Pelvic Organ ProlapseNCT03722563
Total Laparoscopic Hysterectomy With Sacrocolpopexy Versus Total Laparoscopic Hysterectomy With Lateral Suspension in Patients With Pelvic Organ Prolapse
A study testing total laparoscopic hysterectomy with sacrocolpopexy and total laparoscopic hysterectomy with lateral suspension in people with Pelvic Organ Prolapse, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective randomized surgical trial is designed to compare objective and subjective outcomes of total laparoscopic hysterectomy with sacrocolpopexy versus total laparoscopic hysterectomy with lateral suspension for the treatment of pelvic organ prolapse Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- total laparoscopic hysterectomy with sacrocolpopexy and total laparoscopic hysterectomy with lateral suspension
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Jan 2019to 22 Jan 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 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with symptomatic pelvic organ prolapse stage II or higher (according to the International Continence Society Pelvic Organ Prolapse quantification system - POPQ) in anterior and/or apical (central) compartment that require surgical management
Who cannot join
- Patients that are not candidates for general anesthesia or laparoscopy
- Inability to consent
- history of hysterectomy
- history of anterior or apical pelvic organ prolapse surgery
- history of urinary incontinence surgery
- pregnancy or breast-feeding during the study period
- suspicious adnexal masses or other factors that may indicate pelvic malignancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Antalya Training and Research Hospital
Antalya, Muratpaşa, 07230
About this study
Official title: Comparison of Total Laparoscopic Hysterectomy With Sacrocolpopexy Versus Total Laparoscopic Hysterectomy With Lateral Suspension in Patients With Pelvic Organ Prolapse: a Randomized Clinical Trial
This prospective randomized surgical trial is designed to compare objective and subjective outcomes of total laparoscopic hysterectomy with sacrocolpopexy versus total laparoscopic hysterectomy with lateral suspension for the treatment of pelvic organ prolapse
- Conditions
- Pelvic Organ Prolapse
- Being tested
- total laparoscopic hysterectomy with sacrocolpopexy, total laparoscopic hysterectomy with lateral suspension
- Keywords
- lateral suspension, laparoscopic hysterectomy, pelvic organ prolapse, sacrocolpopexy
- 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.
total laparoscopic hysterectomy with sacrocolpopexyProcedure or surgery
Surgical correction of anterior and/or apical pelvic organ prolapse by laparoscopy
total laparoscopic hysterectomy with lateral suspensionProcedure or surgery
Surgical correction of anterior and/or apical pelvic organ prolapse by laparoscopy
| Study group | Role | What they receive |
|---|---|---|
| TLHS | Active comparator | total laparoscopic hysterectomy with sacrocolpopexy will be performed Receives: Procedure: total laparoscopic hysterectomy with sacrocolpopexy |
| TLHLS | Experimental | total laparoscopic hysterectomy with lateral suspension will be performed Receives: Procedure: total laparoscopic hysterectomy with lateral suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of objective cure
Recurrences of vaginal vault prolapse will be assessed as objective cure by using the pelvic organ prolapse quantification (POP-Q) system
Measured: 12 months
Secondary outcomes (3)
Patient Global Impression of Improvement (PGI-I)
Patient Global Impression of Improvement scale is global index that may be used to rate the response of a condition to a therapy.
It is a 7-point scale where a score of 1 indicates that the patient is "very much improved," a score of 4 indicates that the patient has experienced "no change," and a score of 7 indicates that the patient is "very much worse."
Measured: 12 months
International Consultation of Incontinence Questionnaire - Short Form (ICIQ-SF)
The questionnaire contains four items: frequency of urinary incontinence, amount of leakage, overall impact of urinary incontinence and self-diagnostic. The first item has 6 response categories (never, once a week, two or three times a week, once a day, a few times a day, always) and is scored from 0 to 5. The second item has 4 response categories (none, small amount, moderate amount, large amount) and is scored 0, 2, 4, or 6. The third item (how much urine leakage affects your daily life) has 5 response (not at all, mildly, moderately, severely, to a great extent) and is scored from 0 to 10. The first three items are scored and then summed to produce a total score, ranging from 0 to 21. The last item is a diagnostic item to assess the perceived cause of incontinence. This item is included upon the request of clinicians and is not used for scoring. A higher ICIQ-UI-SF score indicates higher frequency, severity, and lower quality of life.
