Obstetric Perineal Trauma and Physiotherapy

NCT02682212 | Completed

• 1 other identifier: LSH-15-001
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective is to investigate effects of perineal trauma at birth on women´s health and whether early physiotherapy improves pelvic floor strength. This will be achieved by an acknowledged/validated questionnaire sent electronically 6 weeks after first delivery. Women with symptomes of urinary incontinence according to the questionnaire will be offered participation in a single-blinded randomized intervention study to compare outcome after targeted physiotherapy with conventional advice and support. Intervention encompasses weekly pelvic floor training for 12 weeks. Pelvic strength will be measured and symptom information collected before and after intervention and 12 months postpartum in both groups. Pelvic floor problems after delivery are common and often persistent, including urinary/fecal incontinence, pelvic organ prolapse and sexual problems. Such symptoms reduce QoL and handicap women in multiple ways, physically, psychologically and socially. More knowledge of whether interventions and guidelines in this field can improve health and QoL is required.

Conditions

Pregnancy Complications

Keywords

Pelvic floor; obstetrics; perineal tear; physiotherapy

Outcome Measures

Primary Outcomes (1)

• Urinary incontinence rates measured by scores on the Australian Female PelvicFloor questionnaire

  Urinary incontinence rates measured by scores on the Australian Female PelvicFloor questionnaire

  16 weeks

Secondary Outcomes (3)

• Fecal/flatal incontinence measured by scores on the Australian Female PelvicFloor questionnaire

  16 weeks

• Sexual dysfunction measured by scores on the Australian Female PelvicFloor questionnaire

  16 weeks

• Quality of life measured by scores on the Australian Female PelvicFloor questionnaire

  16 weeks

Study Arms (2)

Physiotherapy intervention

EXPERIMENTAL

Intensive pelvic floor muscle training (PFMT) given by a physiotherapist with vaginal/rectal pressure feedback once a week for 12 weeks.

Other: Physiotherapy intervention

No intervention

NO INTERVENTION

Standard care

Interventions

Physiotherapy intervention OTHER

Compare the effect of early physiotherapy intervention (pelvic floor muscle training, PFMT) with standard care on pelvic floor dysfunction symptoms, quality of life (QoL) and (pelvic floor muscle (PFM) strength, for women who answered the questionnaire positively for 1) urinary incontinence, 2) other dysfunction of the pelvic floor.

Physiotherapy intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy primiparas after delivery at LSH
• ≥18 years
• Diagnosed with urinary incontinence according to the self administered Australian Pelvic floor Questionnaire (Icelandic version) 6 weeks post partum.
• Able to attend intervention in the capital area
• Answer the Australian Pelvic Floor Questionnaire

You may not qualify if:

• Diseases or conditions that can interfere with pelvic floor function (other than childbirth), such as prior pelvic floor surgery or ability to benefit from the intervention
• Women unable to understand Icelandic
• Woman with cognitive disabilities.

Sponsors & Collaborators

• Landspitali University Hospital: lead
• University of Iceland: collaborator

Study Sites (1)

Tap, Physical Therapy Clinic

Kopavogur, 201, Iceland

Location

Related Publications (2)

• Woodley SJ, Lawrenson P, Boyle R, Cody JD, Morkved S, Kernohan A, Hay-Smith EJC. Pelvic floor muscle training for preventing and treating urinary and faecal incontinence in antenatal and postnatal women. Cochrane Database Syst Rev. 2020 May 6;5(5):CD007471. doi: 10.1002/14651858.CD007471.pub4.

  PMID: 32378735 DERIVED

• Sigurdardottir T, Steingrimsdottir T, Geirsson RT, Halldorsson TI, Aspelund T, Bo K. Can postpartum pelvic floor muscle training reduce urinary and anal incontinence?: An assessor-blinded randomized controlled trial. Am J Obstet Gynecol. 2020 Mar;222(3):247.e1-247.e8. doi: 10.1016/j.ajog.2019.09.011. Epub 2019 Sep 14.

  PMID: 31526791 DERIVED

MeSH Terms

Conditions

Pregnancy Complications

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Thora Steingrimsdottir, MD, PhD

  Landspitali University Hospital/University of Iceland, Reykjavik, Iceland

  PRINCIPAL INVESTIGATOR

• Kari Bo, PhD

  Norwegian School of Sports Sciences, Oslo, Norway

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2015
• First Posted: February 15, 2016
• Study Start: March 16, 2016
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: April 16, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

IC (1)