Pelvic Organ ProlapsePhase 4NCT02178735
Clinical Outcomes and Urodynamic Effects After Vaginal Tailored Mesh Surgery for Pelvic Organ Prolapse
A Phase 4 study testing Anterior vaginal tailored mesh surgery and Posterior vaginal tailored mesh surgery in people with Pelvic Organ Prolapse, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
To evaluate the clinical outcome and urodynamic effect of two novel vaginal tailored mesh surgeries. Read more about this study
- Who is it for?
- Ages 20 to 99 years, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Anterior vaginal tailored mesh surgery and Posterior vaginal tailored mesh surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2014to Nov 2015
- 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 20 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All women with pelvic organ prolapse who underwent either anterior or/and posterior vaginal tailored mesh surgeries in National Taiwan University Hospital between November 2011 and November 2013
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Obstetrics & Gynecology, National Taiwan University Hospital
Taipei, Taipei, 100
About this study
To evaluate the clinical outcome and urodynamic effect of two novel vaginal tailored mesh surgeries.
Read the detailed description
We will review the medical records (including medical data, urodynamic data, pad weight data, etc) of women who underwent either anterior or posterior novel vaginal tailored mesh surgeries at National Taiwan University Hospital between November 2011 and November 2013.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Anterior vaginal tailored mesh surgery, Posterior vaginal tailored mesh surgery
- Keywords
- pelvic organ prolapse, vaginal mesh, urodynamic studies
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior vaginal tailored mesh surgeryProcedure or surgery
Anterior vaginal tailored mesh surgery for repair of cystocele with or without stress urinary incontinence
Posterior vaginal tailored mesh surgeryProcedure or surgery
Posterior vaginal tailored mesh surgery for repair of enterocele, rectocele, vaginal vault prolapse or uterine prolapse
| Study group | Role | What they receive |
|---|---|---|
| Anterior compartment prolapse | Experimental | Woman with cystocele who underwent anterior vaginal tailored mesh surgery Receives: Procedure: Anterior vaginal tailored mesh surgery |
| Posterior compartment prolapse | Experimental | Woman with rectocele, enterocele, uterine prolapse, vaginal stump prolpase who underwent posterior vaginal tailored mesh surgery Receives: Procedure: Posterior vaginal tailored mesh surgery |
| anterior and posterior prolapse | Experimental | Woman with cystocele and rectocele/uterine prolapse/vaginal vault prolapse/enterocele who underwent anterior and posterior vaginal tailored mesh surgery Receives: Procedure: Anterior vaginal tailored mesh surgery; Procedure: Posterior vaginal tailored mesh surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of pelvic organ prolapse
Recurrence rate of cystocele, rectocele, uterine prolapse, or vaginal vault prolapse within 1 year after surgery
Measured: 1 year
Secondary outcomes (3)
The change of pad weight
The change of pad weight between baseline and 3 months after surgery for pelvic organ prolapse
Measured: 3 months
The change of maximum urethral closure pressure
The difference of maximum urethral closure pressure between baseline and 3 months after surgery
Measured: 3 months
Vaginal mesh erosion
Vaginal mesh erosion rate within 1 year after surgery
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 posted1 Jul 2014 (estimated)
- Study startMay 2014
- Primary completionNov 2015
- Study completionNov 2015
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 Pelvic Organ ProlapseStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ho-Hsiung Lin, MD, PhD, Principal investigator, Department of Obstetrics & Gynecology, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02178735
- Sponsor's protocol ID
- 201404024RINC
- Status last verified
- Jan 2016
- First submitted
- 9 Jun 2014
- Last updated
- 29 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chang TC, Hsiao SM, Chen CH, Wu WY, Lin HH. Clinical Outcomes and Urodynamic Effects of Tailored Transvaginal Mesh Surgery for Pelvic Organ Prolapse. Biomed Res Int. 2015;2015:191258. doi: 10.1155/2015/191258. Epub 2015 Nov 8.
PubMed 26634203
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes and Urodynamic Effects After Vaginal Tailored Mesh Surgery for Pelvic Organ Prolapse
- ClinicalTrials.gov ID
- NCT02178735
- Acronym / sponsor ID
- 201404024RINC
- Conditions
- Pelvic Organ Prolapse
- Keywords
- pelvic organ prolapse, vaginal mesh, urodynamic studies
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 1 Jul 2014 (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.
To evaluate the clinical outcome and urodynamic effect of two novel vaginal tailored mesh surgeries.
Detailed description
We will review the medical records (including medical data, urodynamic data, pad weight data, etc) of women who underwent either anterior or posterior novel vaginal tailored mesh surgeries at National Taiwan University Hospital between November 2011 and November 2013.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anterior compartment prolapse | Experimental | Procedure: Anterior vaginal tailored mesh surgeryWoman with cystocele who underwent anterior vaginal tailored mesh surgery |
| Posterior compartment prolapse | Experimental | Procedure: Posterior vaginal tailored mesh surgeryWoman with rectocele, enterocele, uterine prolapse, vaginal stump prolpase who underwent posterior vaginal tailored mesh surgery |
| anterior and posterior prolapse | Experimental | Procedure: Anterior vaginal tailored mesh surgery, Procedure: Posterior vaginal tailored mesh surgeryWoman with cystocele and rectocele/uterine prolapse/vaginal vault prolapse/enterocele who underwent anterior and posterior vaginal tailored mesh surgery |
Who may qualify
- Ages
- 20 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All women with pelvic organ prolapse who underwent either anterior or/and posterior vaginal tailored mesh surgeries in National Taiwan University Hospital between November 2011 and November 2013
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Anterior vaginal tailored mesh surgeryAnterior vaginal tailored mesh surgery for repair of cystocele with or without stress urinary incontinence | Procedure or surgery | Anterior compartment prolapse, anterior and posterior prolapse |
| Posterior vaginal tailored mesh surgeryPosterior vaginal tailored mesh surgery for repair of enterocele, rectocele, vaginal vault prolapse or uterine prolapse | Procedure or surgery | Posterior compartment prolapse, anterior and posterior prolapse |
Primary outcome
Recurrence of pelvic organ prolapse
Time frame: 1 year
Recurrence rate of cystocele, rectocele, uterine prolapse, or vaginal vault prolapse within 1 year after surgery
3 secondary outcomes
The change of pad weight
Time frame: 3 months
The change of maximum urethral closure pressure
Time frame: 3 months
Vaginal mesh erosion
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2016.
- Derived from this study: PubMed 26634203Chang TC, Hsiao SM, Chen CH, Wu WY, Lin HH. Clinical Outcomes and Urodynamic Effects of Tailored Transvaginal Mesh Surgery for Pelvic Organ Prolapse. Biomed Res Int. 2015;2015:191258. doi: 10.1155/2015/191258. Epub 2015 Nov 8.
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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.
Ho-Hsiung Lin, MD, PhD principal investigator
Department of Obstetrics & Gynecology, National Taiwan University Hospital
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 Anterior vaginal tailored mesh surgery and Posterior vaginal tailored mesh surgery in people with Pelvic Organ Prolapse, run by National Taiwan University Hospital at 1 site in Taiwan.
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 0 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: finished, as of the sponsor's last update on 29 Jan 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 Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Recurrence of pelvic organ 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 NCT02178735, 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 29 Jan 2016.