Vulvodynia (Chronic Vulvar Pain)NCT06981611
Vulvodynia Intervention: the Effect of Multimodal Treatment for Provoked Vulvodynia
A study testing Vulvodynia Intervention: a multimodal treatment for provoked vulvodynia in people with Vulvodynia (Chronic Vulvar Pain), run by Karlstad University at 1 site in Sweden.
Trial summary
The purpose of this project is to develop and evaluate a multimodal treatment for provoked vulvodynia, by addressing the following specific research questions: 1. What is the feasibility and acceptability of this multimodal treatment protocol? 2. What are the effects on pain and psychosexual health? 3. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Vulvodynia (Chronic Vulvar Pain)
- What is being tested?
- Vulvodynia Intervention: a multimodal treatment for provoked vulvodynia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSweden
- Study dates
- 11 Mar 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Biological sex: Female 18-40 years old Provoked vulvodynia
Who cannot join
- Severe psychological issues that should be prioritized before vulvodynia treatment (e.g., substance abuse, psychosis)
- Ongoing pregnancy
- Childbirth within the last year
- Post-traumatic stress disorder (PTSD) related to sexual trauma
- Insufficient mastery of the Swedish language
- No experience of vaginal sex, as vaginismus might be suspected, which requires different treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vulvodynia Intervention (VI): the Effect of Multimodal Treatment for Provoked Vulvodynia
The purpose of this project is to develop and evaluate a multimodal treatment for provoked vulvodynia, by addressing the following specific research questions:
- What is the feasibility and acceptability of this multimodal treatment protocol?
- What are the effects on pain and psychosexual health?
- How is the treatment perceived by patients, clinicians and stakeholders in the health care setting, and how do they view the possibilities for implementation?
Read more
Participants will be recruited through their health care unit and receive a multimodal treatment. The treatment consists of individual sessions with different professionals, in total 11 sessions over a time period of four months. It is possible to involve partners in the treatment during two of the treatment sessions. The majority of the sessions are digital video meetings but some are conducted at the health care unit. The treatment are based on physiological and psychosocial components that have previously shown positive effects for individuals with vulvodynia, and includes both educational and practical elements.
The participants will:
- Undergo a gynecological examination and a psychological assessment to determine if the treatment is suitable for their condition
- Undergo a multimodal treatment
- Complete questionnaires regarding their pain, physical tension, psychosexual and relational health and questions about the treatment
- Be asked to participate in an interview about their experience of the treatment and intimacy
Read the detailed description
The study design consists of a mixed-methods design, where different methods are applied in the various sub-studies of the project.
Study 1, is an effectiveness evaluation, applying a sequential single case experimental AB design (SCED) with randomized baseline length, replicated across five healthcare contexts (n≈10-15 per unit, total N≈50-75).
Potential participants will be informed about the study at their health care unit and answer a few questions digitally to ensure that participation in the study is appropriate for them. An assessment will then be conducted and questions will be asked about the pain, psychological, sexual and relational health, and a diagnostic interview will be conducted to exclude other psychological issues that needs to be prioritized before vulvodynia treatment. After the assessment interview and inclusion, participants will be randomized to a 4, 5, or 6 week baseline period. Thereafter, the treatment will begin. During the baseline and treatment period, participants will complete a short self-assessment questionnaire, twice a week, to measure pain (primary outcome) and other key variables. To facilitate the repeated assessments, we will use the m-Path app, which was developed by KU Leuven University in Belgium to easily evaluate treatment for both patients and therapists. In addition to the repeated assessments, the treatment will be evaluated through a comprehensive web-based self-assessment questionnaire before and after the intervention and at a six-month follow-up, using the secure survey system called Survey and Report. through Karlstad university. The outcome measures are based on the ongoing work by the Swedish Agency for Health Technology Assessment and Assessment of Social Services.
Study 2, is a qualitative evaluation and initial assessment of the possibilities for implementing the treatment in the Swedish healthcare context.
Individual interviews with patients will be conducted and questions will be asked regarding their experience of the treatment model. Focus group interviews will be conducted with practitioners and questions will be asked regarding relevance, relative advantages, consistency with standard practices, usability, and adaptability. Since the treatment will be carried out in five healthcare units with different organizational and practical conditions, questions will specifically address unit-specific aspects that therapists and patients perceive as having facilitated or hindered the implementation and what could be improved in both treatment content and execution. The questions are based on the recommendations of the Swedish National Board of Health and Welfare and the Public Health Agency regarding the initial assessment of implementation possibilities.
