TVT-ABBREVO Versus SERASIS for the Treatment of Female Urinary Stress Incontinence: 1 Year Outcomes of a Comparative Study With 2 Trans-obturator Sub Mid Urethral Slings

NCT02867748 | Unknown

• 1 other identifier: 0141-15-NHR
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 2

Brief Summary

Abstract: Urinary Stress Incontinence (USI)- is a discomforting condition that negatively affects the quality of life of many female individuals and frequently treated by surgical intervention. The incontinence curative operations revolutionized at 1995, with the introduction of the first retro-pubic sub-mid urethral synthetic sling, firstly named Intra-Vaginal Sling-plasty (IVS) and then Tension Free Vaginal Tape (TVT), by Ulmsten and Petros. This was later proposed to be done trans-obturatorly (TOT), for avoiding operative bladder injuries. Among other peri-operative complications attributed to the commonly used anti-incontinence TOT are the thigh and groin pain. These pains are subjects of concern for patients and physicians worldwide. Another, rare yet very disturbing post-operative complication is erosion of the polypropylene tape into the vagina. TOT palpation at vaginal examination was claimed to be a predictive sign for future erosion of the polypropylene tape into the vaginal cavity. This current study aims to compare TVT-Abbrevo procedure (12 cm polypropylene tape, Ethicon J\&J Somerville, NJ, USA ) to Serasis procedure (softly knitted monofilament non-absorbable polypropylene, Serag-Wiessner, Naila, Germany) for the cure of USI. The purpose of this study is to evaluate the feasibility, the safety and the cure rate of both procedures, as well as documenting the post-operative immediate, and long term thigh and groin pain levels, and dyspareunia. This study is aimed to evaluate the palpability of the implanted tapes at vaginal examination and the possible relation of this to further vaginal tape exposure. Investigators hypothesized that using Serasis tape, which is made of a softer polypropylene material than rather rigid TVT-Abbrevo polypropylene tape might result in lower pain levels at the short and long term post-operative course, as well as to reduced tape palpability and exposure to the vaginal cavity. investigators believe that favorable results for this study might improve patients' post-operative quality of life and overall satisfaction. Keywords: Serasis, TVT-Abbrevo, USI, pain, groin, thigh, dyspareunia, safety, urinary stress incontinence, sub mid urethral sling, trans-obturator, TOT, Intra-Vaginal-Sling plasty.

Conditions

Urinary Stress Incontinence

Keywords

tvt abbrevo , Serasis

Outcome Measures

Primary Outcomes (1)

• urinary stress incontinence cure

  Primary outcome measure will be the cure of urinary stress incontinence subjective as reported by the patient in percentage of postoperative residual leak vs preoperative leak. Objective cure rate will be the leakage at physical examination cough test with full bladder (200-400ml) verified by US

  one year follow up

Secondary Outcomes (1)

• Safety, intra and postoperative adverse effects

  1 year follow up

Study Arms (2)

1

EXPERIMENTAL

TVT-Abbrevo

Procedure: TVT-Abbrevo

2

EXPERIMENTAL

Serasis

Procedure: Serasis

Interventions

TVT-Abbrevo PROCEDURE

1

Serasis PROCEDURE

2

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women suffering from urinary incontinence during physical exertion proved by clinical examination

You may not qualify if:

• Women younger than 30 and older than 80 years old.
• Women who had surgical procedures involving the pelvic floor, either for the treatment of USI or for Pelvic Organ Prolapse (POP).
• Women who suffer from advanced POP (POP-Quantification system (POP-Q) stage more than 2).
• Patients who have absent or incomplete medical records.
• Women who refuse to participate with the study.
• Women who are not able to give informed consent or participate with this randomized research study for any other reason

Sponsors & Collaborators

• Western Galilee Hospital-Nahariya: lead

Study Sites (2)

Western Galilee MC

Nahariya, 65432, Israel

Location

Assuta MC

Tel Aviv, 45320, Israel

Location

Related Publications (15)

• Citgez S, Onal B, Erdogan S, Demirdag C, Korkmaz M, Demirkesen O, Talat Z, Erozenci A, Cetinel B. Risk Factors for Women to Have Urodynamic Stress Urinary Incontinence at A Turkish Tertiary Referral Center: A Multivariate Analysis Study. Urol J. 2015 Jul 1;12(3):2187-91.

  PMID: 26135936 BACKGROUND

• Canel V, Thubert T, Wigniolle I, Fernandez H, Deffieux X. Postoperative groin pain and success rates following transobturator midurethral sling placement: TVT ABBREVO(R) system versus TVT obturator system. Int Urogynecol J. 2015 Oct;26(10):1509-16. doi: 10.1007/s00192-015-2723-8. Epub 2015 May 12.

