Efficacy/Safety of Urogynecology Synthetic Mesh Surgery

NCT05682989 | Recruiting

• 1 other identifier: 22MMHIS361e
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This is a retrospective cohort study, aiming at analyzing the efficacy and safety of mesh surgery in pelvic organ prolapse. The synthetic mesh for pelvic organ prolapse include transvaginal mesh or laparotomy, laparoscope, or robotic-assisted laparoscopic sacrocolpopexy with mesh augmentation. The investigators would like to evaluate the efficacy and safety, such as recurrence rates and complication rates for women who underwent urogynecology mesh surgery.

Conditions

Pelvic Organ Prolapse; Stage III and IV High Grade Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (1)

• trans-vaginal mesh repair

  Urodynamic investigations (The urodynamic study included free uroflowmetry, postvoid residual, filling and voiding cystometry, and a urethral pressure profile. The filling cystometry and urethral pressure profile were performed with 37 degrees C normal saline similar to body temperature at an infusion rate of 80 ml/min. 1. The urodynamic data of POP patient with grade \> or = II, will be retrograde analyzed and and compared. 2. Pressure-associated parameters, such as abdominal pressure (Pabd), detrusor pressure (Pdet) will be measured as centimeter of water column (cmH2O), volume-associated parameters, such as infused volume (Vinf), voided volume (Vvod) and intravesical volume (Vive) will measured as ml. Derived parameter will be expressed as their results of calculation.

  Generally in our hospital, pre-operative investigation will be done about 30 days before surgery, post-operative investigation will within 1year after surgery.

Study Arms (3)

mesh surgery

Data obtained before the operation

Procedure: Urodynamic investigations before and after a mesh surgery protocol.

Robotic-assisted sacrocolpopexy

Data obtained before the operation

Procedure: Urodynamic investigations before and after a robotic-assisted sacrocolpopexy protocol.

a hysterectomy with trans-vaginal mesh repair (Surelift®, Neomedic International, Barcelona, Spain)

Data obtained before the operation

Procedure: Urodynamic investigations before and after a hysterectomy with trans-vaginal mesh repair

Interventions

Urodynamic investigations before and after a mesh surgery protocol. PROCEDURE

Urodynamic investigations (The urodynamic study included free uroflowmetry, postvoid residual, filling and voiding cystometry, and a urethral pressure profile. The filling cystometry and urethral pressure profile were performed with 37 degrees C normal saline similar to body temperature at an infusion rate of 80 ml/min.

mesh surgery

Urodynamic investigations before and after a robotic-assisted sacrocolpopexy protocol. PROCEDURE

All surgeries were performed using a DaVinci robotic system (Intuitive® Surgical Inc., Sunnyvale, California,US) with standardized technique and materials. Patients were positioned in dorsal lithotomy and steep Trendelenburg position. Trocars were placed bilaterally, and an assistant port was placed laterally. The peritoneum was opened medial to the ureter to develop an avascular space. The mesh was placed on the posterior and anterior vaginal wall and fixed at the level of anterior longitudinal ligaments S1/S2 by sutures. An intraoperative clinical examination was performed to ensure the mesh was in a tension-free position.

Robotic-assisted sacrocolpopexy

Urodynamic investigations before and after a hysterectomy with trans-vaginal mesh repair PROCEDURE

In summary, a vertical incision was made in the anterior vaginal wall to access the vesicovaginal space. The sacrospinous ligament was dissected, and an applicator was inserted and positioned over the SSL. The anchor was fixed to the SSL and the thread was attached to the mesh. The mesh was then adjusted in a tension-free manner, excess mesh was cut, and the incision was closed with suture.

a hysterectomy with trans-vaginal mesh repair (Surelift®, Neomedic International, Barcelona, Spain)

Eligibility Criteria

• Age: 30 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

History of POP patients with concurrent objective and/or subjective voiding dysfunctions who underwent primary TVM surgery for symptomatic POP ≥ stage II (POP Quantification system; POP-Q system) in Mackay Memorial Hospital were recruited.

