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 (OTTAPE)

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)

Study Overview

• Status: Completed
• Conditions: Pelvic-perineal Pathology
• Intervention / Treatment: Other: None. This is a non-interventional observational study.

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 173

Contacts and Locations

Study Locations

• France
  • Nîmes, France
    • CHU Nimes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2019
• Primary Completion (Actual): October 7, 2022
• Study Completion (Actual): October 7, 2022

Study Registration Dates

• First Submitted: October 29, 2019
• First Submitted That Met QC Criteria: October 29, 2019
• First Posted (Actual): October 31, 2019

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: November 27, 2025
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: Local/2018/PM-01; 2019-A00665-52 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No