Pelvic Organ ProlapseNCT03387202
Laparoscopic Lateral Mesh Suspension for Pelvic Organ Prolapse
An observational study of Pelvic Organ Prolapse and Pelvic Floor Prolapse, run by Fatih Sultan Mehmet Training and Research Hospital.
Trial summary
This study is aimed to share our clinical experience in an uterine-preserving laparoscopic lateral suspension of apical prolapses with mesh operation after minor modifications in technique. Transperineal ultrasonography and several questionnaires are used for objective and subjective outcomes. 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?
- Laparoscopic lateral suspension with mesh and Transperineal ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2016to 5 Feb 2018
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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
Study population: Symptomatic women with pelvic organ prolapse
Who may be able to join
- >18 years old symptomatic women with pelvic organ prolapse needing surgery.
- Patients who are not comfortable with using or refusing pessary
- Refusing sacrocolpopexy due to its serious surgical risk
Who cannot join
- Patients who prefer sacrocolpopexy
- Any cue for gynecologic oncological condition
- Patients who approves Le Fort colpocleisis among who does not have any sexual intercourse
About this study
Official title: Uterine Preserving Apical Prolapse Correction With Laparoscopic Lateral Mesh Suspension: Initial Experience by Defining Anatomic and Subjective Success
This study is aimed to share our clinical experience in an uterine-preserving laparoscopic lateral suspension of apical prolapses with mesh operation after minor modifications in technique. Transperineal ultrasonography and several questionnaires are used for objective and subjective outcomes.
Read the detailed description
Vaginal length, bladder neck mobility and pelvic floor biometry with anteroposterior hiatal diameter and pelvic organ descent measurements are measured by transperineal ultrasonography to assess anatomic success in the preoperative and at postoperative 18th months if available.
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) are used to assess subjective success in the preoperative and at postoperative 18th months if available.
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- Conditions
- Pelvic Organ Prolapse, Pelvic Floor Prolapse
- Being tested
- Laparoscopic lateral suspension with mesh, Transperineal ultrasound
- Keywords
- Pelvic Organ Prolapse, Translabial ultrasound, Transperineal ultrasound, Lateral Mesh Suspension, Descensus uteri, Laparoscopic pelvic organ prolapse repair
- 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.
Laparoscopic lateral suspension with meshProcedure or surgery
V-shaped ccm 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 3cmsuperoposterior to the anteriosuperior iliac spine.A grasper is introduced retroperitoneally through the subperitoneum holding the beginning part of mesh until reaching the vesicovaginal space in an oblique route rather than transverse.Broad ligament is lifted upward and tunnel is practiced in its lower third.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
Transperineal ultrasoundDiagnostic test
Also called Translabial ultrasound
Vaginal length, bladder neck mobility and pelvic floor biometry with anterioposterior hiatal diameter and pelvic organ descent measurements are measured by transperineal ultrasonography to assess anatomic success in the preoperative and at postoperative first third and sixth months if available.
| Study group | Role | What they receive |
|---|---|---|
| pelvic organ prolapse | Participants received "Laparoscopic lateral suspension with mesh" as part of routine medical care in apical prolapse, thus, the investigator does not assign a intervention but studies the effects.Vaginal length, bladder neck mobility and pelvic floor biometry with AP hiatal diameter and pelvic organ descent measurements are measured by Transperineal ultrasound to assess anatomic success in the preoperative and at postoperative 18th months. POP-Q assessment and translabial usg for objective success; 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) are used to assess subjective success. Receives: Procedure: Laparoscopic lateral suspension with mesh; Diagnostic Test: Transperineal ultrasound |
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 18th month.
Prolapse degree; Point Ba/C/Bp
Measured: 18 months
Secondary outcomes (9)
Subjective Success - Change from baseline Female Sexual Function Index (FSFI) to measure sexual dysfunction at 18th 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 SF during the previous 4 weeks. 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: 18 months
Subjective Success - Change from baseline Michigan Incontinence Severity Index (M-ISI) to measure urinary incontinence at 18th 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: 18 months
Subjective Success - Change from baseline Prolapse Quality of Life questionnaire (PQoL) to measure quality of life according to pelvic organ prolapse at 18th 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: 18 months
Subjective Success - Change from baseline Pelvic Organ Prolapse Symptom Score (POP-SS) to measure quality of life according to pelvic organ prolapse at 18th 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: 18 months
Subjective Success - Change from baseline Visual Analog Score (VAS) for pain at 18th 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: 18 months
Change from baseline Pelvic Hiatus measurements (mm) at 18th month.
Anteroposterior hiatal length (mm)
Measured: 18 months
Change from baseline Pelvic biometry measurements at 18th month.
Prolapse degree over symphysis pubis (mm) Anterior compartment over 10, Posterior compartment over 15 mm are clinically relevant
Measured: 18 months
Change from baseline bladder neck mobility measurements at 18th month.
