Pelvic Organ Prolapse Clinical Trial
Official title:
Support Women's Decision Making - the Effect of Using an Online App in the Clinical Consultations of Patients With Urogenital Prolapse. A Protocol for a Randomized Controlled Non Blinded Multicenter Study. Assessing Feasibility.
Development of a decision aid for women with urogenital prolapse followed by an intervention
with use of the decision aid to investigate the effect on the perceived shared decision
making in the clinical consultations.
A protocol for a randomized controlled non blinded multicenter trial. A feasibility trial for
the protocol.
Objective :
The objective is to develop a decision aid to increase successful patient involvement and
increased health care professionals integration of preferences in the clinical consultations
with women with urogenital prolapse.
Method:
in the context of consultations an online app solution using a multicriterial analytic
approach is developed and tested in order to support shared decision making (SDM). The
decision aid is developed involving four national gynecological departments through
participatory design. The decision aid is tested in a randomized, controlled multicenter
trial in three hospital departments in the Region of Southern Denmark. A feasibility trial
for the protocol of a randomized controlled trial will decide for further approach in
relations to testing the online app. in a larger scale In the randomized trial patients will
either receive consultations as usual (controls) or consultations using the interface (IF) in
an app. The IF is generated upon data from a patient survey regarding their preferences for
treatment beforehand.
Effect measures are the perceived shared decision making within the consultation (SDM-Q-9 )
and the patientperceived satisfaction with the decision (SWD)
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT05420831 -
Comparison of Vaginal and Laparoscopic Apical Fixation Techniques for Pelvic Organ Prolapse Treatment
|
N/A | |
| Active, not recruiting |
NCT05422209 -
The Influence of Simultaneous Posterior Colporrhaphy and Perineoplasty on the Efficiency and Safety of Mesh-augmented Sacrospinal Fixation (Apical Sling) in Advanced POP Repair.
|
N/A | |
| Completed |
NCT05493735 -
Lidocaine for Pessary Check Pain Reduction
|
Phase 3 | |
| Completed |
NCT06126328 -
Materna Prep Study Phase II
|
Phase 2 | |
| Recruiting |
NCT05542836 -
EVeRLAST 2-Year Follow-Up
|
||
| Recruiting |
NCT05918367 -
Multicenter Ventral Mesh Rectopexy Registry Collaborative
|
||
| Recruiting |
NCT04172272 -
The Influence of TAP Block in the Control of Postoperative Pain After Laparotomy for Gynecological Procedures
|
N/A | |
| Recruiting |
NCT04807920 -
BOTOX® at the Time of Prolapse Surgery for OAB
|
Phase 4 | |
| Completed |
NCT06268782 -
The Effectiveness of an Online Exercise Program on Well-being of Postpartum Women
|
N/A | |
| Recruiting |
NCT03146195 -
The 3D Reconstruction Research of Pelvic Organ Prolapse Disease
|
N/A | |
| Recruiting |
NCT02919852 -
Laparoscopic Retrovesical Colpopectinopexia
|
N/A | |
| Completed |
NCT02925585 -
Vaginal Tactile Imaging for Pelvic Floor Prolapse
|
||
| Not yet recruiting |
NCT02536001 -
Prospective Randomized Study to Compare Results of Pelvic Organ Prolapse Repair With One Versus Two Vaginal Meshes
|
N/A | |
| Recruiting |
NCT02113969 -
Conservative Management of Symptomatic Pelvic Organ Prolapse Using Vaginal Pessaries: Generation of a Standardized Management Protocol
|
N/A | |
| Completed |
NCT02383199 -
Polypropylene Mesh in Prolapse Surgery
|
N/A | |
| Terminated |
NCT01673360 -
Collection of Long Term Patient Outcomes Data Following Implantation of AMS Surgical Devices
|
N/A | |
| Completed |
NCT01842464 -
Sacro-Spinous Ligaments Anterior Apical Anchoring
|
N/A | |
| Withdrawn |
NCT01530191 -
Factors Affecting Perioperative Outcomes
|
N/A | |
| Completed |
NCT01320631 -
Male Sexual Experience and Its Impact on Quality of Life Before and After Their Sexual Partners Undergo Polypropylene Mesh Augmented Pelvic Floor Reconstruction
|
N/A | |
| Completed |
NCT00581412 -
Composite Graft Use in Abdominal Sacrocolpopexy Reduces Erosion Rates
|
N/A |