The Clinical Outcome of TVM or LSC Mesh Suspension for POP

The Clinical and Urodynamic Effects of Transvaginal or Laparoscopic Mesh Suspension for the Treatment of Pelvic Organ Prolapse

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.

Study Overview

• Status: Completed
• Conditions: Pelvic Organ Prolapse
• Intervention / Treatment: Procedure: TVM; Procedure: LSC mesh suspension

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 Type: Observational
• Enrollment (Actual): 466

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan, 807
    • Kaohsiung Medical University Chung-Ho Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
TVM group; Women with mainly uterine prolapse stage II or greater as defined by the POP-Q staging system treated with TVM	Procedure: TVM; 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	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence	The POP-Q stage measurement after the operation	12 months

Collaborators and Investigators

• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

Publications and helpful links

General Publications

• Haylen BT, Maher CF, Barber MD, Camargo S, Dandolu V, Digesu A, Goldman HB, Huser M, Milani AL, Moran PA, Schaer GN, Withagen MI. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic organ prolapse (POP). Int Urogynecol J. 2016 Apr;27(4):655-84. doi: 10.1007/s00192-016-3003-y.
• Korbly NB, Kassis NC, Good MM, Richardson ML, Book NM, Yip S, Saguan D, Gross C, Evans J, Lopes VV, Harvie HS, Sung VW. Patient preferences for uterine preservation and hysterectomy in women with pelvic organ prolapse. Am J Obstet Gynecol. 2013 Nov;209(5):470.e1-6. doi: 10.1016/j.ajog.2013.08.003. Epub 2013 Aug 3.
• Wu MP, Long CY, Huang KH, Chu CC, Liang CC, Tang CH. Changing trends of surgical approaches for uterine prolapse: an 11-year population-based nationwide descriptive study. Int Urogynecol J. 2012 Jul;23(7):865-72. doi: 10.1007/s00192-011-1647-1. Epub 2012 Jan 24.
• Long CY, Wang CL, Ker CR, Juan YS, Tsai EM, Lin KL. Laparoscopic Organopexy with Non-mesh Genital (LONG) Suspension: A Novel Uterine Preservation Procedure for the Treatment of Apical Prolapse. Sci Rep. 2018 Mar 20;8(1):4872. doi: 10.1038/s41598-018-23285-7.
• Maher C, Feiner B, Baessler K, Christmann-Schmid C, Haya N, Brown J. Surgery for women with apical vaginal prolapse. Cochrane Database Syst Rev. 2016 Oct 1;10(10):CD012376. doi: 10.1002/14651858.CD012376.
• Long CY, Hsu CS, Wu CH, Liu CM, Wang CL, Tsai EM. Three-year outcome of transvaginal mesh repair for the treatment of pelvic organ prolapse. Eur J Obstet Gynecol Reprod Biol. 2012 Mar;161(1):105-8. doi: 10.1016/j.ejogrb.2011.12.007. Epub 2012 Jan 9.
• Ker CR, Lin KL, Loo ZX, Juan YS, Long CY. Comparison of UpholdTM Vaginal Mesh Procedure with Hysterectomy or Uterine Preservation for the Treatment of Pelvic Organ Prolapse. Sci Rep. 2018 Jun 21;8(1):9438. doi: 10.1038/s41598-018-27765-8.

Helpful Links

• U.S. Food and Drug Administration. Urogynecologic surgical mesh implants.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2012
• Primary Completion (ACTUAL): December 31, 2018
• Study Completion (ACTUAL): December 31, 2018

Study Registration Dates

• First Submitted: October 23, 2019
• First Submitted That Met QC Criteria: October 23, 2019
• First Posted (ACTUAL): October 25, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 28, 2019
• Last Update Submitted That Met QC Criteria: October 24, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Pelvic organ prolapse; Transvaginal mesh; Laparoscopic mesh suspension
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: KMUHIRB-E(I)-20190015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No