Clinical trial NCT03247660: Perineal Physiotherapy in Postpartum
Official title: Effectiveness of the Perineal Physiotherapy in the Prevention and Treatment of Pelvic Floor Dysfunction in Postpartum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Partum
Lead sponsor: University of Alcala
Sponsor class: OTHER
First posted: 2017-08-14
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3 groups: 2 experimental groups and 1 control group
Primary purpose: PREVENTION

Brief summary: Objective: To find out the effectiveness of pelvic-perineal physiotherapy in prevention and treatment of postpartum pelvic floor dysfunction caused by vaginal delivery.

Detailed description: Design: Randomized, controlled and single blinded clinical trial. Participants will be randomly assigned to one of these groups: Experimental group: pelvic-perineal physical therapy plus hypopressive exercises plus training in lifestyle advice; Experimental group II: hypopressive exercises plus training in lifestyle advice; Control group: just training in lifestyle advice. In the 3 groups several physical therapy assessments will be undertaken: 1st before intervention, 2nd immediately after completing intervention; 3th, 4th, 5th and 6th after 3, 6, 12 and 24 months. Study subjects: Postnatal women (6 and 8 weeks after vaginal delivery), primiparous, whose vaginal delivery has occurred in the "PrÍncipe de Asturias" Hospital, which have not been already treated for pelvic floor dysfunction, and after reading, understanding and freely signing an informed consent form. Sample size: 240 subjects will be included (80 subjects per group). Allowing for 15% of drop-outs and taking into account that 17% of women in the intervention group may develop pelvic floor dysfunction (urinary incontinence) versus 40% in the control group, with an alpha risk of 0.05, a beta risk of 0.1 in a bilateral contrast using the arcsine approximation. Data analysis: A descriptive analysis will be done of all variables. A confidence level of 95% (p \<0,05) will be established for all the cases. Effectiveness will be evaluated by comparing between the two groups of the change in outcome variables between visits.

Eligibility criteria: Inclusion Criteria:

* Postnatal women (6 and 8 weeks after vaginal delivery)
* Primiparous
* Whose vaginal delivery has occurred in the "Príncipe de Asturias" Hospital
* Women have not been already treated for pelvic floor dysfunction
* Women reading, understanding and freely signing an informed consent form

Exclusion Criteria:

* Postnatal women with medical diagnosis of pelvic floor dysfunction (PFD) prior to pregnancy and delivery
* Women with a history of conservative treatment or PFD surgery
* Women with concomitant or systemic disease that may affect the treatment (neurological, gynecological, urological or connective tissue), or with active or recurrent urinary infection without treatment at the time of the intervention proposed in this study, or hematuria
* Postnatal women with cognitive limitations to understand information, respond to questionnaires, consent and / or participate in the study.

Primary outcomes:
measure: Change in life impact of pelvic floor dysfunction
timeFrame: 5 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), 3 months, 6 months and 12 months after the intervention.
measure: Change in symptoms and quality of life
timeFrame: 5 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), , 3 months, 6 months and 12 months after the intervention.
measure: Change in pelvic floor muscle strength
timeFrame: 5 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), , 3 months, 6 months and 12 months after the intervention.
measure: Change in pelvic floor muscle characteristics
timeFrame: 5 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), 3 months, 6 months and 12 months after the intervention.
measure: Change in pelvic floor muscle strength
timeFrame: 5 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), 3 months, 6 months and 12 months after the intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: Alcalá de Henares
country: Spain
facility: University of Alcalá. FPSM research group. HUPA
state: Madrid
Study officials:
References:
citation: 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.