NCT05617092

Brief Summary

The goal of this pilot randomized pilot controlled trial (RTC)is to collect acceptability and feasibility outcomes of a physiotherapy individualized program in women with levator injury that is intended to be used in a larger scale multicenter randomized controlled trial (RTC) in the future. The main questions it aims to answer are if a physiotherapy program in women with a levator injury:

  1. 1.Can improve the pelvic floor morphometry (PFM).
  2. 2.Can improve urogynecological symptoms
  3. 3.The effect of a physiotherapy program in the sexual function
  4. 4.The effect of a physiotherapy program in the patient's fear avoidance beliefs about physical activity and work Type of study: randomized pilot controlled trial (RTC) The design of this trial will be a pilot randomized controlled trial with 3 arms. Participants will be randomized in 2 arm of women with levator ani injury to either physiotherapy or standard care and an arm of woman without levator injury Researchers will compare the 3 groups to see if a physiotherapy program have benefits in morphometry of the pelvic floor, urogynecological symptoms, sexual function and to avoid fear avoidance beliefs about physical activity and work.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 15, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

April 27, 2023

Status Verified

April 1, 2023

Enrollment Period

1.2 years

First QC Date

November 1, 2022

Last Update Submit

April 26, 2023

Conditions

Pelvic Floor DisordersPelvic Floor; Perineal Rupture, ObstetricPhysiotherapy

Outcome Measures

Primary Outcomes (24)

  • Feasibility of the trial.

    The number of those referred to the trial over the study period, who meet the eligibility criteria, the number of eligible patients who consent to participate in the trial over the study period, and the number of patients who decline to participate, the number of participants who consent to participate that remain in the trial by 4-month follow-up, the number/proportion of participants with complete baseline data over the study period, the number/proportion of participants with complete follow-up data at 4 months follow-up, the number/proportion of participants retained at the end of each module of treatment.

    4 months after delivery

  • Feasibility of the trial.

    The number of those referred to the trial over the study period, who meet the eligibility criteria, the number of eligible patients who consent to participate in the trial over the study period, and the number of patients who decline to participate, the number of participants who consent to participate that remain in the trial by 4-month follow-up, the number/proportion of participants with complete baseline data over the study period, the number/proportion of participants with complete follow-up data at 4 months follow-up, the number/proportion of participants retained at the end of each module of treatment.

    6 months after delivery

  • Feasibility of the trial.

    The number of those referred to the trial over the study period, who meet the eligibility criteria, the number of eligible patients who consent to participate in the trial over the study period, and the number of patients who decline to participate, the number of participants who consent to participate that remain in the trial by 4-month follow-up, the number/proportion of participants with complete baseline data over the study period, the number/proportion of participants with complete follow-up data at 4 months follow-up, the number/proportion of participants retained at the end of each module of treatment.

    12 months after delivery

  • Morphometry with ultrasound Area

    3-D Ultrasound examination., Levator hiatus area at rest (cm2),during Valsalva (cm2) and at maximum contraction (cm2)

    10-12 weeks after delivery

  • Morphometry with ultrasound Area

    3-D Ultrasound examination., Levator hiatus area at rest (cm2),during Valsalva (cm2) and at maximum contraction (cm2)

    12 months after delivery

  • Morphometry with ultrasound Levator urethra GAP (LUG)

    The distance between the center of the urethra and the levator insertion (LUG) in cm

    10-12 weeks after delivery

  • Morphometry with ultrasound Levator urethra GAP (LUG)

    The distance between the center of the urethra and the levator insertion (LUG) in cm

    12 months after delivery

  • Morphometry with ultrasound muscle thickness

    Right and left puborectal muscle thickness (mm) .

    10-12 weeks after delivery

  • Morphometry with ultrasound muscle thickness

    Right and left puborectal muscle thickness (mm) .

    12 months after delivery

  • Urogynecological symptoms.

    Pelvic Floor Impact Questionnaire (PFIQ-7)

    3 months after delivery

  • Urogynecological symptoms.

    Pelvic Floor Impact Questionnaire (PFIQ-7)

    6 months after delivery

  • Urogynecological symptoms.

    Pelvic Floor Impact Questionnaire (PFIQ-7)

    12 months after delivery

  • Urogynecological symptoms.

    Pelvic Floor Distress Inventory-20 (PFDI-20)

    3 months after delivery

  • Urogynecological symptoms.

    Pelvic Floor Distress Inventory-20 (PFDI-20)

    6 months after delivery

  • Urogynecological symptoms.

    Pelvic Floor Distress Inventory-20 (PFDI-20)

    12 months after delivery

  • Physics activity level.

    Open questions on Physics activity level.

    3 months after delivery

  • Physics activity level.

    Open questions on Physics activity level.

    6 months after delivery

  • Physics activity level.

    Open questions on Physics activity level.

    12 months after delivery

  • Sexual Function.

    Female Sexual Function Index FSFI-19 questionnaire

    3 months after delivery

  • Sexual Function.

    Female Sexual Function Index FSFI-19 questionnaire

    6 months after delivery

  • Sexual Function.

    Female Sexual Function Index FSFI-19 questionnaire

    12 months after delivery

  • Fear Avoidance Beliefs Questionnaire (Physical Activity/PA)

    Fear-Avoidance Beliefs Questionnaire

    3 months after delivery

  • Fear Avoidance Beliefs Questionnaire (Physical Activity/PA)

    Fear-Avoidance Beliefs Questionnaire

    6 months after delivery

  • Fear Avoidance Beliefs Questionnaire (Physical Activity/PA)

    Fear-Avoidance Beliefs Questionnaire

    12 months after delivery

Secondary Outcomes (13)

  • Pelvic Organ Prolapse Quantification Examination (POP-Q)

    10-12 weeks after delivery

  • Pelvic Organ Prolapse Quantification Examination (POP-Q)

    12 months after delivery

  • Age

    10-12 weeks after delivery

  • Body mass index (BMI)

    10-12 weeks after delivery

  • Body mass index (BMI)

    12 months after delivery

  • +8 more secondary outcomes

Study Arms (3)

Intervention group

EXPERIMENTAL

intervention group will receive a physiotherapy individualized treatment

Other: Physiotherapy treatment

Control Group

NO INTERVENTION

No intervention in women with injury in the levator ani

Healthy controls

NO INTERVENTION

A group of women without injury that will be invited to filling in the questionnaires that will be carried out in the study three, six months and one year postpartum.

Interventions

Physiotherapy treatmentOTHER

physiotherapy individualized treatment according to the needs of the patient and clinical findings and symptoms

Intervention group

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • simplex vaginal first delivery with a elevator ani injury
  • aged ≥18 years
  • understands the Swedish language in speech and writing
  • approves vaginal examination

You may not qualify if:

  • diagnosed sphincter injury grade 3-4
  • serious postpartum disease (heart failure, thrombophlebitis, recent pulmonary embolism, acute infectious disease, genital haemorrhage, severe hypertension, dyspnoea, severe anemia or severe mental illness)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nu sjukvård

Trollhättan, Sweden

RECRUITING

MeSH Terms

Conditions

Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPregnancy ComplicationsMale Urogenital Diseases

Study Officials

  • Rocio Montejo, PhD

    Vastra Gotaland Region

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rocio Montejo, PhD

CONTACT

+46104352244rocio.montejo.rodriguez@vgregion.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

November 1, 2022

First Posted

November 15, 2022

Study Start

April 1, 2023

Primary Completion

June 30, 2024

Study Completion

December 31, 2024

Last Updated

April 27, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)