You may qualify if:

• Pelvic organ prolapse patients with objective / subjective voiding dysfunctions
• Underwent surgery for symptomatic POP ≥ stage II (POP-Q system)

You may not qualify if:

• Patients with a history of pelvic radiation.
• Patients with a history of vesico-/recto-/urethra-vaginal fistula
• Patients unable to be followed up.

Sponsors & Collaborators

• Mackay Medical College: lead

Study Sites (1)

Department of Obstetrics and Gynecology

New Taipei City, Taiwan

RECRUITING

Related Publications (16)

• Abrams P, Andersson KE, Birder L, Brubaker L, Cardozo L, Chapple C, Cottenden A, Davila W, de Ridder D, Dmochowski R, Drake M, Dubeau C, Fry C, Hanno P, Smith JH, Herschorn S, Hosker G, Kelleher C, Koelbl H, Khoury S, Madoff R, Milsom I, Moore K, Newman D, Nitti V, Norton C, Nygaard I, Payne C, Smith A, Staskin D, Tekgul S, Thuroff J, Tubaro A, Vodusek D, Wein A, Wyndaele JJ; Members of Committees; Fourth International Consultation on Incontinence. Fourth International Consultation on Incontinence Recommendations of the International Scientific Committee: Evaluation and treatment of urinary incontinence, pelvic organ prolapse, and fecal incontinence. Neurourol Urodyn. 2010;29(1):213-40. doi: 10.1002/nau.20870. No abstract available.

  PMID: 20025020 BACKGROUND

• GREEN TH Jr. Development of a plan for the diagnosis and treatment of urinary stress incontinence. Am J Obstet Gynecol. 1962 Mar 1;83:632-48. doi: 10.1016/s0002-9378(16)35894-x. No abstract available.

  PMID: 13901453 BACKGROUND

• McGuire EJ, Lytton B, Kohorn EI, Pepe V. The value of urodynamic testing in stress urinary incontinence. J Urol. 1980 Aug;124(2):256-8. doi: 10.1016/s0022-5347(17)55396-3.

  PMID: 7401242 BACKGROUND

• Ulmsten U, Johnson P, Rezapour M. A three-year follow up of tension free vaginal tape for surgical treatment of female stress urinary incontinence. Br J Obstet Gynaecol. 1999 Apr;106(4):345-50. doi: 10.1111/j.1471-0528.1999.tb08272.x.

  PMID: 10426241 BACKGROUND

• Fusco F, Abdel-Fattah M, Chapple CR, Creta M, La Falce S, Waltregny D, Novara G. Updated Systematic Review and Meta-analysis of the Comparative Data on Colposuspensions, Pubovaginal Slings, and Midurethral Tapes in the Surgical Treatment of Female Stress Urinary Incontinence. Eur Urol. 2017 Oct;72(4):567-591. doi: 10.1016/j.eururo.2017.04.026. Epub 2017 May 4.

  PMID: 28479203 BACKGROUND

• Jiao B, Lai S, Xu X, Zhang M, Diao T, Zhang G. A systematic review and meta-analysis of single-incision mini-slings (MiniArc) versus transobturator mid-urethral slings in surgical management of female stress urinary incontinence. Medicine (Baltimore). 2018 Apr;97(14):e0283. doi: 10.1097/MD.0000000000010283.

  PMID: 29620645 BACKGROUND

• Stav K, Dwyer PL, Rosamilia A, Schierlitz L, Lim YN, Lee J. Risk factors of treatment failure of midurethral sling procedures for women with urinary stress incontinence. Int Urogynecol J. 2010 Feb;21(2):149-55. doi: 10.1007/s00192-009-1020-9. Epub 2009 Oct 24.