To obtain the healthcare organization's perspective on implementation possibilities, interviews will be held with health care stakeholders within the participating healthcare units. These interviews will also focus on relevance, relative advantages, consistency with standard practices, usability, and adaptability.
The individual and focus group interviews will be conducted in person at the health care units or through digital video meetings. Data from focus group interviews and individual interviews will be recorded by audio, transcribed, and analyzed according to standard qualitative analysis methods, primarily inductive empirically driven Thematic Analysis (TA).
- Conditions
- Vulvodynia (Chronic Vulvar Pain)
- Being tested
- Vulvodynia Intervention: a multimodal treatment for provoked vulvodynia
- Keywords
- Vulvodynia, Provoked vulvodynia, multimodal treatment, cognitive behavioral therapy, cbt, couple treatment, single-case experimental design, sced, chronic pain, Vulvodynia Intervention
- Medical subject headings
- Vulvodynia, Color Vision Defects, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vulvodynia Intervention: a multimodal treatment for provoked vulvodyniaBehavioural
The intervention is based around physiological and psychosocial components working with goal-directed behavioral change. Includes both educational and practical elements, examples of these are vulva care, lubrication exercises, pelvic floor relaxation, work with thoughts, feelings, and behaviors related to the pain, as well as thoughts, feelings and behaviors related to sex and desire, and educational and practical elements focusing on open communication and validation. The treatment sessions are approximately 60 minutes each. There is a possibility for the participants to involve partner during two of the treatment sessions.
| Study group | Role | What they receive |
|---|---|---|
| Vulvodynia Intervention: a multimodal treatment for provoked vulvodynia | Experimental | A multimodal treatment consisting of approximately 11 treatment sessions, for provoked vulvodynia. Working with goal-directed behavior change that has both physiological and psychosocial components. The treatment sessions will be conducted with various professionals, via digital video meetings and meetings at the health care facilities. The first five sessions are conducted weekly, and the last six sessions are conducted biweekly. A follow-up session is conducted three months after the end of the treatment. Repeated measurements (twice a week) are being collected throughout this period. Receives: Behavioral: Vulvodynia Intervention: a multimodal treatment for provoked vulvodynia |
| Randomized to waiting period of 4, 5 or 6 weeks | No intervention | Participants are randomized to a 4, 5 or 6 week waiting period/baseline. Repeated measurements (twice a week) are being collected throughout this period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain during touch and/or insertion of an object
Provoked pain during sexual and non-sexual activities. Seven activities where pain is rated on a scale from 0 to 10. Higher scoring indicates higher degree of pain. There are also subsequent questions regarding whether they have performed the described activity or not within a specific time frame.
Measured: Pre, post treatment (25 weeks after the baseline measurement started) and at 6 month follow-up, during baseline (4, 5 or 6 weeks) and treatment period measured twice a week for 25 weeks.
Secondary outcomes (10)
Change in sexual function
The Female Sexual Function Index (FSFI) is a self-report measure of female sexual function that assesses six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. It consists of 19 questions, rated on a 5-point scale, with a higher score indicating a better sexual function.
Measured: Pre and post treatment (25 weeks after the baseline measurement started) and at 6 months follow-up
Change in treatment goal attainment
Participants chose an individual treatment goal and rate treatment goal attainment, from 0-10, 0= the goal is not at all achieved, 10= the goal is achieved.
Measured: Pre, post treatment (25 weeks after the baseline measurement started) and at 6 month follow-up. Repeated measures twice a week during baseline (4, 5 or 6 weeks) and treatment period, for 25 weeks.
Change in pelvic floor tension
Self-report assessment of pelvic floor tension and pelvic floor relaxation. Two items rated on a 11-point scale, from 0-10, higher scores indicate greater tension and more difficulty relaxing the pelvic floor, and physiotherapeutic examination.
Measured: Pre, post treatment (25 weeks after the baseline measurement started) and at a 6 month follow-up. During baseline and treatment period measured twice a week, for 25 weeks.
