Vaginal ProlapseNCT04078802
0050-19-RMB CTIL - VNOTES Compared to VH for Vaginal Apex Prolapse
A study testing VNOTES/VH in people with Vaginal Prolapse, run by Rambam Health Care Campus.
Trial summary
VNOTES (Transvaginal natural orifice transluminal endoscopic surgery) is a relatively new surgery for Hysterectomy and Uterosacral ligament suspension to treat Vaginal prolapse. The investigators wish to run a randomized control trial comparing it to classic Vaginal hysterectomy for the same indication. Read more about this study
- Who is it for?
- Ages 25 to 75 years, women only
- Conditions the study is for
- Vaginal Prolapse
- What is being tested?
- VNOTES/VH
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Oct 2019to Nov 2020
- 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 25 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women with vaginal prolapse
- capable of having a surgery - assessed by an anesthesiologist
- women who approve of having the surgery
Who cannot join
- BMI over 40
- women who have recurrent PID (pelvic inflammatory disease)
- women with oncology records
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Transvaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) Compared With Traditional Vaginal Utero-sacral Ligament Suspension for Vaginal Apex Prolapse
VNOTES (Transvaginal natural orifice transluminal endoscopic surgery) is a relatively new surgery for Hysterectomy and Uterosacral ligament suspension to treat Vaginal prolapse. The investigators wish to run a randomized control trial comparing it to classic Vaginal hysterectomy for the same indication.
Read the detailed description
The investigators will recruit 60 women with indication for surgery to treat uterine prolapse. 30 women will undergo VNOTES surgery and 30 women will undergo classic vaginal hysterectomy. The investigators will compare outcomes of the surgeries such as surgery time, bleeding and clinical outcomes after 3 and 6 months post operation.
- Conditions
- Vaginal Prolapse
- Being tested
- VNOTES/VH
- Medical subject headings
- Uterine Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VNOTES/VHProcedure or surgery
same as above
| Study group | Role | What they receive |
|---|---|---|
| VNOTES ARM | Experimental | treatment of Vaginal prolapse with VNOTES surgery and apical suspension to the uterosacral ligaments. Receives: Procedure: VNOTES/VH |
| Vaginal hysterectomy Arm | Experimental | treatment of Vaginal prolapse with classic vaginal hysterectomy surgery and apical suspension to the uterosacral ligaments. Receives: Procedure: VNOTES/VH |
What is being measured
The primary outcome is the main question the study is designed to answer.
surgery time
time of surgery
Measured: from admission up to 6 hours post operation
Secondary outcomes (4)
bleeding
bleeding at surgery - volume of blood loss estimated by the surgeon performing the operation.
Measured: from admission up to 6 hours post operation
hospital days
how many days after surgery for hospitalization
Measured: from admission up to 96 hours post operation
PISQ12 score - Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire
Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire is a scoring index used to measure sexual function of women affected by pelvic organ prolapse. range 0-48. 0 marks good sexual function and 48 measures sexual disability affected from pelvic organ prolapse
Measured: from admission up to 6 hours post operation
PFDI score - Pelvic Floor Disability Index
The Pelvic Floor Disability Index is an index used to obtain an objective score regarding pelvic floor disability comprising of bowel, bladder, or pelvic symptoms over the last 3 months prior to answering the questionnaire. score ranges 0-300. 0 outcome is no pelvic floor disability and 300 marks a high level of pelvic floor disability.
Measured: from admission up to 6 hours post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study startOct 2019 (estimated)
- Primary completionOct 2020 (estimated)
- Study completionNov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omer MOR MD, Rambam Health Care Campus
- Investigators
- Omer Mor, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04078802
- Sponsor's protocol ID
- RambamMD
- Status last verified
- Sep 2019
- First submitted
- 2 Sep 2019
- Last updated
- 9 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transvaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) Compared With Traditional Vaginal Utero-sacral Ligament Suspension for Vaginal Apex Prolapse
- ClinicalTrials.gov ID
- NCT04078802
- Acronym / sponsor ID
- RambamMD
- Conditions
- Vaginal Prolapse
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Oct 2019 (estimated)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 6 Sep 2019 (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.
VNOTES (Transvaginal natural orifice transluminal endoscopic surgery) is a relatively new surgery for Hysterectomy and Uterosacral ligament suspension to treat Vaginal prolapse. The investigators wish to run a randomized control trial comparing it to classic Vaginal hysterectomy for the same indication.
Detailed description
The investigators will recruit 60 women with indication for surgery to treat uterine prolapse. 30 women will undergo VNOTES surgery and 30 women will undergo classic vaginal hysterectomy. The investigators will compare outcomes of the surgeries such as surgery time, bleeding and clinical outcomes after 3 and 6 months post operation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VNOTES ARM | Experimental | Procedure: VNOTES/VHtreatment of Vaginal prolapse with VNOTES surgery and apical suspension to the uterosacral ligaments. |
| Vaginal hysterectomy Arm | Experimental | Procedure: VNOTES/VHtreatment of Vaginal prolapse with classic vaginal hysterectomy surgery and apical suspension to the uterosacral ligaments. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- women with vaginal prolapse
- capable of having a surgery - assessed by an anesthesiologist
- women who approve of having the surgery
Key exclusion criteria (3 listed)
- BMI over 40
- women who have recurrent PID (pelvic inflammatory disease)
- women with oncology records
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 |
|---|---|---|
| VNOTES/VHsame as above | Procedure or surgery | VNOTES ARM, Vaginal hysterectomy Arm |
Primary outcome
surgery time
Time frame: from admission up to 6 hours post operation
time of surgery
4 secondary outcomes
bleeding
Time frame: from admission up to 6 hours post operation
hospital days
Time frame: from admission up to 96 hours post operation
PISQ12 score - Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire
Time frame: from admission up to 6 hours post operation
PFDI score - Pelvic Floor Disability Index
Time frame: from admission up to 6 hours post operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2019.
- Individual participant dataSharing planned: No
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Apical Suspension Repair for Vault Prolapse In a Three-Arm Randomized Trial Design
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PREPARE: Perioperative REhabilitation Around Vaginal Prolapse RepAir Surgery for Recovery Enhancement
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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.
Omer Mor, MD principal investigator
Rambam Health Care Campus
Questions about this trial
What is this clinical trial studying?
A study testing VNOTES/VH in people with Vaginal Prolapse, run by Rambam Health Care Campus.
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 3 inclusion and 3 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 9 Sep 2019. 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?
Contact Omer Mor, mD (972546486414, omermor23@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
surgery time (time frame: from admission up to 6 hours post operation). 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 9 Sep 2019.