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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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13 November 2023 |
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Main ID: |
NCT02246387 |
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Date of registration:
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11/09/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Follow-up Study After Manchester Operation for Pelvic Organ Prolapse
MAP-POP |
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Scientific title:
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Does the Manchester Operation for Pelvic Organ Prolapse Give Sufficient Apical Fixation? |
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Date of first enrolment:
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October 2014 |
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Target sample size:
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209 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT02246387 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Norway
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Contacts
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Name:
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Rune Svenningsen, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Oslo University Hospital; University of Oslo |
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Name:
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Anne C Staff, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Oslo University Hospital; University of Oslo |
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Name:
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Sissel H Oversand, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Oslo University Hospital |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Pelvic Organ Prolapse
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Intervention(s)
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Procedure: Manchester Operation
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Primary Outcome(s)
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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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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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Secondary Outcome(s)
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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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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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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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Secondary ID(s)
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2013/2093/REK
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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