It is hypothesized that bilateral sacrospinous colposuspension using a BSC mesh is non-inferior in surgical success and superior in improvement of quality of life related to the pelvic floor as compared to unilateral sacrospinous ligament fixation…
ID
Bron
Verkorte titel
Aandoening
pelvic organ prolapse, prolapse, uterine prolapse, vaginal vault prolapse
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. Surgical success in the treatment of apical prolapse: The primary outcome measure will be surgical “success” or “failure” assessed one year after surgery. The primary outcome measure has three components:<br>
- An anatomic assessment of prolapse, using the POPQ examination<br>
- The presence or absence of bulge symptoms specific to prolapse, using two questions from the PFDI-20 questionnaire;<br>
- An assessment of additional treatment (surgical or non-surgical) for prolapse after the index surgery.<br>
2. Improvement of quality of life related to pelvic floor function: PFDI-20 questionnaire.
Achtergrond van het onderzoek
Pelvic organ prolapse is a common condition. Unilateral sacrospinous ligament fixation (SSF) is the recommended treatment option for patients suffering from POP in the apical compartment. It has high objective cure rates and relatively low recurrence rates. However direct fixation will lead to a posterior deviation of the vaginal axis, which leads to an anatomical alteration of the vagina and rectum. This can have possible consequences on voiding, defecation and sexual function. Also, this might lead to an increase of stress on the anterior compartment and to a higher risk of developing a cystocele.
It is hypothesized that bilateral sacrospinous colposuspension using a polypropylene mesh (BSC mesh) is non-inferior in surgical success and superior in improvement of quality of life related to the pelvic floor as compared to unilateral SSF with sutures.
This is a multicenter, non-inferiority, randomized-controlled trial for women with at least a stage 2 apical prolapse (according to the International Continence Society) who are planned to undergo vaginal surgical correction.
Doel van het onderzoek
It is hypothesized that bilateral sacrospinous colposuspension using a BSC mesh is non-inferior in surgical success and superior in improvement of quality of life related to the pelvic floor as compared to unilateral sacrospinous ligament fixation with suturus (SSF).
Onderzoeksopzet
Baseline
Operation
Post-operation: 6 weeks, 6 months, 12 months
Onderzoeksproduct en/of interventie
- Unilateral Sacrospinous Ligament Fixation: Unilateral SSF is the recommended treatment option for patients suffering from apical POP. In SSF, the top of the vagina is sutured with non-degradable sutures to the sacrospinous ligament, most commonly to the right side to prevent lesions of the rectum.
- The Bilateral Sacrospinous Colposuspension using BSC-mesh: the BSC Mesh is designed to induce the formation of neo-ligaments by establishing symmetrical, bilateral suspension of the vaginal vault from the sacrospinous ligament. It recreates the support previously provided by the natural ligaments which are no longer functioning.
Publiek
K.W.J. (Kim) Verhorstert
Meibergdreef 9
Amsterdam 1105 AZ
The Netherlands
020-5661973
k.w.verhorstert@amc.uva.nl
Wetenschappelijk
K.W.J. (Kim) Verhorstert
Meibergdreef 9
Amsterdam 1105 AZ
The Netherlands
020-5661973
k.w.verhorstert@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Subject is female;
2. Subject is least 18 years of age;
3. Subject has at least a stage 2 apical prolapse and is planned to undergo vaginal surgical correction.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Subjects who are pregnant or want to become pregnant;
2. Subjects who are not capable of giving informed consent;
3. Subject has a known sensitivity to polypropylene;
4. Subject has an indication for a concomitant procedure to treat SUI;
5. Subject is known with pelvic organ cancer (e.g. uterine, ovarian, bladder or cervical);
6. Subject has chronic systemic pain that includes the pelvic area or chronic focal pain that involves the pelvis;
7. Subject has a known neurologic or medical condition affecting bladder function (e.g. multiple sclerosis, spinal cord injury or stroke with residual neurologic deficit).
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL6979 |
| NTR-old | NTR7168 |
| CCMO | NL60451.018.17 |
| OMON | NL-OMON47591 |