Use of Pessary Reduce the Number of Prolapse RecurrencepfgpNCT03056586
The Effect of Pessary Post Vaginal Prolapse Repair, for One Month, to Reduce the Recurrence Rate of Prolapse
A study testing vaginal pessary in people with Use of Pessary Reduce the Number of Prolapse Recurrence and Uterine Prolapse, run by Meir Medical Center.
Trial summary
Genital prolapse is a common complain. 30-40% of women will complain of uterine prolapse or cystocele or rectocele, or mixed. About half of them will require surgical repair for the prolapse, with or without hysterectomy. Read more about this study
- Who is it for?
- Ages 30 to 80 years, women only
- Conditions the study is for
- Use of Pessary Reduce the Number of Prolapse Recurrence, Uterine Prolapse, Cystocele
- What is being tested?
- vaginal pessary
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 20 Mar 2017to 20 Dec 2019
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all healthy patients with genital prolapse grade 3-4, going for vaginal surgery
- age 30-80years
Who cannot join
- patients with pelvic inflammatory disease
- patients after pelvic irradiation
- large vaginal erosion
- vaginal bleeding uncontrolled or undiagnosed
- patients going for surgery with mesh
About this study
Official title: The Recurrence Rate of Genital Prolapse Post Repair With the Use of PESSARY for One Month Post Operative
Genital prolapse is a common complain. 30-40% of women will complain of uterine prolapse or cystocele or rectocele, or mixed. About half of them will require surgical repair for the prolapse, with or without hysterectomy. Of these patients about 30-40% will have recurrence of the prolapse, which in some cases requires second operation.
In this study the investigators want to investigate whether a vaginal pessary inserting in the end of the primary surgery, for 4 weeks, will reduce the recurrence rate.
Read the detailed description
All patients going for vaginal surgery for genital prolapse, stage 3-4, with cystocele, rectocele or uterine cervix prominent from the vagina. These patients, after signing an informed consent, a vaginal pessary will insert at the end of the operation and will stay for 4 weeks post-op.
After 4 weeks the pessary will be removed, and the patient will followed for 2 years, for recurrence of prolapse.
- Conditions
- Use of Pessary Reduce the Number of Prolapse Recurrence, Uterine Prolapse, Cystocele, Rectocele
- Being tested
- vaginal pessary
- Medical subject headings
- Uterine Prolapse, Cystocele, Rectocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vaginal pessaryDevice
A vaginal pessary will be inserted at the end of the operation, for genital prolapse, and will be sutured to the vaginal wall. The pessary will stay in the vagina for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1. study group | Experimental | 100 patients who agree to participate in the study, will be operate according to our protocol for pelvic organ prolapse. At the end of the operation a vaginal pessary will be inserted and suture to the vaginal walls for a 4 week period.
Follow-up will be after 3, 6, and 12 month period. Receives: Device: vaginal pessary |
| 2. control | No intervention | 100 Women who will refuse to participate in the study, will agree to be follow-up by our team for 3, 6, and 12 month post operative. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of recurrence rate of vaginal prolapse, post vaginal surgery repair.
The investigators hope to see a low percentage of prolapse recurrence in the study (pessary) group, comparing to the control (no pessary) group
Measured: 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2017
- Study start20 Mar 2017 (estimated)
- Primary completion20 Dec 2018 (estimated)
- Study completion20 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Use of Pessary Reduce the Number of Prolapse RecurrenceStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Klein zvi, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03056586
- Sponsor's protocol ID
- 0188-16-MMC
- Acronym
- pfgp
- Status last verified
- Mar 2017
- First submitted
- 15 Feb 2017
- Last updated
- 7 Mar 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Recurrence Rate of Genital Prolapse Post Repair With the Use of PESSARY for One Month Post Operative
- ClinicalTrials.gov ID
- NCT03056586
- Acronym / sponsor ID
- pfgp / 0188-16-MMC
- Conditions
- Use of Pessary Reduce the Number of Prolapse Recurrence, Uterine Prolapse, Cystocele, Rectocele
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- 20 Mar 2017 (estimated)
- Primary completion
- 20 Dec 2018 (estimated)
- Study completion
- 20 Dec 2019 (estimated)
- First posted
- 17 Feb 2017 (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.
Genital prolapse is a common complain. 30-40% of women will complain of uterine prolapse or cystocele or rectocele, or mixed. About half of them will require surgical repair for the prolapse, with or without hysterectomy. Of these patients about 30-40% will have recurrence of the prolapse, which in some cases requires second operation.
In this study the investigators want to investigate whether a vaginal pessary inserting in the end of the primary surgery, for 4 weeks, will reduce the recurrence rate.
Detailed description
All patients going for vaginal surgery for genital prolapse, stage 3-4, with cystocele, rectocele or uterine cervix prominent from the vagina. These patients, after signing an informed consent, a vaginal pessary will insert at the end of the operation and will stay for 4 weeks post-op.
After 4 weeks the pessary will be removed, and the patient will followed for 2 years, for recurrence of prolapse.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. study group | Experimental | Device: vaginal pessary100 patients who agree to participate in the study, will be operate according to our protocol for pelvic organ prolapse. At the end of the operation a vaginal pessary will be inserted and suture to the vaginal walls for a 4 week period. Follow-up will be after 3, 6, and 12 month period. |
| 2. control | No intervention | –100 Women who will refuse to participate in the study, will agree to be follow-up by our team for 3, 6, and 12 month post operative. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- all healthy patients with genital prolapse grade 3-4, going for vaginal surgery
- age 30-80years
Key exclusion criteria (5 listed)
- patients with pelvic inflammatory disease
- patients after pelvic irradiation
- large vaginal erosion
- vaginal bleeding uncontrolled or undiagnosed
- patients going for surgery with mesh
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 |
|---|---|---|
| vaginal pessaryA vaginal pessary will be inserted at the end of the operation, for genital prolapse, and will be sutured to the vaginal wall. The pessary will stay in the vagina for 4 weeks. | Device | 1. study group |
Primary outcome
Reduction of recurrence rate of vaginal prolapse, post vaginal surgery repair.
Time frame: 24 month
The investigators hope to see a low percentage of prolapse recurrence in the study (pessary) group, comparing to the control (no pessary) group
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2017.
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 vaginal pessary in people with Use of Pessary Reduce the Number of Prolapse Recurrence and Uterine Prolapse, run by Meir Medical Center.
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 5 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 7 Mar 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?
Results are not available in the source record.
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?
Reduction of recurrence rate of vaginal prolapse, post vaginal surgery repair. (time frame: 24 month). 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 7 Mar 2017.