Pelvic Organ ProlapseVAULTNCT01377142
Vaginal Uphold Hysteropexy and Laparoscopic Sacral Hysteropexy for the Treatment of Uterovaginal Pelvic Organ Prolapse
An observational study of Pelvic Organ Prolapse, run by The Cleveland Clinic at 8 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate surgical success or failure one year after surgery for pelvic organ prolapse. Read more about this study
- Who is it for?
- Ages 40 to 75 years, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Laparoscopic sacral hysteropexy and Vaginal mesh hysteropexy
- Type of treatment
- Medical device
- How many people
- 148 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Jun 2011to Dec 2015
- 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 40 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Adult women with symptomatic uterovaginal prolapse planning to undergo laparsocopic sacral hysteropexy or vaginal uphold hysteropexy
Who may be able to join
- Desires surgical treatment for uterovaginal prolapse.
- Symptomatic stage II-IV POP including:
- cystocele (AA or BA > or = 0) by POP-Q and
- apical descent below the mid-vagina (point C > -(TVL / 2)) by the POP-Q and
- a positive response to questions 3 of the PFDI 20: Do you usually have a bulge or something falling out that you can see or feel in the vaginal area? (Appendix A)
- Eligible for and undergoing one of the following procedures: laparoscopic sacral hysteropexy (LSHP) or Vaginal Uphold hysteropexy (VUHP)
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- Female age 40 to 75.
- Completed childbearing confirmed by subject or practicing reliable form of birth control defined as permanent sterilization, hormonal contraception, abstinence, IUD.
- Normal size uterus (length less than 10 cm) on bimanual exam or ultrasound within the past 6 months.
Who cannot join
- Prior hysterectomy.
- Patient with synthetic material placed to augment previous pelvic organ prolapse repair. (previous prolapse repair without synthetic mesh is acceptable).
- Current vaginal or pelvic foreign body complications (including but not limited to erosion, fistula, abscess). This includes foreign bodies of any type (e.g. synthetic and biologic including allograft, xenograft).
- Desires hysterectomy at the time of prolapse repair.
- Cervical elongation with anticipated need for cervical shortening at the time of prolapse repair as determined by surgeon.
- History of cervical dysplasia (diagnosed within the past 5 years) or increased risk of cervical dysplasia (HIV, immunocompromise, DES exposure), chronic pelvic pain, uterine abnormalities (symptomatic uterine fibroids, polyps, endometrial hyperplasia, cancer) or any uterine disease that would preclude prolapse repair with uterine preservation in the opinion of the surgeon.
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- Any postmenopausal bleeding in the past 12 months (regardless of endometrial biopsy or ultrasound results) or any postmenopausal bleeding more than 12 months prior without adequate evaluation in the opinion of the investigator.
- Premenopausal women with menstrual issues including irregular bleeding, menorrhagia, dysmenorrhea,
- Pregnancy (confirmed before surgery with a pregnancy test).
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States7 sites
Greater Baltimore Medical Center
Baltimore, Maryland, 21204
UNC
Chapel Hill, North Carolina, 27599
The Christ Hospital
Cincinnati, Ohio, 45069
Cleveland Clinic
Cleveland, Ohio, 44195
Women & Infant's Hospital
Providence, Rhode Island, 02903
Stanford University
Stanford, California, 94305
Washington Hospital
Washington D.C., District of Columbia, 20010
About this study
The purpose of this study is to evaluate surgical success or failure one year after surgery for pelvic organ prolapse.
Read the detailed description
This will be a prospective parallel cohort study comparing a laparoscopic sacral hysteropexy (LSHP) to a vaginal Uphold hysteropexy (VUHP). Symptomatic and anatomic improvement of pelvic organ prolapse will be evaluated at 3 months and 1 year.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Laparoscopic sacral hysteropexy, Vaginal mesh hysteropexy
- Keywords
- Uterovaginal prolapse, hysteropexy, mesh
- 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 sacral hysteropexyDevice
Laparoscopic sacral hysteropexy is performed laparoscopically with or without robotic assistance
Vaginal mesh hysteropexyDevice
Uphold device used which includes sacrospinous ligament fixation
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic sacral hysteropexy | Laparoscopic sacral hysteropexy is performed laparoscopically with or without robotic assistance Receives: Device: Laparoscopic sacral hysteropexy | |
| Vaginal mesh hysteropexy | Vaginal Mesh Hysteropexy using the Uphold device which includes Sacrospinous Ligament Fixation Receives: Device: Vaginal mesh hysteropexy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure will be surgical "success" or "failure" as a dichotomous outcome 1 year after surgery. Subjects will be considered a success if they meet the definitions of anatomic cure and deny vaginal bulging symptoms.
Anatomic sure is defined as cervix above mid-vagina, and no prolapse beyond the hymen and no surgical treatment for pelvic organ prolapse or pessary use.
Symptomatic cure is defined as the absence of vaginal bulge symptoms as indicated by a negative response question 3 of the pelvic floor distress inventory- 20.
Measured: 12 months
Secondary outcomes (4)
Anatomic outcomes
Evaluation of the anterior and posterior walls using point Aa, Ba, Ap and Bp, C, posterior fornix D and total vaginal length TVL; evaluate the size of the genital hiatus and perineal body; evaluation of cervical elongation and record any additional surgical procedures for anterior and posterior vaginal wall prolapse.
Measured: 12 months
Symptomatic improvement
Relief of symptoms of pelvic floor disorders, including incontinence, voiding dysfunction, pelvic organ prolapse, fecal incontinence defecation disorders and sexual dysfunction using validated instruments collected postoperatively at 3 months, and 1 year.
