Pelvic Organ ProlapseNCT03764891
Clinical Outcomes of Transvaginal Mesh Procedures for Cystocele Repair: Comparisons of Uphold and Perigee Systems
An observational study of Pelvic Organ Prolapse and Surgical Mesh, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
Pelvic organ prolapse (POP) is a major health concern, affecting more than 30% of women. The aim of this study was to compare the clinical outcomes of Uphold system and Perigee system in treating women with cystocele. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse, Surgical Mesh
- What is being tested?
- Uphold and Perigee
- Type of treatment
- Surgery or procedure
- How many people
- 152 participants
- Where
- 1 siteTaiwan
- Study dates
- 2 Nov 2018to 30 Jul 2020
- 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: Pelvic organ prolapse patients underwent Uphold or Perigee surgeries
Who may be able to join
- Vaginal anterior wall prolapse greater than or equal to second phase of POP-Q
- Underwent Uphold or Perigee procedures
Who cannot join
- nil
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital
Banqiao District, New Taipei, 22050
About this study
Official title: Far Eastern Memorial Hospital
Pelvic organ prolapse (POP) is a major health concern, affecting more than 30% of women.
The aim of this study was to compare the clinical outcomes of Uphold system and Perigee system in treating women with cystocele.
Read the detailed description
Pelvic organ prolapse (POP) is a major health concern, affecting more than 30% of women. Traditional vaginal surgery with native tissue is associated with high recurrence rate. Thus, synthetic meshes were introduced into POP surgery and became the mainstream. Several transvaginal mesh procedures, such as Uphold system (Boston Scientific) and Perigee system (American Medical Systems Inc), have been used for cystocele repair. Perigee system is a trans-obturator four-arm mesh device attached to proximal and distal arcus tendineus fasciae pelvis. Nonetheless, Uphold system, is a single incised, two-arm anterior sacrospinous mesh fixation system. Both systems can be used for cystocele repair, despite Uphold system can be used for concomitant repair of apical prolapse. The aim of this study was to compare the clinical outcomes of Uphold system and Perigee system in treating women with cystocele.
- Conditions
- Pelvic Organ Prolapse, Surgical Mesh
- Being tested
- Uphold, Perigee
- 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.
UpholdProcedure or surgery
Uphold system in treating women with cystocele
PerigeeProcedure or surgery
Perigee system in treating women with cystocele
| Study group | Role | What they receive |
|---|---|---|
| Uphold | Patients who underwent Uphold procedure Receives: Procedure: Uphold | |
| Perigee | Patients who underwent Perigee procedure Receives: Procedure: Perigee |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate of pelvic organ prolapse
Compare the recurrence rate of Uphold system and Perigee system in treating women with cystocele.
Measured: 10 year
Secondary outcomes (1)
Complication rate
Compare the complication rate (such as mesh extrusion, dyspareunia, pelvic pain, voiding difficult, etc) of Uphold system and Perigee system in treating women with cystocele.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study start2 Nov 2018
- Primary completion28 Apr 2020
- Study completion30 Jul 2020
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.
- 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-control
- Time perspective
- Retrospective
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheng-Mou Hsiao, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03764891
- Sponsor's protocol ID
- 107159-E
- Status last verified
- Sep 2023
- First submitted
- 4 Dec 2018
- Last updated
- 15 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Far Eastern Memorial Hospital
- ClinicalTrials.gov ID
- NCT03764891
- Acronym / sponsor ID
- 107159-E
- Conditions
- Pelvic Organ Prolapse, Surgical Mesh
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- 2 Nov 2018 (actual)
- Primary completion
- 28 Apr 2020 (actual)
- Study completion
- 30 Jul 2020 (actual)
- First posted
- 5 Dec 2018 (actual)
- 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.
Pelvic organ prolapse (POP) is a major health concern, affecting more than 30% of women.
The aim of this study was to compare the clinical outcomes of Uphold system and Perigee system in treating women with cystocele.
Detailed description
Pelvic organ prolapse (POP) is a major health concern, affecting more than 30% of women. Traditional vaginal surgery with native tissue is associated with high recurrence rate. Thus, synthetic meshes were introduced into POP surgery and became the mainstream. Several transvaginal mesh procedures, such as Uphold system (Boston Scientific) and Perigee system (American Medical Systems Inc), have been used for cystocele repair. Perigee system is a trans-obturator four-arm mesh device attached to proximal and distal arcus tendineus fasciae pelvis. Nonetheless, Uphold system, is a single incised, two-arm anterior sacrospinous mesh fixation system. Both systems can be used for cystocele repair, despite Uphold system can be used for concomitant repair of apical prolapse. The aim of this study was to compare the clinical outcomes of Uphold system and Perigee system in treating women with cystocele.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Uphold | – | Procedure: UpholdPatients who underwent Uphold procedure |
| Perigee | – | Procedure: PerigeePatients who underwent Perigee procedure |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pelvic organ prolapse patients underwent Uphold or Perigee surgeries
Key inclusion criteria (2 listed)
- Vaginal anterior wall prolapse greater than or equal to second phase of POP-Q
- Underwent Uphold or Perigee procedures
Key exclusion criteria (1 listed)
- nil
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 |
|---|---|---|
| UpholdUphold system in treating women with cystocele | Procedure or surgery | Uphold |
| PerigeePerigee system in treating women with cystocele | Procedure or surgery | Perigee |
Primary outcome
Recurrence rate of pelvic organ prolapse
Time frame: 10 year
Compare the recurrence rate of Uphold system and Perigee system in treating women with cystocele.
1 secondary outcome
Complication rate
Time frame: 10 years
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 15 Sep 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Surgical Mesh, run by Far Eastern Memorial 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 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: finished, as of the sponsor's last update on 15 Sep 2023. 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?
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 rate of pelvic organ prolapse (time frame: 10 year). 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 15 Sep 2023.