NCT05713864

Brief Summary

This study will evaluate the clinical efficacy of the BTL-899 and HPM-6000UF devices in combination for non-invasive strengthening of the core muscles and overall improvement in quality of life in female patients after childbirth.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 8, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 10, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

February 6, 2023

Completed
Last Updated

April 13, 2023

Status Verified

April 1, 2023

Enrollment Period

7 months

First QC Date

January 10, 2023

Last Update Submit

April 11, 2023

Conditions

Muscle Weakness

Outcome Measures

Primary Outcomes (2)

  • Assessment of core muscles strength measured by pressure biofeedback device

    Change in core muscles strength measured by pressure biofeedback device. The maximal pressure before and after the study therapy will be compared for each subject, according to the study phase. Through the change in pressure, the change in strength will be evaluated.

    5 months

  • Assessment of subject's quality of life based on Subject Satisfaction and Experience

    Change in subject's quality of life based on Subject Satisfaction and Experience Questionnaire. The subjects will answer questions about their lifestyle where the best possible answer is "Strongly agree" and the worst is "Strongly disagree".

    5 months

Study Arms (2)

BTL-899 Treatments

EXPERIMENTAL

The BTL-899 will be applied over the abdomen, and the device will induce visible muscle contractions along with mild heating of the muscles. Four (4) treatments once a week will be delivered.

Device: BTL-899

HPM-6000UF Treatments

EXPERIMENTAL

The HPM-6000UF device will induce pelvic floor muscle contractions. Six (6) treatments 2-4 days apart will be delivered.

Device: HPM-6000UF

Interventions

BTL-899DEVICE

The BTL-899 will be applied over the abdomen, and the device will induce visible muscle contractions along with mild heating of the muscles. Four (4) treatments once a week will be delivered.

BTL-899 Treatments
HPM-6000UFDEVICE

The HPM-6000UF device will induce pelvic floor muscle contractions. Six (6) treatments 2-4 days apart will be delivered.

HPM-6000UF Treatments

Eligibility Criteria

Age22 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsHealthy female subjects aged 22 years or older who have given birth to a baby 6 to 60 months prior to their enrolment in the study
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy female subjects aged 22 years or older who have given birth to a baby 6 to 60 months prior to their enrolment in the study seeking treatment for strengthening their pelvic floor and abdominal muscles
  • Having a body mass index (BMI) less than 35 kg/m2
  • Subjects should be able to understand the investigative nature of the treatment, the possible benefits and side effects, and must sign the Informed Consent Form.
  • Subjects willing and able to abstain from partaking in any concurrent treatments on abdomen and pelvic floor other than the study procedures during study participation.
  • Willingness to comply with study instructions, to return to the clinic for the required visits, and to have photographs taken.

You may not qualify if:

  • Ongoing Pregnancy, nursing or IVF procedure
  • Electronic implants (such as cardiac pacemakers, defibrillators, and neurostimulators)
  • Metal implants in the treated area
  • Drug pumps
  • Malignant tumor
  • Pulmonary insufficiency
  • Injured or otherwise impaired muscles in the treated area
  • Cardiovascular diseases
  • Disturbance of temperature or pain perception
  • Hemorrhagic conditions
  • Septic conditions and empyema
  • Acute inflammations in the treated area
  • Systemic or local infection such as osteomyelitis and tuberculosis
  • Contagious skin disease
  • Elevated body temperature
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Contour Medical

Gilbert, Arizona, 85297, United States

Location

Julene B. Samuels

River Bluff, Kentucky, 40059, United States

Location

Southern Urogynecology

West Columbia, South Carolina, 29169, United States

Location

MeSH Terms

Conditions

Muscle Weakness

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2023

First Posted

February 6, 2023

Study Start

March 8, 2022

Primary Completion

September 28, 2022

Study Completion

November 30, 2022

Last Updated

April 13, 2023

Record last verified: 2023-04

Locations

US(3)