Uterine ProlapseTVMvsmTVMNCT02935803
A Study on the Anti-incontinent Effectiveness of the mTVM Method in POPQ Stage II-III Patients
A study testing Trans-vaginal Mesh operation in people with Uterine Prolapse and Urinary Stress Incontinence, run by Szeged University at 1 site in Hungary.
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… Read more about this study
- Who is it for?
- Ages 45 to 75 years, women only
- Conditions the study is for
- Uterine Prolapse, Urinary Stress Incontinence, Side Effects
- What is being tested?
- Trans-vaginal Mesh operation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteHungary
- Study dates
- Jul 2016to Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Coexisting SUI and POP Q St II-III and signature of the informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Hungary1 site, 1 recruiting
- Recruiting
Univ. of Szeged. Dep. of Obstetrics and Gynaecology
Szeged, 6720
Fekete Zoltan, M.D., 209724158, zoltan.fekete@med.u-szeged.hu
About this study
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
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.
Read the 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
- Being tested
- Trans-vaginal Mesh operation
- Medical subject headings
- Uterine Prolapse, Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans-vaginal Mesh operationProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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.) Receives: Procedure: Trans-vaginal Mesh operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of the mTVM on genuine stress incontinence.
Measuring the anti incontinence effect of the used method by urodynamic examination anf pelvic floor sonography
Measured: 36 months flollow up
Secondary outcomes (4)
Telorability of the mTVM method
Measuring the tolerability of the used method by the Clavien-Dindo classification system
Measured: 36 month follow up
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)
Measured: 36 month
Improvement in pelvic floor symphtoms
Define the change in quality of life after the used procedures by Pelvic Floor Distress Inventory (PFDI-20)
Measured: 3 years follow up
Improvement in quality of life
Define the change in quality of life after the used procedures by urogenital distress inventory (UDI-6)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study startJul 2016
- Primary completionJun 2017 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Uterine ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Szeged University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zoltan Fekete, Szeged University
- Investigators
- Zoltan Fekete, M.D., Principal investigator, Szeged UniversityGábor Németh, M.D., Ph.D., Study director, Szeged University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02935803
- Sponsor's protocol ID
- TVM/mTVM 55/2016
- Acronym
- TVMvsmTVM
- Status last verified
- Oct 2016
- First submitted
- 20 May 2016
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
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.
PubMed 18238969Kirss 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.
PubMed 24171152Akkus 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.
PubMed 26638154Tinelli 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.
PubMed 19629013Molander 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.
PubMed 2333037Lau 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.
PubMed 26156205Sergent 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.
PubMed 19643459Fekete 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.
PubMed 29282115
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02935803
- Acronym / sponsor ID
- TVMvsmTVM / TVM/mTVM 55/2016
- Conditions
- Uterine Prolapse, Urinary Stress Incontinence, Side Effects
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Szeged UniversityUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 18 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified TVM operation | Other | Procedure: Trans-vaginal Mesh operationModified 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 | Other | Procedure: Trans-vaginal Mesh operation76 Participants as control group undergo a traditional Trans-vaginal Mesh operation (TVM) with polypropylene monofilament meshes produced by Aspide® . (Sergent et al.) |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Coexisting SUI and POP Q St II-III and signature of the informed consent
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trans-vaginal Mesh operationModified 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 | Procedure or surgery | Control group, Modified TVM operation |
Primary outcome
Efficacy of the mTVM on genuine stress incontinence.
Time frame: 36 months flollow up
Measuring the anti incontinence effect of the used method by urodynamic examination anf pelvic floor sonography
4 secondary outcomes
Telorability of the mTVM method
Time frame: 36 month follow up
Improvement in sexual life
Time frame: 36 month
Improvement in pelvic floor symphtoms
Time frame: 3 years follow up
Improvement in quality of life
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2016.
- Background: PubMed 18238969Minassian 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.
- Background: PubMed 24171152Kirss 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.
- Background: PubMed 26638154Akkus 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.
- Background: PubMed 19629013Tinelli 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.
- Background: PubMed 2333037Molander 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.
- Background: PubMed 26156205Lau 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.
- Background: PubMed 19643459Sergent 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.
- Derived from this study: PubMed 29282115Fekete 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.
- Surge-Mesh Prolapse by Aspide is used for both TVM methodLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zoltan Fekete, M.D. principal investigator
Szeged University
Gábor Németh, M.D., Ph.D. study director
Szeged University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trans-vaginal Mesh operation in people with Uterine Prolapse and Urinary Stress Incontinence, run by Szeged University at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zoltán Fekete, M.D. (36209724158, zoltan.fekete@freemail.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of the mTVM on genuine stress incontinence. (time frame: 36 months flollow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02935803, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2016.