Pelvic Organ ProlapseNCT04306250
Comparison of Posterior and Anterior Approach to Sacrospinous Ligament Apical Fixation - Randomized Controlled Trial
A study testing Apical prolapse fixation - anterior access and Apical prolapse fixation - posterior access in people with Pelvic Organ Prolapse and Surgical Procedure, Unspecified, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
Pelvic organ prolapse (POP) is a common problem among women. Apical prolapse (AP) is a prolapse of the uterus, or vaginal cuff, in women post hysterectomy. Apical fixation to the sacrospinous ligament (SSLF) was first introduced in 1968 by K.RICHTER. 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, Surgical Procedure, Unspecified
- What is being tested?
- Apical prolapse fixation - anterior access and Apical prolapse fixation - posterior access
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteIsrael
- Study dates
- 9 Jul 2020to 31 Dec 2025
- 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 with grade 2 or above apical prolapse, according to POP Q, combined with Grade II or above of anterior wall prolapse.
- Women who suffer from symptomatic POP and care for a surgical treatment
Who cannot join
- Women with a contra-indication for surgical treatment
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Haemek Medical Center
Afula
Meirav Breverman, MD, meirav_al@clalit.org.il
Sivan Witzman, 972-4-6495348, sivan_we@clalit.org.il
About this study
Pelvic organ prolapse (POP) is a common problem among women. Apical prolapse (AP) is a prolapse of the uterus, or vaginal cuff, in women post hysterectomy.
Apical fixation to the sacrospinous ligament (SSLF) was first introduced in 1968 by K.RICHTER. .In a large review study, the subjective cure rate after SSLF ranged from 70 to 98%, while objective cure rate was 67-97%.
Read more
The success rates of SSLF in a randomized study comparing SSLF to uterosacral ligament fixation after two years were 63.1%. In women with combined apical and anterior wall prolapse, SSLF can be performed in two ways: anterior access through the anterior vaginal wall or posterior approach through the posterior vaginal wall.
A retrospective comparison of the two methods was performed, demonstrating some efficacy to the anterior approach over the posterior approach mainly in respect to the vaginal length.
From the literature review to date, no comparisons were made between the methods in a randomized controlled trial.
Objective: To compare the success rates between two approaches (anterior and posterior) for SSLF
Read the detailed description
Pelvic organ prolapse (POP) is a common problem among women and its incidence is rising due to population aging. Approximately 11-19% of women will undergo surgery for pelvic organ prolapse (POP) or urinary incontinence during their lifetime and approximately 30% will need repeat surgery during their lifetime .Apical prolapse (AP) is a prolapse of the uterus, or vaginal cuff, in women post hysterectomy. The severity of the prolapsed organ can be graded according to the POP-Q classification .There are several approaches to apical fixation, some of which are done vaginally and include fixation by sutures to the uterosacral ligament (USLF) or the sacrospinous ligament (SSLF). A mesh can be used for ligament fixation as well. The abdominal approach is also an option, the sacro-colpo-pexy fixation using a Y mesh. Apical fixation to the SSL was first introduced in 1968 by K.RICHTER. medical devices such as the Capio that assist in performing SSLF were also developed with ease.
In a review article that included 2,390 women undergoing SSLF subjective cure rate ranged from 70 to 98%, while objective cure rate was 67-97% .Such fixation in combination with posterior or anterior wall repair, especially after hysterectomy, showed a 94% objective cure rate at 7-year postoperative follow-up. A randomized study (The "OPTIMAL randomised trial") comparing SSLF with USLF found no preference for either method. Success rates were measured according to three criteria - 1) no significant vaginal dome or one of the vaginal walls 2) no vaginal bulge symptoms 3) no need for repeated surgery within two years of the original surgery. According to this study, the success rates of SSLF after two years were 63.1%.
