Pelvic Organ ProlapseMAP-POPNCT02246387
Follow-up Study After Manchester Operation for Pelvic Organ Prolapse
An observational study of Pelvic Organ Prolapse, run by Oslo University Hospital at 1 site in Norway.
Trial summary
Native tissue repair for pelvic organ prolapse (POP) is the predominant surgical technique in the investigators department and the Manchester operation the preferred procedure. The investigators long-term reoperation rates for pevic organ prolapse are very low, as documented in the investigators previous long-term… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Manchester Operation
- Type of treatment
- Surgery or procedure
- How many people
- 209 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2014to Jan 2023
- 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: Women referred to out outpatient clinic for surgery for pelvic organ prolapse.
Who may be able to join
- Women aged ≥ 18 years, understanding and reading Scandinavian or English language and being able to sign an informed consent. Non- Scandinavian speakers can be enrolled in the study as long as they understand and can communicate in English or Norwegian.
- Subjective distress from pelvic organ prolapse
- Cystocele Stage I - III with descent of the cervix Stage I-III, with or without a defect of the posterior wall (rectocele, enterocele, hypotrophic perineum).
Who cannot join
- Previous total hysterectomy (including removal of the cervix and the cardinal ligaments) or previous subtotal hysterectomy (removal of copus uteri).
- Previous surgery for POP
- Patients with a true Uterine prolapse with a descent of the corpus uteri stage II-III and not just an elongated cervix, as this group may benefit from other procedures than a Manchester operation (vaginal hysterectomy and sacrospinous fixation)
- Unable to understand patient information (in Norwegian or English) and sign an informed consent.
- Patients in whom a colpocleisis (closing of the vagina) is deemed the better surgical treatment, such as in elderly women not sexually active and not interested in future vaginal intercourse.
Trial locations and contacts
1 site in 1 country.
Norway1 site
Gynekologisk avdeling, Oslo Universitetssykehus Ullevål
Oslo, 0424
About this study
Official title: Does the Manchester Operation for Pelvic Organ Prolapse Give Sufficient Apical Fixation?
Native tissue repair for pelvic organ prolapse (POP) is the predominant surgical technique in the investigators department and the Manchester operation the preferred procedure. The investigators long-term reoperation rates for pevic organ prolapse are very low, as documented in the investigators previous long-term follow-up study (Oversand et al, International Urogynecology Journal 2013), however the data were retrospective and patients with avulsions of the levator ani muscle were not identified. The investigators hypothesize that correct fixation and elevation of the vaginal apex, as part of a three-compartment repair procedure, is essential in the POP surgical repair, also when treating women with levator ani avulsions.
The purpose of this study is to:
- prospectively evaluate if cardinal/sacrouterine ligament plication (as part of the 3-compartment Manchester procedure) gives an adequate elevation and fixation of the vaginal apex.
- assess changes in subjective symptoms between the preoperative evaluation and the 1 and 5-year postoperative evaluations.
- evaluate whether the patients identified with levator avulsions in the investigators population have an increased risk of failure (objectively and subjectively).
Read the detailed description
Many studies have shown high recurrence rates after POP surgical repair using native tissue techniques, and this led to the introduction of synthetic meshes in vaginal repair in the early 2000s. However the use of mesh has recently been put under scrutiny due to a high risk of complications, such as mesh exposure. The gran majority of the investigators patients are operated with native tissue repairs, about 60% of them by a Manchester procedure, where ligament plication is an essential part of the procedure. The investigators previous study documented high patient satisfaction and low risk of recurrence, but the data available were mainly collected retrospectively and no data were available on possible levator avulsions. Lateral defects caused by avulsions of the levator ani muscle represent a special sub-group amongst patients with POP, and are shown in several studies to have higher recurrence rates. There is no consensus on how to best repair a lateral defect in a POP, but since the prevalence of levator avulsions in patients with POP is shown to be high, the investigators find it credible that the Manchester Operation can give good results .
