DyspareuniaNCT05417334
Effect of Radiofrequency in the Treatment of de Novo Dyspareunia at 4 to 12 Months Postpartum.
A study testing Resistive Capicitive Monopolar Radiofrequency in people with Dyspareunia, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
This study evaluates if the application of resistive capacitive monopolar radiofrequency therapy associated with Thiele massage is effective when treating de novo dyspareunia at 4 to 12 months postpartum. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Dyspareunia
- What is being tested?
- Resistive Capicitive Monopolar Radiofrequency
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 18 Mar 2021to 21 Jun 2024
- Phase
- Interventional
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 4-12 postpartum
- de novo dyspareunia after delivery
- obstetric injury
- Grant informed consent
Who cannot join
- radiofrequency contraindications (pacemaker, active infection or pregnancy)
- cesarean section
- dyspareunia previous to labour
- previous vulvo-vaginal pathology
- patients with postpartum depression
- patients with a pelvic region oncological history
- patients with a history of pelvic trauma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Radiofrequency in the Treatment of de Novo Dyspareunia at 4 to 12 Months Postpartum: Randomised Prospective Trial
This study evaluates if the application of resistive capacitive monopolar radiofrequency therapy associated with Thiele massage is effective when treating de novo dyspareunia at 4 to 12 months postpartum.
Read the detailed description
Dyspareunia is a type of genito-pelvic pain (GPP) that takes place during vaginal penetration at some point in sexual intercourse. It greatly affects quality of life as well as psychological and sexual wellbeing. A delivery with episiotomy, perineal tearing or labor dystocia using forceps or vacuum, are risk factors that contribute to the appearance of de novo dyspareunia with a prevalence of 17-45% at 6 months postpartum.
There is no evidence in the scientific literature of the effect of radiofrequency is this group of patients, however there is a clinical trial that describes the effect in scar tissue although not in the perineum. It is for all of the above that the following project is proposed, to evaluate the effect of RF in perineal healing and vaginal trigger points caused as a consequence of GPP.
The main objective of this study is to evaluate the role that radiofrequency (RF) plays in reducing the level of pain in de novo dyspareunia in postpartum women that persists from 4 to 12 months.
- Conditions
- Dyspareunia
- Being tested
- Resistive Capicitive Monopolar Radiofrequency
- Keywords
- dyspareunia, radiofrequency, postpartum pain, perineal massage, episiotomy
- Medical subject headings
- Dyspareunia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistive Capicitive Monopolar RadiofrequencyDevice
5 Radiofrequency sessions including the abdominal region, the vulva and pelvic floor tissue and Thiele massage done daily by the patient at home
| Study group | Role | What they receive |
|---|---|---|
| ON Radiofrequency treatment | Active comparator | Application of the technique in the intervention group (activated resistive capacitive monopolar radiofrequency therapy): the intervention group will receive treatment with activated RF, with the electrode at a medium intensity for 20 minutes per session during a total of 5 sessions, the 3 first ones held weekly and the 2 last ones every other week. Receives: Device: Resistive Capicitive Monopolar Radiofrequency |
| Sham Radiofrequency treatment | Sham comparator | Application of the technique in the intervention group (inactive resistive capacitive monopolar radiofrequency therapy): the intervention group will receive treatment with inactive RF, with the electrode at a medium intensity for 20 minutes per session during a total of 5 sessions, the 3 first ones held weekly and the 2 last ones every other week. Receives: Device: Resistive Capicitive Monopolar Radiofrequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the baseline Level of pain during penetration and after 5 sessions
Using the Visual Analogue Scale (VAS), where 10 is the highest level of pain possible and 0 is no pain at all.
Measured: Baseline and after 7 weeks
Secondary outcomes (4)
Change of the baseline Sexual function and after 5 sessions
Using the Female Sexual Function Index (FSFI), where higher scores indicate higher degrees of sexual functioning of a total of 36 points (and lower pain).
Measured: Baseline and after 7 weeks
Change of the baseline muscle pain points and after 5 sessions
A physical evaluation held by the physical therapist seeking for pain points and asking the patient to score the amount of pain using the visual analogue scale (VAS) where 10 is the highest level of pain possible and 0 is no pain at all.
Measured: Baseline and after 7 weeks
Change in Pelvic floor dysfunctions in the baseline assesment and after 5 sessions
Using the Pelvic Floor Distress Inventory-20 questionnaire (PFDI-20), in which the higher the score the greater the perceived impact that the pelvic floor dysfunction has on the patient's life (range 0 to 300 points).
