Urinary Stress Incontinence Clinical Trial
— TVMvsmTVMOfficial title:
A Prospective and Randomised Single Centre Study on the Anti-incontinent Effectiveness of the Modified Trans Vaginal Mesh Method in POPQ Stage II-III Patients
An increasing number of specific procedures have been described for the surgical repair of pelvic organ prolapse (POP) and concomitant stress urinary incontinence (SUI). The investigators introduced an alternative operative method for POP-Q II-III repair and anti-incontinence with the trans vaginal mesh (TVM) anterior edge fixed to the periurethral tissues at the level of mid-urethra. The efficacy and short- and long-term complication profile, of this new surgical technique as compared with those of non-modified TVM.
Status | Recruiting |
Enrollment | 76 |
Est. completion date | June 2020 |
Est. primary completion date | June 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 45 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Coexisting SUI and POP Q St II-III and signature of the informed consent Exclusion Criteria: - Urge, mixed or neurogenic incontinency, occult SUI, previous mesh operations, antidepressive medical therapy, cancer of the pelvic organs, urinary infections, any sign of voiding difficulties |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Hungary | Univ. of Szeged. Dep. of Obstetrics and Gynaecology | Szeged |
Lead Sponsor | Collaborator |
---|---|
Szeged University |
Hungary,
Akkus Y, Pinar G. Evaluation of the prevalence, type, severity, and risk factors of urinary incontinence and its impact on quality of life among women in Turkey. Int Urogynecol J. 2016 Jun;27(6):887-93. doi: 10.1007/s00192-015-2904-5. Epub 2015 Dec 5. — View Citation
Kirss F, Lang K, Toompere K, Veerus P. Prevalence and risk factors of urinary incontinence among Estonian postmenopausal women. Springerplus. 2013 Oct 17;2:524. doi: 10.1186/2193-1801-2-524. eCollection 2013. — View Citation
Lau HH, Huang WC, Cheng YW, Wang H, Su TH. Changes in urodynamic measurements and bladder neck position after single-incision trans-vaginal mesh for pelvic organ prolapse. Int Urogynecol J. 2015 Nov;26(11):1629-35. doi: 10.1007/s00192-015-2753-2. Epub 2015 Jul 10. — View Citation
Minassian VA, Stewart WF, Wood GC. Urinary incontinence in women: variation in prevalence estimates and risk factors. Obstet Gynecol. 2008 Feb;111(2 Pt 1):324-31. doi: 10.1097/01.AOG.0000267220.48987.17. — View Citation
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Sergent F, Gay-Crosier G, Bisson V, Resch B, Verspyck E, Marpeau L. Ineffectiveness of associating a suburethral tape to a transobturator mesh for cystocele correction on concomitant stress urinary incontinence. Urology. 2009 Oct;74(4):765-70. doi: 10.1016/j.urology.2009.05.038. Epub 2009 Jul 30. — View Citation
Tinelli A, Malvasi A, Rahimi S, Negro R, Vergara D, Martignago R, Pellegrino M, Cavallotti C. Age-related pelvic floor modifications and prolapse risk factors in postmenopausal women. Menopause. 2010 Jan-Feb;17(1):204-12. doi: 10.1097/gme.0b013e3181b0c2ae. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy of the mTVM on genuine stress incontinence. | Measuring the anti incontinence effect of the used method by urodynamic examination anf pelvic floor sonography | 36 months flollow up | No |
Secondary | Telorability of the mTVM method | Measuring the tolerability of the used method by the Clavien-Dindo classification system | 36 month follow up | Yes |
Secondary | Improvement in sexual life | Define the change in quality of sexual life after the used procedures by Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) | 36 month | No |
Secondary | Improvement in pelvic floor symphtoms | Define the change in quality of life after the used procedures by Pelvic Floor Distress Inventory (PFDI-20) | 3 years follow up | Yes |
Secondary | Improvement in quality of life | Define the change in quality of life after the used procedures by urogenital distress inventory (UDI-6) | 3 years | Yes |
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