Pelvic-perineal PathologyOTTAPENCT04146194
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
An observational study of Pelvic-perineal Pathology, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic-perineal Pathology
- What is being tested?
- None. This is a non-interventional observational study.
- How many people
- 173 participants
- Where
- 1 siteFrance
- Study dates
- 30 Dec 2019to 7 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients with pelvic-perineal pathology
- Patients who are not opposed to prospective data collection.
Who cannot join
- Patients with contraindications to these new therapies
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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)
Read the 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
- Being tested
- None. This is a non-interventional observational study.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None. This is a non-interventional observational study.Other
None. This is a non-interventional observational study.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2019
- Study start30 Dec 2019
- Primary completion7 Oct 2022
- Study completion7 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pelvic-perineal PathologyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04146194
- Sponsor's protocol ID
- Local/2018/PM-01
- Other IDs
- 2019-A00665-52
- Acronym
- OTTAPE
- Status last verified
- Feb 2023
- First submitted
- 29 Oct 2019
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 37183056
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04146194
- Acronym / sponsor ID
- OTTAPE / Local/2018/PM-01
- Conditions
- Pelvic-perineal Pathology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 30 Dec 2019 (actual)
- Primary completion
- 7 Oct 2022 (actual)
- Study completion
- 7 Oct 2022 (actual)
- First posted
- 31 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients with pelvic-perineal pathology
- Patients who are not opposed to prospective data collection.
Key exclusion criteria (1 listed)
- Patients with contraindications to these new therapies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| None. This is a non-interventional observational study.None. This is a non-interventional observational study. | Other | – |
Primary outcome
Characteristics of patients who are candidates for these new therapies
Time frame: 12 month
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.
First-line treatment tried
Time frame: 12 month
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.
Type of therapy used and for which type of pathology
Time frame: 12 month
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.
Number of sessions performed
Time frame: 12 month
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.
Possible use of a second therapy
Time frame: 12 month
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Results publication: PubMed 37183056Forret 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic-perineal Pathology, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characteristics of patients who are candidates for these new therapies (time frame: 12 month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04146194, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.