Hyperthermy Endocavitary Treatment in Pelvic Pain

NCT02837588 | Unknown Phase 1 DMC

• 1 other identifier: Hyperthermy pelvic floor
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

• Treatment at pelvic floor with hyperactivity with hyperthermy electrode MJS
• MJS electrode is effective for transvaginal treatment at pelvic pain patients
• Hyperthermy treatment with MJS electrode is more effective to usual drugs treatment

Conditions

Pelvic Pain

Keywords

chronic pelvic pain; trigger points; hiperthermy

Outcome Measures

Primary Outcomes (1)

• NIH-CPSI questionnaire

  questions for pelvic pain evaluation

  four weeks

Secondary Outcomes (1)

• pain measure questionnaire

  four weeks

Study Arms (2)

Hyperthermy treatment with MJS electrode

ACTIVE COMPARATOR

30 patients who are diagnosed with myofascial syndrome by gyneacologist or urologist goes to Pelvic Floor Physiotherapist for 4 session with hyperthermy treatment with MJS electrode at pelvic floor trigger points

Device: Hyperthermy treatment with MJS electrode

CONTROL

NO INTERVENTION

No intervention with radiofrequency treatment, only evaluation to usual drug treatment

Interventions

Hyperthermy treatment with MJS electrode DEVICE

30 patients who are diagnosed Pelvic pain with myofascial syndrome by gyneacologist or urologist goes to Pelvic Floor Physiotherapist for 4 session with hyperthermy treatment with MJS electrode at pelvic floor trigger points

Hyperthermy treatment with MJS electrode

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women with chronic pelvic pain

You may not qualify if:

• chronic pelvic pain or neurological degenerative etiology
• Presence of pathology or infectious processes genitourinary level
• possibility of pregnancy or lactating.
• Lack of informed consent, mental disorders, dementia, dependent people who need tutor.

Sponsors & Collaborators

• Universidad Rey Juan Carlos: lead
• Hospital Universitario Virgen de la Victoria: collaborator

Study Sites (1)

Marta Sainz

Málaga, Málaga, 29018, Spain

Location

MeSH Terms

Conditions

Pelvic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Carolina Walker, Dr

  Universitat Central de Catalunya

  STUDY DIRECTOR

• Marta Losa, Dr

  Universidad Rey Juan Carlos

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, coordinator of Pelvic floor department, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: July 6, 2016
• First Posted: July 19, 2016
• Study Start: August 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 5, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will share

Locations

ES (1)