Pelvic Organ ProlapseNCT05143658
Comparison of Laparoscopic Pectopexy and Laparoscopic Lateral Suspension Techniques in Uterine-preserving Apical Prolapsus Repair
A study testing LLS versus LP in people with Pelvic Organ Prolapse, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study will be to compare the laparoscopic pectopexy (LP) and laparoscopic lateral suspension (LLS) techniques in the management of uterine sparing apical prolapse (POP-Q >2) at 1 year and yearly up to 2 years. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- LLS versus LP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Dec 2021to 4 Mar 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women with symptomatic stage 2 or greater (point C -1 or more pelvic organ prolapse quantification POP-Q) apical prolapse
Who cannot join
- Women not eligible for surgery for medical or anesthesiological reasons
- Inability to comprehend questionnaires
- Inability to give informed consent
- Inability to return for a review
- Prior laparoscopic prolapse repair
- Prior vaginal mesh prolapse procedure
Show all 10Show fewer
- Severe cardiovascular or respiratory disease
- Women who don't want uterine preserving surgery
- Pregnancy
- Age <18 years, Age >45 years
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kanuni Sultan Suleyman Training and Research Hospital
Istanbul, 34307
About this study
The aim of the study will be to compare the laparoscopic pectopexy (LP) and laparoscopic lateral suspension (LLS) techniques in the management of uterine sparing apical prolapse (POP-Q >2) at 1 year and yearly up to 2 years.
Read the detailed description
Primary and secondary endpoints:
Primary outcome measures will be the subjective cure of prolapse ("absence or presence of a bulge in the vagina"), objective success with anatomic absence of advanced prolapse at POP-Q sites Ba, C and Bp defined as less than 1 cm individually and as a total.
Secondary outcome measures include all other parameters such as perioperative outcomes, patient satisfaction, quality of life outcomes, complications, scores on questionnaires, and reoperations.
The study protocol will be submitted to the institutional review boards of every participating study site and written informed consent will be obtained from all participants on enrolment.
Project design: The investigators will perform an international multicentre single-blind randomized controlled trial with participating our tertiary referral hospital.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- LLS versus LP
- Keywords
- pectopexy, lateral suspension, pelvic organ prolapse, uterine sparing, laparoscopy
- 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.
LLS versus LPProcedure or surgery
Procedure: Laparoscopic repair of anterior and apical pelvic organ prolapse Surgical correction of anterior and apical pelvic organ prolapse by laparoscopy
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic Lateral Suspension Group (LLS) | Active comparator | Anterior and apical prolapse repair via LLS Receives: Procedure: LLS versus LP |
| Laparoscopic Pectopexy (LP) | Experimental | Anterior and apical prolapse repair via LP Receives: Procedure: LLS versus LP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective cure rate of prolapse
Provided by the patient's feeling of the "Absence of a bulge in the vagina"
Measured: [ Time Frame: 12 months after intervention ]
Objective success
Defined as anatomic absence of advanced prolapse at POP-Q sites Ba, C and Bp defined as less than 1 cm individually and as a total
Measured: [ Time Frame: 12 months after intervention ]
Secondary outcomes (6)
Prolapse-related Quality of life
This will be assessed using a validated questionnaire (Prolapse Quality of Life questionnaire P-QoL) The questionnaire contains 9 domains. Each answer of the patient will have values that range between 1 to 4 or 1 to 5 for the 1st question only). (1 very good 4/5 very poor). There is no overall score. A symptomatic woman might have only one domain impaired and another one might have all domains impaired. We consider both of them symptomatic but in different or same aspects of quality of life. To differentiate different domains, it is important for the decision of our surgery (we will be careful in shortening and narrowing a vagina of a woman who had only a preoperative high (impaired) Personal relationships domain score and other domains in the normal range).
This will also help us in the follow up visits.
Measured: [ Time Frame: 12 months after intervention ]
Failure (%)
Recurrence rate
Measured: [ Time Frame: 12 months after intervention ]
Complications
İnjury ( bowel, intestinal, blood vessel injuries, mesh erosions)
Measured: [ Time Frame: 12 months after intervention ]
Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)
The PISQ-12 is a self-adminestered questionnaire that evaluates sexual function of women with pelvic organ prolapse or urinary incontinence. The questionnaire has 12 items. Other than the first 4 questions that are scored from 4 to 0, all questions are scored from 0 to 4. The total score is calculated with totaling the score of each question. The maximum score is 48. Higher scores show good sexual functioning of women.
