Pelvic Organ ProlapseNCT03421457
Laparoscopic Lateral Suspension With Mesh & Sacrocervicopexy for the Treatment of Uterine Prolapse
A study testing Uterus-preserving laparoscopic lateral suspension with mesh and Uterus-preserving laparoscopic sacrocervicopexy with mesh in people with Pelvic Organ Prolapse and Pelvic Floor Prolapse, run by Fatih Sultan Mehmet Training and Research Hospital at 2 sites in Turkey (Türkiye).
Trial summary
This study is aimed to compare the efficiency of two uterus-preserving laparoscopic methods to treat uterine prolapse in a randomized controlled trial. Laparoscopic lateral suspension with mesh (LLSM) will be compared with laparoscopic sacrohysteropexy (LS). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse, Pelvic Floor Prolapse
- What is being tested?
- Uterus-preserving laparoscopic lateral suspension with mesh and Uterus-preserving laparoscopic sacrocervicopexy with mesh
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 24 Jan 2018to 14 Mar 2019
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 years old
- > Symptomatic prolapse of central compartment with a Pelvic Organ Prolapse Quantitative (POP-Q) stage 2 associated or not with anterior or posterior compartment prolapse.
- Patients who are not comfortable with using or refusing pessary
- Wish to preserve the uterus
Who cannot join
- Any cue for gynecologic oncological condition
- Patients who approves Le Fort colpocleisis among who does not have any sexual intercourse
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Fatih Sultan Mehmet Training and Research Hospital, Sancaktepe Campus
Istanbul, Sancaktepe, 34785
Sisli Hamidiye Etfal Training and Research Hospital
Istanbul, Sisli, 34371
About this study
Official title: A Multicenter, Randomized, Prospective, Controlled Study Comparing Uterine Preserving Laparoscopic Lateral Suspension With Mesh Versus Laparoscopic Sacrocervicopexy in the Treatment of Uterine Prolapse: A Randomized Controlled Trial
This study is aimed to compare the efficiency of two uterus-preserving laparoscopic methods to treat uterine prolapse in a randomized controlled trial. Laparoscopic lateral suspension with mesh (LLSM) will be compared with laparoscopic sacrohysteropexy (LS). Both procedures are known as sufficient uterus preserving methods. LLSM was introduced to be an alternative to others with avoiding dissection of promontory and therefore being safer, faster and feasible technique.
Read the detailed description
Patient with uterine prolapse can participate in this study. A total of 44 women will be included. At random 22 patients undergo laparoscopic lateral suspension with mesh operation and 22 patients undergo laparoscopic sacrohysteropexy operation. Evaluation will take place during the surgery, at the postoperative visit after 4 weeks, 6th months and 12th months. Quality of life, degree of vaginal prolapse, safety, operation time and complications will be evaluated.
Subjective assessments will include Female Sexual Function Index (FSFI), Michigan Incontinence Severity Index (M-ISI), Prolapse Quality of Life questionnaire (PQoL), Pelvic Organ Prolapse Symptom Score (POP-SS) and Visual Analog Score (VAS).
Objective assessments will include routine gynecologic sonography, Pelvic Organ Prolapse Quantification System (POP-Q) and pelvic floor biometry measured by transperineal sonography.
Transperineal sonography will include those measurements:
Urethral rotation, Pelvic organ descent, Hiatal Diameter and the Anatomical localization of apex.
- Conditions
- Pelvic Organ Prolapse, Pelvic Floor Prolapse
- Being tested
- Uterus-preserving laparoscopic lateral suspension with mesh, Uterus-preserving laparoscopic sacrocervicopexy with mesh
- Keywords
- Pelvic Organ Prolapse, Translabial ultrasound, Transperineal ultrasound, Lateral Mesh Suspension, Descensus uteri, Laparoscopic pelvic organ prolapse repair, Uterus preserving, hysteropexy, uterine-preserving, fertility-sparing, sacropexy, cervicopexy, sacrocervicopexy, sacrohysteropexy, mesh prolapse surgery
- Medical subject headings
- Pelvic Organ Prolapse, Uterine Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uterus-preserving laparoscopic lateral suspension with meshProcedure or surgery
V-shaped 2cm wide and 25cm length mesh strip is prepared from a 30x30cm Prolene mesh (Ethicon J\&J).Deep dissection of the uterovesical space is performed.Cutaneous incisions are bilaterally made 3-4 cm superoposterior to the anterosuperior iliac spine.A grasper is introduced retroperitoneally through the sub-peritoneum holding the beginning part of mesh until reaching the vesicovaginal space in an oblique route rather than transverse.Round ligament is lifted upward and tunnel is practiced horizontally.Assistant grasper catches the distal mesh and pulls out through the opposite subperitoneal tunnel.Corner of mesh is fixed to the pubocervical fascia,uterine cervix and isthmus with Absorba-Tack™(Covidien, Mansfield,USA).Tension-free lateral mesh suspension is achieved at the desired level.
