Pelvic Organ ProlapseNCT05876975
Vaginal Axis on Magnetic Resonance Imaging After Laparoscopic Pectopexy Surgery: a Controlled Study
A study testing laparoscopic pectopexy in people with Pelvic Organ Prolapse, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
Trial summary
Pelvic organ prolapse (POP) is a major public health concern that adversely affects the physical and psychological well-being of women. In fact, the lifetime risk of POP surgery is 12.6%, highlighting the magnitude of the problem. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- laparoscopic pectopexy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Jan 2023to 1 Jul 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women diagnosed with apical pelvic organ prolapse (POP), who did not require an additional posterior colporrhaphy procedure, and desired to undergo uterus-preserving surgery were scheduled for laparoscopic pectopexy.
- Nulliparous women without pelvic organ prolapse (asymptomatic grade 1 or less) who presented to the outpatient clinic with complaints other than POP symptoms (e.g., menstrual irregularity) were randomly selected and assigned as the control group.
Who cannot join
- Women with uterine size greater than 10 cm or a pelvic mass that may alter or interfere with accurate measurement.
- Women with any congenital or acquired anatomical or reproductive anomaly.
- Women diagnosed with enterocele through transperineal ultrasound prior to enrollment.
- Women who require hysterectomy or concomitant pelvic organ prolapse (POP) or anti- incontinence procedure.
- Women with abnormal uterine bleeding.
- Women with abnormal cervical screening test results.
Show all 13Show fewer
- In Control Group
- Women who have given birth previously.
- Women with a history of pelvic organ prolapse or any pelvic floor disorders.
- Women who have undergone pelvic surgery.
- Women with any congenital or acquired anatomical or reproductive anomaly.
- Women with abnormal uterine bleeding.
- Women with abnormal cervical screening test results.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Prof. Dr. Cemil Taşcıoğlu City Hospital
Istanbul
pelin ilhan, +902123145555 ext. 10057, stratejicemiltascioglu@gmail.com
About this study
Official title: Vaginal Axis on MRI After Laparoscopic Pectopexy Surgery: a Controlled Study
Pelvic organ prolapse (POP) is a major public health concern that adversely affects the physical and psychological well-being of women. In fact, the lifetime risk of POP surgery is 12.6%, highlighting the magnitude of the problem. The most common form of POP involves defects in the anterior vaginal wall accompanied by apical prolapse. The primary objective of surgical treatment for POP is to mitigate symptoms and restore the pelvic support anatomy. Normally, the vaginal axis is directed posteriorly towards the S3 and S4 vertebrae, lying relatively horizontally to the levator plate, and forming an angle of about 130º between the middle and lower vagina. Although sacrocolpopexy (SCP) is considered the gold standard for treating POP, it alters the normal anatomical position of the vaginal axis towards the sacral promontory, which may increase the abdominal pressure load on the anterior wall and cause urge symptoms or de novo anterior compartment prolapse. Similarly, sacrospinous ligament fixation (SSLF) increases the risk of anterior vaginal wall prolapse, as it deviates the vaginal axis towards the posterior. However, laparoscopic lateral mesh suspension has recently become popular because it preserves the normal position of the vaginal axis, preventing such complications. A previous study found that the pectineal ligament (Cooper's ligament) is composed of stronger and more durable tissue than the sacrospinous ligament and arcus tendineus of the fascia pelvis. This structure is robust and can hold sutures well, and it is possible to find sufficient material for a suture in the lateral part of the iliopectineal ligament, facilitating pelvic floor reconstruction. This segment of the ligament is located at the second sacral vertebra (S2) level, which is the optimal level for the physiological axis of the vagina. S2 level serves as the anchor point for the physiological axis of the vagina. Further studies have demonstrated that laparoscopic pectopexy provides outcomes comparable to those of laparoscopic sacrocolpopexy for supporting the apical compartment during intermediate follow-up duration. The current study aimed to investigate the level of anatomical correction following laparoscopic pectopexy and compare the vaginal axis of patients with apical genital prolapse to that of nulliparous women using magnetic resonance imaging (MRI).
Read the detailed description
Pelvic organ prolapse (POP) is a significant health concern that has a negative impact on the physical and psychological well-being of women. In fact, the lifetime risk of undergoing POP surgery is 12.6%. The most common form of POP involves defects in the anterior vaginal wall accompanied by apical prolapse. The primary goal of surgical treatment for POP is to alleviate symptoms and restore the anatomy of the pelvic support. The normal position of the vaginal axis is directed posteriorly towards the S3 and S4 vertebrae, lying relatively horizontally to the levator plate, and forming an angle of about 130º between the middle and lower vagina. Sacrocolpopexy (SCP) is considered the gold standard for treating POP, but it alters the normal anatomical position of the vaginal axis towards the sacral promontory, which may increase the abdominal pressure load on the anterior wall and cause urge symptoms or de novo anterior compartment prolapse. Although sacrospinous ligament fixation (SSLF) has promising long-term outcomes for correcting the apical anatomy, it increases the risk of anterior vaginal wall prolapse, like SCP, due to the deviation of the vaginal axis towards the posterior. Recently, laparoscopic lateral mesh suspension, which keeps the vaginal axis close to normal, has become popular. In a previous study, it was found that the pectineal ligament (Cooper's ligament) is composed of stronger and more durable tissue than the sacrospinous ligament and arcus tendineus of the fascia pelvis. This structure is robust and can hold sutures well. Sufficient material for a suture can also be found in the lateral part of the iliopectineal ligament, making pelvic floor reconstruction easier. This segment of the ligament is located at the second sacral vertebra (S2) level, which is the optimal level for the physiological axis of the vagina. S2 level is the anchor point for the physiological axis of the vagina. Further studies have demonstrated comparable outcomes for supporting the apical compartment at intermediate follow-up duration compared to laparoscopic sacrocolpopexy. This study aimed to investigate the level of anatomical correction following Laparoscopic pectopexy and compare the vaginal axis of patients with apical genital prolapse to that of nulliparous women using magnetic resonance imaging (MRI).