Measured: [ Time Frame: 12 months after intervention ]
Incontinence Impact Questionnaire (IIQ-7)
evaluating the impact of urinary incontinence
Measured: [ Time Frame: 12 months after intervention ]
Pelvic Floor Distress Inventory (PFDI - 20)
evaluating the bowel, bladder, or pelvic symptoms
Measured: [ Time Frame: 12 months after intervention ]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start6 Dec 2021
- Primary completion6 Dec 2021
- Study completion4 Mar 2024
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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozan Karadeniz, Kanuni Sultan Suleyman Training and Research Hospital
- Investigators
- Ozan Karadeniz, MD, Principal investigator, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05143658
- Sponsor's protocol ID
- KanuniSSS
- Status last verified
- Mar 2024
- First submitted
- 28 Oct 2021
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Laparoscopic Pectopexy and Laparoscopic Lateral Suspension Techniques in Uterine-preserving Apical Prolapsus Repair
- ClinicalTrials.gov ID
- NCT05143658
- Acronym / sponsor ID
- KanuniSSS
- Conditions
- Pelvic Organ Prolapse
- Keywords
- pectopexy, lateral suspension, pelvic organ prolapse, uterine sparing, laparoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 6 Dec 2021 (actual)
- Primary completion
- 6 Dec 2021 (actual)
- Study completion
- 4 Mar 2024 (actual)
- First posted
- 3 Dec 2021 (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 aim of the study will be to compare the laparoscopic pectopexy (LP) and laparoscopic lateral suspension (LLS) techniques in the management of uterine sparing apical prolapse (POP-Q >2) at 1 year and yearly up to 2 years.
Detailed description
Primary and secondary endpoints:
Primary outcome measures will be the subjective cure of prolapse ("absence or presence of a bulge in the vagina"), objective success with anatomic absence of advanced prolapse at POP-Q sites Ba, C and Bp defined as less than 1 cm individually and as a total.
Secondary outcome measures include all other parameters such as perioperative outcomes, patient satisfaction, quality of life outcomes, complications, scores on questionnaires, and reoperations.
The study protocol will be submitted to the institutional review boards of every participating study site and written informed consent will be obtained from all participants on enrolment.
Project design: The investigators will perform an international multicentre single-blind randomized controlled trial with participating our tertiary referral hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Lateral Suspension Group (LLS) | Active comparator | Procedure: LLS versus LPAnterior and apical prolapse repair via LLS |
| Laparoscopic Pectopexy (LP) | Experimental | Procedure: LLS versus LPAnterior and apical prolapse repair via LP |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women with symptomatic stage 2 or greater (point C -1 or more pelvic organ prolapse quantification POP-Q) apical prolapse
Key exclusion criteria (10 listed)
- Women not eligible for surgery for medical or anesthesiological reasons
- Inability to comprehend questionnaires
- Inability to give informed consent
- Inability to return for a review
- Prior laparoscopic prolapse repair
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 |
|---|---|---|
| LLS versus LPProcedure: Laparoscopic repair of anterior and apical pelvic organ prolapse Surgical correction of anterior and apical pelvic organ prolapse by laparoscopy | Procedure or surgery | Laparoscopic Lateral Suspension Group (LLS), Laparoscopic Pectopexy (LP) |
Primary outcome
Subjective cure rate of prolapse
Time frame: [ Time Frame: 12 months after intervention ]
Provided by the patient's feeling of the "Absence of a bulge in the vagina"
Objective success
Time frame: [ Time Frame: 12 months after intervention ]
Defined as anatomic absence of advanced prolapse at POP-Q sites Ba, C and Bp defined as less than 1 cm individually and as a total
6 secondary outcomes
Prolapse-related Quality of life
Time frame: [ Time Frame: 12 months after intervention ]
Failure (%)
Time frame: [ Time Frame: 12 months after intervention ]
Complications
Time frame: [ Time Frame: 12 months after intervention ]
Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)
Time frame: [ Time Frame: 12 months after intervention ]
Incontinence Impact Questionnaire (IIQ-7)
Time frame: [ Time Frame: 12 months after intervention ]
Pelvic Floor Distress Inventory (PFDI - 20)
Time frame: [ Time Frame: 12 months after intervention ]
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 5 Mar 2024.
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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.
Ozan Karadeniz, MD principal investigator
Kanuni Sultan Suleyman 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 LLS versus LP in people with Pelvic Organ Prolapse, run by Kanuni Sultan Suleyman 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 10 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 5 Mar 2024. 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?
Subjective cure rate of prolapse (time frame: [ Time Frame: 12 months after intervention ]). The study lists 2 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 5 Mar 2024.