VaginismusNCT03176069
Evaluation and Comparison of Women Pelvic Floor With and Without Sexual Dysfunction (Vaginismus)
A study testing Evaluation and Comparison of women pelvic floor with and without sexual dysfunction and The physiotherapeutic treatment in people with Vaginismus and Sexual Dysfunctions, run by Faculdade de Ciências Médicas da Santa Casa de São Paulo at 1 site in Brazil.
Trial summary
Sexuality is considered one of the pillars of quality of life, an integral part of the personality of each individual. Being a basic human being need, it cannot be separated from other aspects of life. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginismus, Sexual Dysfunctions, Muscular Hypertonicity
- What is being tested?
- Evaluation and Comparison of women pelvic floor with and without sexual dysfunction and The physiotherapeutic treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Feb 2017to 3 Jun 2019
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female
- Sexual orientation - heterosexual
- Be in a stable relationship for at least six months
- Present vaginismus
- Did not initiated and/or performed previous vaginismus treatment
- Elementary school level
- Be available for weekly attendance at ambulatory
Who cannot join
- Severe psychiatric illness (psychosis) or physical incapacity (previous or current)
- Vaginismus, whose characteristics suggest the need for surgical treatment
- Cognitive downgrade
- Absence of a stable relationship
- Partner with sexual dysfunction that prevents penetration
- Presence of genital prolapse
Trial locations and contacts
1 site in 1 country.
About this study
Sexuality is considered one of the pillars of quality of life, an integral part of the personality of each individual. Being a basic human being need, it cannot be separated from other aspects of life. For several centuries and until recently, sexuality was considered the "lower instincts" expression related only to the sexual act. Sex is associated with "reproduction" of the sexual energy. On the other hand, the exercise of sexuality includes various factors such as the building of the sensitivity between individuals like touch, dance, fantasy, look, etc. For a long time feminine sexuality was predominantly focused on procreation and has only recently been considered as an integral part of sexual and reproductive rights of women. Vaginismus is a female sexual dysfunction that affects the quality of sexual and psychosocial lives of women, influencing the quality of the couple's relationship. The scientific literature emphasizes the importance of the examination, diagnosis and physical therapy for this dysfunction, but until now there is no quantification or evaluation of the pelvic floor muscles for this group of women, which justifies the realization of this project.
Read the detailed description
Psychosocial, cultural and relational factors, frequently influenced by a rigid education, have been related to the etiology of sexual difficulties. Women with stable partners who maintain an no consummated pattern of sexual intercourse (vaginismus) reveal a history of sexual life affected by these factors.
Vaginismus is a female sexual dysfunction that affects the quality of sexual and psychosocial lives of women. It may influence both the quality of the couple's relationship and the overall emotional and motivational state of people in their daily activities.
There is a concordance in the scientific literature that physiotherapy is of high importance in the treatment of vaginismus. The scientific literature presents some studies confirming its importance and highlighting the satisfactory results obtained at posttreatment of these dysfunctions.
Considering the impact of vaginismus in the sexual life of couples, as well as the relevance of the development of wide-ranging intervention models in the treatment of this disorder, it is appropriate to conduct this study in order to identify and recognize parameters of muscle tonus of women with and without a diagnosis of vaginismus and also to study the effectiveness of physiotherapy resources applied in the treatment of vaginismus.
Objectives
- Evaluate and compare the pelvic floor musculature of women with and without a diagnosis of vaginismus, by algometry and perineal electromyographic biofeedback;
- Evaluate and compare the parameters of muscle tonus of the pelvic floor by perineal electromyographic biofeedback in women with and without a diagnosis of vaginismus;
- Evaluate the pelvic floor musculature of women diagnosed with vaginismus, through algometry and electromyographic biofeedback, after the physiotherapeutic treatment;
- Evaluate the quality of sexual life and sexual function of women with and without a diagnosis of vaginismus;
- Evaluate the quality of sexual life and sexual function of women diagnosed with vaginismus, after physiotherapeutic treatment.
