Pelvic Organ ProlapseLULS-1NCT03553511
Laparoscopic Hysterectomy With Vaginal Vault Suspension to the Uterosacral Ligaments for Stage II-III Pelvic Organ Prolapse.
A study testing Vaginal vault suspension to the uterosacral ligaments and McCall culdoplasty in people with Pelvic Organ Prolapse, run by Università degli Studi dell'Insubria.
Trial summary
The International Continence Society defines post-hysterectomy vault prolapse (PHVP) as descent of the vaginal cuff scar below a point that is 2 cm less than the total vaginal length above the plane of the hymen. The incidence of PHVP has been reported to affect up to 43% of hysterectomies. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Vaginal vault suspension to the uterosacral ligaments and McCall culdoplasty
- 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
- May 2022to May 2024
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage II-III pelvic organ prolapse
- Bilateral preservation of the ovaries
- Sexually active women
Who cannot join
- Smoking
- Body Mass Index > 30
- Strenuous activity (frequent heavy lifting)
- Other gynecological and non-gynecological (chronic endocrine, metabolic, autoimmune, neoplastic diseases) comorbidities
- Pharmacological and/or nonpharmacological treatment (including pelvic floor exercises) in the six months preceding the surgery or during the study period
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Short and Long-term Outcomes After Total Laparoscopic Hysterectomy With Vaginal Vault Suspension to the Uterosacral Ligaments Versus Vaginal Hysterectomy With McCall Culdoplasty for the Treatment of Stage II-III Pelvic Organ Prolapse.
The International Continence Society defines post-hysterectomy vault prolapse (PHVP) as descent of the vaginal cuff scar below a point that is 2 cm less than the total vaginal length above the plane of the hymen. The incidence of PHVP has been reported to affect up to 43% of hysterectomies. The risk of prolapse following hysterectomy is 5.5 times more common in women whose initial hysterectomy was for pelvic organ prolapse as opposed to other reasons.
Techniques available to manage PHVP aim to ultimately suspend the vaginal vault. Approaches include vaginal, e.g. uterosacral ligament suspension, sacrospinous ligament fixation, open procedures and more recently laparoscopic, e.g. sacrocolpopexy and uterosacral plication.
Data published so far do not allow to draw a firm conclusion about the best treatment to prevent PHVP for women undergoing hysterectomy for stage II-III pelvic organ prolapse. Considering this scenario, in the current study the investigators aim to evaluate short and long-term outcomes after total laparoscopic hysterectomy with vaginal vault suspension to the uterosacral ligaments versus vaginal hysterectomy with McCall culdoplasty for the treatment of stage II-III pelvic organ prolapse.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Vaginal vault suspension to the uterosacral ligaments, McCall culdoplasty
- Keywords
- Laparoscopy, Hysterectomy, Uterosacral ligaments suspension, McCall culdoplasty, Post-hysterectomy vault prolapse
- 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.
Vaginal vault suspension to the uterosacral ligamentsProcedure or surgery
Laparoscopic hysterectomy with vaginal vault suspension to the uterosacral ligaments
McCall culdoplastyProcedure or surgery
Vaginal hysterectomy with McCall culdoplasty
| Study group | Role | What they receive |
|---|---|---|
| Uterosacral ligaments suspension | Experimental | Women affected by stage II-III pelvic organ prolapse undergoing total laparoscopic hysterectomy with vaginal vault suspension to the uterosacral ligaments. Receives: Procedure: Vaginal vault suspension to the uterosacral ligaments |
| McCall culdoplasty | Active comparator | Women affected by stage II-III pelvic organ prolapse undergoing vaginal hysterectomy with McCall culdoplasty. Receives: Procedure: McCall culdoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence
Vaginal vault prolapse
Measured: 12 months after surgery
Secondary outcomes (4)
Urinary impact questionnaire score (total score minimum: 0, maximum: 100)
A specific questionnaire developed to investigate the impact of urinary symptoms and signs on the quality of life.
Measured: 12 months after surgery
Pelvic Organ Prolapse Impact Questionnaire (total score minimum: 0, maximum: 100)
A specific questionnaire developed to investigate the impact of prolapse-related symptoms and signs on the quality of life.
Measured: 12 months after surgery
Colorectal-Anal Impact questionnaire (total score minimum: 0, maximum: 100)
A specific questionnaire developed to investigate the impact of prolapse-related colorectal and anal symptoms and signs on the quality of life.
Measured: 12 months after surgery
Prolapse/urinary incontinence sexual questionnaire score (total score minimum: 0, maximum: 48)
A specific questionnaire developed to investigate the impact of prolapse/urinary incontinence on sexual functions.
Measured: 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2018
- Study startMay 2022 (estimated)
- Primary completionMay 2023 (estimated)
- Study completionMay 2024 (estimated)
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.
