Uterine ProlapseNCT01594372
Comparison of Laparoscopic to Vaginal Surgical Repair for Uterine Prolapse
A study testing Laparoscopic supracervical hysterectomy with sacropexy and Vaginal hysterectomy with uterosacral colposuspension in people with Uterine Prolapse, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
Investigators intend to conduct a prospective randomized trial to compare vaginal hysterectomy with uterosacral colposuspension to laparoscopic supracervical hysterectomy with sacrocervicopexy. Both surgeries are minimally-invasive surgical standards of care for uterine prolapse repair. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Uterine Prolapse
- What is being tested?
- Laparoscopic supracervical hysterectomy with sacropexy and Vaginal hysterectomy with uterosacral colposuspension
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to May 2015
- 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 18 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with primary symptomatic uterine prolapse
- ≥ 18 years of age
- Considering pelvic reconstructive surgery
Who cannot join
- Unwillingness to be randomized to one of two surgical approaches
- Pregnant or planning to maintain their future fertility
- Unable to have general anesthesia
- Currently undergoing chemotherapy OR has current or history of pelvic radiation
- Previous adverse reaction to synthetic mesh
- Recent history of abnormal paps (past 10 years)
Show all 15Show fewer
- Cervical or uterine cancers
- Previous hysterectomy
- Previous central vault or uterine prolapse repair
- Uterus ≥ 14 weeks size
- Uterine cancer
- History of significant pelvic adhesive disease
- Elongated cervix (length D to C > 6cm)
- Fibroid ≥ 7cm
- Post menopausal with enlarged uterus
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham And Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Randomized Trial Comparing Vaginal Hysterectomy to Laparoscopic Supracervical Hysterectomy With Vault Suspension for Symptomatic Uterine Prolapse
Investigators intend to conduct a prospective randomized trial to compare vaginal hysterectomy with uterosacral colposuspension to laparoscopic supracervical hysterectomy with sacrocervicopexy. Both surgeries are minimally-invasive surgical standards of care for uterine prolapse repair. Nobody knows if one procedure is superior to the other, as they have not been compared directly. The investigators hypothesize that there is no difference in objective, subjective, or cost-effectiveness between the two procedures for up to two years after surgery.
- Conditions
- Uterine Prolapse
- Being tested
- Laparoscopic supracervical hysterectomy with sacropexy, Vaginal hysterectomy with uterosacral colposuspension
- Keywords
- Uterine Prolapse, Laparoscopy, Hysterectomy, vaginal
- Medical subject headings
- Uterine Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic supracervical hysterectomy with sacropexyProcedure or surgery
Will involve laparoscopic entry to the abdomen to remove the uterus and suspension of the cervix and vaginal cuff to the sacrum with mesh. We will allow surgeons to conduct the surgery as they have perfected it
Vaginal hysterectomy with uterosacral colposuspensionProcedure or surgery
Will involve removing the uterus vaginally followed by suspending the vaginal cuff to the high (proximal) uterosacral ligaments bilaterally restoring the vagina to its normal axis.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic Repair | Active comparator | Laparoscopic supracervical hysterectomy with sacropexy Receives: Procedure: Laparoscopic supracervical hysterectomy with sacropexy |
| Vaginal Repair | Active comparator | Vaginal hysterectomy with uterosacral colposuspension Receives: Procedure: Vaginal hysterectomy with uterosacral colposuspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whether or not POPQ points AA, BA, Ap, or Bp are at less than 0 cm from the hymen OR whether point C descends less than 1/3 of the total vaginal length (TVL)
Measured: 24 months
Absence of re-treatment for prolapse at 2 years
Measured: 24 months
A negative response to "Do you usually have a bulge or something falling out that you can see or feel in the vaginal area?"
This is a question from the standardized questionnaire called Pelvic Floor Discomfort Inventory (PFDI).
Measured: 24 months
Secondary outcomes (4)
Changes in POPQ measurements
Measured: baseline, 6 week, and 3, 12, and 24 months
Changes in Patient-reported quality of life scores from the EQ-5D, PFDI, PFIQ, SF-12, Standard Gamble Interview, Pain Scale and Activity Assessment
EQ-5D assesses a patient's health that day PFDI- pelvic floor discomfort questions PFIQ - pelvic floor impact on daily activity questions SF-12 - general health/quality of life questions Standard Gamble Interview - an overall general health/quality of life questionnaire
Measured: baseline, 3, 12, and 24 months
Change in patient reported sexual questionnaire, PISQ
PISQ - pelvic organ prolapse/urinary incontinence sexual questionnaire
Measured: baseline, 3, 12 and 24 months
Frequencies of surgical and post-operative complications
Complications will be classified and reported, based on severity.