- Conditions
- Pelvic Organ Prolapse
- Being tested
- laparoscopic pectopexy
- Keywords
- Magnetic resonance imaging (MRI), vaginal angle, vaginal axis, pelvic organ prolapse (POP)
- 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 pectopexyProcedure or surgery
Women with pelvic organ prolapse and suitable indications underwent laparoscopic pectopexy.
| Study group | Role | What they receive |
|---|---|---|
| procedure: laparoscopic pectopexy | Active comparator | MRI evaluation will be conducted on eleven participants who underwent laparoscopic pectopexy surgery after one month. Receives: Procedure: laparoscopic pectopexy |
| Nulliparous women with no uterovaginal prolapsed | No intervention | Ten nulliparous participants with no uterovaginal prolapsed will be evaluate by MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anatomic Success
anatomic success will be evaluated by using magnetic resonance imaging. Vaginal axis (distance to spin ischiadic a and sacrum) will be measure on three plane
Measured: 3 months
Secondary outcomes (2)
Urge Symptoms stres incontinence
UDI-6 Th e UDI-6 was developed to evaluate the functions of the bladder and to establish which symptom causes the problem. It comprises 6 questions. Th e fi rst 2 questions are related to irritative symptoms (urgency, frequency, and pain), questions 3 and 4 are related to stress incontinence, and the last 2 questions are related to obstructive or voiding diffi culty symptoms. High UDI-6 scores show the severity of the urogenital complaints
Measured: 3 month
Sexual functions
The 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 tFhat 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: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start4 Jan 2023
- Primary completion4 Jun 2023 (estimated)
- Study completion1 Jul 2023 (estimated)
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
- None (open label)
- Enrolment
- 21 participants (estimated)
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
- Investigators
- fatih şahin, MD, Principal investigator, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05876975
- Sponsor's protocol ID
- 77
- Status last verified
- May 2023
- First submitted
- 11 May 2023
- Last updated
- 26 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang H, Shen J, Li S, Gao Z, Ke K, Gu P. The feasibility of uterine-vaginal axis MRI-based as evaluation of surgical efficacy in women with pelvic organ prolapse. Ann Transl Med. 2022 Apr;10(8):447. doi: 10.21037/atm-22-1173.
PubMed 35571410
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Axis on MRI After Laparoscopic Pectopexy Surgery: a Controlled Study
- ClinicalTrials.gov ID
- NCT05876975
- Acronym / sponsor ID
- 77
- Conditions
- Pelvic Organ Prolapse
- Keywords
- Magnetic resonance imaging (MRI), vaginal angle, vaginal axis, pelvic organ prolapse (POP)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital OrganizationUniversity, hospital or other
- Study start
- 4 Jan 2023 (actual)
- Primary completion
- 4 Jun 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 26 May 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.
Pelvic organ prolapse (POP) is a major public health concern that adversely affects the physical and psychological well-being of women. In fact, the lifetime risk of POP surgery is 12.6%, highlighting the magnitude of the problem. The most common form of POP involves defects in the anterior vaginal wall accompanied by apical prolapse. The primary objective of surgical treatment for POP is to mitigate symptoms and restore the pelvic support anatomy. Normally, the vaginal axis is directed posteriorly towards the S3 and S4 vertebrae, lying relatively horizontally to the levator plate, and forming an angle of about 130º between the middle and lower vagina. Although sacrocolpopexy (SCP) is considered the gold standard for treating POP, it alters the normal anatomical position of the vaginal axis towards the sacral promontory, which may increase the abdominal pressure load on the anterior wall and cause urge symptoms or de novo anterior compartment prolapse. Similarly, sacrospinous ligament fixation (SSLF) increases the risk of anterior vaginal wall prolapse, as it deviates the vaginal axis towards the posterior. However, laparoscopic lateral mesh suspension has recently become popular because it preserves the normal position of the vaginal axis, preventing such complications. A previous study found that the pectineal ligament (Cooper's ligament) is composed of stronger and more durable tissue than the sacrospinous ligament and arcus tendineus of the fascia pelvis. This structure is robust and can hold sutures well, and it is possible to find sufficient material for a suture in the lateral part of the iliopectineal ligament, facilitating pelvic floor reconstruction. This segment of the ligament is located at the second sacral vertebra (S2) level, which is the optimal level for the physiological axis of the vagina. S2 level serves as the anchor point for the physiological axis of the vagina. Further studies have demonstrated that laparoscopic pectopexy provides outcomes comparable to those of laparoscopic sacrocolpopexy for supporting the apical compartment during intermediate follow-up duration. The current study aimed to investigate the level of anatomical correction following laparoscopic pectopexy and compare the vaginal axis of patients with apical genital prolapse to that of nulliparous women using magnetic resonance imaging (MRI).
