Pelvic Floor ProlapseNCT01387685
Treatment of Pelvic Organ Prolapse by PIVS Versus Surgeon Cut Mesh
An observational study of Pelvic Floor Prolapse, run by Western Galilee Hospital-Nahariya at 2 sites in Israel.
Trial summary
Women with pelvic floor prolapse who underwent surgery with mesh will be enrolled. The investigators will compare data from the chart, telephone interviews and physical examinations between those who underwent mesh placement to those who underwent placement of PIVS. Read more about this study
- Who is it for?
- Ages 18 to 95 years, women only
- Conditions the study is for
- Pelvic Floor Prolapse
- How many people
- 0 participants
- Where
- 2 sitesIsrael
- Study dates
- Feb 2009to Jan 2013
- 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 18 to 95 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women who underwent surgery for pelvic floor prolapse who underwent surgery by eithe surgeon-cut-mesh or by PIVS
Who may be able to join
- Women who underwent surgery for pelvic floor prolapse
Who cannot join
- Women who did not have surgery for pelvic floor prolapse.
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Department of Obstetrics and Gynecology, Western Galilee Hospital
Nahariya
Dr Neuman clinic
Tel Aviv
About this study
Women with pelvic floor prolapse who underwent surgery with mesh will be enrolled. The investigators will compare data from the chart, telephone interviews and physical examinations between those who underwent mesh placement to those who underwent placement of PIVS.
- Conditions
- Pelvic Floor Prolapse
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction with study outcome
Measured: six to twelve months after surgery
Secondary outcomes (1)
Side effects of the surgery: pain, vaginal erosion by tape, bleeding
Measured: Within six to twelve months after study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2011 (estimated)
- Study startFeb 2009
- Primary completionJan 2013 (estimated)
- Study completionJan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Floor 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western Galilee Hospital-Nahariya
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01387685
- Sponsor's protocol ID
- 920090042
- Status last verified
- Jun 2014
- First submitted
- 29 Jun 2011
- Last updated
- 20 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Pelvic Organ Prolapse by PIVS Versus Surgeon Cut Mesh
- ClinicalTrials.gov ID
- NCT01387685
- Acronym / sponsor ID
- 920090042
- Conditions
- Pelvic Floor Prolapse
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Western Galilee Hospital-NahariyaOther government
- Study start
- Feb 2009
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Jan 2013 (estimated)
- First posted
- 4 Jul 2011 (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.
Women with pelvic floor prolapse who underwent surgery with mesh will be enrolled. The investigators will compare data from the chart, telephone interviews and physical examinations between those who underwent mesh placement to those who underwent placement of PIVS.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 95 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women who underwent surgery for pelvic floor prolapse who underwent surgery by eithe surgeon-cut-mesh or by PIVS
Key inclusion criteria (1 listed)
- Women who underwent surgery for pelvic floor prolapse
Key exclusion criteria (1 listed)
- Women who did not have surgery for pelvic floor prolapse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Satisfaction with study outcome
Time frame: six to twelve months after surgery
1 secondary outcome
Side effects of the surgery: pain, vaginal erosion by tape, bleeding
Time frame: Within six to twelve months after study
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2014.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Floor Prolapse, run by Western Galilee Hospital-Nahariya at 2 sites in Israel.
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: withdrawn, as of the sponsor's last update on 20 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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 was withdrawn before enrolling participants, so there are no results.
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?
Satisfaction with study outcome (time frame: six to twelve months after surgery). 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 20 Jun 2014.