Measured: Baseline and after 7 weeks
Change of the baseline affection on the quality of life and after 5 sessions
Using the EuroQuality of life-5D (EQ5D),where the maximum score of 1 indicates the best health state and therefore, higher scores indicate more severe or frequent problems (range from 0 to 10)
Measured: Baseline and after 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start18 Mar 2021
- Primary completion3 Jun 2024
- Study completion21 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspareuniaStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carla Box, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05417334
- Sponsor's protocol ID
- HCB/2020/0484
- Status last verified
- Jun 2026
- First submitted
- 2 Jun 2022
- Last updated
- 9 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Radiofrequency in the Treatment of de Novo Dyspareunia at 4 to 12 Months Postpartum: Randomised Prospective Trial
- ClinicalTrials.gov ID
- NCT05417334
- Acronym / sponsor ID
- HCB/2020/0484
- Conditions
- Dyspareunia
- Keywords
- dyspareunia, radiofrequency, postpartum pain, perineal massage, episiotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 18 Mar 2021 (actual)
- Primary completion
- 3 Jun 2024 (actual)
- Study completion
- 21 Jun 2024 (actual)
- First posted
- 14 Jun 2022 (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.
This study evaluates if the application of resistive capacitive monopolar radiofrequency therapy associated with Thiele massage is effective when treating de novo dyspareunia at 4 to 12 months postpartum.
Detailed description
Dyspareunia is a type of genito-pelvic pain (GPP) that takes place during vaginal penetration at some point in sexual intercourse. It greatly affects quality of life as well as psychological and sexual wellbeing. A delivery with episiotomy, perineal tearing or labor dystocia using forceps or vacuum, are risk factors that contribute to the appearance of de novo dyspareunia with a prevalence of 17-45% at 6 months postpartum.
There is no evidence in the scientific literature of the effect of radiofrequency is this group of patients, however there is a clinical trial that describes the effect in scar tissue although not in the perineum. It is for all of the above that the following project is proposed, to evaluate the effect of RF in perineal healing and vaginal trigger points caused as a consequence of GPP.
The main objective of this study is to evaluate the role that radiofrequency (RF) plays in reducing the level of pain in de novo dyspareunia in postpartum women that persists from 4 to 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ON Radiofrequency treatment | Active comparator | Device: Resistive Capicitive Monopolar RadiofrequencyApplication of the technique in the intervention group (activated resistive capacitive monopolar radiofrequency therapy): the intervention group will receive treatment with activated RF, with the electrode at a medium intensity for 20 minutes per session during a total of 5 sessions, the 3 first ones held weekly and the 2 last ones every other week. |
| Sham Radiofrequency treatment | Sham comparator | Device: Resistive Capicitive Monopolar RadiofrequencyApplication of the technique in the intervention group (inactive resistive capacitive monopolar radiofrequency therapy): the intervention group will receive treatment with inactive RF, with the electrode at a medium intensity for 20 minutes per session during a total of 5 sessions, the 3 first ones held weekly and the 2 last ones every other week. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 4-12 postpartum
- de novo dyspareunia after delivery
- obstetric injury
- Grant informed consent
Key exclusion criteria (7 listed)
- radiofrequency contraindications (pacemaker, active infection or pregnancy)
- cesarean section
- dyspareunia previous to labour
- previous vulvo-vaginal pathology
- patients with postpartum depression
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 |
|---|---|---|
| Resistive Capicitive Monopolar Radiofrequency5 Radiofrequency sessions including the abdominal region, the vulva and pelvic floor tissue and Thiele massage done daily by the patient at home | Device | ON Radiofrequency treatment, Sham Radiofrequency treatment |
Primary outcome
Change of the baseline Level of pain during penetration and after 5 sessions
Time frame: Baseline and after 7 weeks
Using the Visual Analogue Scale (VAS), where 10 is the highest level of pain possible and 0 is no pain at all.
4 secondary outcomes
Change of the baseline Sexual function and after 5 sessions
Time frame: Baseline and after 7 weeks
Change of the baseline muscle pain points and after 5 sessions
Time frame: Baseline and after 7 weeks
Change in Pelvic floor dysfunctions in the baseline assesment and after 5 sessions
Time frame: Baseline and after 7 weeks
Change of the baseline affection on the quality of life and after 5 sessions
Time frame: Baseline and after 7 weeks
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 9 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Dyspareunia
RecruitingObservational study
Rigid Hymenal Ring as a Cause for Insertional Dyspareunia
Dyspareunia (Female)
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
RecruitingPhase 2
Proof of Concept Study of Vaginal AZU-101 in Vulvovaginal Atrophy in Postmenopausal Women
Vulvo Vaginal Atrophy (VVA)
RecruitingObservational study
Association of Ultrasound Features of the Myometrium Suggestive of Adenomyosis and Clinical Symptoms
Adenomyosis of Uterus
Recruiting
F-GYN for Vaginal Dryness and Vulvovaginal Atrophy
Atrophic Vaginitis, Atrophic Vulvovaginitis
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?
A study testing Resistive Capicitive Monopolar Radiofrequency in people with Dyspareunia, run by Hospital Clinic of Barcelona at 1 site in Spain.
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 4 inclusion and 7 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 9 Jun 2026. 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 Spain. 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. Some participants in this study may receive a placebo. 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?
Change of the baseline Level of pain during penetration and after 5 sessions (time frame: Baseline and after 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jun 2026.