HerniaPhase 4Nazcatc™NCT00676325
Surgical Treatment To Greater Anterior Vaginal Prolapse
A Phase 4 study testing Surgical treatment of Anterior Vaginal Prolapse, NAZCA TC™ POP REPAIR SYSTEM ,promedon® , argentina. and surgical treatment for anterior vaginal wall prolapse in people with Hernia and Cystocele, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
A RCT study to compare traditional colporrhaphy versus polypropylene mesh in treatment of the anterior vaginal wall prolapse. Read more about this study
- Who is it for?
- Ages 50 years and older, women onlyHealthy volunteers can take part
- What is being tested?
- Surgical treatment of Anterior Vaginal Prolapse, NAZCA TC™ POP REPAIR SYSTEM ,promedon® , argentina. and surgical treatment for anterior vaginal wall prolapse
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2007to Dec 2009
- Phase
- Phase 4
- 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 50 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women 50 years and older with greater anterior vaginal prolapse,whit stress incontinence or not,point (Ba)ics96, below hymenal ring requiring surgical correction were eligible for participation.
Who cannot join
- Patients were excluded if they had:
- Stage 0 or I (ics96) anterior vaginal support
- Declined participation
- Were pregnant or contemplating future pregnancy
- Had prior anterior vaginal prolapse repair with biologic or synthetic graft
- Active or latent systemic infection
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- Compromised immune system
- Uncontrolled diabetes mellitus,
- Previous pelvic irradiation or cancer
- Known hypersensitivity to polypropylene.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial Study, To Compare Colporrhaphy Versus NAZCA TC™ ,Macroporous Polypropylene Mesh, In Surgical Treatment To Greater Anterior Vaginal Prolapse .
A RCT study to compare traditional colporrhaphy versus polypropylene mesh in treatment of the anterior vaginal wall prolapse.
Read the detailed description
Seventy patients with greater anterior vaginal prolapse, whit stress incontinence or not, were randomly assigned to either colporrhaphy or polypropylene mesh repair( NAZCA TC™ POP REPAIR SYSTEM) . The primary outcome was recurrent anterior vaginal prolapse, and secondary outcomes were effects on quality of life and sexual symptom scores, operative time, length of hospitalization, and adverse events.
- Being tested
- Surgical treatment of Anterior Vaginal Prolapse, NAZCA TC™ POP REPAIR SYSTEM ,promedon® , argentina., surgical treatment for anterior vaginal wall prolapse
- Keywords
- anterior vaginal prolapse, traditional treatment, mesh, graft, NAZCA TC™ POP REPAIR SYSTEM, colporrhaphy
- Medical subject headings
- Hernia, Cystocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical treatment of Anterior Vaginal ProlapseProcedure or surgery
Also called traditional colporraphy anterior vaginal wall, polypropylene mesh - NAZCA TC™ POP REPAIR SYSTEM
seventy patients with greater anterior vaginal prolapse, whit stress incontinence or not, were randomly assigned to either colporrhaphy or polypropylene mesh repair (NAZCA TC™ POP REPAIR SYSTEM ) . The primary outcome was recurrent anterior vaginal prolapse, and secondary outcomes were effects on quality of life and sexual symptom scores, operative time, blood loss, length of hospitalization, and adverse events.
NAZCA TC™ POP REPAIR SYSTEM ,promedon® , argentina.Device
Also called traditional colporraphy
Women 50 years and older with greater anterior vaginal prolapse,whit stress incontinence or not, requiring surgical correction .
surgical treatment for anterior vaginal wall prolapseProcedure or surgery
Also called NAZCA TC™ POP REPAIR SYSTEM
Women 50 years and older with greater anterior vaginal prolapse,whit stress incontinence or not requiring surgical correction were eligible for participation.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Women 50 years and older with greater anterior vaginal prolapse,whit stress incontinence or not, requiring surgical correction were eligible for participation.traditional colporrhaphy in this group. Receives: Procedure: Surgical treatment of Anterior Vaginal Prolapse; Device: NAZCA TC™ POP REPAIR SYSTEM ,promedon® , argentina. |
| 2 | Active comparator | The NAZCA TC™ POP REPAIR SYSTEM (polypropylene mesh repair),promedon™ , cordoba, argentina, is used to repair anterior vaginal prolapse by a transobturator and pre pubic approach . Helical needles are used to anchor graft to the pelvic sidewall at two points transobturator, the other two arms pre pubic needles is used. We designed this randomized control trial to compare the anatomic success rates, effect on quality of life and sexual symptom scores, and rates of adverse events of the procedure with polypropylene mesh with that of anterior colporrhaphy, with planned follow-up of 1 years. Receives: Procedure: Surgical treatment of Anterior Vaginal Prolapse; Device: NAZCA TC™ POP REPAIR SYSTEM ,promedon® , argentina.; Procedure: surgical treatment for anterior vaginal wall prolapse |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure is recurrent anterior vaginal prolapse
Measured: 1 year
Secondary outcomes (1)
Secondary outcomes are, first, operative time (from first incision to closure of last incision), blood loss (preoperative minus postoperative day one hemoglobin), length of hospitalization, adverse events, PQol , FSFI and Dyspareunia .