Detailed description
Pelvic organ prolapse (POP) is a significant health concern that has a negative impact on the physical and psychological well-being of women. In fact, the lifetime risk of undergoing POP surgery is 12.6%. The most common form of POP involves defects in the anterior vaginal wall accompanied by apical prolapse. The primary goal of surgical treatment for POP is to alleviate symptoms and restore the anatomy of the pelvic support. The normal position of the vaginal axis is directed posteriorly towards the S3 and S4 vertebrae, lying relatively horizontally to the levator plate, and forming an angle of about 130º between the middle and lower vagina. Sacrocolpopexy (SCP) is considered the gold standard for treating POP, but it alters the normal anatomical position of the vaginal axis towards the sacral promontory, which may increase the abdominal pressure load on the anterior wall and cause urge symptoms or de novo anterior compartment prolapse. Although sacrospinous ligament fixation (SSLF) has promising long-term outcomes for correcting the apical anatomy, it increases the risk of anterior vaginal wall prolapse, like SCP, due to the deviation of the vaginal axis towards the posterior. Recently, laparoscopic lateral mesh suspension, which keeps the vaginal axis close to normal, has become popular. In a previous study, it was found that the pectineal ligament (Cooper's ligament) is composed of stronger and more durable tissue than the sacrospinous ligament and arcus tendineus of the fascia pelvis. This structure is robust and can hold sutures well. Sufficient material for a suture can also be found in the lateral part of the iliopectineal ligament, making pelvic floor reconstruction easier. This segment of the ligament is located at the second sacral vertebra (S2) level, which is the optimal level for the physiological axis of the vagina. S2 level is the anchor point for the physiological axis of the vagina. Further studies have demonstrated comparable outcomes for supporting the apical compartment at intermediate follow-up duration compared to laparoscopic sacrocolpopexy. This study aimed to investigate the level of anatomical correction following Laparoscopic pectopexy and compare the vaginal axis of patients with apical genital prolapse to that of nulliparous women using magnetic resonance imaging (MRI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| procedure: laparoscopic pectopexy | Active comparator | Procedure: laparoscopic pectopexyMRI evaluation will be conducted on eleven participants who underwent laparoscopic pectopexy surgery after one month. |
| Nulliparous women with no uterovaginal prolapsed | No intervention | –Ten nulliparous participants with no uterovaginal prolapsed will be evaluate by MRI |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women diagnosed with apical pelvic organ prolapse (POP), who did not require an additional posterior colporrhaphy procedure, and desired to undergo uterus-preserving surgery were scheduled for laparoscopic pectopexy.
- Nulliparous women without pelvic organ prolapse (asymptomatic grade 1 or less) who presented to the outpatient clinic with complaints other than POP symptoms (e.g., menstrual irregularity) were randomly selected and assigned as the control group.
Key exclusion criteria (13 listed)
- Women with uterine size greater than 10 cm or a pelvic mass that may alter or interfere with accurate measurement.
- Women with any congenital or acquired anatomical or reproductive anomaly.
- Women diagnosed with enterocele through transperineal ultrasound prior to enrollment.
- Women who require hysterectomy or concomitant pelvic organ prolapse (POP) or anti- incontinence procedure.
- Women with abnormal uterine bleeding.
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 pectopexyWomen with pelvic organ prolapse and suitable indications underwent laparoscopic pectopexy. | Procedure or surgery | procedure: laparoscopic pectopexy |
Primary outcome
Anatomic Success
Time frame: 3 months
anatomic success will be evaluated by using magnetic resonance imaging. Vaginal axis (distance to spin ischiadic a and sacrum) will be measure on three plane
2 secondary outcomes
Urge Symptoms stres incontinence
Time frame: 3 month
Sexual functions
Time frame: 3 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2023.
- Background: PubMed 35571410Wang H, Shen J, Li S, Gao Z, Ke K, Gu P. The feasibility of uterine-vaginal axis MRI-based as evaluation of surgical efficacy in women with pelvic organ prolapse. Ann Transl Med. 2022 Apr;10(8):447. doi: 10.21037/atm-22-1173.
- Individual participant dataSharing planned: No
Related trials for Pelvic Organ Prolapse
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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.
fatih şahin, MD principal investigator
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic pectopexy in people with Pelvic Organ Prolapse, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization 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 2 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 26 May 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fatih Şahin, MD (+905447430167, fatih_sahin67@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anatomic Success (time frame: 3 months). 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 NCT05876975, 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 26 May 2023.