Change in sexual satisfaction
Global measure of sexual satisfaction (GMSEX), 5 items rated on a 7-point scale. Higher scores indicate a higher degree of sexual satisfaction.
Measured: Pre and post treatment (25 weeks after the baseline measurement started) and at 6 months follow-up
Change in interpersonal and self focused sexual goals
Approach avoidance sexual goals (AASQ), self focused sexual goals and interpersonal sexual goals, 23 items rated on a 7-point scale, participants rates the importance of self focused or interpersonal reasons, influencing why they typically engage in sex. Higher scores indicates greater importance.
Measured: Pre and post treatment (25 weeks after the baseline measurement started), and at 6 months follow-up
Change in perceived intimacy
9 items regarding self and partner disclosure, partner responsiveness and closeness, rated on a 7-point scale, with higher scores indicating greater perceived intimacy.
Measured: Pre and post treatment (25 weeks after the baseline measurement started), and at 6 months follow-up
Change in life interference, sexual function interference and impact on relationship
Vulvar pain assessment questionnaire (VPAQ) Inventory is a disease-specific set of measurement scales to capture the biopsychosocial nature of vulvodynia. We are using the parts from the questionnaire that evaluates life interference, sexual function interference, impact on relationship and sexual communication.
Life interference: 11 items rated on a 6-point scale from 0 (not at all) to 4 (avoid because of pain). Higher scores indicating greater life interference.
Sexual function interference: 10 items rated on a 6-point scale from 0 (not at all) to 4 (avoid because of pain)
Impact on relationship: 6 items about intimacy and, general and sexual communication rated on a 5-point scale from much worse to much better. Higher scoring indicates that the vulva pain has lower impact on the relationship.
6 items about communication with partner rated on a 5-point scale from 0 (largely uncomfortable) to 4 (largely comfortable). Higher scoring indicates
Measured: Pre and post treatment (25 weeks after the baseline measurement started) and at 6 months follow-up
Change in depressive symptoms
Using the patient health questionnaire (PHQ-9), 9 items are rated on a 4-point scale, from 0 to 3. Higher scores indicating higher degree of depression symtoms.
Measured: Pre and post treatment (25 weeks after the baseline measurement started) and at 6 months follow-up
Change in anxiety symptoms
Using the Generalized Anxiety Disorder questionnaire (GAD-7), 7 items rated on a 4-point scale from 0 to 3, higher scoring indicating a higher degree of anxiety symptoms.
Measured: Pre and post treatment (25 weeks after the baseline measurement started) and at 6 months follow-up
Change in quality of life
World Health Organization Quality of Life-BREF, 1 item where participants rates their quality of life, on a 5-point scale from 1 to 5, higher scoring indicating greater quality of life.
Measured: Pre and post treatment (25 weeks after the baseline measurement started) and at 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start11 Mar 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulvodynia (Chronic Vulvar Pain)Studies of the same condition, open and under way.
- 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
- Sequential
- Model description
- The study utilizes a sequential single-case experimental AB design with randomized waiting period length (4, 5 or 6 weeks). Included in the design is also a pre-, post- and 6 month follow up measurement allowing for single group analysis of change. In addition, we collect qualitative data from patients, to explore experiences of participation in the study and the treatment.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karlstad University
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm, Region Örebro County, Region Jönköping County, Region Värmland
- Responsible party
- Principal investigator, Ida Flink, Karlstad University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06981611
- Sponsor's protocol ID
- 2024-03946-01
- Other IDs
- 2023-00377, 2023
- Status last verified
- Aug 2026
- First submitted
- 10 Mar 2025
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Because of the sensitive nature of the data. Data can be provided by request.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vulvodynia Intervention (VI): the Effect of Multimodal Treatment for Provoked Vulvodynia
- ClinicalTrials.gov ID
- NCT06981611
- Acronym / sponsor ID
- 2024-03946-01
- Conditions
- Vulvodynia (Chronic Vulvar Pain)
- Keywords
- Vulvodynia, Provoked vulvodynia, multimodal treatment, cognitive behavioral therapy, cbt, couple treatment, single-case experimental design, sced
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Karlstad UniversityUniversity, hospital or other
- Collaborators
- Region Stockholm, Region Örebro County, Region Jönköping County, Region Värmland
- Study start
- 11 Mar 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 May 2025 (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.