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2008 (estimated)
- Study startJan 2007
- Primary completionDec 2008 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HerniaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Investigators
- carlos a del roy, M D, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00676325
- Sponsor's protocol ID
- unifespcep 1790/06
- Acronym
- Nazcatc™
- Status last verified
- May 2008
- First submitted
- 1 May 2008
- Last updated
- 13 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Riccetto C, Miyaoka R, de Fraga R, Barbosa R, Dambros M, Teixeira A, Palma P. Impact of the structure of polypropylene meshes in local tissue reaction: in vivo stereological study. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Aug;19(8):1117-23. doi: 10.1007/s00192-008-0582-2. Epub 2008 Mar 20.
PubMed 18351281
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Study, To Compare Colporrhaphy Versus NAZCA TC™ ,Macroporous Polypropylene Mesh, In Surgical Treatment To Greater Anterior Vaginal Prolapse .
- ClinicalTrials.gov ID
- NCT00676325
- Acronym / sponsor ID
- Nazcatc™ / unifespcep 1790/06
- Keywords
- anterior vaginal prolapse, traditional treatment, mesh, graft, NAZCA TC™ POP REPAIR SYSTEM, colporrhaphy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Dec 2008 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 13 May 2008 (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.
A RCT study to compare traditional colporrhaphy versus polypropylene mesh in treatment of the anterior vaginal wall prolapse.
Detailed description
Seventy patients with greater anterior vaginal prolapse, whit stress incontinence or not, were randomly assigned to either colporrhaphy or polypropylene mesh repair( NAZCA TC™ POP REPAIR SYSTEM) . The primary outcome was recurrent anterior vaginal prolapse, and secondary outcomes were effects on quality of life and sexual symptom scores, operative time, length of hospitalization, and adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Surgical treatment of Anterior Vaginal Prolapse, Device: NAZCA TC™ POP REPAIR SYSTEM ,promedon® , argentina.Women 50 years and older with greater anterior vaginal prolapse,whit stress incontinence or not, requiring surgical correction were eligible for participation.traditional colporrhaphy in this group. |
| 2 | Active comparator | Procedure: Surgical treatment of Anterior Vaginal Prolapse, Device: NAZCA TC™ POP REPAIR SYSTEM ,promedon® , argentina., Procedure: surgical treatment for anterior vaginal wall prolapseThe NAZCA TC™ POP REPAIR SYSTEM (polypropylene mesh repair),promedon™ , cordoba, argentina, is used to repair anterior vaginal prolapse by a transobturator and pre pubic approach . Helical needles are used to anchor graft to the pelvic sidewall at two points transobturator, the other two arms pre pubic needles is used. We designed this randomized control trial to compare the anatomic success rates, effect on quality of life and sexual symptom scores, and rates of adverse events of the procedure with polypropylene mesh with that of anterior colporrhaphy, with planned follow-up of 1 years. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women 50 years and older with greater anterior vaginal prolapse,whit stress incontinence or not,point (Ba)ics96, below hymenal ring requiring surgical correction were eligible for participation.
Key exclusion criteria (10 listed)
- Stage 0 or I (ics96) anterior vaginal support
- Declined participation
- Were pregnant or contemplating future pregnancy
- Had prior anterior vaginal prolapse repair with biologic or synthetic graft
- Active or latent systemic infection
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 |
|---|---|---|
| Surgical treatment of Anterior Vaginal ProlapseAlso: traditional colporraphy anterior vaginal wall, polypropylene mesh - NAZCA TC™ POP REPAIR SYSTEMseventy patients with greater anterior vaginal prolapse, whit stress incontinence or not, were randomly assigned to either colporrhaphy or polypropylene mesh repair (NAZCA TC™ POP REPAIR SYSTEM ) . The primary outcome was recurrent anterior vaginal prolapse, and secondary outcomes were effects on quality of life and sexual symptom scores, operative time, blood loss, length of hospitalization, and adverse events. | Procedure or surgery | 1, 2 |
| NAZCA TC™ POP REPAIR SYSTEM ,promedon® , argentina.Also: traditional colporraphyWomen 50 years and older with greater anterior vaginal prolapse,whit stress incontinence or not, requiring surgical correction . | Device | 1, 2 |
| surgical treatment for anterior vaginal wall prolapseAlso: NAZCA TC™ POP REPAIR SYSTEMWomen 50 years and older with greater anterior vaginal prolapse,whit stress incontinence or not requiring surgical correction were eligible for participation. | Procedure or surgery | 2 |
Primary outcome
The primary outcome measure is recurrent anterior vaginal prolapse
Time frame: 1 year
1 secondary outcome
Secondary outcomes are, first, operative time (from first incision to closure of last incision), blood loss (preoperative minus postoperative day one hemoglobin), length of hospitalization, adverse events, PQol , FSFI and Dyspareunia .
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2008.
- Results publication: PubMed 18351281Riccetto C, Miyaoka R, de Fraga R, Barbosa R, Dambros M, Teixeira A, Palma P. Impact of the structure of polypropylene meshes in local tissue reaction: in vivo stereological study. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Aug;19(8):1117-23. doi: 10.1007/s00192-008-0582-2. Epub 2008 Mar 20.
- INTERNATIONAL UROGYNECOLOGICAL ASSOCIATIONLink provided by the sponsor.
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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.
carlos a del roy, M D principal investigator
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Surgical treatment of Anterior Vaginal Prolapse, NAZCA TC™ POP REPAIR SYSTEM ,promedon® , argentina. and surgical treatment for anterior vaginal wall prolapse in people with Hernia and Cystocele, run by Federal University of São Paulo at 1 site in Brazil.
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 10 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 13 May 2008. 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 Brazil. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome measure is recurrent anterior vaginal prolapse (time frame: 1 year). 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 NCT00676325, which also lists 1 linked publication.
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 13 May 2008.