Pelvic Organ ProlapseNCT06072456
Comparison of Vaginal Axis on MRI in Alternative Apical Prolapse Surgeries to Sacrocolpopexy
A study testing laparoscopic lateral suspension, laparoscopic pectopexy and Sacrospinous ligament fixation in people with Pelvic Organ Prolapse, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 2 sites in Turkey (Türkiye).
Trial summary
Sacrocolpopexy remains the preeminent modality in addressing apical prolapse surgically. Nevertheless, amplified morbidity rates within cohorts characterized by obesity and advanced age constrain the advantages conferred by the procedure. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- laparoscopic lateral suspension, laparoscopic pectopexy and Sacrospinous ligament fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Aug 2023to 27 Dec 2023
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female with genital prolapse
Who cannot join
- Patients who had pouch of Douglas obliteration
- Patients with enterocele
- Patients who have any congenital or acquired anatomic and reproductive anomaly
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Cemil Taşcıoğlu Hospital
Istanbul, 34320
Prof.Dr.Cemil Taşcıoğlu Hospital
Istanbul, 34320
About this study
Sacrocolpopexy remains the preeminent modality in addressing apical prolapse surgically. Nevertheless, amplified morbidity rates within cohorts characterized by obesity and advanced age constrain the advantages conferred by the procedure. Recent years have witnessed a proliferation of inquiries appraising the efficacy of laparoscopic lateral suspension, pectopexy, and sacrospinous ligament fixation interventions, which have, over time, garnered extensive clinical application, in relation to recurrence rates. A multitude of investigations have been undertaken to delineate the optimal vaginal axis. In the present investigation, we have delineated a research protocol aimed at scrutinizing these alternative surgical modalities with regard to their impact on the vaginal axis.
Read the detailed description
The study objective pertains to the assessment of vaginal axis in patients undergoing apical prolapse surgery, whether they have undergone hysterectomy or not. The investigation is designed to test the null hypothesis by means of a comparative analysis of preoperative and postoperative Magnetic Resonance Imaging images capturing the vaginal axis. This examination will be conducted on patients slated to receive lateral mesh suspension, pectopexy, and sacrospinous ligament fixation procedures for the correction of apical prolapse.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- laparoscopic lateral suspension, laparoscopic pectopexy, Sacrospinous ligament fixation
- Keywords
- pelvic organ prolapse, apical prolapse, pectopexy, sacrospinous ligament fixation, Lateral suspension
- 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.
laparoscopic lateral suspensionProcedure or surgery
Lateral suspension involves the lateral attachment or suspension of vaginal tissue to a stable structure, often using mesh or sutures, to provide support and stability to the pelvic organs. Control groups consist of hysterectomized women without cuff prolapse and nulliparous women.
laparoscopic pectopexyProcedure or surgery
Pectopexy involves attaching or suspending the vaginal vault to the pectineal ligament, which is a strong ligament in the pelvis. Control groups consist of hysterectomized women without cuff prolapse and nulliparous women.
Sacrospinous ligament fixationProcedure or surgery
Sacrospinous ligament fixation entails the attachment or fixation of the vaginal vault to the sacrospinous ligament, which is a strong fibrous band located in the pelvis
| Study group | Role | What they receive |
|---|---|---|
| lateral suspension | Experimental | Suspending the cervix to the bilateral abdominal wall through subperitoneal tunnels may properly mimic cardinal ligament and restore the normal vaginal axis. Preoperative and postoperative MRI results were evaluated Receives: Procedure: laparoscopic lateral suspension |
| pectopexy | Experimental | The cervix or vaginal cuff was suspended by the Cooper ligament.Preoperative and postoperative MRI results were evaluated Receives: Procedure: laparoscopic pectopexy |
| sacrospinous ligament fixation | Experimental | vaginal cuff/uterus was sutured to the unilateral sacrospinous ligament.Preoperative and postoperative MRI results were evaluated Receives: Procedure: Sacrospinous ligament fixation |
| hysterectomized patients | No intervention | Vaginal axis MRI of women who have previously been hysterectomized and who do not have apical prolapse |
| Nulliparous women | No intervention | MRI of nulliparous women was evaluated for vaginal axis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal axis
From the images obtained in the sagittal plane, the vagina, which will be observed as a high signal intensity linear structure in T2A images, and the levator plate extending as a flow-signal intensity flat structure in T1A images, will be evaluated.
Measured: at 4th months after the operation
Vaginal distances
The distance between the posterior vaginal fornix and the midpoint of the anterior side of the 2nd vertebra will be measured in the mid-sagittal plane (PF-S2). The distance between the right spina ischiadica and right vaginal fornix (RSI-RF), and, the distance between the left spina ischiadica and left vaginal fornix (LSI-LF) will be measured on T2A images acquired in the axial plane.
