The Clinical Outcome of TVM or LSC Mesh Suspension for POP

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

466 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-01

Study Completion Date

2018-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pelvic Organ Prolapse

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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TVM group

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

TVM

Intervention Type PROCEDURE

Transvaginal mesh kit is delivered into the pelvis via vagina route.

LSC mesh suspension group

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

LSC mesh suspension

Intervention Type PROCEDURE

Long mesh, a synthetic T-shaped mesh (Gynemsh, Ethicon, San Lorenzo, Puerto Rico), is delivered into the pelvic cavity. Bilateral mesh arms are extracted outside trocar wounds bilaterally to stabilize mesh position. The center piece is fixed to the cervix with 5mm ProTack screws (Covidien, New Haven, Connecticut). Fixation is strengthened with Stratafix 2-0 sutures (Ethicon, Norderstedt, Germany), followed by Tisseel fibrin sealant (Baxter, Deerfield, Illinois) for better hemostasis among surrounding tissues. An extraperitoneal tunnel is created along the left round ligament until reaching 2cm medial to the anterior superior iliac spine (ASIS). One arm of the long mesh is pulled out along the tunnel underneath round ligament and fixed with the fascia of oblique abdominis. The same procedure is repeated for the contralateral side. Bilateral round ligaments and the mesh arms are sutured continuously with Stratafix 2-0.

Interventions

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LSC mesh suspension

Long mesh, a synthetic T-shaped mesh (Gynemsh, Ethicon, San Lorenzo, Puerto Rico), is delivered into the pelvic cavity. Bilateral mesh arms are extracted outside trocar wounds bilaterally to stabilize mesh position. The center piece is fixed to the cervix with 5mm ProTack screws (Covidien, New Haven, Connecticut). Fixation is strengthened with Stratafix 2-0 sutures (Ethicon, Norderstedt, Germany), followed by Tisseel fibrin sealant (Baxter, Deerfield, Illinois) for better hemostasis among surrounding tissues. An extraperitoneal tunnel is created along the left round ligament until reaching 2cm medial to the anterior superior iliac spine (ASIS). One arm of the long mesh is pulled out along the tunnel underneath round ligament and fixed with the fascia of oblique abdominis. The same procedure is repeated for the contralateral side. Bilateral round ligaments and the mesh arms are sutured continuously with Stratafix 2-0.

Intervention Type PROCEDURE

TVM

Transvaginal mesh kit is delivered into the pelvis via vagina route.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No