Pelvic Floor Muscle Training (PFMT) in Treatment and Prevention of POP (POP Study)
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|ClinicalTrials.gov Identifier: NCT00271297|
Recruitment Status : Completed
First Posted : December 30, 2005
Last Update Posted : September 21, 2009
The pelvic floor muscles (PFM) are located inside the pelvis, surrounding the urethra, vagina and rectum. They provide structural support for the pelvic organs. Dysfunctional PFM can lead to urine and fecal incontinence, pelvic organ prolapse (POP), sexual problems and chronic pain syndromes. POP increases with age, parity and weakness in the PFM. Symptoms associated with POP are backache, bladder, bowel and sexual dysfunction, and pelvic heaviness. Thus the condition is debilitating and can greatly affect the quality of life, interfering with day-to-day activities and reduce participation in physical activity.
The aim of the project:
As life expectancy increases, more women may experience POP. Hence it is important to prevent and treat the condition at an early stage. Despite being a common disorder among women, little research has been done on POP. The aim of this study is to evaluate the effect of pelvic floor muscle training (PFMT). PFMT is a non-invasive method with no adverse effects. If there is significant effect, the main goal is to incorporate this method in clinical practice among physiotherapists and medical doctors. If PFM training is effective, more emphasis of PFM training can be put into regular female fitness programs. The prevalence of POP increases with age.
This is a single blind randomised controlled trial to evaluate the effect of PFMT on POP. 100 women with POP will be randomised to either training or control group. The training programme will last for six months, training once a week with a physiotherapist in addition to a structured home training programme. A blinded case-control study will also be carried out. 50 women without POP will be matched for age and vaginal deliveries. Before starting the RCT study, a reproducibility study on perineal ultrasound will be carried out in 18 women.
|Condition or disease||Intervention/treatment||Phase|
|Uterine Prolapse Bladder Diseases Cystocele Rectocele||Behavioral: Pelvic floor muscle training||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||168 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Effect of Pelvic Floor Muscle Training (PFMT) in Prevention and Treatment of Female Pelvic Organ Prolapse (POP).|
|Study Start Date :||December 2005|
|Actual Primary Completion Date :||February 2009|
|Actual Study Completion Date :||April 2009|
- Localisation of bladder neck, cervix and rectal ampulla at rest (translabial ultrasound)
- Subjective symptoms score (Mouritsen and Larsen 2003, Tegerstedt et al in press, Avery et al 2004)
- Ultrasound measurement of changes in muscle morphology: 1. thickness of levator ani
- Size of levator hiatus
- Levator activity during contraction, coughing and Valsava manoeuvre.
- Case control study:
- Comparison of background variables and risk factors
- Presence of "Benign Hypermobility Joint Syndrome"
- Measurement PFM strength
- Reproducibility study:
- Reproducibility of ultrasound examination of localisation and function of PFM and POP (same measurements as in the RCT)
- RCT study:
- Independent variables (muscle function and strength)is vaginal palpation, visual observation of perineum, measurement of muscle strength with Camtech fibreoptic microtransducer connected to a vaginal balloon(Camtech AS, Sandvika, Norway)
- * Training diary for registration of adherence
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00271297
|Norwegian School of Sport Sciences, department of Sports Medicine|
|Oslo, Norway, 0806|
|Study Director:||Kari Bø, Prof, Dr.sci||Norwegian School of Sport Sciences|