Pelvic Organ Prolapse Clinical Trial
Official title:
A Feasibility Study on the Value of Pelvic Floor Training After Pelvic Organ Prolapse Surgery
The main objective is to assess the feasibility of a randomized controlled trial that
investigates the effects of pelvic floor training on recurrence in pelvic organ prolapse
surgeries. This will be achieved by measuring POP-Q stage and by a validated questionnaire
before surgery and one year after. Women having POP surgery at Landspitali will be offered to
participate if they meet the criteria of the research. Participants will be randomized into
two groups, interventions and control group that gets standard care at the hospital. The
intervention group will meet a physiotherapist 6 weeks post-op for targeted physiotherapy
with pelvic floor training, conventional advice and support. Over 16 weeks period
participants in intervention group will get physiotherapy four times and get two follow up
phone calls. Pelvic floor activity will be measured with EMG and symptoms collected with
questionnaire before surgery and year post-op.
Recurrent surgeries are common problem shortly after the first one. POP symtoms can be
bothersome for women and reduce their quality of life. More knowledge is needed to figure out
if targeted physiotherapy with pelvic floor training can help reduce recurrency and
bothersome symptoms.
A feasibility study to assess the practicality of physiotherapy treatment after pelvic organ
prolapse (POP) surgery and the effect on recurrent POP symptoms, pelvic floor activity and
general physical fitness.
Pelvic organ prolapse is a common problem among women and many do need surgery. Little is
known about recurrence of POP surgeries. Pelvic floor muscle training (PFMT) has positive
effects on POP symptoms and quality of life. Research shows PFMT can reduce stage of the
prolapse.
Before surgery POP-Q stage will be measured by urogynocologist. Pelvic floor muscle activity
will be measured with EMG vaginal probes. General physical fitness will be tested with 30s
chair-stand and core strenght with prone bride test. An Icelandic version of The Australian
Female PelvicFloor questionnaire will be used to assess symptoms and affect on quality of
life.
Participants will be randomized into two groups, intervention and control group. The control
group gets standard care at the hospital. The interventional group gets physiotherapy with
PFMT, conventional advise and support. During 16 weeks intervention participants get four
sessions with specialized physiotherapist and two follow up phone calls. Follow up measures
will be made at 12 months.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| 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 | |
| Active, not recruiting |
NCT05420831 -
Comparison of Vaginal and Laparoscopic Apical Fixation Techniques for Pelvic Organ Prolapse Treatment
|
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 |
NCT02919852 -
Laparoscopic Retrovesical Colpopectinopexia
|
N/A | |
| Recruiting |
NCT03146195 -
The 3D Reconstruction Research of Pelvic Organ Prolapse Disease
|
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 |