Measured: at 4th months after the operation
Secondary outcomes (7)
Prolapse symptoms, Colorectal-Anal Impact Questionnaire
The Pelvic Floor Impact Questionnaire-Short Form 7 (PFIQ-7) consists of three scales of seven questions, each taken from the Urinary Incontinence Impact Questionnaire, the Pelvic Organ Prolapse Impact Questionnaire, and the Colorectal-Anal Impact Questionnaire. The three scales are scored from 0 (least impact) to 100 (greatest impact) and an overall summary score (0 to 300) describes the impact on day to day activities. It is useful to determine changes in symptom-severity over time and before and after treatments
Measured: at 4th months after the operation
Prolapse symptoms
The Pelvic Floor Distress Inventory-Short Form 20 (PFDI-20) measures both pelvic floor symptoms and the degree of bother and distress associated with those symptoms. The PFDI-20 includes 20 questions and three scales. Each of the three scales is scored from 0 (least distress) to 100 (greatest distress), again with an overall score ranging from 0-300 and higher scores indicating lower quality of life. The three scales include questions taken from the Urogenital Distress Inventory-6 questions, the Pelvic Organ Prolapse Distress Inventory-6 questions, and the Colorectal-Anal Distress Inventory-8 questions.
Measured: at 4th months after the operation
Urinary Symptoms
Validated scales were applied for this purpose, including the urogenital distress inventory-6 (UDI-6), which is a shortened version of a condition-specific quality of life instrument. The UDI-6 is frequently used due to its feasibility and is validated at level A according to the International Continence Society (ICI) grading system. The UDI-6 scale includes six items that assess various aspects of urinary symptoms and their impact on daily life. These items include: 1) Frequent urination, 2) Leakage related to the feeling of urgency, 3) Leakage related to activity, 4) Coughing or sneezing small amounts of leakage (drops), 5) Difficulty emptying the bladder, and 6) Pain or discomfort in the lower abdominal or genital area. Higher scores on the UDI-6 indicate a higher level of disability in these areas.
Measured: at 4th months after the operation
Postoperative de novo dyspareunia
Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) Postoperative de novo dyspareunia assessed by the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) with main focus on Question 5, which represents how the participant feels about her sex life (I feel frustrated by my sex life/I feel sexually inferior because of my incontinence and/or prolapse/I feel angry because of the impact that incontinence and/or prolapse has on my sex life)
Measured: at 4th months after the operation
Sexual functions
The Female Sexual Function Index (FSFI) evaluates sexual functioning in women and comprises of 19 questions with different answer choice scales referring the sexual life in the previous 4 weeks. The answer choices in the FSFI carry a number of points and are summed to obtain six domain scores and an overall score. For the latter, there is a threshold at 26.55 which means that all values below are classed as indicating female sexual dysfunction (FSD). The domain scores are obtained as the sum of points attributed to questions in that domain multiplied by the domain factor.
Measured: at 4th months after the operation
Quality of life measures
General health Short Form Health Survey (SF-12) Form includes two questions concerning physical functioning; two questions on role limitations due to physical health problems; one question on bodily pain; one question on general health perceptions; one question on vitality (energy/fatigue); one question on social functioning; two questions on role limitations due to emotional problems; and two questions on general mental health (psychological distress and psychological well-being
Measured: at 4th months after the operation
Patient Global Impression of Improvement (PGI-I)
Patient Global Impression of Improvement (PGI-I). A low score on the PGI-I indicates an overall improvement in a woman's perception of her condition after treatment (PGI-I score of 1 or 2 = very much better and much better, respectively
Measured: at 4th months after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start1 Aug 2023
- Primary completion1 Dec 2023
- Study completion27 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, fatih sahin, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06072456
- Sponsor's protocol ID
- E-10840098-772.02-4704
- Status last verified
- Dec 2023
- First submitted
- 3 Oct 2023
- Last updated
- 28 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Senturk MB, Kilicci C, Aydin S, Polat M, Abide Yayla C, Karateke A. Vaginal axis on MRI after unilateral and bilateral sacral hysteropexy: a controlled study. J Obstet Gynaecol. 2018 Jan;38(1):115-120. doi: 10.1080/01443615.2017.1336754. Epub 2017 Aug 17.
PubMed 28816554Pulatoglu C, Yassa M, Turan G, Turkyilmaz D, Dogan O. Vaginal axis on MRI after laparoscopic lateral mesh suspension surgery: a controlled study. Int Urogynecol J. 2021 Apr;32(4):851-858. doi: 10.1007/s00192-020-04596-8. Epub 2020 Nov 11.
PubMed 33175232
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Vaginal Axis on MRI in Alternative Apical Prolapse Surgeries to Sacrocolpopexy
- ClinicalTrials.gov ID
- NCT06072456
- Acronym / sponsor ID
- E-10840098-772.02-4704
- Conditions
- Pelvic Organ Prolapse
- Keywords
- pelvic organ prolapse, apical prolapse, pectopexy, sacrospinous ligament fixation, Lateral suspension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital OrganizationUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 27 Dec 2023 (actual)
- First posted
- 10 Oct 2023 (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.
