Pelvic Floor Muscle Training (PFMT) in Treatment and Prevention of POP (POP Study)

NCT00271297 | Completed

• 2 other identifiers: S-05146200501371 SM/RH (NSD)
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Uterine Prolapse; Bladder Diseases; Cystocele; Rectocele

Keywords

pelvic floor; exercise therapy; prevention; ultrasonography; risk factors

Outcome Measures

Primary Outcomes (12)

• 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)

Secondary Outcomes (3)

• 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

Interventions

Pelvic floor muscle training BEHAVIORAL

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Parous women in Oslo and Akershus
• POP grade 1-3 on POP-Q.
• Age 18-70

You may not qualify if:

• 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

Sponsors & Collaborators

• Norwegian School of Sport Sciences: lead
• Norwegian Foundation for Health and Rehabilitation: collaborator
• The Norwegian Women´s Public Health Association: collaborator

Study Sites (1)

Norwegian School of Sport Sciences, department of Sports Medicine

Oslo, Oslo County, 0806, Norway

Location

Related Publications (1)

• Hoff Braekken I, Majida M, Engh ME, Bo K. Morphological changes after pelvic floor muscle training measured by 3-dimensional ultrasonography: a randomized controlled trial. Obstet Gynecol. 2010 Feb;115(2 Pt 1):317-324. doi: 10.1097/AOG.0b013e3181cbd35f.

  PMID: 20093905 DERIVED

MeSH Terms

Conditions

Uterine Prolapse; Urinary Bladder Diseases; Cystocele; Rectocele

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pelvic Organ Prolapse; Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Urologic Diseases; Male Urogenital Diseases; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Hernia

Study Officials

• Kari Bø, Prof, Dr.sci

  Norwegian School of Sport Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 29, 2005
• First Posted: December 30, 2005
• Study Start: December 1, 2005
• Primary Completion: February 1, 2009
• Study Completion: April 1, 2009
• Last Updated: September 21, 2009

Record last verified: 2009-09

Locations

NO (1)