Among women with anterior vaginal wall prolapse and AP, SSLF can be performed in two ways: anterior access, ie dissection through the anterior wall of the vagina or fixation through the posterior wall of the vagina. A retrospective comparison of the two methods was performed, demonstrating some efficacy in anterior approach in terms of vaginal length and postoperative apical fixation with less reference to healing rates or impact on the anterior compartment, compared with a posterior approach.
From the literature review to date, no comparisons were made between the methods in a randomized controlled trial.
Objective: To compare the success rates of two approaches (anterior and posterior) for SSLF
- Being tested
- Apical prolapse fixation - anterior access, Apical prolapse fixation - posterior access
- 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.
Apical prolapse fixation - anterior accessProcedure or surgery
The surgery is done in anterior access
Apical prolapse fixation - posterior accessProcedure or surgery
The surgery is done in posterior access
| Study group | Role | What they receive |
|---|---|---|
| anterior approach for apical fixation to the SSL | Experimental | In this group the apical fixation will be done using the anterior access, ie dissection through the anterior vaginal wall. Receives: Procedure: Apical prolapse fixation - anterior access |
| posterior approach for apical fixation to the SSL | Active comparator | In this group the apical fixation will be done using the posterior access, ie fixation through the vaginal posterior wall. Receives: Procedure: Apical prolapse fixation - posterior access |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compound cure rate
A compound cure rate is composite outcome used to measure the success rate of a surgery designed to repair pelvic organ prolapse. Surgery will be considered successful based on each of the following criteria at the 6-month follow-up (and will be further followed yearly until 2 years of total follow up):
- Lack of apical and anterior wall prolapse beyond stage 1 (POP-Q stage<=1) b. Subjective success- a negative response ("no" or not at all to the question, "Do you usually have a bulge or something falling out that you can see or feel in your vaginal area?" (Question 3 on the PFDI-20 questionnaire), (score <2).
- No re-treatment (surgical/ non-surgical) for index compartment
Measured: 6-month (and will be further followed yearly until 2 years of total follow up)
Secondary outcomes (10)
Duration of surgery
Duration of surgery in minutes
Measured: From the time of the first cut of the surgery to the time the surgery ends (as documented in the surgery report), up to 240 minutes
Change in hemoglobin level from pre-operation level to post-operative level in g/dl units
to assess the difference in Hb level before and after the surgery
Measured: Hb level will be measured up to 1 month before the surgery and at the 24 hours after surgery. Further examinations will be taken if there is clinical suspicious for bleeding, up to the day of discharge)
Intraoperative complications
Any documented event of perforation of adjacent organs such as bladder, ureter, intestine or blood vessel injury that occured during the surgery
Measured: Any complication the occured during the duration of the surgery
Peri-operative complications
Any event of fever / abnormal discharge / abscess / contaminated hematoma/ need for blood transfusion
Measured: Any complications that occured from the end of the surgery until the first check-up visit (6 weeks after rthe surgery)
Maximal pain score
To assess a patient's pain level, the investigators will use visual analog scale (VAS)- scale for patient self-reporting of pain. 0 represents no pain, 1-3 represents mild pain, 4-6 represents moderate pain, 7-10 represents severe pain).
the investigators will assess the maximum pain level during the 6 weeks after the surgery
Measured: Maximal pain level during the 6 weeks after the surgery
Change in PFDI-20 score
Mean scores and change from baseline of PFDI-20 score at 6 and 12, 24 months. To evaluate prolapse, urinary and bowel function(PFDI-20).
Measured: 6, 12 and 24 months post the operation
Patient global impression of improvement from surgery
Mean scores of PGI-I at 6 and 12, 24 months. To evaluate patient satisfaction from the surgery.
Measured: 6, 12 and 24 months post the operation
Cure rate at 12 months post-operation
A compound cure rate is composite outcome used to measure the success rate of a surgery designed to repair pelvic organ prolapse. Surgery will be considered successful based on each of the following criteria at the 12-month follow-up :
- Lack of apical and anterior wall prolapse beyond stage 1 (POP-Q stage<=1) b. Subjective success- a negative response ("no" or not at all to the question, "Do you usually have a bulge or something falling out that you can see or feel in your vaginal area?" (Question 3 on the PFDI-20 questionnaire), (score <2).