The main justification for this study is that the investigators already have identified a surgical technique that has documented excellent results, but studies with more detailed data quality are needed in order to better evaluate the procedure's advantages and potential disadvantages. As the use of mesh in vaginal surgery has shown unacceptable high risks of new and serious complications, there is an international focus and interest in traditional native tissue repairs and how to optimize their performance.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Manchester Operation
- Keywords
- Pelvic Organ Prolapse, Gynecologic Surgery Procedures, Treatment Outcome
- 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.
Manchester OperationProcedure or surgery
A 3- compartment native tissue repair procedure for Pelvic Organ Prolapse.
| Study group | Role | What they receive |
|---|---|---|
| Manchester Operation | Manchester Operation: Native tissue repair Receives: Procedure: Manchester Operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage with POP-Q point C equal to or less than -5 at the 1 and 5 year postoperative control compared to preoperative findings for the whole population vs subgroup with levator avulsions.
Measured: Up to 7 years
Changes in point C and D at the 1 and 5 year postoperative control compared to preoperative findings for the whole population vs subgroup with levator avulsions.
Measured: Up to 7 years
Secondary outcomes (3)
Subjective satisfaction at the 1 and 5 year postoperative control (whole population vs subgroup with levator avulsions).
Measured: Up to 7 years
Changes in dyspareunia between the preoperative evaluation and at the 1 and 5 year postoperative control (whole population vs subgroup with levator avulsions).
Measured: Up to 7 years
De novo urinary incontinence at the 1 and 5 year postoperative control (whole population vs subgroup with levator avulsions).
Measured: Up to 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2014 (estimated)
- Study startOct 2014
- Primary completionJan 2018
- Study completionJan 2023
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.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sissel Oversand, Oslo University Hospital
- Investigators
- Sissel H Oversand, MD, Principal investigator, Oslo University HospitalAnne C Staff, PhD, Study chair, Oslo University Hospital; University of OsloRune Svenningsen, PhD, Study director, Oslo University Hospital; University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02246387
- Sponsor's protocol ID
- 2013/2093/REK
- Acronym
- MAP-POP
- Status last verified
- Oct 2023
- First submitted
- 11 Sep 2014
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Manchester Operation for Pelvic Organ Prolapse Give Sufficient Apical Fixation?
- ClinicalTrials.gov ID
- NCT02246387
- Acronym / sponsor ID
- MAP-POP / 2013/2093/REK
- Conditions
- Pelvic Organ Prolapse
- Keywords
- Pelvic Organ Prolapse, Gynecologic Surgery Procedures, Treatment Outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2023 (actual)
- First posted
- 22 Sep 2014 (estimated)
- 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.
Native tissue repair for pelvic organ prolapse (POP) is the predominant surgical technique in the investigators department and the Manchester operation the preferred procedure. The investigators long-term reoperation rates for pevic organ prolapse are very low, as documented in the investigators previous long-term follow-up study (Oversand et al, International Urogynecology Journal 2013), however the data were retrospective and patients with avulsions of the levator ani muscle were not identified. The investigators hypothesize that correct fixation and elevation of the vaginal apex, as part of a three-compartment repair procedure, is essential in the POP surgical repair, also when treating women with levator ani avulsions.
The purpose of this study is to:
- prospectively evaluate if cardinal/sacrouterine ligament plication (as part of the 3-compartment Manchester procedure) gives an adequate elevation and fixation of the vaginal apex.
- assess changes in subjective symptoms between the preoperative evaluation and the 1 and 5-year postoperative evaluations.
- evaluate whether the patients identified with levator avulsions in the investigators population have an increased risk of failure (objectively and subjectively).
