- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02246387
Follow-up Study After Manchester Operation for Pelvic Organ Prolapse (MAP-POP)
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).
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Oslo, Norway, 0424
- Gynekologisk avdeling, Oslo Universitetssykehus Ullevål
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Manchester Operation
Manchester Operation: Native tissue repair
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A 3- compartment native tissue repair procedure for Pelvic Organ Prolapse.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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Up to 7 years
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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
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Up to 7 years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Subjective satisfaction at the 1 and 5 year postoperative control (whole population vs subgroup with levator avulsions).
Time Frame: Up to 7 years
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Up to 7 years
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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
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Up to 7 years
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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
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Up to 7 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sissel H Oversand, MD, Oslo University Hospital
- Study Chair: Anne C Staff, PhD, Oslo University Hospital; University of Oslo
- Study Director: Rune Svenningsen, PhD, Oslo University Hospital; University of Oslo
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013/2093/REK
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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