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

NCT ID: NCT04146194

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 173 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-12-30
• Study Completion Date: 2022-10-07

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)

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.

Conditions

Pelvic-perineal Pathology

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

None. This is a non-interventional observational study.

None. This is a non-interventional observational study.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Nimes

Nîmes, , France

Countries

France

References

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.

Reference Type: RESULT

PMID: 37183056 (View on PubMed)

Other Identifiers

2019-A00665-52

Identifier Type: OTHER

Identifier Source: secondary_id

Local/2018/PM-01

Identifier Type: -

Identifier Source: org_study_id