Detailed description
Many studies have shown high recurrence rates after POP surgical repair using native tissue techniques, and this led to the introduction of synthetic meshes in vaginal repair in the early 2000s. However the use of mesh has recently been put under scrutiny due to a high risk of complications, such as mesh exposure. The gran majority of the investigators patients are operated with native tissue repairs, about 60% of them by a Manchester procedure, where ligament plication is an essential part of the procedure. The investigators previous study documented high patient satisfaction and low risk of recurrence, but the data available were mainly collected retrospectively and no data were available on possible levator avulsions. Lateral defects caused by avulsions of the levator ani muscle represent a special sub-group amongst patients with POP, and are shown in several studies to have higher recurrence rates. There is no consensus on how to best repair a lateral defect in a POP, but since the prevalence of levator avulsions in patients with POP is shown to be high, the investigators find it credible that the Manchester Operation can give good results .
The main justification for this study is that the investigators already have identified a surgical technique that has documented excellent results, but studies with more detailed data quality are needed in order to better evaluate the procedure's advantages and potential disadvantages. As the use of mesh in vaginal surgery has shown unacceptable high risks of new and serious complications, there is an international focus and interest in traditional native tissue repairs and how to optimize their performance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Manchester Operation | – | Procedure: Manchester OperationManchester Operation: Native tissue repair |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women referred to out outpatient clinic for surgery for pelvic organ prolapse.
Key inclusion criteria (3 listed)
- Women aged ≥ 18 years, understanding and reading Scandinavian or English language and being able to sign an informed consent. Non- Scandinavian speakers can be enrolled in the study as long as they understand and can communicate in English or Norwegian.
- Subjective distress from pelvic organ prolapse
- Cystocele Stage I - III with descent of the cervix Stage I-III, with or without a defect of the posterior wall (rectocele, enterocele, hypotrophic perineum).
Key exclusion criteria (5 listed)
- Previous total hysterectomy (including removal of the cervix and the cardinal ligaments) or previous subtotal hysterectomy (removal of copus uteri).
- Previous surgery for POP
- Patients with a true Uterine prolapse with a descent of the corpus uteri stage II-III and not just an elongated cervix, as this group may benefit from other procedures than a Manchester operation (vaginal hysterectomy and sacrospinous fixation)
- Unable to understand patient information (in Norwegian or English) and sign an informed consent.
- Patients in whom a colpocleisis (closing of the vagina) is deemed the better surgical treatment, such as in elderly women not sexually active and not interested in future vaginal 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 |
|---|---|---|
| Manchester OperationA 3- compartment native tissue repair procedure for Pelvic Organ Prolapse. | Procedure or surgery | Manchester Operation |
Primary outcome
Percentage with POP-Q point C equal to or less than -5 at the 1 and 5 year postoperative control compared to preoperative findings for the whole population vs subgroup with levator avulsions.
Time frame: Up to 7 years
Changes in point C and D at the 1 and 5 year postoperative control compared to preoperative findings for the whole population vs subgroup with levator avulsions.
Time frame: Up to 7 years
3 secondary outcomes
Subjective satisfaction at the 1 and 5 year postoperative control (whole population vs subgroup with levator avulsions).
Time frame: Up to 7 years
Changes in dyspareunia between the preoperative evaluation and at the 1 and 5 year postoperative control (whole population vs subgroup with levator avulsions).
Time frame: Up to 7 years
De novo urinary incontinence at the 1 and 5 year postoperative control (whole population vs subgroup with levator avulsions).
Time frame: Up to 7 years
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 2 Nov 2023.
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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.
Sissel H Oversand, MD principal investigator
Oslo University Hospital
Anne C Staff, PhD study chair
Oslo University Hospital; University of Oslo
Rune Svenningsen, PhD study director
Oslo University Hospital; University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Organ Prolapse, run by Oslo University Hospital at 1 site in Norway.
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 5 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 2 Nov 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 Norway. 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?
Percentage with POP-Q point C equal to or less than -5 at the 1 and 5 year postoperative control compared to preoperative findings for the whole population vs subgroup with levator avulsions. (time frame: Up to 7 years). 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?
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 Nov 2023.