Prolapse of Vaginal Vault After HysterectomyNCT01364025
Prophylactic Uterosacral Ligament Suspension at the Time of Hysterectomy for Prevention of Vaginal Vault Prolapse
A study testing uterosacral ligament suspension colpopexy bilateral in people with Prolapse of Vaginal Vault After Hysterectomy, run by Kaiser Permanente at 1 site in United States.
Trial summary
Is routine uterosacral ligament suspension an appropriate clinical adjunct at the time of hysterectomy? The answers to these questions will facilitate the treatment of many American women. Read more about this study
- Who is it for?
- Ages 21 to 99 years, women only
- Conditions the study is for
- Prolapse of Vaginal Vault After Hysterectomy
- What is being tested?
- uterosacral ligament suspension colpopexy bilateral
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to 21 Feb 2021
- 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 21 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligibility for primary procedure (hysterectomy either total or supracervical, performed either vaginally or abdominally, via laparoscopic or open approach)
- Eligibility for secondary procedure (uterosacral ligament suspension colpopexy)
- Prolapse in any compartment not extending beyond the hymen as measured by Pelvic Organ Prolapse Quantitative system
- No subjective complaints of Pelvic Organ Prolapse as determined by answer "no" to questions #3 of the short form of Pelvic Floor Distress Inventory: #3. Do you usually have a bulge or something falling out that you can see or feel in the vaginal area?
Who cannot join
- Contraindication for uterosacral ligament suspension colpopexy. (Surgeon's judgment that a contraindication to uterosacral ligament suspension colpopexy exists).
- Anticipated geographic relocation within the 12 months after surgery
- Inability to provide informed consent or to complete testing or data collection.
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente San Diego
San Diego, California, 92110
About this study
Official title: Prophylactic Uterosacral Ligament Suspension at the Time of Hysterectomy for Prevention of Vaginal Vault Prolapse (PULS)
Is routine uterosacral ligament suspension an appropriate clinical adjunct at the time of hysterectomy?
The answers to these questions will facilitate the treatment of many American women. With the results of this study, the investigators would anticipate a reduction in the number of surgeries for pelvic organ prolapse. In addition, if uterosacral ligament suspension was shown to be ineffective, it would not be used routinely in the setting of hysterectomy and women will be spared the additional procedure and possibility of side effects or complications.
The relative risks and benefits of adding a prophylactic uterosacral ligament suspension at the time of hysterectomy in women without symptomatic prolapse symptoms have never been studied prospectively.
- Being tested
- uterosacral ligament suspension colpopexy bilateral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
uterosacral ligament suspension colpopexy bilateralProcedure or surgery
Also called uterosacral ligament suspension at the time of hysterectomy
Uterosacral ligament suspension colpopexy bilateral
| Study group | Role | What they receive |
|---|---|---|
| uterosacral ligament suspension | Experimental | uterosacral ligament suspension colpopexy sutures will be placed bilaterally at the time of hysterectomy Receives: Procedure: uterosacral ligament suspension colpopexy bilateral |
| hysterectomy alone | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the occurrence of objective findings of pelvic organ prolapse beyond hymen after uterosacral ligament suspension of the vaginal apex at the time of hysterectomy vs. hysterectomy alone using Pelvic Floor Quantitative Examination
Measured: one year and annual thereafter for 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2011 (estimated)
- Study startAug 2011
- Primary completion21 Feb 2021 (estimated)
- Study completion21 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prolapse of Vaginal Vault After HysterectomyStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital
- Responsible party
- Sponsor
- Investigators
- Marianna Alperin, MD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01364025
- Sponsor's protocol ID
- PULS
- Status last verified
- Feb 2020
- First submitted
- 31 May 2011
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Uterosacral Ligament Suspension at the Time of Hysterectomy for Prevention of Vaginal Vault Prolapse (PULS)
- ClinicalTrials.gov ID
- NCT01364025
- Acronym / sponsor ID
- PULS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital
- Study start
- Aug 2011
- Primary completion
- 21 Feb 2021 (estimated)
- Study completion
- 21 Feb 2021 (estimated)
- First posted
- 2 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.
Is routine uterosacral ligament suspension an appropriate clinical adjunct at the time of hysterectomy?
The answers to these questions will facilitate the treatment of many American women. With the results of this study, the investigators would anticipate a reduction in the number of surgeries for pelvic organ prolapse. In addition, if uterosacral ligament suspension was shown to be ineffective, it would not be used routinely in the setting of hysterectomy and women will be spared the additional procedure and possibility of side effects or complications.
The relative risks and benefits of adding a prophylactic uterosacral ligament suspension at the time of hysterectomy in women without symptomatic prolapse symptoms have never been studied prospectively.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| uterosacral ligament suspension | Experimental | Procedure: uterosacral ligament suspension colpopexy bilateraluterosacral ligament suspension colpopexy sutures will be placed bilaterally at the time of hysterectomy |
| hysterectomy alone | No intervention | – |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Eligibility for primary procedure (hysterectomy either total or supracervical, performed either vaginally or abdominally, via laparoscopic or open approach)
- Eligibility for secondary procedure (uterosacral ligament suspension colpopexy)
- Prolapse in any compartment not extending beyond the hymen as measured by Pelvic Organ Prolapse Quantitative system
- No subjective complaints of Pelvic Organ Prolapse as determined by answer "no" to questions #3 of the short form of Pelvic Floor Distress Inventory: #3. Do you usually have a bulge or something falling out that you can see or feel in the vaginal area?
Key exclusion criteria (3 listed)
- Contraindication for uterosacral ligament suspension colpopexy. (Surgeon's judgment that a contraindication to uterosacral ligament suspension colpopexy exists).
- Anticipated geographic relocation within the 12 months after surgery
- Inability to provide informed consent or to complete testing or data collection.
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 |
|---|---|---|
| uterosacral ligament suspension colpopexy bilateralAlso: uterosacral ligament suspension at the time of hysterectomyUterosacral ligament suspension colpopexy bilateral | Procedure or surgery | uterosacral ligament suspension |
Primary outcome
To compare the occurrence of objective findings of pelvic organ prolapse beyond hymen after uterosacral ligament suspension of the vaginal apex at the time of hysterectomy vs. hysterectomy alone using Pelvic Floor Quantitative Examination
Time frame: one year and annual thereafter for 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
Related trials for Prolapse of Vaginal Vault After Hysterectomy
Recruiting
Post-Hysterectomy Vaginal Length: Horizontal vs. Vertical Closure
Prolapse, Vaginal, Vaginal Vault Prolapse
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.
Marianna Alperin, MD principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing uterosacral ligament suspension colpopexy bilateral in people with Prolapse of Vaginal Vault After Hysterectomy, run by Kaiser Permanente 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 4 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 25 Feb 2020. 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?
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?
To compare the occurrence of objective findings of pelvic organ prolapse beyond hymen after uterosacral ligament suspension of the vaginal apex at the time of hysterectomy vs. hysterectomy alone using Pelvic Floor Quantitative Examination (time frame: one year and annual thereafter for 5 years). 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 25 Feb 2020.