  PMID: 25963058 BACKGROUND

• Ulmsten U, Petros P. Intravaginal slingplasty (IVS): an ambulatory surgical procedure for treatment of female urinary incontinence. Scand J Urol Nephrol. 1995 Mar;29(1):75-82. doi: 10.3109/00365599509180543.

  PMID: 7618052 BACKGROUND

• Atan A, Basar MM. A multicenter study of tension-free vaginal tape (TVT) for surgical treatment of stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2000;11(2):130-2. doi: 10.1007/s001920050084. No abstract available.

  PMID: 10805273 BACKGROUND

• Nilsson CG, Palva K, Aarnio R, Morcos E, Falconer C. Seventeen years' follow-up of the tension-free vaginal tape procedure for female stress urinary incontinence. Int Urogynecol J. 2013 Aug;24(8):1265-9. doi: 10.1007/s00192-013-2090-2. Epub 2013 Apr 6.

  PMID: 23563892 BACKGROUND

• Delorme E. [Transobturator urethral suspension: mini-invasive procedure in the treatment of stress urinary incontinence in women]. Prog Urol. 2001 Dec;11(6):1306-13. French.

  PMID: 11859672 BACKGROUND

• de Leval J. Novel surgical technique for the treatment of female stress urinary incontinence: transobturator vaginal tape inside-out. Eur Urol. 2003 Dec;44(6):724-30. doi: 10.1016/j.eururo.2003.09.003.

  PMID: 14644127 BACKGROUND

• de Leval J, Thomas A, Waltregny D. The original versus a modified inside-out transobturator procedure: 1-year results of a prospective randomized trial. Int Urogynecol J. 2011 Feb;22(2):145-56. doi: 10.1007/s00192-010-1264-4. Epub 2010 Sep 21.

  PMID: 20857087 BACKGROUND

• Menahem N. Tension-free vaginal tape obturator: midterm data on an operative procedure for the cure of female stress urinary incontinence performed on 100 patients. J Minim Invasive Gynecol. 2008 Jan-Feb;15(1):92-6. doi: 10.1016/j.jmig.2007.10.012.

  PMID: 18262152 BACKGROUND

• Neuman M, Sosnovski V, Kais M, Ophir E, Bornstein J. Transobturator vs single-incision suburethral mini-slings for treatment of female stress urinary incontinence: early postoperative pain and 3-year follow-up. J Minim Invasive Gynecol. 2011 Nov-Dec;18(6):769-73. doi: 10.1016/j.jmig.2011.08.718.

  PMID: 22024263 BACKGROUND

• Tommaselli GA, Formisano C, Di Carlo C, Fabozzi A, Nappi C. Effects of a modified technique for TVT-O positioning on postoperative pain: single-blind randomized study. Int Urogynecol J. 2012 Sep;23(9):1293-9. doi: 10.1007/s00192-012-1758-3. Epub 2012 Apr 18.

  PMID: 22527555 BACKGROUND

• Ross S, Robert M, Lier D, Eliasziw M, Jacobs P. Surgical management of stress urinary incontinence in women: safety, effectiveness and cost-utility of trans-obturator tape (TOT) versus tension-free vaginal tape (TVT) five years after a randomized surgical trial. BMC Womens Health. 2011 Jul 22;11:34. doi: 10.1186/1472-6874-11-34.

  PMID: 21781314 BACKGROUND

• Ross S, Robert M, Swaby C, Dederer L, Lier D, Tang S, Brasher P, Birch C, Cenaiko D, Mainprize T, Murphy M, Carlson K, Baverstock R, Jacobs P, Williamson T. Transobturator tape compared with tension-free vaginal tape for stress incontinence: a randomized controlled trial. Obstet Gynecol. 2009 Dec;114(6):1287-1294. doi: 10.1097/AOG.0b013e3181c2a151.

  PMID: 19935032 BACKGROUND

• Toozs-Hobson P, Freeman R, Barber M, Maher C, Haylen B, Athanasiou S, Swift S, Whitmore K, Ghoniem G, de Ridder D. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for reporting outcomes of surgical procedures for pelvic organ prolapse. Int Urogynecol J. 2012 May;23(5):527-35. doi: 10.1007/s00192-012-1726-y.

  PMID: 22476543 RESULT

• Carter E, Johnson EE, Still M, Al-Assaf AS, Bryant A, Aluko P, Jeffery ST, Nambiar A. Single-incision sling operations for urinary incontinence in women. Cochrane Database Syst Rev. 2023 Oct 27;10(10):CD008709. doi: 10.1002/14651858.CD008709.pub4.

  PMID: 37888839 DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2016
• First Posted: August 16, 2016
• Study Start: September 1, 2016
• Primary Completion: September 1, 2018
• Study Completion: March 1, 2019
• Last Updated: October 5, 2018

Record last verified: 2017-11

Locations

IL (2)