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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 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 173

Last updated 2025-12-04

No results posted yet for this study

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

Interventions

OTHER

None. This is a non-interventional observational study.

None. This is a non-interventional observational study.

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Nīmes

    lead OTHER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-30
Primary Completion
2022-10-07
Completion
2022-10-07

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04146194 on ClinicalTrials.gov