  PMID: 19855914 BACKGROUND

• Ford AA, Ogah JA. Retropubic or transobturator mid-urethral slings for intrinsic sphincter deficiency-related stress urinary incontinence in women: a systematic review and meta-analysis. Int Urogynecol J. 2016 Jan;27(1):19-28. doi: 10.1007/s00192-015-2797-3. Epub 2015 Jul 29.

  PMID: 26220506 BACKGROUND

• Sand PK, Bowen LW, Panganiban R, Ostergard DR. The low pressure urethra as a factor in failed retropubic urethropexy. Obstet Gynecol. 1987 Mar;69(3 Pt 1):399-402.

  PMID: 3822288 BACKGROUND

• McGuire EJ, Fitzpatrick CC, Wan J, Bloom D, Sanvordenker J, Ritchey M, Gormley EA. Clinical assessment of urethral sphincter function. J Urol. 1993 Nov;150(5 Pt 1):1452-4. doi: 10.1016/s0022-5347(17)35806-8.

  PMID: 8411422 BACKGROUND

• Uebersax JS, Wyman JF, Shumaker SA, McClish DK, Fantl JA. Short forms to assess life quality and symptom distress for urinary incontinence in women: the Incontinence Impact Questionnaire and the Urogenital Distress Inventory. Continence Program for Women Research Group. Neurourol Urodyn. 1995;14(2):131-9. doi: 10.1002/nau.1930140206.

  PMID: 7780440 BACKGROUND

• Kenton K, Stoddard AM, Zyczynski H, Albo M, Rickey L, Norton P, Wai C, Kraus SR, Sirls LT, Kusek JW, Litman HJ, Chang RP, Richter HE. 5-year longitudinal followup after retropubic and transobturator mid urethral slings. J Urol. 2015 Jan;193(1):203-10. doi: 10.1016/j.juro.2014.08.089. Epub 2014 Aug 23.

  PMID: 25158274 BACKGROUND

• Foss Hansen M, Lose G, Kesmodel US, Gradel KO. Reoperation for urinary incontinence: a nationwide cohort study, 1998-2007. Am J Obstet Gynecol. 2016 Feb;214(2):263.e1-263.e8. doi: 10.1016/j.ajog.2015.08.069. Epub 2015 Sep 5.

  PMID: 26344752 BACKGROUND

• Sun MJ, Chuang YL, Lau HH, Lo TS, Su TH. The efficacy and complications of using transvaginal mesh to treat pelvic organ prolapse in Taiwan: A 10-year review. Taiwan J Obstet Gynecol. 2021 Mar;60(2):187-192. doi: 10.1016/j.tjog.2021.01.031.

  PMID: 33678316 BACKGROUND

• Lau HH, Lai CY, Hsieh MC, Peng HY, Chou D, Su TH, Lee JJ, Lin TB. Uneven effects of trans-vaginal mesh reconstruction on the viscoelastic property of the urinary bladder in patients with pelvic organ prolapse. Front Bioeng Biotechnol. 2026 Jan 12;13:1677779. doi: 10.3389/fbioe.2025.1677779. eCollection 2025.

  PMID: 41602457 DERIVED

• Lau HH, Lai CY, Hsieh MC, Peng HY, Chou D, Su TH, Lee JJ, Lin TB. Pressure-volume analysis of thermodynamic workload of voiding - an application in pelvic organ prolapse patients subjected to robotic-assisted sacrocolpopexy. Biomed Eng Lett. 2024 Dec 30;15(2):357-365. doi: 10.1007/s13534-024-00453-5. eCollection 2025 Mar.

  PMID: 40026886 DERIVED

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Hui-Hsuan Lau, M.D.

  Department of Ear, Nose, and Throat, MacKay Memorial Hospital, Taipei, Taiwan

  STUDY CHAIR

Central Study Contacts

Hui-Hsuan Lau, M.D.

CONTACT

+886-975-835928; huihsuan1220@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The Office of Research and Development

Study Record Dates

• First Submitted: December 28, 2022
• First Posted: January 12, 2023
• Study Start: August 1, 2022
• Primary Completion: August 1, 2023
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 5, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)