The purpose of this project is to develop and evaluate a multimodal treatment for provoked vulvodynia, by addressing the following specific research questions:
- What is the feasibility and acceptability of this multimodal treatment protocol?
- What are the effects on pain and psychosexual health?
- How is the treatment perceived by patients, clinicians and stakeholders in the health care setting, and how do they view the possibilities for implementation?
Participants will be recruited through their health care unit and receive a multimodal treatment. The treatment consists of individual sessions with different professionals, in total 11 sessions over a time period of four months. It is possible to involve partners in the treatment during two of the treatment sessions. The majority of the sessions are digital video meetings but some are conducted at the health care unit. The treatment are based on physiological and psychosocial components that have previously shown positive effects for individuals with vulvodynia, and includes both educational and practical elements.
The participants will:
- Undergo a gynecological examination and a psychological assessment to determine if the treatment is suitable for their condition
- Undergo a multimodal treatment
- Complete questionnaires regarding their pain, physical tension, psychosexual and relational health and questions about the treatment
- Be asked to participate in an interview about their experience of the treatment and intimacy
Detailed description
The study design consists of a mixed-methods design, where different methods are applied in the various sub-studies of the project.
Study 1, is an effectiveness evaluation, applying a sequential single case experimental AB design (SCED) with randomized baseline length, replicated across five healthcare contexts (n≈10-15 per unit, total N≈50-75).
Potential participants will be informed about the study at their health care unit and answer a few questions digitally to ensure that participation in the study is appropriate for them. An assessment will then be conducted and questions will be asked about the pain, psychological, sexual and relational health, and a diagnostic interview will be conducted to exclude other psychological issues that needs to be prioritized before vulvodynia treatment. After the assessment interview and inclusion, participants will be randomized to a 4, 5, or 6 week baseline period. Thereafter, the treatment will begin. During the baseline and treatment period, participants will complete a short self-assessment questionnaire, twice a week, to measure pain (primary outcome) and other key variables. To facilitate the repeated assessments, we will use the m-Path app, which was developed by KU Leuven University in Belgium to easily evaluate treatment for both patients and therapists. In addition to the repeated assessments, the treatment will be evaluated through a comprehensive web-based self-assessment questionnaire before and after the intervention and at a six-month follow-up, using the secure survey system called Survey and Report. through Karlstad university. The outcome measures are based on the ongoing work by the Swedish Agency for Health Technology Assessment and Assessment of Social Services.
Study 2, is a qualitative evaluation and initial assessment of the possibilities for implementing the treatment in the Swedish healthcare context.
Individual interviews with patients will be conducted and questions will be asked regarding their experience of the treatment model. Focus group interviews will be conducted with practitioners and questions will be asked regarding relevance, relative advantages, consistency with standard practices, usability, and adaptability. Since the treatment will be carried out in five healthcare units with different organizational and practical conditions, questions will specifically address unit-specific aspects that therapists and patients perceive as having facilitated or hindered the implementation and what could be improved in both treatment content and execution. The questions are based on the recommendations of the Swedish National Board of Health and Welfare and the Public Health Agency regarding the initial assessment of implementation possibilities.
To obtain the healthcare organization's perspective on implementation possibilities, interviews will be held with health care stakeholders within the participating healthcare units. These interviews will also focus on relevance, relative advantages, consistency with standard practices, usability, and adaptability.
The individual and focus group interviews will be conducted in person at the health care units or through digital video meetings. Data from focus group interviews and individual interviews will be recorded by audio, transcribed, and analyzed according to standard qualitative analysis methods, primarily inductive empirically driven Thematic Analysis (TA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study utilizes a sequential single-case experimental AB design with randomized waiting period length (4, 5 or 6 weeks). Included in the design is also a pre-, post- and 6 month follow up measurement allowing for single group analysis of change. In addition, we collect qualitative data from patients, to explore experiences of participation in the study and the treatment.
