Pelvic Organ ProlapseNCT02911584
Laparoscopic Sacrocolpopexy Versus POPS in the Management of Pelvic Prolapse
A study testing Laparoscopic procedure in people with Pelvic Organ Prolapse, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial summary
This is the first study comparing the laparoscopic sacropexy with Pelvic Organs Prolapse Suspension (POPS) to treat pelvic organ prolapse. This prospective randomized surgical trial is designed to test the clinical and functional effects of the two different laparoscopic procedures in terms of anatomical correction of… Read more about this study
- Who is it for?
- Ages 30 to 70 years, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Laparoscopic procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Sep 2017
- Phase
- Interventional
- 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 30 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who required surgical treatment for symptomatic pelvic organ prolapse stage ≥ 2 with or without stress urinary incontinence
Who cannot join
- Age > 70 years
- Severe cardiovascular or respiratory disease
- Pregnancy
- Previous surgical procedure for POP correction
About this study
Official title: Laparoscopic Sacrocolpopexy Versus POPS in the Surgical Management of Pelvic Organ Prolapse: A Prospective Randomized Trial
This is the first study comparing the laparoscopic sacropexy with Pelvic Organs Prolapse Suspension (POPS) to treat pelvic organ prolapse. This prospective randomized surgical trial is designed to test the clinical and functional effects of the two different laparoscopic procedures in terms of anatomical correction of the prolapse, post-operative and long term morbidity, rate of recurrence and subjective satisfaction of the patient evaluated by a quality of life questionnaire.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Laparoscopic procedure
- 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.
Laparoscopic procedureProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Sacral colpopexy | Active comparator | Laparoscopic procedure Receives: Procedure: Laparoscopic procedure |
| POPS | Active comparator | Laparoscopic procedure: Pelvic Organs Prolapse Suspension Receives: Procedure: Laparoscopic procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with anatomical correction of the prolapse
Anatomical correction of the prolapse evaluated by gynecological visit
Measured: up to 6 months
Secondary outcomes (2)
Rate of recurrence
Measured: up to 6 months
Post operative quality of life
Subjective satisfaction of the patient evaluated by a quality of life questionnaire.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionMay 2017
- Study completionSep 2017
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 Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Miulli General Hospital
- Responsible party
- Principal investigator, Valeria Tagliaferri, Miulli General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02911584
- Sponsor's protocol ID
- CSP1
- Status last verified
- Nov 2017
- First submitted
- 15 Sep 2016
- Last updated
- 6 Dec 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Sacrocolpopexy Versus POPS in the Surgical Management of Pelvic Organ Prolapse: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT02911584
- Acronym / sponsor ID
- CSP1
- Conditions
- Pelvic Organ Prolapse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Collaborators
- Miulli General Hospital
- Study start
- Oct 2016
- Primary completion
- May 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 22 Sep 2016 (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.
This is the first study comparing the laparoscopic sacropexy with Pelvic Organs Prolapse Suspension (POPS) to treat pelvic organ prolapse. This prospective randomized surgical trial is designed to test the clinical and functional effects of the two different laparoscopic procedures in terms of anatomical correction of the prolapse, post-operative and long term morbidity, rate of recurrence and subjective satisfaction of the patient evaluated by a quality of life questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sacral colpopexy | Active comparator | Procedure: Laparoscopic procedureLaparoscopic procedure |
| POPS | Active comparator | Procedure: Laparoscopic procedureLaparoscopic procedure: Pelvic Organs Prolapse Suspension |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who required surgical treatment for symptomatic pelvic organ prolapse stage ≥ 2 with or without stress urinary incontinence
Key exclusion criteria (4 listed)
- Age > 70 years
- Severe cardiovascular or respiratory disease
- Pregnancy
- Previous surgical procedure for POP correction
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 |
|---|---|---|
| Laparoscopic procedure | Procedure or surgery | POPS, Sacral colpopexy |
Primary outcome
Number of patients with anatomical correction of the prolapse
Time frame: up to 6 months
Anatomical correction of the prolapse evaluated by gynecological visit
2 secondary outcomes
Rate of recurrence
Time frame: up to 6 months
Post operative quality of life
Time frame: up to 6 months
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 6 Dec 2017.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic procedure in people with Pelvic Organ Prolapse, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
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 4 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 6 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Number of patients with anatomical correction of the prolapse (time frame: up to 6 months). 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 6 Dec 2017.