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Pelvic organ prolapse is a common problem. A lot of women have surgery for prolapse. The recurrence rate op pelvic organ prolapse after surgical treatment is high. Placement of a mesh aims at reducing the recurrence rate, but mesh implants can cause complications.
This study is designed to determine the effectiveness of one type of mesh (tensionfree vaginal mesh; Prolift), compared with the standard prolapse surgery. A secondary objective is to track the complications of both procedures.
Patients with recurrent prolapse after surgery can participate in this study. A total of 194 women will be included. At random 97 patients undergo a standard prolapse operation and 97 patients undergo an operation with the mesh. Evaluation will take place during surgery, at the postoperative visit after six weeks, and after six months and twelve months. Quality of life, degree of vaginal prolapse, subjective effectiveness, safety and incidence of complications will be evaluated.
An amendment to the original study has been approved by the Ethical Committee to examine long term outcome of this RCT at 7 years. This study was completed in december 2015.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mesh surgery | Experimental | Trocar guided tension free vaginal mesh insertion by Prolift mesh kit |
|
| Conventional vaginal surgery | Active Comparator | Classical vaginal prolapse surgery (fascia plication) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tensionfree vaginal mesh kit (Prolift) | Device | Insertion of a tension free vaginal mesh using a Prolift mesh kit |
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| Measure | Description | Time Frame |
|---|---|---|
| Prolapse by "Pelvic Organ Prolapse Quantification System" (POP-Q), at 12 Months | Number of participants with anatomic failures defined as "Pelvic Organ Prolapse" (POP) stage II or higher | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mesh Exposure at 12 Months | cumulative number of patients with mesh exposure at 12 months (if diagnosed at 6 weeks or 6 months and treated, the exposure is calculated at 12 months, even if the exposure was not there anymore) | 12 months |
| "Patient Global Impression of Improvement" (PGI-I) at 12 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mariella ij Withagen, Drs. | UMC St Radboud | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gelre ziekenhuizen | Apeldoorn | Netherlands | ||||
| Slysis Zorggroep, location Rijnstate |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21252735 | Result | Withagen MI, Milani AL, den Boon J, Vervest HA, Vierhout ME. Trocar-guided mesh compared with conventional vaginal repair in recurrent prolapse: a randomized controlled trial. Obstet Gynecol. 2011 Feb;117(2 Pt 1):242-250. doi: 10.1097/AOG.0b013e318203e6a5. | |
| 29167974 | Derived | Milani AL, Damoiseaux A, IntHout J, Kluivers KB, Withagen MIJ. Long-term outcome of vaginal mesh or native tissue in recurrent prolapse: a randomized controlled trial. Int Urogynecol J. 2018 Jun;29(6):847-858. doi: 10.1007/s00192-017-3512-3. Epub 2017 Nov 22. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mesh | Insertion of Tensionfree vaginal mesh (Prolift) Tensionfree vaginal mesh kit (Prolift): Insertion of a tension free vaginal mesh using a Prolift mesh kit. 95 randomized for mesh, 2 refused surgery; 93 underwent mesh insertion |
| FG001 | Conventional |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| classic vaginal prolapse surgery (fascia plication) | Procedure | classic vaginal prolapse surgery (fascia plication) to correct Pelvic Organ prolapse |
|
|
Number of participants with much to very much improvement compared to baseline |
| at 12 months |
| Bulge Symptoms | Bulge symptoms defined as Prolapse domain score of the "Urogenital Distress Inventory" (UDI) at 12 months. Scores range from 0 (least/no bother) to 100 (maximum bother) | 12 months |
| Arnhem |
| Netherlands |
| Reinier de Graaf Gasthuis | Delft | Netherlands |
| Medisch Spectrum Twente | Enschede | Netherlands |
| Groene Hart Ziekenhuis | Gouda | Netherlands |
| St. Antonius Ziekenhuis | Nieuwegein | Netherlands |
| UMC St Radboud | Nijmegen | Netherlands |
| Ikazia | Rotterdam | Netherlands |
| Refaja | Stadskanaal | Netherlands |