Measured: 12 months
International Consultation on Incontinence Questionnaire on Vaginal Symptoms (ICIQ-VS)
The questionnaire evaluates several pelvic floor dysfunctions including questions regarding intestinal, vaginal, sexual symptoms and quality of life impact. It includes 14 questions (dragging abdominal pain, vaginal soreness, reduced sensation around vagina, vagina too loose/lax, lump coming down in vagina, lump coming out of vagina, dry vagina, digitation for bowel opening, tight vagina, current sex life, worries about vagina affect sex life, relationship, sex life spoilt, overall impact on everyday life) and divided into three independent domains. Vaginal symptoms score varies from 0 to 53. Sexual symptoms score varies from 0 to 58. Quality of life impact score varies from 0 to 10. Usually each question has 3 to 5 possible answers; the higher the score, the most severe is the symptom or the negative quality of life impact.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2018
- Study start8 Jan 2019
- Primary completion22 Jan 2021
- Study completion22 Jan 2021
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antalya Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, bekirsitkiisenlik, Antalya Training and Research Hospital
- Investigators
- Bekir Sıtkı İsenlik, MD, Principal investigator, Antalya Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03722563
- Sponsor's protocol ID
- TLHSvsTLHLS
- Status last verified
- Feb 2021
- First submitted
- 25 Oct 2018
- Last updated
- 12 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Total Laparoscopic Hysterectomy With Sacrocolpopexy Versus Total Laparoscopic Hysterectomy With Lateral Suspension in Patients With Pelvic Organ Prolapse: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03722563
- Acronym / sponsor ID
- TLHSvsTLHLS
- Conditions
- Pelvic Organ Prolapse
- Keywords
- lateral suspension, laparoscopic hysterectomy, pelvic organ prolapse, sacrocolpopexy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Antalya Training and Research HospitalOther government
- Study start
- 8 Jan 2019 (actual)
- Primary completion
- 22 Jan 2021 (actual)
- Study completion
- 22 Jan 2021 (actual)
- First posted
- 29 Oct 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.
This prospective randomized surgical trial is designed to compare objective and subjective outcomes of total laparoscopic hysterectomy with sacrocolpopexy versus total laparoscopic hysterectomy with lateral suspension for the treatment of pelvic organ prolapse
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TLHS | Active comparator | Procedure: total laparoscopic hysterectomy with sacrocolpopexytotal laparoscopic hysterectomy with sacrocolpopexy will be performed |
| TLHLS | Experimental | Procedure: total laparoscopic hysterectomy with lateral suspensiontotal laparoscopic hysterectomy with lateral suspension will be performed |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women with symptomatic pelvic organ prolapse stage II or higher (according to the International Continence Society Pelvic Organ Prolapse quantification system - POPQ) in anterior and/or apical (central) compartment that require surgical management
Key exclusion criteria (7 listed)
- Patients that are not candidates for general anesthesia or laparoscopy
- Inability to consent
- history of hysterectomy
- history of anterior or apical pelvic organ prolapse surgery
- history of urinary incontinence surgery
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 |
|---|---|---|
| total laparoscopic hysterectomy with sacrocolpopexySurgical correction of anterior and/or apical pelvic organ prolapse by laparoscopy | Procedure or surgery | TLHS |
| total laparoscopic hysterectomy with lateral suspensionSurgical correction of anterior and/or apical pelvic organ prolapse by laparoscopy | Procedure or surgery | TLHLS |
Primary outcome
Rate of objective cure
Time frame: 12 months
Recurrences of vaginal vault prolapse will be assessed as objective cure by using the pelvic organ prolapse quantification (POP-Q) system
3 secondary outcomes
Patient Global Impression of Improvement (PGI-I)
Time frame: 12 months
International Consultation of Incontinence Questionnaire - Short Form (ICIQ-SF)
Time frame: 12 months
International Consultation on Incontinence Questionnaire on Vaginal Symptoms (ICIQ-VS)
Time frame: 12 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 12 Feb 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
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i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)
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Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)
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Pelvic Floor Muscle Training During Pregnancy
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Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
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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.
Bekir Sıtkı İsenlik, MD principal investigator
Antalya Training and Research 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 total laparoscopic hysterectomy with sacrocolpopexy and total laparoscopic hysterectomy with lateral suspension in people with Pelvic Organ Prolapse, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 7 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 12 Feb 2021. 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 Turkey (Türkiye). 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?
Rate of objective cure (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 12 Feb 2021.