Pelvic Organ Prolapse
Conditions
Keywords
Pelvic organ prolapse, recurrence, mesh, complications, treatment
Brief summary
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.
Detailed description
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.
Interventions
DEVICETensionfree vaginal mesh kit (Prolift)
Insertion of a tension free vaginal mesh using a Prolift mesh kit
PROCEDUREclassic vaginal prolapse surgery (fascia plication)
classic vaginal prolapse surgery (fascia plication) to correct Pelvic Organ prolapse
Sponsors
Radboud University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* recurrent anterior and/or posterior prolapse POP-Q stage 2 or more * patient has agreed to undergo implantation of TVM (prolift) or fascial plication * patient is willing to return for follow-up evaluation at 6 weeks, 6 months and 12 months * patient is willing to complete quality of life questionnaires at 6 and 12 months
Exclusion criteria
* patient is or wants to become pregnant * patient has had previous synthetic mesh procedure (a previous mid-urethral sling procedure is NOT an exclusion criterion) * patient has current urinary tract or vaginal infections * patient has a blood coagulation disorder * patient has a compromised immune system or any other condition that would compromise healing * patient has renal insufficiency and/or upper urinary tract obstruction * patient is unwilling or unable to return for evaluation * patient has had previous irradiation * patient has any malignancy * patient has large ovarian cysts of large myoma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prolapse by Pelvic Organ Prolapse Quantification System (POP-Q), at 12 Months | 12 months | Number of participants with anatomic failures defined as Pelvic Organ Prolapse (POP) stage II or higher |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mesh Exposure at 12 Months | 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) |
| Patient Global Impression of Improvement (PGI-I) at 12 Months | at 12 months | Number of participants with much to very much improvement compared to baseline |
| Bulge Symptoms | 12 months | 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) |
Countries
Netherlands
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mesh Insertion of Tensionfree vaginal mesh (Prolift)
Tensionfree vaginal mesh kit (Prolift): Insertion of a tension free vaginal mesh using a Prolift mesh kit | 93 |
| Conventional Classical vaginal prolapse surgery (fascia plication)
classic vaginal prolapse surgery (fascia plication): classic vaginal prolapse surgery (fascia plication) to correct Pelvic Organ prolapse | 97 |
| Total | 190 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 1 |
Baseline characteristics
| Characteristic | Mesh | Conventional | Total |
|---|---|---|---|
| Age, Continuous | 64 years STANDARD_DEVIATION 10.5 | 64 years STANDARD_DEVIATION 10.2 | 64 years STANDARD_DEVIATION 10.3 |
| Sex: Female, Male Female | 93 Participants | 97 Participants | 190 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 25 / 93 | 11 / 97 |
| serious Total, serious adverse events | 8 / 93 | 2 / 97 |
Outcome results
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
Time frame: 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mesh | Prolapse by Pelvic Organ Prolapse Quantification System (POP-Q), at 12 Months | anatomic failures | 8 participants |
| Mesh | Prolapse by Pelvic Organ Prolapse Quantification System (POP-Q), at 12 Months | anatomic success | 75 participants |
| Mesh | Prolapse by Pelvic Organ Prolapse Quantification System (POP-Q), at 12 Months | no anatomic evaluation | 7 participants |
| Conventional | Prolapse by Pelvic Organ Prolapse Quantification System (POP-Q), at 12 Months | anatomic failures | 38 participants |
| Conventional | Prolapse by Pelvic Organ Prolapse Quantification System (POP-Q), at 12 Months | anatomic success | 46 participants |
| Conventional | Prolapse by Pelvic Organ Prolapse Quantification System (POP-Q), at 12 Months | no anatomic evaluation | 13 participants |
p-value: <0.05Chi-squared
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)
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mesh | Bulge Symptoms | 6 units on a scale | Standard Deviation 17 |
| Conventional | Bulge Symptoms | 5 units on a scale | Standard Deviation 17 |
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)
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mesh | Mesh Exposure at 12 Months | 14 participants |
| Conventional | Mesh Exposure at 12 Months | 0 participants |
Secondary
Patient Global Impression of Improvement (PGI-I) at 12 Months
Number of participants with much to very much improvement compared to baseline
Time frame: at 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mesh | Patient Global Impression of Improvement (PGI-I) at 12 Months | 54 participants |
| Conventional | Patient Global Impression of Improvement (PGI-I) at 12 Months | 54 participants |