- Being tested
- Evaluation and Comparison of women pelvic floor with and without sexual dysfunction, The physiotherapeutic treatment
- Keywords
- Vaginismus, Muscle Tone, Sexual dysfunctions
- Medical subject headings
- Vaginismus, Muscle Hypertonia, Muscle Hypotonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation and Comparison of women pelvic floor with and without sexual dysfunctionOther
Pelvic floor muscles will also be evaluated by electromyographic biofeedback.
The physiotherapeutic treatmentOther
The available treatment tools are educational, behavioral and rehabilitating. The physiotherapeutic treatment will consist of the following features:
- Kinesiotherapy
- Manual therapy
- Electrotherapy (electric electrostimulation, ultrasound)
- Behavioral therapy
| Study group | Role | What they receive |
|---|---|---|
| Group A - women diagnosed with vaginismus | Active comparator | All patients will be submitted to anamnesis, physical examination, examination of the pelvic floor. The algometry will be performed with patient will be lying in a supine position (belly up), with the pelvis in a neutral position, back at 45º and feet supported in stirrups, for the verification the perineal pain threshold.
The available treatment tools are educational, behavioral and rehabilitating. The physiotherapeutic treatment will consist of the following features:
Kinesiotherapy Manual therapy Electrotherapy (electric electrostimulation, ultrasound) Behavioral therapy Receives: Other: The physiotherapeutic treatment |
| Group B - women without a diagnosis of vaginismus | Active comparator | All patients will be submitted to anamnesis, physical examination, examination of the pelvic floor. The algometry will be performed with patient will be lying in a supine position (belly up), with the pelvis in a neutral position, back at 45º and feet supported in stirrups, for the verification the perineal pain threshold. Receives: Other: Evaluation and Comparison of women pelvic floor with and without sexual dysfunction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality sex life
Female Sexual Function Index
Measured: 3 months
Female Sexual Function
Sex Index - Female Version (QS-F)
Measured: 3 months
Verification of female anxiety
Hamilton Anxiety Rating Scale (Ham-A)
Measured: 3 months
Verification of female depression
Beck Depression Inventory (BDI)
Measured: 3 months
Check Muscle Activity
Electromyographic biofeedback
Measured: 3 months
Evaluation of Pain
Functional pain scale
Measured: 3 months
Evaluation of Pain
Algometry
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start1 Feb 2017
- Primary completion3 Jun 2019
- Study completion3 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for VaginismusStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculdade de Ciências Médicas da Santa Casa de São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Profa. Dra. Vera Lúcia dos Santos Alves, Faculdade de Ciências Médicas da Santa Casa de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03176069
- Sponsor's protocol ID
- 51995515.4.0000.5479
- Status last verified
- Jun 2019
- First submitted
- 12 May 2016
- Last updated
- 7 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Herbenick D, Schick V, Sanders SA, Reece M, Fortenberry JD. Pain experienced during vaginal and anal intercourse with other-sex partners: findings from a nationally representative probability study in the United States. J Sex Med. 2015 Apr;12(4):1040-51. doi: 10.1111/jsm.12841. Epub 2015 Feb 4.
PubMed 25648245Edenfield AL, Levin PJ, Dieter AA, Amundsen CL, Siddiqui NY. Sexual activity and vaginal topography in women with symptomatic pelvic floor disorders. J Sex Med. 2015 Feb;12(2):416-23. doi: 10.1111/jsm.12716. Epub 2014 Oct 8.
PubMed 25293781Rosenbaum TY. Physiotherapy treatment of sexual pain disorders. J Sex Marital Ther. 2005 Jul-Sep;31(4):329-40. doi: 10.1080/00926230590950235.
