A Study on the Anti-incontinent Effectiveness of the mTVM Method in POPQ Stage II-III Patients

Urinary Stress Incontinence Clinical Trial

— TVMvsmTVM  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02935803
• Other study ID #: TVM/mTVM 55/2016
• Status: Recruiting
• Phase: N/A
• First received: May 20, 2016
• Last updated: October 13, 2016
• Start date: July 2016
• Est. completion date: June 2020

Study information

• Verified date: October 2016
• Source: Szeged University
• Contact: Zoltán Fekete, M.D.
• Phone: 36209724158
• Email: zoltan.fekete[@]freemail.hu
• Is FDA regulated: No
• Health authority: Hungary: Institutional Ethics CommitteeHungary: Ministry of Health, Social and Family Affairs
• Study type: Interventional

Clinical Trial Summary

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.

Description:

The prospective randomized double blind study comprised 152 women who presented for the correction of stress urinary incontinence (SUI) in conjunction with anterior compartment pelvic organ prolapse stage II-III (POP-Q II-III) at the Departments of Obstetrics and Gynecology at the University of Szeged, Hungary, between June of 2016 and June 2017. After a block randomization method, the patients will divide into two arms, the study group which consist of 76 patients will undergo modified trans vaginal mesh operation (TVM), the rest 76 patients as a control group will undergo a traditional TVM operation. Inclusion criteria in the study is coexisting SUI and POP Q St II-III and signature of the informed consent. The exclusion criteria are as follows: urge, mixed or neurogenic incontinence, occult SUI, previous mesh operations, anti-depressive medical therapy, cancer of the pelvic organs, urinary infections, any sign of voiding difficulties. The transobturator TVM operation (Sergent et al.) has been modofied by inserting a stabilizing suture, which fixing the anterior edge of the mesh to the para-urethral tissues at the level of the mid-urethra with two non-resolvable anchoring stitches thereby promoting the proper elevation and closure of the urethra. The hypothesis is the stabilizing suture treat the coexisting SUI as well. In all cases, urodynamic examinations were carried out before the surgery and urodynamic examinations comprising uroflowmetry, cystography and Valsalva leak point pressure tests and pelvic floor ultrasonography will be performed to determine the coexisting SUI. The efficacy of the POP repair is taken as a significant (>1 cm) improvement at points Aa, Ba, C and D according to the POP-Q system (International Continence Society) during the follow-up. The anti-incontinence efficacy is classified as no further SUI diagnosed by urodynamic examination and pelvic floor sonography. All patients will fill two validated Hungarian language questionnaires as "A short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire" (PISQ-12) and "Pelvic Floor Distress Inventory" PFDI. After a one-year application phase all patients will be followed for 36 months. During follow- up phase repeated urodynamic studies, pelvic floor sonography urine culturing will be done after 3, 12, 24 and 36 months. The evaluation of the POP-Q system and Bonney's cough test and the PISQ-12 and PFDI questionnaires will be performed at every regular check-ups

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prolapse
• Side Effects
• Urinary Incontinence, Stress
• Urinary Stress Incontinence
• Uterine Prolapse

Intervention

Procedure:
• Trans-vaginal Mesh operation
Modified the transobturator TVM operation reported by Sergent et al. by inserting a stabilizing suture, which fixing the anterior edge of the mesh to the paraurethral tissues at the level of the mid-urethra with two non-resolvable anchoring stitches thereby promoting the proper elevation and closure of the urethra

Locations

Country	Name	City	State
Hungary	Univ. of Szeged. Dep. of Obstetrics and Gynaecology	Szeged

Sponsors (1)

Lead Sponsor	Collaborator
Szeged University

Country where clinical trial is conducted

Hungary, 

References & Publications (7)

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

Molander U, Milsom I, Ekelund P, Mellström D. An epidemiological study of urinary incontinence and related urogenital symptoms in elderly women. Maturitas. 1990 Apr;12(1):51-60. — View Citation

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

Outcome

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