Uterus-preserving laparoscopic sacrocervicopexy with meshProcedure or surgery
The peritoneum over the sacral promontory is incised until the anterior longitudinal ligament is reached and ureters are identified. Peritoneal relaxing incision is made medial to the right ureter, down into the pelvis, posterior to the cervix and rectovaginal fascia, laterally to the rectum. The arm of the mesh is sutured to the posterior cervix by 2.0 prolene and fixated to the sacral promontory by either Tacker (Covidien) and/or 2.0 prolene as tension-free. Complete peritonisation of the mesh is performed.
| Study group | Role | What they receive |
|---|---|---|
| Lateral suspension | Experimental | "Uterus-preserving Laparoscopic lateral suspension with mesh" technique will be performed in this arm. Receives: Procedure: Uterus-preserving laparoscopic lateral suspension with mesh |
| Sacrocervicopexy | Experimental | "Uterus-preserving Laparoscopic sacrocervicopexy with mesh" technique will be performed in this arm. Receives: Procedure: Uterus-preserving laparoscopic sacrocervicopexy with mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline POP-Q measurements (mm) at 12th month.
Prolapse degree; Point Ba/C/Bp
Measured: 12 months for each participant
Secondary outcomes (11)
Subjective Success - Change from baseline Female Sexual Function Index (FSFI) to measure sexual dysfunction at 12th month.
Validated into Turkish language form will be used to compare preoperative and postoperative period. The FSFI is a multiple-trait scoring, self-report document used to assess female sexual function. It consists of 19 items that encompass six separate domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. The maximum score is 36 points and the minimum score is 2 points. After completion of the questionnaire, the total SF score was calculated as follows: no sexual dysfunction (SD) (≥ 30 points) , mild SD (between <29 and > 23 points), and severe SD (≤ 22 points).
Measured: 12 months for each participant
Subjective Success - Change from baseline Michigan Incontinence Severity Index (M-ISI) to measure urinary incontinence at 12th month.
Validated into Turkish language form will be used to compare preoperative and postoperative period. It has ten items, consisting of a total M-ISI domain (the sum of items 1-8) and a distinct Bother domain (the sum of items 9 and 10). The total M-ISI score consists of three subdomains (items 1-3 for stress urinary incontinence [SUI], items 4-6 for UUI, and items 7 and 8 for PU). The responses for each item range from 0 to 4 on a Likert-type scale, with higher values representing greater symptoms and greater bother. The total M-ISI domain ranges from 0 to 32, the Bother domain ranges from 0 to 8, the SUI and UUI subdomains range from 0 to 12, and the PU subdomain ranges from 0 to 8. Total domain and subdomain scores are obtained by simply adding the respective answers. The minimally important difference has been determined for the following domains/subdomains: total M-ISI (4 points), SUI (2 points), UUI (2 points), and PU (1 point).
Measured: 12 months for each participant
Subjective Success - Change from baseline Prolapse Quality of Life questionnaire (PQoL) to measure quality of life according to pelvic organ prolapse at 12th month.
Validated into Turkish language form will be used to compare preoperative and postoperative period. he questionnaire included 20 questions grouped in sections (domains) related to a particular aspect of quality of life. A total of nine domains covering general health, prolapse impact, role limitations, physical and social limitations, personal relationships, emotional problems, sleep/energy disturbance as well as severity symptoms measurements were defined. Questions regarding bladder, bowel and sexual function were also separately included and validated for reproducibility and internal consistency. Responses ranged from 'none/not at all', through 'slightly/a little' and 'moderately' to 'a lot' to produce a four-point scoring system for each item. Scores in each domain ranged between 0 and 100 with a high total score indicating a greater impairment of quality of life.
Measured: 12 months for each participant
Subjective Success - Change from baseline Pelvic Organ Prolapse Symptom Score (POP-SS) to measure quality of life according to pelvic organ prolapse at 12th month.
Validated into Turkish language form will be used to compare preoperative and postoperative period. Total range scores: 28 (min:0, max:28). Higher values represent a worse outcome.
Measured: 12 months for each participant
Subjective Success - Change from baseline Visual Analog Score (VAS) for pain at 12th month.
Participant describes the pain related to the mesh. The respondent selects a whole number (0-10 integers) that best reflects the intensity of their pain with a format of a horizontal bar.
Measured: 12 months for each participant
Change from baseline Pelvic Hiatus measurements (mm) at 12th month.
Anteroposterior hiatal length (mm)
Measured: 12 months for each participant
Change from baseline Pelvic biometry measurements at 12th month.
