Pelvic Organ Prolapse, Pelvic Floor Disorders
Conditions
Keywords
Exercise Therapy, Pelvic Floor, Preoperative Care
Brief summary
The lifetime risk for a woman to undergo surgery for either vaginal prolapse or urinary incontinence is high. There are many different surgical techniques for treatment of prolapse, but there is a lack of knowledge about factors that contribute to objective result and patient satisfaction after surgery. The aim of the study is to investigate factors that could be related to patient satisfaction and objective result such as pelvic floor muscle contractility/strength and muscle injury, objective measures of prolapse and women's symptoms. This study will investigate whether systematic pelvic floor exercise and life style advise before surgery can improve outcomes after surgery for either vaginal prolapse. Another aim is to determine an ultrasound scale for measure of pelvic floor muscle contraction.
Interventions
BEHAVIORALpelvic floor exercises
In preparation for surgery, patients receive individual information by a physiotherapist on pelvic floor anatomy and correct pelvic floor contraction. Patients are told to do the following pelvic floor exercises 3 times a day: 8-12 maximal contractions, hold contractions during 10 seconds, and 3 fast contractions after each long contraction. In addition exercise in groups with skilled physical therapists once a week during 12 weeks.
OTHERWaiting list
patients wait as usual until surgery without special treatment.
Sponsors
Norwegian University of Science and Technology
St. Olavs Hospital
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
* referred to surgery for urogenital prolapse * informed consent
Exclusion criteria
* not able to communicate in Norwegian or English * not able or willing to sign informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pelvic floor muscle strength assessed by palpation | 9 months | Muscle strength is evaluated using 6 point modified Oxford Scale (MOS) range 0-5. |
| Pelvic floor muscle strength assessed by ultrasound | 9 months | Changes in pelvic floor muscle at rest and during pelvic floor contraction, measured in mm and calculated proportional change |
| Symptoms of pelvic floor disorders | 9 months | Symptoms of pelvic floor disorders assessed by validated questionnaire (PDFI-20) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of anatomical sphincter ani defect | 9 months | Anatomical sphincter ani defect assessed by transperineal ultrasound |
| Proportion of levator ani muscle trauma | 9 months | Assessed by transperineal ultrasound on contraction and Valsalva |
| Proportion of anatomical pelvic organ prolapse | 9 months | Assessment with the Pelvic Organ Prolapse Quantification (POP-Q) System |
| Imaging of synthetic implants assessed by ultrasound | 9 months | Registration of implants after pelvic floor surgery and their relations to anatomical structures in mm. |
| Symptoms of pelvic floor disorders | 9 months | Symptoms of pelvic floor disorders assessed by validated questionnaire (PFIQ-7) |
| Assessment of pelvic organ mobility as a measure of pelvic organ function/dysfunction | 9 months | Movement of the pelvic organs during Valsalva and contraction |
| Pelvic floor muscle strength assessed by perineometry | 9 months | measuring the pressure with vaginal manometry in cm H2O during pelvic floor contraction |
| Pelvic floor muscle strength assessed by electromyography | 9 months | Assessed by vaginal surface electrode during pelvic floor contraction, measured in mV |
Countries
Norway
Outcome results
None listed