| St. Elisabeth hospital | Tilburg | Netherlands |
| Twee Steden Ziekenhuis | Tilburg | Netherlands |
| Zaans Medisch Centrum | Zaandam | Netherlands |
| Isala klinieken | Zwolle | Netherlands |
| 22239416 | Derived | Withagen MI, Milani AL, de Leeuw JW, Vierhout ME. Development of de novo prolapse in untreated vaginal compartments after prolapse repair with and without mesh: a secondary analysis of a randomised controlled trial. BJOG. 2012 Feb;119(3):354-60. doi: 10.1111/j.1471-0528.2011.03231.x. |
Classical vaginal prolapse surgery (fascia plication) classic vaginal prolapse surgery (fascia plication): classic vaginal prolapse surgery (fascia plication) to correct Pelvic Organ prolapse 99 randomized to conventional surgery, 1 refused surgery for comorbidity, 1 died prior to surgery; 97 underwent conventional surgery |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Mesh | Insertion of Tensionfree vaginal mesh (Prolift) Tensionfree vaginal mesh kit (Prolift): Insertion of a tension free vaginal mesh using a Prolift mesh kit |
| BG001 | Conventional | Classical vaginal prolapse surgery (fascia plication) classic vaginal prolapse surgery (fascia plication): classic vaginal prolapse surgery (fascia plication) to correct Pelvic Organ prolapse |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | age at randomization | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Prolapse by "Pelvic Organ Prolapse Quantification System" (POP-Q), at 12 Months | Number of participants with anatomic failures defined as "Pelvic Organ Prolapse" (POP) stage II or higher | Posted | Number | participants | 12 months |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mesh Exposure at 12 Months | cumulative number of patients with mesh exposure at 12 months (if diagnosed at 6 weeks or 6 months and treated, the exposure is calculated at 12 months, even if the exposure was not there anymore) | Posted | Number | participants | 12 months |
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| Secondary | "Patient Global Impression of Improvement" (PGI-I) at 12 Months | Number of participants with much to very much improvement compared to baseline | Posted | Number | participants | at 12 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Bulge Symptoms | Bulge symptoms defined as Prolapse domain score of the "Urogenital Distress Inventory" (UDI) at 12 months. Scores range from 0 (least/no bother) to 100 (maximum bother) | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mesh | Insertion of Tensionfree vaginal mesh (Prolift) Tensionfree vaginal mesh kit (Prolift): Insertion of a tension free vaginal mesh using a Prolift mesh kit | 8 | 93 | 25 | 93 | ||
| EG001 | Conventional | Classical vaginal prolapse surgery (fascia plication) classic vaginal prolapse surgery (fascia plication): classic vaginal prolapse surgery (fascia plication) to correct Pelvic Organ prolapse | 2 | 97 | 11 | 97 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bladder perforation | Renal and urinary disorders | Systematic Assessment |
| ||
| Repeat surgery for postoperative hematoma | Surgical and medical procedures | Systematic Assessment |
| ||
| Hematoma | Surgical and medical procedures | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mesh exposure | Surgical and medical procedures | Systematic Assessment |
| ||
| de novo dyspareunia | Reproductive system and breast disorders | Systematic Assessment | you can only develop de novo dyspareunia, if you had no dyspareunia before. therefore the number of women at risk is lower than in total |
| |
| de novo SUI | Renal and urinary disorders | Systematic Assessment | you can only develop de novo SUI, if you had no SUI before, therefore the number is different from the total number of women at risk |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. M.I.J.Withagen | Radboud University Medical Center | +31 6 51262468 | M.I.J.Withagen@umcutrecht.nl |
| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D003226 | Congresses as Topic |
| ID | Term |
|---|---|
| D009938 | Organizations |
| D004472 | Health Care Economics and Organizations |
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| Male |
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| no anatomic evaluation |
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