NCT02935803

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 18, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

October 18, 2016

Status Verified

October 1, 2016

Enrollment Period

11 months

First QC Date

May 20, 2016

Last Update Submit

October 13, 2016

Conditions

Uterine ProlapseUrinary Stress IncontinenceSide Effects

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Telorability of the mTVM method

    36 month follow up

  • Improvement in sexual life

    36 month

  • Improvement in pelvic floor symphtoms

    3 years follow up

  • Improvement in quality of life

    3 years

Study Arms (2)

Modified TVM operation

OTHER

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.

Procedure: Trans-vaginal Mesh operation

Control group

OTHER

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

Procedure: Trans-vaginal Mesh operation

Interventions

Trans-vaginal Mesh operationPROCEDURE

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 groupModified TVM operation

Eligibility Criteria

Age45 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Coexisting SUI and POP Q St II-III and signature of the informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univ. of Szeged. Dep. of Obstetrics and Gynaecology

Szeged, 6720, Hungary

RECRUITING

Related Publications (8)

  • 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.

    PMID: 18238969BACKGROUND

  • 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.

    PMID: 24171152BACKGROUND

  • 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.

    PMID: 26638154BACKGROUND

  • 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.

    PMID: 19629013BACKGROUND

  • Molander U, Milsom I, Ekelund P, Mellstrom D. An epidemiological study of urinary incontinence and related urogenital symptoms in elderly women. Maturitas. 1990 Apr;12(1):51-60. doi: 10.1016/0378-5122(90)90060-j.

    PMID: 2333037BACKGROUND

  • 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.

    PMID: 26156205BACKGROUND

  • 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.

    PMID: 19643459BACKGROUND

  • 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.

    PMID: 29282115DERIVED

Related Links

MeSH Terms

Conditions

Uterine ProlapseUrinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Uterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesPelvic Organ ProlapseProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsUrinary IncontinenceUrination DisordersUrologic DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and Symptoms

Study Officials

  • Zoltan Fekete, M.D.

    Szeged University

    PRINCIPAL INVESTIGATOR

  • Gábor Németh, M.D., Ph.D.

    Szeged University

    STUDY DIRECTOR

Central Study Contacts

Zoltán Fekete, M.D.

CONTACT

36209724158zoltan.fekete@freemail.hu

Gábor Németh, M.D., PhD

CONTACT

3662545499nemethgdr@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

May 20, 2016

First Posted

October 18, 2016

Study Start

July 1, 2016

Primary Completion

June 1, 2017

Study Completion

June 1, 2020

Last Updated

October 18, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will share

Locations

HU(1)