Sacrocolpopexy remains the preeminent modality in addressing apical prolapse surgically. Nevertheless, amplified morbidity rates within cohorts characterized by obesity and advanced age constrain the advantages conferred by the procedure. Recent years have witnessed a proliferation of inquiries appraising the efficacy of laparoscopic lateral suspension, pectopexy, and sacrospinous ligament fixation interventions, which have, over time, garnered extensive clinical application, in relation to recurrence rates. A multitude of investigations have been undertaken to delineate the optimal vaginal axis. In the present investigation, we have delineated a research protocol aimed at scrutinizing these alternative surgical modalities with regard to their impact on the vaginal axis.
Detailed description
The study objective pertains to the assessment of vaginal axis in patients undergoing apical prolapse surgery, whether they have undergone hysterectomy or not. The investigation is designed to test the null hypothesis by means of a comparative analysis of preoperative and postoperative Magnetic Resonance Imaging images capturing the vaginal axis. This examination will be conducted on patients slated to receive lateral mesh suspension, pectopexy, and sacrospinous ligament fixation procedures for the correction of apical prolapse.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| lateral suspension | Experimental | Procedure: laparoscopic lateral suspensionSuspending the cervix to the bilateral abdominal wall through subperitoneal tunnels may properly mimic cardinal ligament and restore the normal vaginal axis. Preoperative and postoperative MRI results were evaluated |
| pectopexy | Experimental | Procedure: laparoscopic pectopexyThe cervix or vaginal cuff was suspended by the Cooper ligament.Preoperative and postoperative MRI results were evaluated |
| sacrospinous ligament fixation | Experimental | Procedure: Sacrospinous ligament fixationvaginal cuff/uterus was sutured to the unilateral sacrospinous ligament.Preoperative and postoperative MRI results were evaluated |
| hysterectomized patients | No intervention | –Vaginal axis MRI of women who have previously been hysterectomized and who do not have apical prolapse |
| Nulliparous women | No intervention | –MRI of nulliparous women was evaluated for vaginal axis. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Female with genital prolapse
Key exclusion criteria (3 listed)
- Patients who had pouch of Douglas obliteration
- Patients with enterocele
- Patients who have any congenital or acquired anatomic and reproductive anomaly
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 suspensionLateral suspension involves the lateral attachment or suspension of vaginal tissue to a stable structure, often using mesh or sutures, to provide support and stability to the pelvic organs. Control groups consist of hysterectomized women without cuff prolapse and nulliparous women. | Procedure or surgery | lateral suspension |
| laparoscopic pectopexyPectopexy involves attaching or suspending the vaginal vault to the pectineal ligament, which is a strong ligament in the pelvis. Control groups consist of hysterectomized women without cuff prolapse and nulliparous women. | Procedure or surgery | pectopexy |
| Sacrospinous ligament fixationSacrospinous ligament fixation entails the attachment or fixation of the vaginal vault to the sacrospinous ligament, which is a strong fibrous band located in the pelvis | Procedure or surgery | sacrospinous ligament fixation |
Primary outcome
Vaginal axis
Time frame: at 4th months after the operation
From the images obtained in the sagittal plane, the vagina, which will be observed as a high signal intensity linear structure in T2A images, and the levator plate extending as a flow-signal intensity flat structure in T1A images, will be evaluated.
Vaginal distances
Time frame: at 4th months after the operation
The distance between the posterior vaginal fornix and the midpoint of the anterior side of the 2nd vertebra will be measured in the mid-sagittal plane (PF-S2). The distance between the right spina ischiadica and right vaginal fornix (RSI-RF), and, the distance between the left spina ischiadica and left vaginal fornix (LSI-LF) will be measured on T2A images acquired in the axial plane.
7 secondary outcomes
Prolapse symptoms, Colorectal-Anal Impact Questionnaire
Time frame: at 4th months after the operation
Prolapse symptoms
Time frame: at 4th months after the operation
Urinary Symptoms
Time frame: at 4th months after the operation
Postoperative de novo dyspareunia
Time frame: at 4th months after the operation
Sexual functions
Time frame: at 4th months after the operation
Quality of life measures
Time frame: at 4th months after the operation
Patient Global Impression of Improvement (PGI-I)
Time frame: at 4th months after the operation
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 28 Dec 2023.
- Results publication: PubMed 28816554Senturk MB, Kilicci C, Aydin S, Polat M, Abide Yayla C, Karateke A. Vaginal axis on MRI after unilateral and bilateral sacral hysteropexy: a controlled study. J Obstet Gynaecol. 2018 Jan;38(1):115-120. doi: 10.1080/01443615.2017.1336754. Epub 2017 Aug 17.
- Results publication: PubMed 33175232Pulatoglu C, Yassa M, Turan G, Turkyilmaz D, Dogan O. Vaginal axis on MRI after laparoscopic lateral mesh suspension surgery: a controlled study. Int Urogynecol J. 2021 Apr;32(4):851-858. doi: 10.1007/s00192-020-04596-8. Epub 2020 Nov 11.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic lateral suspension, laparoscopic pectopexy and Sacrospinous ligament fixation in people with Pelvic Organ Prolapse, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization 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 1 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 28 Dec 2023. 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?
Vaginal axis (time frame: at 4th months after the operation). 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?
On the ClinicalTrials.gov record for NCT06072456, which also lists 2 linked publications.
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 28 Dec 2023.