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

NCT ID: NCT02935803

Last Updated: 2016-10-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2020-06-30

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

Conditions

Uterine Prolapse; Urinary Stress Incontinence; Side Effects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Modified TVM 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.

Group Type: OTHER

Trans-vaginal Mesh operation

Intervention Type: PROCEDURE

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

Control group

76 Participants as control group undergo a traditional Trans-vaginal Mesh operation (TVM) with polypropylene monofilament meshes produced by Aspide® . (Sergent et al.)

Group Type: OTHER

Trans-vaginal Mesh operation

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Szeged University

OTHER

Sponsor Role: lead

Responsible Party

Zoltan Fekete

assistant lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zoltan Fekete, M.D.

Role: PRINCIPAL_INVESTIGATOR

Szeged University

Gábor Németh, M.D., Ph.D.

Role: STUDY_DIRECTOR

Szeged University

Locations

Univ. of Szeged. Dep. of Obstetrics and Gynaecology

Szeged, , Hungary

Site Status: RECRUITING

Countries

Hungary

Central Contacts

Zoltán Fekete, M.D.

Role: CONTACT

zoltan.fekete@freemail.hu

36209724158

Gábor Németh, M.D., PhD

Role: CONTACT

nemethgdr@gmail.com

3662545499

Facility Contacts

Fekete Zoltan, M.D.

Role: primary

zoltan.fekete@med.u-szeged.hu

209724158

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 24171152 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 19629013 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 2333037 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26156205 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19643459 (View on PubMed)

Fekete Z, Suranyi A, Renes L, Nemeth G, Kozinszky Z. Efficacy of anchoring the four-arm transvaginal mesh to the mid-urethra vs original surgery as a surgical correction for stress urine incontinence in coexisting anterior vaginal prolapse grades II and III: study protocol for a randomized controlled trial. Trials. 2017 Dec 28;18(1):624. doi: 10.1186/s13063-017-2314-8.

Reference Type: DERIVED

PMID: 29282115 (View on PubMed)

Related Links

http://www.aspide.com/en/gynecological-urological-surgery/p/surgimesh-prolapse

Surge-Mesh Prolapse by Aspide is used for both TVM method

Other Identifiers

TVM/mTVM 55/2016

Identifier Type: -

Identifier Source: org_study_id