PubMed 16020150Rosenbaum T. Addressing anxiety in vivo in physiotherapy treatment of women with severe vaginismus: a clinical approach. J Sex Marital Ther. 2011;37(2):89-93. doi: 10.1080/0092623X.2011.547340.
PubMed 21400333van Lankveld JJ, ter Kuile MM, de Groot HE, Melles R, Nefs J, Zandbergen M. Cognitive-behavioral therapy for women with lifelong vaginismus: a randomized waiting-list controlled trial of efficacy. J Consult Clin Psychol. 2006 Feb;74(1):168-78. doi: 10.1037/0022-006X.74.1.168.
PubMed 16551154Addar MH. The unconsummated marriage: causes and management. Clin Exp Obstet Gynecol. 2004;31(4):279-81.
PubMed 15672966Lahaie MA, Boyer SC, Amsel R, Khalife S, Binik YM. Vaginismus: a review of the literature on the classification/diagnosis, etiology and treatment. Womens Health (Lond). 2010 Sep;6(5):705-19. doi: 10.2217/whe.10.46.
PubMed 20887170Aydin S, Arioglu Aydin C, Batmaz G, Dansuk R. Effect of vaginal electrical stimulation on female sexual functions: a randomized study. J Sex Med. 2015 Feb;12(2):463-9. doi: 10.1111/jsm.12788. Epub 2014 Dec 3.
PubMed 25470078BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. doi: 10.1001/archpsyc.1961.01710120031004. No abstract available.
PubMed 13688369Biswas A, Ratnam SS. Vaginismus and outcome of treatment. Ann Acad Med Singap. 1995 Sep;24(5):755-8.
PubMed 8579326Bortolami A, Vanti C, Banchelli F, Guccione AA, Pillastrini P. Relationship between female pelvic floor dysfunction and sexual dysfunction: an observational study. J Sex Med. 2015 May;12(5):1233-41. doi: 10.1111/jsm.12882. Epub 2015 Apr 8.
PubMed 25855126De Lorenzi DR, Saciloto B. [Factors related to frequency of sexual activity of postmenopausal women]. Rev Assoc Med Bras (1992). 2006 Jul-Aug;52(4):256-60. doi: 10.1590/s0104-42302006000400027. Portuguese.
PubMed 16967145Engman M, Wijma K, Wijma B. Long-term coital behaviour in women treated with cognitive behaviour therapy for superficial coital pain and vaginismus. Cogn Behav Ther. 2010;39(3):193-202. doi: 10.1080/16506070903571014.
PubMed 20390584Kingsberg S, Althof SE. Evaluation and treatment of female sexual disorders. Int Urogynecol J Pelvic Floor Dysfunct. 2009 May;20 Suppl 1:S33-43. doi: 10.1007/s00192-009-0833-x.
PubMed 19440781Lewis RW, Fugl-Meyer KS, Corona G, Hayes RD, Laumann EO, Moreira ED Jr, Rellini AH, Segraves T. Definitions/epidemiology/risk factors for sexual dysfunction. J Sex Med. 2010 Apr;7(4 Pt 2):1598-607. doi: 10.1111/j.1743-6109.2010.01778.x.
PubMed 20388160
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Comparison of Women Pelvic Floor With and Without Sexual Dysfunction (Vaginismus)
- ClinicalTrials.gov ID
- NCT03176069
- Acronym / sponsor ID
- 51995515.4.0000.5479
- Keywords
- Vaginismus, Muscle Tone, Sexual dysfunctions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Faculdade de Ciências Médicas da Santa Casa de São PauloUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 3 Jun 2019 (actual)
- Study completion
- 3 Jun 2019 (actual)
- First posted
- 5 Jun 2017 (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.
