TVM or LSC mesh suspension were retrospectively recruited. Clinical evaluations before and 6 months after surgery included pelvic examination, urodynamic study, and a personal interview to evaluate urinary and sexual symptoms using questionnaires.

Detailed Description

All women with mainly uterine prolapse stage II or greater as defined by the POP-Q staging system receiving TVM or LSC mesh suspension surgeries at a tertiary referral center in Taiwan were included. The investigators excluded women with a hypertrophic uterus, huge fibroids, history of cervical dysplasia or endometrial pathology, history of postmenopausal bleeding in the past 12 months, and those unwilling to preserve their uterus. Concomitant mid-urethral sling operations were performed in women with current urodynamic stress incontinence unless the participants did not prefer a concomitant surgery. Cervical amputation was performed if the corpus/cervix ratio was less than 1 on the ultrasound. Concomitant anterior and posterior colporrhaphy were performed as needs.

The clinical evaluations consisted of a detailed history before and 6 months after surgery, including urinary analysis, pelvic examination using POP-Q system, urodynamic studies (UDS), transabdominal ultrasound, and personal interview to identify urinary and sexual symptoms with the Overactive Bladder Symptom Score (OABSS), the short forms of Urogenital Distress Inventory (UDI-6), the Incontinence Impact Questionnaire (IIQ-7), the Female Sexual Function Index (FSFI) questionnaire, and the Pelvic Organ Prolapse Distress Inventory (POPDI-6). Urinary symptoms with the standardized questionnaire taking into account the 2002 ICS definitions. The participants were asked to fill out the visual analog scale (VAS) scores during the postoperative day 1 round. Urodynamic studies, including non-instrumented uroflowmetry, filling and voiding cystometry, and urethral pressure profilometry, were performed according to the recommendations by the International Continence Society with a 6-channel urodynamic monitor (MMS; UD2000, Enschede, Netherlands). Any uninhibited detrusor contraction during filling cystometry was deemed positive for detrusor overactivity (DO).

As a follow-up, postoperative outpatient visits were at 1, 2, 3, 6, and 12 months and then semiannually beyond one year. Pelvic examination was performed routinely in every visit to clinics. Recurrence was defined as the most dependent portion of POP stage II or greater. The Clavien-Dindo grading was used for the classification of the intraoperative and postoperative complications of Long mesh surgery.

Study Timeline

• Study Start: 2012-01-01
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2019-01
• Study First Submitted: 2019-10-23
• Study First Submitted QC: 2019-10-23
• Last Update Submitted: 2019-10-24
• Study First Posted: 2019-10-25
• Last Update Posted: 2019-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 466

Inclusion Criteria

• Women with mainly uterine prolapse stage II or greater as defined by the POP-Q staging system

Exclusion Criteria

• A hypertrophic uterus, huge fibroids
• History of cervical dysplasia or endometrial pathology
• History of postmenopausal bleeding in the past 12 months
• Unwilling to preserve their uterus

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TVM group	TVM	Women with mainly uterine prolapse stage II or greater as defined by the POP-Q staging system treated with TVM
LSC mesh suspension group	LSC mesh suspension	Women with mainly uterine prolapse stage II or greater as defined by the POP-Q staging system treated with LSC mesh suspension

Primary Outcome Measures

Name	Time	Method
Recurrence	12 months	The POP-Q stage measurement after the operation

Trial Locations

Locations (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan