Pelvic Organ ProlapseNCT02465710
Comparisons of Clinical Outcomes Between Novel Tailored Transvaginal Mesh Surgery and Vaginal Native Tissue Repair Surgery for Pelvic Organ Prolapse
An observational study of Pelvic Organ Prolapse, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The issue of whether utilizing the mesh in the surgical treatment of pelvic organ prolapse remained undetermined.Thus, the aim of this study is to analyze clinical outcome of women who underwent pelvic organ prolapse surgeries with and without mesh implantation in the Department of Obstetrics \& Gynecology of National… Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Pelvic organ prolapse surgery without mesh and Pelvic organ prolapse surgery with mesh
- Type of treatment
- Surgery or procedure
- How many people
- 350 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2015to Apr 2016
- Phase
- Observational
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: All women who underwent surgical treatment of pelvic organ prolapse were enrolled in this study.
Who may be able to join
- All women who underwent surgical treatment of pelvic organ prolapse were enrolled in this study.
- ≥ 20 years old female.
Who cannot join
- Healthy women
- Without underwent surgical treatment of pelvic organ prolapse
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Obstetrics & Gynecology, National Taiwan University Hospital
Taipei, Taiwan, 100
Ho-Hsiung Lin, MD, PhD, 886-2-23123456 ext. 71557, hhlin@ntuh.gov.tw
Sheng-Mou Hsiao, 886-2-89667000 ext. 1818, smhsiao2@gmail.com
About this study
The issue of whether utilizing the mesh in the surgical treatment of pelvic organ prolapse remained undetermined.Thus, the aim of this study is to analyze clinical outcome of women who underwent pelvic organ prolapse surgeries with and without mesh implantation in the Department of Obstetrics \& Gynecology of National Taiwan University Hospital.
Read the detailed description
Hypothesis / aims of study:
The use of mesh for women with pelvic organ prolapsed (POP) remains under debate, despite a recent randomized trial reported a favourable anatomic outcome of transvaginal mesh (TVM) surgery for cystocele, compared with anterior colporrhaphy. Besides, the issue of preserving uterus or not in women with POP during operation is still undetermined. Thus, the aim of this study is to compare clinical outcomes of the novel tailored TVM surgeries and conventional transvaginal native tissue repair (NTR) surgeries for POP.
Study design, materials and methods:
Between November 2011 and September 2014, the medical records of all consecutive women who underwent POP surgeries in a medical centre were reviewed. The choice of surgery method was according to the surgeons' preference. Clinical characteristics and intraoperative data and postoperative clinical outcomes were recorded. Wilcoxon rank-sum test was used to compare the data between two groups. Kaplan-Meier survival analysis was used to compare the recurrence rate between two groups.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Pelvic organ prolapse surgery without mesh, Pelvic organ prolapse surgery with mesh
- Keywords
- pelvic organ prolapse, pelvic floor reconstruction surgery, transvaginal mesh surgery, Women, Surgical treatment
- 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.
Pelvic organ prolapse surgery without meshProcedure or surgery
retrospective study
Pelvic organ prolapse surgery with meshProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| pelvic organ prolapse | All women who underwent surgical treatment of pelvic organ prolapse in this study. Receives: Procedure: Pelvic organ prolapse surgery without mesh; Procedure: Pelvic organ prolapse surgery with mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate of pelvic organ prolapse
follow-up till postoperative 5 years
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study startApr 2015
- Primary completionApr 2016 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02465710
- Sponsor's protocol ID
- 201504023RINC
- Status last verified
- Dec 2015
- First submitted
- 4 Jun 2015
- Last updated
- 16 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparisons of Clinical Outcomes Between Novel Tailored Transvaginal Mesh Surgery and Vaginal Native Tissue Repair Surgery for Pelvic Organ Prolapse
- ClinicalTrials.gov ID
- NCT02465710
- Acronym / sponsor ID
- 201504023RINC
- Conditions
- Pelvic Organ Prolapse
- Keywords
- pelvic organ prolapse, pelvic floor reconstruction surgery, transvaginal mesh surgery, Women, Surgical treatment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 8 Jun 2015 (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.
The issue of whether utilizing the mesh in the surgical treatment of pelvic organ prolapse remained undetermined.Thus, the aim of this study is to analyze clinical outcome of women who underwent pelvic organ prolapse surgeries with and without mesh implantation in the Department of Obstetrics \& Gynecology of National Taiwan University Hospital.
Detailed description
Hypothesis / aims of study:
The use of mesh for women with pelvic organ prolapsed (POP) remains under debate, despite a recent randomized trial reported a favourable anatomic outcome of transvaginal mesh (TVM) surgery for cystocele, compared with anterior colporrhaphy. Besides, the issue of preserving uterus or not in women with POP during operation is still undetermined. Thus, the aim of this study is to compare clinical outcomes of the novel tailored TVM surgeries and conventional transvaginal native tissue repair (NTR) surgeries for POP.
Study design, materials and methods:
Between November 2011 and September 2014, the medical records of all consecutive women who underwent POP surgeries in a medical centre were reviewed. The choice of surgery method was according to the surgeons' preference. Clinical characteristics and intraoperative data and postoperative clinical outcomes were recorded. Wilcoxon rank-sum test was used to compare the data between two groups. Kaplan-Meier survival analysis was used to compare the recurrence rate between two groups.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pelvic organ prolapse | – | Procedure: Pelvic organ prolapse surgery without mesh, Procedure: Pelvic organ prolapse surgery with meshAll women who underwent surgical treatment of pelvic organ prolapse in this study. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All women who underwent surgical treatment of pelvic organ prolapse were enrolled in this study.
Key inclusion criteria (2 listed)
- All women who underwent surgical treatment of pelvic organ prolapse were enrolled in this study.
- ≥ 20 years old female.
Key exclusion criteria (2 listed)
- Healthy women
- Without underwent surgical treatment of pelvic organ prolapse
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 |
|---|---|---|
| Pelvic organ prolapse surgery without meshretrospective study | Procedure or surgery | pelvic organ prolapse |
| Pelvic organ prolapse surgery with mesh | Procedure or surgery | pelvic organ prolapse |
Primary outcome
Recurrence rate of pelvic organ prolapse
Time frame: 5 years
follow-up till postoperative 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2015.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 2 inclusion and 2 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 16 Dec 2015. 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.
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 Ho-Hsiung Lin, MD,PhD (886-2-23123456 ext. 71557, hhlin@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rate of pelvic organ prolapse (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Dec 2015.