Status:
UNKNOWN
Effectiveness Prolift+M Versus Conventional Vaginal Prolapse Surgery
Lead Sponsor:
Radboud University Medical Center
Conditions:
Pelvic Organ Prolapse
Cystocele
Eligibility:
FEMALE
45+ years
Phase:
NA
Brief Summary
Pelvic organ prolapse is highly prevalent in the female population. The recurrence rate of pelvic organ prolapse after surgical treatment is high. This emphasizes the clinical need for improvement of ...
Detailed Description
Rationale: Pelvic organ prolapse is highly prevalent in the female population. The incidence of pelvic organ prolapse increases with age, so the longer life expectancy of women may cause pelvic organ ...
Eligibility Criteria
Inclusion
- Subject has a anterior and/or posterior prolapse POP-Q stage II or more. Subjects with a middle compartment prolapse may only be included if there is a co-existing anterior or posterior defect which needs surgical correction.
- Subject has agreed to undergo implantation of Prolift+MTM or fascial plication
- Subject is willing to return for follow-up evaluation and QoL questionnaires completion at 6weeks, 6 months, 12 months and 24 months follow-ups.
Exclusion
- Pregnancy
- Age \< 45 years
- Subject has had a previous surgery for pelvic organ prolapse. A previous mid-urethral sling procedure is not an exclusion criterion.
- Have current urinary tract or vaginal infections
- Have blood coagulation disorders
- Have a compromised immune system or any other conditions that would compromise healing
- Are unwilling or unable to return for evaluation
- Previous irradiation
- Presence of any malignancy
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2015
Estimated Enrollment :
176 Patients enrolled
Trial Details
Trial ID
NCT02231099
Start Date
January 1 2011
End Date
September 1 2015
Last Update
February 6 2015
Active Locations (5)
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1
Gelre ziekenhuizen Apeldoorn
Apeldoorn, Netherlands
2
Reinier de Graaf Group
Delft, Netherlands, 2625 AD
3
UMC St Radboud
Nijmegen, Netherlands, 6500 HB
4
Zaans Medisch Centre
Zaandam, Netherlands, 1500 EE