Measured: 3months and 12 months
Shortterm morbidity
We will compare the treatment groups with respect to perioperative morbidity and mortality. Perioperative morbidity will be recorded at completion of surgery and at hospital discharge. Postoperative morbidity will be recorded at any time after discharge- 6 weeks, 3 months and 1 year and all adverse events will be documented. Perioperative measures of morbidity will include operative time, estimated blood loss, and complications. Length of hospital stay will also be recorded. Complications will be categorized using the Dindo surgical complication grading scale.
Measured: 6 weeks, 3 months, 12 months
Pain and functional activity
Postoperative pain- subjects will complete the modified surgical pain scale and a diary of pain medication use preoperatively, then daily for two weeks after surgery, then again at 6 weeks postoperatively. Postoperative functional activity level- subjects will complete the activity assessment scale which measures postoperative functional activity preoperatively, 2 weeks, 6 weeks and 6 months after surgery.
Measured: 6 weeks and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionDec 2015
- Study completionDec 2015
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 The Cleveland ClinicThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- The Christ Hospital, Medstar Health Research Institute, Providence Healthcare, Stanford University, Women and Infants Hospital of Rhode Island, Greater Baltimore Medical Center, University of North Carolina
- Responsible party
- Sponsor
- Investigators
- Robert E Gutman, MD, Principal investigator, Medstar Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01377142
- Sponsor's protocol ID
- 11-409
- Acronym
- VAULT
- Status last verified
- Jun 2016
- First submitted
- 10 Jun 2011
- Last updated
- 14 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Uphold Hysteropexy and Laparoscopic Sacral Hysteropexy for the Treatment of Uterovaginal Pelvic Organ Prolapse
- ClinicalTrials.gov ID
- NCT01377142
- Acronym / sponsor ID
- VAULT / 11-409
- Conditions
- Pelvic Organ Prolapse
- Keywords
- Uterovaginal prolapse, hysteropexy, mesh
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- The Christ Hospital, Medstar Health Research Institute, Providence Healthcare, Stanford University, Women and Infants Hospital of Rhode Island, Greater Baltimore Medical Center, University of North Carolina
- Study start
- Jun 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 21 Jun 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.
The purpose of this study is to evaluate surgical success or failure one year after surgery for pelvic organ prolapse.
Detailed description
This will be a prospective parallel cohort study comparing a laparoscopic sacral hysteropexy (LSHP) to a vaginal Uphold hysteropexy (VUHP). Symptomatic and anatomic improvement of pelvic organ prolapse will be evaluated at 3 months and 1 year.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic sacral hysteropexy | – | Device: Laparoscopic sacral hysteropexyLaparoscopic sacral hysteropexy is performed laparoscopically with or without robotic assistance |
| Vaginal mesh hysteropexy | – | Device: Vaginal mesh hysteropexyVaginal Mesh Hysteropexy using the Uphold device which includes Sacrospinous Ligament Fixation |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult women with symptomatic uterovaginal prolapse planning to undergo laparsocopic sacral hysteropexy or vaginal uphold hysteropexy
Key inclusion criteria (9 listed)
- Desires surgical treatment for uterovaginal prolapse.
- Symptomatic stage II-IV POP including:
- cystocele (AA or BA > or = 0) by POP-Q and
- apical descent below the mid-vagina (point C > -(TVL / 2)) by the POP-Q and
- a positive response to questions 3 of the PFDI 20: Do you usually have a bulge or something falling out that you can see or feel in the vaginal area? (Appendix A)
Key exclusion criteria (9 listed)
- Prior hysterectomy.
- Patient with synthetic material placed to augment previous pelvic organ prolapse repair. (previous prolapse repair without synthetic mesh is acceptable).
- Current vaginal or pelvic foreign body complications (including but not limited to erosion, fistula, abscess). This includes foreign bodies of any type (e.g. synthetic and biologic including allograft, xenograft).
- Desires hysterectomy at the time of prolapse repair.
- Cervical elongation with anticipated need for cervical shortening at the time of prolapse repair as determined by surgeon.
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 sacral hysteropexyLaparoscopic sacral hysteropexy is performed laparoscopically with or without robotic assistance | Device | Laparoscopic sacral hysteropexy |
| Vaginal mesh hysteropexyUphold device used which includes sacrospinous ligament fixation | Device | Vaginal mesh hysteropexy |
Primary outcome
The primary outcome measure will be surgical "success" or "failure" as a dichotomous outcome 1 year after surgery. Subjects will be considered a success if they meet the definitions of anatomic cure and deny vaginal bulging symptoms.
Time frame: 12 months
Anatomic sure is defined as cervix above mid-vagina, and no prolapse beyond the hymen and no surgical treatment for pelvic organ prolapse or pessary use. Symptomatic cure is defined as the absence of vaginal bulge symptoms as indicated by a negative response question 3 of the pelvic floor distress inventory- 20.
4 secondary outcomes
Anatomic outcomes
Time frame: 12 months
Symptomatic improvement
Time frame: 3months and 12 months
Shortterm morbidity
Time frame: 6 weeks, 3 months, 12 months
Pain and functional activity
Time frame: 6 weeks and 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 14 Jun 2016.
- Individual participant dataSharing planned: No
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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.
Robert E Gutman, MD principal investigator
Medstar Health Research Institute
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Organ Prolapse, run by The Cleveland Clinic at 8 sites in 2 countries.
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 9 inclusion and 9 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 14 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Canada. 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 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?
The primary outcome measure will be surgical "success" or "failure" as a dichotomous outcome 1 year after surgery. Subjects will be considered a success if they meet the definitions of anatomic cure and deny vaginal bulging symptoms. (time frame: 12 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 14 Jun 2016.