NCT03686956

Repair by Rehabilitation of Pelvic Floor Lesions After Vaginal Delivery Identified by Transperineal Ultrasound 3/4 D

Completed NA Last updated 17 August 2020

What this trial tests

NA trial testing Physiotherapy treatment in Pelvic Floor Disorders in 92 participants. Completed in 1 June 2019.

Timeline

1 August 2018

Primary endpoint
1 March 2019

1 June 2019

Quick facts

Lead sponsor	Hospital Universitario de Valme
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	92
Start date	1 August 2018
Primary completion	1 March 2019
Estimated completion	1 June 2019
Sites	1 location across Spain

Drugs / interventions tested

• Physiotherapy treatment

Conditions studied

• Pelvic Floor Disorders — all drugs for Pelvic Floor Disorders →
• Obstetric Trauma — all drugs for Obstetric Trauma →
• Physical Disorder — all drugs for Physical Disorder →
• Physical Activity — all drugs for Physical Activity →

Sponsor

Hospital Universitario de Valme

Who can join

18 and older, female only, with Pelvic Floor Disorders or Obstetric Trauma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

SUMMARY: (Objective, design, scope of the study, subjects of study, instrumentation, results, conclusions)

Objectives: To evaluate if the physiotherapy treatment in pelvic floor dysfunctions, identified by transperineal ultrasound 3 / 4D, in postpartum improve the tone and functionality of pelvic floor.

Design: Post-authorization, prospective, longitudinal randomized intervention study

Scope: Full-term deliveries at the University Hospital. Subjects of study: Full-term primiparous and full-term pregnancies with pelvic floor lesion, identified by transperineal ultrasound 3 / 4D, which are randomized between the physiotherapy treatment of pelvic floor and the non-work.

Variables: Primary variable: Assess the improvement in contractility / tone, evaluation by manometry and assess the anatomical improvement of the area of ?? the genital hiatus, stay by transperineal ultrasound 3 / 4D. Secondary variables: Identify the levator ani muscle injury rate, estimate the sonographic changes in the levator ani muscle through rehabilitation. Analyze the improvement of the symptoms associated with the public organic prolapse and evaluate the improvement of the quality of life.

Data analysis: To detect a difference of 10% in the reduction of the size of the index between the study groups (not intervened / intervened) after 6 months of intervention, standard deviation 10%, Error-alpha 5%, Error- beta 10% (P90%) we need 23 women in each group. Assuming a loss of 10% in the follow-up, the final size would be 52 women, 26 per group.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Quantification of 3/4D ultrasound pelvic floor changes induced by postpartum muscle training in patients with levator ani muscle avulsion: a parallel randomized controlled trial.
   Sainz-Bueno JA, Bonomi MJ, Suárez-Serrano C, Medrano-Sánchez EM, et al · · 2022 · cited 4× · PMID 35371949 · DOI 10.21037/qims-21-877