OTTAPE : Observatory on the Use of New Therapies (LED Photobiomodulation, Radiofrequency, Laser and Injectable Hyaluronic Acid) in the Treatment of Women's Pelvic-perineal Pathologies After Failure, Partial or Total, of First-line Medical Treatment

NCT04146194 | Completed

• 2 other identifiers: Local/2018/PM-012019-A00665-52
• Study Type: observational
• Target: 173
• Locations: 1 country
• Sites: 1

Brief Summary

Women's pelvic-perineal pathologies are a very frequent reason for consultation in gynaecology. The symptoms reported are diverse and range from the most frequent (genital prolapse, urinary or anal incontinence, dysuria, chronic pain) to new complaints (dyspareunia, vaginal laxity, perineum scarring, vulvo-vaginal atrophy). Currently, first-line medical treatments are no longer sufficient to improve patients. New therapies have emerged, namely LED photobiomodulation, radio frequency, Erbium or fractionated CO2 laser and injectable hyaluronic acid. These new treatments have been used in common practice for several years, but no studies have standardized practices. There are no recommendations regarding these new therapies to give specific indications for their use. The aim is to standardise the indications for these new technologies.

• LED photobiomodulation: management of scar perineas with pain, scarring disorders or trophic disorders.
• The Erbium laser or fractionated CO2: treatment of vulvo-vaginal atrophy.
• radiofrequency: management of chronic pelvic-perineal and postpartum pain.
• injectable hyaluronic acid: treatment of vestibulodynia and trophic disorders. Non-validated indications are proposed for these therapies (urinary incontinence, vaginal laxity and prolapse)

Conditions

Pelvic-perineal Pathology

Outcome Measures

Primary Outcomes (5)

• Characteristics of patients who are candidates for these new therapies

  Set up an observatory to carry out an inventory of the use of these new technologies and provide answers to basic questions: who uses them, for which patients, in which indications and for which therapeutic gain? Collect the practices of professionals and make it possible to evaluate the effectiveness of the therapeutic choice by the physician and the patient.

  12 month

• First-line treatment tried

  Set up an observatory to carry out an inventory of the use of these new technologies and provide answers to basic questions: who uses them, for which patients, in which indications and for which therapeutic gain? Collect the practices of professionals and make it possible to evaluate the effectiveness of the therapeutic choice by the physician and the patient.

  12 month

• Type of therapy used and for which type of pathology

  Set up an observatory to carry out an inventory of the use of these new technologies and provide answers to basic questions: who uses them, for which patients, in which indications and for which therapeutic gain? Collect the practices of professionals and make it possible to evaluate the effectiveness of the therapeutic choice by the physician and the patient.

  12 month

• Number of sessions performed

  Set up an observatory to carry out an inventory of the use of these new technologies and provide answers to basic questions: who uses them, for which patients, in which indications and for which therapeutic gain? Collect the practices of professionals and make it possible to evaluate the effectiveness of the therapeutic choice by the physician and the patient.

  12 month

• Possible use of a second therapy

  Set up an observatory to carry out an inventory of the use of these new technologies and provide answers to basic questions: who uses them, for which patients, in which indications and for which therapeutic gain? Collect the practices of professionals and make it possible to evaluate the effectiveness of the therapeutic choice by the physician and the patient.

  12 month

Interventions

None. This is a non-interventional observational study. OTHER

None. This is a non-interventional observational study.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Initially, this involves the follow-up of patients treated in the Gynaecology-Obstetrics department of the University Hospital of Nîmes and the Karis medical centre of Perpignan for a pelvi-perineal pathology. Other centres will be gradually incremented. Patients will have received a letter of information and no objection to the prospective collection of her data as part of routine management without any other intervention. These patients should not have any contraindications to the use of these new therapies.

You may qualify if:

• Patients with pelvic-perineal pathology
• Patients who are not opposed to prospective data collection.

You may not qualify if:

• Patients with contraindications to these new therapies

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU Nimes

Nîmes, France

Location

Related Publications (1)

• Forret A, Mares P, Delacroix C, Chevallier T, Potier H, Fatton B, Masia F, Ripart S, Letouzey V, de Tayrac R, Salerno J. [Photobiomodulation and vulvovaginal disorders after anticancer treatments]. Bull Cancer. 2023 Sep;110(9):883-892. doi: 10.1016/j.bulcan.2023.03.018. Epub 2023 May 12. French.

  PMID: 37183056 RESULT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2019
• First Posted: October 31, 2019
• Study Start: December 30, 2019
• Primary Completion: October 7, 2022
• Study Completion: October 7, 2022
• Last Updated: December 4, 2025

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)