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

Pelvic-perineal Pathology Clinical Trial

— OTTAPE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04146194
• Other study ID #: Local/2018/PM-01
• Status: Completed
• Start date: December 30, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2023
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

Description:

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.

At inclusion, the patient receives a pelvic-perineal clinical examination and a functional assessment (vaginal sampling), pain (EVA). The FSFI questionnaire will be administered.

During this visit, the investigator will set up a treatment with a new therapy. This treatment will be chosen by the operator before recommendations are made. The operator must detail the type of device and the protocol chosen.

The patient will be reviewed 4 weeks after the end of her treatment: she will benefit from an evaluation identical in all respects to the inclusion visit with the administration of the PGI-I questionnaire.

All information concerning the discontinuation, continuation or change of treatment will be documented in this follow-up phase.

In case of failure, second line treatment may be offered. Possible adverse reactions will be collected at all times.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. completion date: December 31, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with pelvic-perineal pathology

• Patients who are not opposed to prospective data collection.

Exclusion Criteria:

• Patients with contraindications to these new therapies

Related Conditions & MeSH terms

• Pelvic-perineal Pathology

Intervention

Other:
• None. This is a non-interventional observational study.
None. This is a non-interventional observational study.

Locations

Country	Name	City	State
France	CHU Nimes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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