- 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
- Model description
- Prospective Randomized Clinical trial
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università degli Studi dell'Insubria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Simone Laganà, Università degli Studi dell'Insubria
- Investigators
- Antonio Simone Laganà, M.D., Principal investigator, Università degli Studi dell'InsubriaJvan Casarin, M.D., Principal investigator, Università degli Studi dell'InsubriaAntonella Cromi, M.D., Ph.D., Study chair, Università degli Studi dell'InsubriaFabio Ghezzi, M.D., Study director, Università degli Studi dell'Insubria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03553511
- Sponsor's protocol ID
- LULS-1
- Acronym
- LULS-1
- Status last verified
- Sep 2021
- First submitted
- 30 May 2018
- Last updated
- 30 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short and Long-term Outcomes After Total Laparoscopic Hysterectomy With Vaginal Vault Suspension to the Uterosacral Ligaments Versus Vaginal Hysterectomy With McCall Culdoplasty for the Treatment of Stage II-III Pelvic Organ Prolapse.
- ClinicalTrials.gov ID
- NCT03553511
- Acronym / sponsor ID
- LULS-1 / LULS-1
- Conditions
- Pelvic Organ Prolapse
- Keywords
- Laparoscopy, Hysterectomy, Uterosacral ligaments suspension, McCall culdoplasty, Post-hysterectomy vault prolapse
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Università degli Studi dell'InsubriaUniversity, hospital or other
- Study start
- May 2022 (estimated)
- Primary completion
- May 2023 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 12 Jun 2018 (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.
The International Continence Society defines post-hysterectomy vault prolapse (PHVP) as descent of the vaginal cuff scar below a point that is 2 cm less than the total vaginal length above the plane of the hymen. The incidence of PHVP has been reported to affect up to 43% of hysterectomies. The risk of prolapse following hysterectomy is 5.5 times more common in women whose initial hysterectomy was for pelvic organ prolapse as opposed to other reasons.
Techniques available to manage PHVP aim to ultimately suspend the vaginal vault. Approaches include vaginal, e.g. uterosacral ligament suspension, sacrospinous ligament fixation, open procedures and more recently laparoscopic, e.g. sacrocolpopexy and uterosacral plication.
Data published so far do not allow to draw a firm conclusion about the best treatment to prevent PHVP for women undergoing hysterectomy for stage II-III pelvic organ prolapse. Considering this scenario, in the current study the investigators aim to evaluate short and long-term outcomes after total laparoscopic hysterectomy with vaginal vault suspension to the uterosacral ligaments versus vaginal hysterectomy with McCall culdoplasty for the treatment of stage II-III pelvic organ prolapse.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective Randomized Clinical trial
| Arm | Type | Receives |
|---|---|---|
| Uterosacral ligaments suspension | Experimental | Procedure: Vaginal vault suspension to the uterosacral ligamentsWomen affected by stage II-III pelvic organ prolapse undergoing total laparoscopic hysterectomy with vaginal vault suspension to the uterosacral ligaments. |
| McCall culdoplasty | Active comparator | Procedure: McCall culdoplastyWomen affected by stage II-III pelvic organ prolapse undergoing vaginal hysterectomy with McCall culdoplasty. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Stage II-III pelvic organ prolapse
- Bilateral preservation of the ovaries
- Sexually active women
Key exclusion criteria (5 listed)
- Smoking
- Body Mass Index > 30
- Strenuous activity (frequent heavy lifting)
- Other gynecological and non-gynecological (chronic endocrine, metabolic, autoimmune, neoplastic diseases) comorbidities
- Pharmacological and/or nonpharmacological treatment (including pelvic floor exercises) in the six months preceding the surgery or during the study period
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 vault suspension to the uterosacral ligamentsLaparoscopic hysterectomy with vaginal vault suspension to the uterosacral ligaments | Procedure or surgery | Uterosacral ligaments suspension |
| McCall culdoplastyVaginal hysterectomy with McCall culdoplasty | Procedure or surgery | McCall culdoplasty |
Primary outcome
Recurrence
Time frame: 12 months after surgery
Vaginal vault prolapse
4 secondary outcomes
Urinary impact questionnaire score (total score minimum: 0, maximum: 100)
Time frame: 12 months after surgery
Pelvic Organ Prolapse Impact Questionnaire (total score minimum: 0, maximum: 100)
Time frame: 12 months after surgery
Colorectal-Anal Impact questionnaire (total score minimum: 0, maximum: 100)
Time frame: 12 months after surgery
Prolapse/urinary incontinence sexual questionnaire score (total score minimum: 0, maximum: 48)
Time frame: 12 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Pelvic Organ Prolapse
Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
Active, not recruitingObservational study
i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)
Pelvic Organ Prolapse, Genital Prolapse
Recruiting
Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)
Pelvic Organ Prolapse (POP), Synthetic Mesh
Recruiting
Pelvic Floor Muscle Training During Pregnancy
Urinary Incontinence, Anal Incontinence
Not yet recruiting
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
Pelvic Floor Dysfunction, Perineal Laceration
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.
Antonio Simone Laganà, M.D. principal investigator
Università degli Studi dell'Insubria
Jvan Casarin, M.D. principal investigator
Università degli Studi dell'Insubria
Antonella Cromi, M.D., Ph.D. study chair
Università degli Studi dell'Insubria
Questions about this trial
What is this clinical trial studying?
A study testing Vaginal vault suspension to the uterosacral ligaments and McCall culdoplasty in people with Pelvic Organ Prolapse, run by Università degli Studi dell'Insubria.
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 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 30 Sep 2021. 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 Antonio Simone Laganà, M.D. (3296279579 ext. +39, antoniosimone.lagana@asst-settelaghi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence (time frame: 12 months after surgery). 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 30 Sep 2021.