Measured: up to 2 years post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2012 (estimated)
- Study startJan 2013
- Primary completionMay 2015
- Study completionMay 2015
Why it stopped: Laproscopic procedure not offered at this time; will not be offered for the foreseeable, thus we are unable to randomize participants between the two arms.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine ProlapseStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vatche Arakel Minassian, Brigham and Women's Hospital
- Investigators
- Vatche A Minassian, MD, MPH, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01594372
- Sponsor's protocol ID
- VM-2012-01
- Status last verified
- Mar 2022
- First submitted
- 4 May 2012
- Last updated
- 4 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Comparing Vaginal Hysterectomy to Laparoscopic Supracervical Hysterectomy With Vault Suspension for Symptomatic Uterine Prolapse
- ClinicalTrials.gov ID
- NCT01594372
- Acronym / sponsor ID
- VM-2012-01
- Conditions
- Uterine Prolapse
- Keywords
- Uterine Prolapse, Laparoscopy, Hysterectomy, vaginal
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Laproscopic procedure not offered at this time; will not be offered for the foreseeable, thus we are unable to randomize participants between the two arms.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 9 May 2012 (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.
Investigators intend to conduct a prospective randomized trial to compare vaginal hysterectomy with uterosacral colposuspension to laparoscopic supracervical hysterectomy with sacrocervicopexy. Both surgeries are minimally-invasive surgical standards of care for uterine prolapse repair. Nobody knows if one procedure is superior to the other, as they have not been compared directly. The investigators hypothesize that there is no difference in objective, subjective, or cost-effectiveness between the two procedures for up to two years after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Repair | Active comparator | Procedure: Laparoscopic supracervical hysterectomy with sacropexyLaparoscopic supracervical hysterectomy with sacropexy |
| Vaginal Repair | Active comparator | Procedure: Vaginal hysterectomy with uterosacral colposuspensionVaginal hysterectomy with uterosacral colposuspension |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with primary symptomatic uterine prolapse
- ≥ 18 years of age
- Considering pelvic reconstructive surgery
Key exclusion criteria (15 listed)
- Unwillingness to be randomized to one of two surgical approaches
- Pregnant or planning to maintain their future fertility
- Unable to have general anesthesia
- Currently undergoing chemotherapy OR has current or history of pelvic radiation
- Previous adverse reaction to synthetic 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 |
|---|---|---|
| Laparoscopic supracervical hysterectomy with sacropexyWill involve laparoscopic entry to the abdomen to remove the uterus and suspension of the cervix and vaginal cuff to the sacrum with mesh. We will allow surgeons to conduct the surgery as they have perfected it | Procedure or surgery | Laparoscopic Repair |
| Vaginal hysterectomy with uterosacral colposuspensionWill involve removing the uterus vaginally followed by suspending the vaginal cuff to the high (proximal) uterosacral ligaments bilaterally restoring the vagina to its normal axis. | Procedure or surgery | Vaginal Repair |
Primary outcome
Whether or not POPQ points AA, BA, Ap, or Bp are at less than 0 cm from the hymen OR whether point C descends less than 1/3 of the total vaginal length (TVL)
Time frame: 24 months
Absence of re-treatment for prolapse at 2 years
Time frame: 24 months
A negative response to "Do you usually have a bulge or something falling out that you can see or feel in the vaginal area?"
Time frame: 24 months
This is a question from the standardized questionnaire called Pelvic Floor Discomfort Inventory (PFDI).
4 secondary outcomes
Changes in POPQ measurements
Time frame: baseline, 6 week, and 3, 12, and 24 months
Changes in Patient-reported quality of life scores from the EQ-5D, PFDI, PFIQ, SF-12, Standard Gamble Interview, Pain Scale and Activity Assessment
Time frame: baseline, 3, 12, and 24 months
Change in patient reported sexual questionnaire, PISQ
Time frame: baseline, 3, 12 and 24 months
Frequencies of surgical and post-operative complications
Time frame: up to 2 years post-operatively
Results and safety
The study was stopped early (reason given: Laproscopic procedure not offered at this time; will not be offered for the foreseeable, thus we are unable to randomize participants between the two arms.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
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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.
Vatche A Minassian, MD, MPH principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic supracervical hysterectomy with sacropexy and Vaginal hysterectomy with uterosacral colposuspension in people with Uterine Prolapse, run by Brigham and Women's Hospital at 1 site in United States.
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 15 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: stopped early, as of the sponsor's last update on 4 Mar 2022. 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 United States. 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 stopped early (reason given: Laproscopic procedure not offered at this time; will not be offered for the foreseeable, thus we are unable to randomize participants between the two arms.). 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?
Whether or not POPQ points AA, BA, Ap, or Bp are at less than 0 cm from the hymen OR whether point C descends less than 1/3 of the total vaginal length (TVL) (time frame: 24 months). The study lists 3 primary outcomes in all. 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 4 Mar 2022.