Urinary Stress Incontinence Clinical Trial
Verified date | November 2017 |
Source | Western Galilee Hospital-Nahariya |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 99 |
Est. completion date | March 2019 |
Est. primary completion date | September 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 30 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Women suffering from urinary incontinence during physical exertion proved by clinical examination Exclusion Criteria: 1. Women younger than 30 and older than 80 years old. 2. Women who had surgical procedures involving the pelvic floor, either for the treatment of USI or for Pelvic Organ Prolapse (POP). 3. Women who suffer from advanced POP (POP-Quantification system (POP-Q) stage more than 2). 4. Patients who have absent or incomplete medical records. 5. Women who refuse to participate with the study. 6. Women who are not able to give informed consent or participate with this randomized research study for any other reason |
Country | Name | City | State |
---|---|---|---|
Israel | Western Galilee MC | Nahariya | |
Israel | Assuta MC | Tel Aviv |
Lead Sponsor | Collaborator |
---|---|
Western Galilee Hospital-Nahariya |
Israel,
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. — View Citation
Canel V, Thubert T, Wigniolle I, Fernandez H, Deffieux X. Postoperative groin pain and success rates following transobturator midurethral sling placement: TVT ABBREVO® 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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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):1287-94. doi: 10.1097/AOG.0b013e3181c2a151. — View Citation
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. — View Citation
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 ou — View Citation
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. — View Citation
* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Safety, intra and postoperative adverse effects | the ability to palpate the sling at vaginal examination (yes/no) | 1 year follow up |
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