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

Not Applicable

• Conditions: Urinary Stress Incontinence; Side Effects; Uterine Prolapse
• Interventions: Procedure: Trans-vaginal Mesh operation

• Registration Number: NCT02935803
• Lead Sponsor: Szeged University

Brief 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.

Detailed 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

Study Timeline

• Study First Submitted: 2016-05-20
• Study Start: 2016-07
• Status Verified: 2016-10
• Study First Submitted QC: 2016-10-13
• Last Update Submitted: 2016-10-13
• Study First Posted: 2016-10-18
• Last Update Posted: 2016-10-18
• Primary Completion: 2017-06
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 76

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Modified TVM operation	Trans-vaginal Mesh operation	Modified Trans-vaginal Mesh operation (mTVM): polypropylene monofilament meshes produced by Aspide® fixed up to the mid urethra by a resolvable suture. 76 participants will be involved.
Control group	Trans-vaginal Mesh operation	76 Participants as control group undergo a traditional Trans-vaginal Mesh operation (TVM) with polypropylene monofilament meshes produced by Aspide® . (Sergent et al.)

Primary Outcome Measures

Name	Time	Method
Efficacy of the mTVM on genuine stress incontinence.	36 months flollow up	Measuring the anti incontinence effect of the used method by urodynamic examination anf pelvic floor sonography

Secondary Outcome Measures

Name	Time	Method
Improvement in pelvic floor symphtoms	3 years follow up	Define the change in quality of life after the used procedures by Pelvic Floor Distress Inventory (PFDI-20)
Telorability of the mTVM method	36 month follow up	Measuring the tolerability of the used method by the Clavien-Dindo classification system
Improvement in sexual life	36 month	Define the change in quality of sexual life after the used procedures by Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)
Improvement in quality of life	3 years	Define the change in quality of life after the used procedures by urogenital distress inventory (UDI-6)

Trial Locations

Locations (1)

Univ. of Szeged. Dep. of Obstetrics and Gynaecology; 🇭🇺 Szeged, Hungary