Pelvic Floor Muscle Training (PFMT) in Treatment and Prevention of POP (POP Study)
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Purpose
Background:
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.
Method:
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 | Intervention |
|---|---|
|
Uterine Prolapse Bladder Diseases Cystocele Rectocele |
Behavioral: Pelvic floor muscle training |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment |
| Official Title: | Effect of Pelvic Floor Muscle Training (PFMT) in Prevention and Treatment of Female Pelvic Organ Prolapse (POP). |
- RCT:
- 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
| Estimated Enrollment: | 168 |
| Study Start Date: | December 2005 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Pelvic organ prolapse (POP) is defined as grade 1 or more on POP-Q. This means that the most distal portion of the prolapse is less than 1 cm above the level of the hymen or that the distal edge of the cervix or vaginal cuff (post hysterectomy) is more than 2 cm lower than the total vaginal length.
Inclusion Criteria:
- Parous women in Oslo and Akershus
- POP grade 1-3 on POP-Q.
- Age 18-70
Exclusion Criteria:
- Women with POP-Q grade 0 or 4 and women with cervix elongation
- Women with other disease: radiating back pain, neurological disorders, previous pelvic cancer, psychiatric or other disorders that have an impact on ability to train or the condition (l.o. asthma). Women who is under treatment for cancer or uses muscle relaxants
- Previous POP surgery
- Women who wants to use pessary/ ring during the intervention period and three weeks prior to this
- Pregnant or nursing women, or women planning to become pregnant in the intervention period
- Women with untreated urinary tract infection
- Women who do not understand Norwegian
- Woman planning to be away more than 4 weeks of the intervention period
- Women who cannot contract the PFM
Contacts and Locations| Norway | |
| Norwegian School of Sport Sciences, department of Sports Medicine | |
| Oslo, Norway, 0806 | |
| Study Director: | Kari Bø, Prof, Dr.sci | Norwegian School of Sport Sciences |
More Information
No publications provided by Norwegian School of Sport Sciences
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00271297 History of Changes |
| Other Study ID Numbers: | S-05146, 200501371 SM/RH (NSD) |
| Study First Received: | December 29, 2005 |
| Last Updated: | September 18, 2009 |
| Health Authority: | Norway: Norwegian Social Science Data Services Norway:National Committee for Medical and Health Research Ethics |
Keywords provided by Norwegian School of Sport Sciences:
|
pelvic floor exercise therapy prevention ultrasonography risk factors |
Additional relevant MeSH terms:
|
Urinary Bladder Diseases Cystocele Prolapse Uterine Prolapse Rectocele Pelvic Organ Prolapse Urologic Diseases |
Pathological Conditions, Anatomical Uterine Diseases Genital Diseases, Female Rectal Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013