| Arm | Type | Receives |
|---|---|---|
| Vulvodynia Intervention: a multimodal treatment for provoked vulvodynia | Experimental | Behavioral: Vulvodynia Intervention: a multimodal treatment for provoked vulvodyniaA multimodal treatment consisting of approximately 11 treatment sessions, for provoked vulvodynia. Working with goal-directed behavior change that has both physiological and psychosocial components. The treatment sessions will be conducted with various professionals, via digital video meetings and meetings at the health care facilities. The first five sessions are conducted weekly, and the last six sessions are conducted biweekly. A follow-up session is conducted three months after the end of the treatment. Repeated measurements (twice a week) are being collected throughout this period. |
| Randomized to waiting period of 4, 5 or 6 weeks | No intervention | –Participants are randomized to a 4, 5 or 6 week waiting period/baseline. Repeated measurements (twice a week) are being collected throughout this period. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Biological sex: Female 18-40 years old Provoked vulvodynia
Key exclusion criteria (6 listed)
- Severe psychological issues that should be prioritized before vulvodynia treatment (e.g., substance abuse, psychosis)
- Ongoing pregnancy
- Childbirth within the last year
- Post-traumatic stress disorder (PTSD) related to sexual trauma
- Insufficient mastery of the Swedish language
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 |
|---|---|---|
| Vulvodynia Intervention: a multimodal treatment for provoked vulvodyniaThe intervention is based around physiological and psychosocial components working with goal-directed behavioral change. Includes both educational and practical elements, examples of these are vulva care, lubrication exercises, pelvic floor relaxation, work with thoughts, feelings, and behaviors related to the pain, as well as thoughts, feelings and behaviors related to sex and desire, and educational and practical elements focusing on open communication and validation. The treatment sessions are approximately 60 minutes each. There is a possibility for the participants to involve partner during two of the treatment sessions. | Behavioural | Vulvodynia Intervention: a multimodal treatment for provoked vulvodynia |
Primary outcome
Change in pain during touch and/or insertion of an object
Time frame: Pre, post treatment (25 weeks after the baseline measurement started) and at 6 month follow-up, during baseline (4, 5 or 6 weeks) and treatment period measured twice a week for 25 weeks.
Provoked pain during sexual and non-sexual activities. Seven activities where pain is rated on a scale from 0 to 10. Higher scoring indicates higher degree of pain. There are also subsequent questions regarding whether they have performed the described activity or not within a specific time frame.
10 secondary outcomes
Change in sexual function
Time frame: Pre and post treatment (25 weeks after the baseline measurement started) and at 6 months follow-up
Change in treatment goal attainment
Time frame: Pre, post treatment (25 weeks after the baseline measurement started) and at 6 month follow-up. Repeated measures twice a week during baseline (4, 5 or 6 weeks) and treatment period, for 25 weeks.
Change in pelvic floor tension
Time frame: Pre, post treatment (25 weeks after the baseline measurement started) and at a 6 month follow-up. During baseline and treatment period measured twice a week, for 25 weeks.
Change in sexual satisfaction
Time frame: Pre and post treatment (25 weeks after the baseline measurement started) and at 6 months follow-up
Change in interpersonal and self focused sexual goals
Time frame: Pre and post treatment (25 weeks after the baseline measurement started), and at 6 months follow-up
Change in perceived intimacy
Time frame: Pre and post treatment (25 weeks after the baseline measurement started), and at 6 months follow-up
Change in life interference, sexual function interference and impact on relationship
Time frame: Pre and post treatment (25 weeks after the baseline measurement started) and at 6 months follow-up
Change in depressive symptoms
Time frame: Pre and post treatment (25 weeks after the baseline measurement started) and at 6 months follow-up
Change in anxiety symptoms
Time frame: Pre and post treatment (25 weeks after the baseline measurement started) and at 6 months follow-up
Change in quality of life
Time frame: Pre and post treatment (25 weeks after the baseline measurement started) and at 6 months follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: No. Because of the sensitive nature of the data. Data can be provided by request.
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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?
A study testing Vulvodynia Intervention: a multimodal treatment for provoked vulvodynia in people with Vulvodynia (Chronic Vulvar Pain), run by Karlstad University at 1 site in Sweden.
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 1 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 12 Aug 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
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 in pain during touch and/or insertion of an object (time frame: Pre, post treatment (25 weeks after the baseline measurement started) and at 6 month follow-up, during baseline (4, 5 or 6 weeks) and treatment period measured twice a week for 25 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 12 Aug 2026.