Prolapse degree over symphysis pubis (mm) Anterior compartment over 10mm, Posterior compartment over 15 mm are clinically relevant
Measured: 12 months for each participant
Change from baseline bladder neck mobility measurements at 12th month.
Urethral rotation (degree) between rest and valsalva maneuver states
Measured: 12 months for each participant
Failure (%)
Failure is defined by any recurrence of prolapse, mesh erosion and need for additional surgery
Measured: 12 months for each participant
Complications
Perioperative and postoperative complications including Severe bleeding, hematoma, bladder injury, bowel injury, ureter injury, vascular injury, nerve injury, abscess, lower urinary tract infections, mesh extrusion, mesh exposure, prolapse recurrence, De novo SUI/OAB, dyspareunia, pelvic pain
Measured: 12 months for each participant
Operation time
Duration of the operation between the first skin incision and suturing the skin of the trocar entries
Measured: Operation time will noted for each participant at the same day of the operation. Operation time will be determined with using a chronometer,from the time of first skin incision until the suturing the skin of the trocar entry, assessed up to 52 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start24 Jan 2018
- Primary completion14 Mar 2019
- Study completion14 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sisli Hamidiye Etfal Training and Research Hospital
- Responsible party
- Principal investigator, MURAT YASSA, Fatih Sultan Mehmet Training and Research Hospital
- Investigators
- Niyazi Tug, As.Prof., Study director, Chief of the Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03421457
- Sponsor's protocol ID
- RCTPOPS
- Status last verified
- Mar 2019
- First submitted
- 21 Jan 2018
- Last updated
- 18 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study Protocol
Publications
Veit-Rubin N, Dubuisson JB, Gayet-Ageron A, Lange S, Eperon I, Dubuisson J. Patient satisfaction after laparoscopic lateral suspension with mesh for pelvic organ prolapse: outcome report of a continuous series of 417 patients. Int Urogynecol J. 2017 Nov;28(11):1685-1693. doi: 10.1007/s00192-017-3327-2. Epub 2017 Apr 17.
PubMed 28417156
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Prospective, Controlled Study Comparing Uterine Preserving Laparoscopic Lateral Suspension With Mesh Versus Laparoscopic Sacrocervicopexy in the Treatment of Uterine Prolapse: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03421457
- Acronym / sponsor ID
- RCTPOPS
- Conditions
- Pelvic Organ Prolapse, Pelvic Floor Prolapse
- Keywords
- Pelvic Organ Prolapse, Translabial ultrasound, Transperineal ultrasound, Lateral Mesh Suspension, Descensus uteri, Laparoscopic pelvic organ prolapse repair, Uterus preserving, hysteropexy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Collaborators
- Sisli Hamidiye Etfal Training and Research Hospital
- Study start
- 24 Jan 2018 (actual)
- Primary completion
- 14 Mar 2019 (actual)
- Study completion
- 14 Mar 2019 (actual)
- First posted
- 5 Feb 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 study is aimed to compare the efficiency of two uterus-preserving laparoscopic methods to treat uterine prolapse in a randomized controlled trial. Laparoscopic lateral suspension with mesh (LLSM) will be compared with laparoscopic sacrohysteropexy (LS). Both procedures are known as sufficient uterus preserving methods. LLSM was introduced to be an alternative to others with avoiding dissection of promontory and therefore being safer, faster and feasible technique.
Detailed description
Patient with uterine prolapse can participate in this study. A total of 44 women will be included. At random 22 patients undergo laparoscopic lateral suspension with mesh operation and 22 patients undergo laparoscopic sacrohysteropexy operation. Evaluation will take place during the surgery, at the postoperative visit after 4 weeks, 6th months and 12th months. Quality of life, degree of vaginal prolapse, safety, operation time and complications will be evaluated.
Subjective assessments will include Female Sexual Function Index (FSFI), Michigan Incontinence Severity Index (M-ISI), Prolapse Quality of Life questionnaire (PQoL), Pelvic Organ Prolapse Symptom Score (POP-SS) and Visual Analog Score (VAS).
Objective assessments will include routine gynecologic sonography, Pelvic Organ Prolapse Quantification System (POP-Q) and pelvic floor biometry measured by transperineal sonography.
Transperineal sonography will include those measurements:
Urethral rotation, Pelvic organ descent, Hiatal Diameter and the Anatomical localization of apex.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lateral suspension | Experimental | Procedure: Uterus-preserving laparoscopic lateral suspension with mesh"Uterus-preserving Laparoscopic lateral suspension with mesh" technique will be performed in this arm. |
| Sacrocervicopexy | Experimental | Procedure: Uterus-preserving laparoscopic sacrocervicopexy with mesh"Uterus-preserving Laparoscopic sacrocervicopexy with mesh" technique will be performed in this arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- >18 years old
- > Symptomatic prolapse of central compartment with a Pelvic Organ Prolapse Quantitative (POP-Q) stage 2 associated or not with anterior or posterior compartment prolapse.
