Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-30 @ 10:26 AM
Study NCT ID:
NCT04146194
Status:
COMPLETED
Last Update Posted:
2025-12-04
First Post:
2019-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief 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
Sponsor:
Centre Hospitalier Universitaire de Nīmes
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OTTAPE
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)
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2019-A00665-52 | OTHER | ANSM | View |