- No re-treatment (surgical/ non-surgical) for index compartment
Measured: 12 months post the operation
Cure rate at 24 months post-operation
A compound cure rate is composite outcome used to measure the success rate of a surgery designed to repair pelvic organ prolapse. Surgery will be considered successful based on each of the following criteria at the 24-month follow-up :
- Lack of apical and anterior wall prolapse beyond stage 1 (POP-Q stage<=1) b. Subjective success- a negative response ("no" or not at all to the question, "Do you usually have a bulge or something falling out that you can see or feel in your vaginal area?" (Question 3 on the PFDI-20 questionnaire), (score <2).
- No re-treatment (surgical/ non-surgical) for index compartment
Measured: 24 months post the operation
long term complications
Incidence of new-onset dyspareunia; de-novo urinary or bowel problems; re-operation for prolapse in the index compartment; de-novo pelvic pain.
Measured: 6, 12 and 24 months post the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2020
- Study start9 Jul 2020
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meirav Braverman, HaEmek Medical Center, Israel
- Investigators
- meirav breverman, MD, Principal investigator, haemek medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04306250
- Sponsor's protocol ID
- 145-19
- Status last verified
- Mar 2024
- First submitted
- 24 Feb 2020
- Last updated
- 2 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Posterior and Anterior Approach to Sacrospinous Ligament Apical Fixation - Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04306250
- Acronym / sponsor ID
- 145-19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- 9 Jul 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 12 Mar 2020 (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 common problem among women. Apical prolapse (AP) is a prolapse of the uterus, or vaginal cuff, in women post hysterectomy.
Apical fixation to the sacrospinous ligament (SSLF) was first introduced in 1968 by K.RICHTER. .In a large review study, the subjective cure rate after SSLF ranged from 70 to 98%, while objective cure rate was 67-97%.
The success rates of SSLF in a randomized study comparing SSLF to uterosacral ligament fixation after two years were 63.1%. In women with combined apical and anterior wall prolapse, SSLF can be performed in two ways: anterior access through the anterior vaginal wall or posterior approach through the posterior vaginal wall.
A retrospective comparison of the two methods was performed, demonstrating some efficacy to the anterior approach over the posterior approach mainly in respect to the vaginal length.
From the literature review to date, no comparisons were made between the methods in a randomized controlled trial.
Objective: To compare the success rates between two approaches (anterior and posterior) for SSLF
Detailed description
Pelvic organ prolapse (POP) is a common problem among women and its incidence is rising due to population aging. Approximately 11-19% of women will undergo surgery for pelvic organ prolapse (POP) or urinary incontinence during their lifetime and approximately 30% will need repeat surgery during their lifetime .Apical prolapse (AP) is a prolapse of the uterus, or vaginal cuff, in women post hysterectomy. The severity of the prolapsed organ can be graded according to the POP-Q classification .There are several approaches to apical fixation, some of which are done vaginally and include fixation by sutures to the uterosacral ligament (USLF) or the sacrospinous ligament (SSLF). A mesh can be used for ligament fixation as well. The abdominal approach is also an option, the sacro-colpo-pexy fixation using a Y mesh. Apical fixation to the SSL was first introduced in 1968 by K.RICHTER. medical devices such as the Capio that assist in performing SSLF were also developed with ease.
In a review article that included 2,390 women undergoing SSLF subjective cure rate ranged from 70 to 98%, while objective cure rate was 67-97% .Such fixation in combination with posterior or anterior wall repair, especially after hysterectomy, showed a 94% objective cure rate at 7-year postoperative follow-up. A randomized study (The "OPTIMAL randomised trial") comparing SSLF with USLF found no preference for either method. Success rates were measured according to three criteria - 1) no significant vaginal dome or one of the vaginal walls 2) no vaginal bulge symptoms 3) no need for repeated surgery within two years of the original surgery. According to this study, the success rates of SSLF after two years were 63.1%.