- Patients who are not comfortable with using or refusing pessary
- Wish to preserve the uterus
Key exclusion criteria (2 listed)
- Any cue for gynecologic oncological condition
- Patients who approves Le Fort colpocleisis among who does not have any sexual intercourse
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 |
|---|---|---|
| Uterus-preserving laparoscopic lateral suspension with meshV-shaped 2cm wide and 25cm length mesh strip is prepared from a 30x30cm Prolene mesh (Ethicon J\&J).Deep dissection of the uterovesical space is performed.Cutaneous incisions are bilaterally made 3-4 cm superoposterior to the anterosuperior iliac spine.A grasper is introduced retroperitoneally through the sub-peritoneum holding the beginning part of mesh until reaching the vesicovaginal space in an oblique route rather than transverse.Round ligament is lifted upward and tunnel is practiced horizontally.Assistant grasper catches the distal mesh and pulls out through the opposite subperitoneal tunnel.Corner of mesh is fixed to the pubocervical fascia,uterine cervix and isthmus with Absorba-Tack™(Covidien, Mansfield,USA).Tension-free lateral mesh suspension is achieved at the desired level. | Procedure or surgery | Lateral suspension |
| Uterus-preserving laparoscopic sacrocervicopexy with meshThe peritoneum over the sacral promontory is incised until the anterior longitudinal ligament is reached and ureters are identified. Peritoneal relaxing incision is made medial to the right ureter, down into the pelvis, posterior to the cervix and rectovaginal fascia, laterally to the rectum. The arm of the mesh is sutured to the posterior cervix by 2.0 prolene and fixated to the sacral promontory by either Tacker (Covidien) and/or 2.0 prolene as tension-free. Complete peritonisation of the mesh is performed. | Procedure or surgery | Sacrocervicopexy |
Primary outcome
Change from baseline POP-Q measurements (mm) at 12th month.
Time frame: 12 months for each participant
Prolapse degree; Point Ba/C/Bp
11 secondary outcomes
Subjective Success - Change from baseline Female Sexual Function Index (FSFI) to measure sexual dysfunction at 12th month.
Time frame: 12 months for each participant
Subjective Success - Change from baseline Michigan Incontinence Severity Index (M-ISI) to measure urinary incontinence at 12th month.
Time frame: 12 months for each participant
Subjective Success - Change from baseline Prolapse Quality of Life questionnaire (PQoL) to measure quality of life according to pelvic organ prolapse at 12th month.
Time frame: 12 months for each participant
Subjective Success - Change from baseline Pelvic Organ Prolapse Symptom Score (POP-SS) to measure quality of life according to pelvic organ prolapse at 12th month.
Time frame: 12 months for each participant
Subjective Success - Change from baseline Visual Analog Score (VAS) for pain at 12th month.
Time frame: 12 months for each participant
Change from baseline Pelvic Hiatus measurements (mm) at 12th month.
Time frame: 12 months for each participant
Change from baseline Pelvic biometry measurements at 12th month.
Time frame: 12 months for each participant
Change from baseline bladder neck mobility measurements at 12th month.
Time frame: 12 months for each participant
Failure (%)
Time frame: 12 months for each participant
Complications
Time frame: 12 months for each participant
Operation time
Time frame: Operation time will noted for each participant at the same day of the operation. Operation time will be determined with using a chronometer,from the time of first skin incision until the suturing the skin of the trocar entry, assessed up to 52 weeks.
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 18 Mar 2019.
- Background: PubMed 28417156Veit-Rubin N, Dubuisson JB, Gayet-Ageron A, Lange S, Eperon I, Dubuisson J. Patient satisfaction after laparoscopic lateral suspension with mesh for pelvic organ prolapse: outcome report of a continuous series of 417 patients. Int Urogynecol J. 2017 Nov;28(11):1685-1693. doi: 10.1007/s00192-017-3327-2. Epub 2017 Apr 17.
- Individual participant dataSharing planned: No. Study Protocol
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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.
Niyazi Tug, As.Prof. study director
Chief of the Department
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Uterus-preserving laparoscopic lateral suspension with mesh and Uterus-preserving laparoscopic sacrocervicopexy with mesh in people with Pelvic Organ Prolapse and Pelvic Floor Prolapse, run by Fatih Sultan Mehmet Training and Research Hospital at 2 sites 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 4 inclusion and 2 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 18 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Change from baseline POP-Q measurements (mm) at 12th month. (time frame: 12 months for each participant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03421457, which also lists 1 linked publication.
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 18 Mar 2019; AzTrials last refreshed its copy on 8 Nov 2026.