Urethral rotation (degree) between rest and valsalva maneuver states
Measured: 18 months
Failure (%)
Failure is defined by any recurrence of prolapse, mesh erosion and need for additional surgery
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2018
- Study start1 Nov 2016
- Primary completion12 Jan 2018
- Study completion5 Feb 2018
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MURAT YASSA, Fatih Sultan Mehmet Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03387202
- Sponsor's protocol ID
- FSM KAEHK
- Status last verified
- Feb 2018
- First submitted
- 1 Apr 2017
- Last updated
- 7 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uterine Preserving Apical Prolapse Correction With Laparoscopic Lateral Mesh Suspension: Initial Experience by Defining Anatomic and Subjective Success
- ClinicalTrials.gov ID
- NCT03387202
- Acronym / sponsor ID
- FSM KAEHK
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 12 Jan 2018 (actual)
- Study completion
- 5 Feb 2018 (actual)
- First posted
- 2 Jan 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 share our clinical experience in an uterine-preserving laparoscopic lateral suspension of apical prolapses with mesh operation after minor modifications in technique. Transperineal ultrasonography and several questionnaires are used for objective and subjective outcomes.
Detailed description
Vaginal length, bladder neck mobility and pelvic floor biometry with anteroposterior hiatal diameter and pelvic organ descent measurements are measured by transperineal ultrasonography to assess anatomic success in the preoperative and at postoperative 18th months if available.
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) are used to assess subjective success in the preoperative and at postoperative 18th months if available.
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Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pelvic organ prolapse | – | Procedure: Laparoscopic lateral suspension with mesh, Diagnostic Test: Transperineal ultrasoundParticipants received "Laparoscopic lateral suspension with mesh" as part of routine medical care in apical prolapse, thus, the investigator does not assign a intervention but studies the effects.Vaginal length, bladder neck mobility and pelvic floor biometry with AP hiatal diameter and pelvic organ descent measurements are measured by Transperineal ultrasound to assess anatomic success in the preoperative and at postoperative 18th months. POP-Q assessment and translabial usg for objective success; 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) are used to assess subjective success. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Symptomatic women with pelvic organ prolapse
Key inclusion criteria (3 listed)
- >18 years old symptomatic women with pelvic organ prolapse needing surgery.
- Patients who are not comfortable with using or refusing pessary
- Refusing sacrocolpopexy due to its serious surgical risk
Key exclusion criteria (3 listed)
- Patients who prefer sacrocolpopexy
- 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 |
|---|---|---|
| Laparoscopic lateral suspension with meshV-shaped ccm 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 3cmsuperoposterior to the anteriosuperior iliac spine.A grasper is introduced retroperitoneally through the subperitoneum holding the beginning part of mesh until reaching the vesicovaginal space in an oblique route rather than transverse.Broad ligament is lifted upward and tunnel is practiced in its lower third.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 | pelvic organ prolapse |
| Transperineal ultrasoundAlso: Translabial ultrasoundVaginal length, bladder neck mobility and pelvic floor biometry with anterioposterior hiatal diameter and pelvic organ descent measurements are measured by transperineal ultrasonography to assess anatomic success in the preoperative and at postoperative first third and sixth months if available. | Diagnostic test | pelvic organ prolapse |
Primary outcome
Change from baseline POP-Q measurements (mm) at 18th month.
Time frame: 18 months
Prolapse degree; Point Ba/C/Bp
9 secondary outcomes
Subjective Success - Change from baseline Female Sexual Function Index (FSFI) to measure sexual dysfunction at 18th month.
Time frame: 18 months
Subjective Success - Change from baseline Michigan Incontinence Severity Index (M-ISI) to measure urinary incontinence at 18th month.
Time frame: 18 months
Subjective Success - Change from baseline Prolapse Quality of Life questionnaire (PQoL) to measure quality of life according to pelvic organ prolapse at 18th month.
Time frame: 18 months
Subjective Success - Change from baseline Pelvic Organ Prolapse Symptom Score (POP-SS) to measure quality of life according to pelvic organ prolapse at 18th month.
Time frame: 18 months
Subjective Success - Change from baseline Visual Analog Score (VAS) for pain at 18th month.
Time frame: 18 months
Change from baseline Pelvic Hiatus measurements (mm) at 18th month.
Time frame: 18 months
Change from baseline Pelvic biometry measurements at 18th month.
Time frame: 18 months
Change from baseline bladder neck mobility measurements at 18th month.
Time frame: 18 months
Failure (%)
Time frame: 18 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 7 Feb 2018.
- Individual participant dataSharing planned: Yes. 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Organ Prolapse and Pelvic Floor Prolapse, run by Fatih Sultan Mehmet Training and Research Hospital.
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 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: finished, as of the sponsor's last update on 7 Feb 2018. 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?
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 18th month. (time frame: 18 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 7 Feb 2018.