Among women with anterior vaginal wall prolapse and AP, SSLF can be performed in two ways: anterior access, ie dissection through the anterior wall of the vagina or fixation through the posterior wall of the vagina. A retrospective comparison of the two methods was performed, demonstrating some efficacy in anterior approach in terms of vaginal length and postoperative apical fixation with less reference to healing rates or impact on the anterior compartment, compared with a posterior approach.
From the literature review to date, no comparisons were made between the methods in a randomized controlled trial.
Objective: To compare the success rates of two approaches (anterior and posterior) for SSLF
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| anterior approach for apical fixation to the SSL | Experimental | Procedure: Apical prolapse fixation - anterior accessIn this group the apical fixation will be done using the anterior access, ie dissection through the anterior vaginal wall. |
| posterior approach for apical fixation to the SSL | Active comparator | Procedure: Apical prolapse fixation - posterior accessIn this group the apical fixation will be done using the posterior access, ie fixation through the vaginal posterior wall. |
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 with grade 2 or above apical prolapse, according to POP Q, combined with Grade II or above of anterior wall prolapse.
- Women who suffer from symptomatic POP and care for a surgical treatment
Key exclusion criteria (1 listed)
- Women with a contra-indication for surgical treatment
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 |
|---|---|---|
| Apical prolapse fixation - anterior accessThe surgery is done in anterior access | Procedure or surgery | anterior approach for apical fixation to the SSL |
| Apical prolapse fixation - posterior accessThe surgery is done in posterior access | Procedure or surgery | posterior approach for apical fixation to the SSL |
Primary outcome
Compound cure rate
Time frame: 6-month (and will be further followed yearly until 2 years of total follow up)
A compound cure rate is composite outcome used to measure the success rate of a surgery designed to repair pelvic organ prolapse. Surgery will be considered successful based on each of the following criteria at the 6-month follow-up (and will be further followed yearly until 2 years of total follow up): A. Lack of apical and anterior wall prolapse beyond stage 1 (POP-Q stage<=1) b. Subjective success- a negative response ("no" or not at all to the question, "Do you usually have a bulge or something falling out that you can see or feel in your vaginal area?" (Question 3 on the PFDI-20 questionnaire), (score <2). c. No re-treatment (surgical/ non-surgical) for index compartment
10 secondary outcomes
Duration of surgery
Time frame: From the time of the first cut of the surgery to the time the surgery ends (as documented in the surgery report), up to 240 minutes
Change in hemoglobin level from pre-operation level to post-operative level in g/dl units
Time frame: Hb level will be measured up to 1 month before the surgery and at the 24 hours after surgery. Further examinations will be taken if there is clinical suspicious for bleeding, up to the day of discharge)
Intraoperative complications
Time frame: Any complication the occured during the duration of the surgery
Peri-operative complications
Time frame: Any complications that occured from the end of the surgery until the first check-up visit (6 weeks after rthe surgery)
Maximal pain score
Time frame: Maximal pain level during the 6 weeks after the surgery
Change in PFDI-20 score
Time frame: 6, 12 and 24 months post the operation
Patient global impression of improvement from surgery
Time frame: 6, 12 and 24 months post the operation
Cure rate at 12 months post-operation
Time frame: 12 months post the operation
Cure rate at 24 months post-operation
Time frame: 24 months post the operation
long term complications
Time frame: 6, 12 and 24 months post the operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
meirav breverman, MD principal investigator
haemek medical center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Apical prolapse fixation - anterior access and Apical prolapse fixation - posterior access in people with Pelvic Organ Prolapse and Surgical Procedure, Unspecified, run by HaEmek Medical Center, Israel at 1 site in Israel.
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 1 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 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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 meirav breverman, MD (97246495507, meirav_al@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compound cure rate (time frame: 6-month (and will be further followed yearly until 2 years of total follow up)). 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 2 Apr 2024.