Sexuality is considered one of the pillars of quality of life, an integral part of the personality of each individual. Being a basic human being need, it cannot be separated from other aspects of life. For several centuries and until recently, sexuality was considered the "lower instincts" expression related only to the sexual act. Sex is associated with "reproduction" of the sexual energy. On the other hand, the exercise of sexuality includes various factors such as the building of the sensitivity between individuals like touch, dance, fantasy, look, etc. For a long time feminine sexuality was predominantly focused on procreation and has only recently been considered as an integral part of sexual and reproductive rights of women. Vaginismus is a female sexual dysfunction that affects the quality of sexual and psychosocial lives of women, influencing the quality of the couple's relationship. The scientific literature emphasizes the importance of the examination, diagnosis and physical therapy for this dysfunction, but until now there is no quantification or evaluation of the pelvic floor muscles for this group of women, which justifies the realization of this project.
Detailed description
Psychosocial, cultural and relational factors, frequently influenced by a rigid education, have been related to the etiology of sexual difficulties. Women with stable partners who maintain an no consummated pattern of sexual intercourse (vaginismus) reveal a history of sexual life affected by these factors.
Vaginismus is a female sexual dysfunction that affects the quality of sexual and psychosocial lives of women. It may influence both the quality of the couple's relationship and the overall emotional and motivational state of people in their daily activities.
There is a concordance in the scientific literature that physiotherapy is of high importance in the treatment of vaginismus. The scientific literature presents some studies confirming its importance and highlighting the satisfactory results obtained at posttreatment of these dysfunctions.
Considering the impact of vaginismus in the sexual life of couples, as well as the relevance of the development of wide-ranging intervention models in the treatment of this disorder, it is appropriate to conduct this study in order to identify and recognize parameters of muscle tonus of women with and without a diagnosis of vaginismus and also to study the effectiveness of physiotherapy resources applied in the treatment of vaginismus.
Objectives
- Evaluate and compare the pelvic floor musculature of women with and without a diagnosis of vaginismus, by algometry and perineal electromyographic biofeedback;
- Evaluate and compare the parameters of muscle tonus of the pelvic floor by perineal electromyographic biofeedback in women with and without a diagnosis of vaginismus;
- Evaluate the pelvic floor musculature of women diagnosed with vaginismus, through algometry and electromyographic biofeedback, after the physiotherapeutic treatment;
- Evaluate the quality of sexual life and sexual function of women with and without a diagnosis of vaginismus;
- Evaluate the quality of sexual life and sexual function of women diagnosed with vaginismus, after physiotherapeutic treatment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A - women diagnosed with vaginismus | Active comparator | Other: The physiotherapeutic treatmentAll patients will be submitted to anamnesis, physical examination, examination of the pelvic floor. The algometry will be performed with patient will be lying in a supine position (belly up), with the pelvis in a neutral position, back at 45º and feet supported in stirrups, for the verification the perineal pain threshold. The available treatment tools are educational, behavioral and rehabilitating. The physiotherapeutic treatment will consist of the following features: Kinesiotherapy Manual therapy Electrotherapy (electric electrostimulation, ultrasound) Behavioral therapy |
| Group B - women without a diagnosis of vaginismus | Active comparator | Other: Evaluation and Comparison of women pelvic floor with and without sexual dysfunctionAll patients will be submitted to anamnesis, physical examination, examination of the pelvic floor. The algometry will be performed with patient will be lying in a supine position (belly up), with the pelvis in a neutral position, back at 45º and feet supported in stirrups, for the verification the perineal pain threshold. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Female
- Sexual orientation - heterosexual
- Be in a stable relationship for at least six months
- Present vaginismus
- Did not initiated and/or performed previous vaginismus treatment
Key exclusion criteria (6 listed)
- Severe psychiatric illness (psychosis) or physical incapacity (previous or current)
- Vaginismus, whose characteristics suggest the need for surgical treatment
- Cognitive downgrade
- Absence of a stable relationship
- Partner with sexual dysfunction that prevents penetration
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 |
|---|---|---|
| Evaluation and Comparison of women pelvic floor with and without sexual dysfunctionPelvic floor muscles will also be evaluated by electromyographic biofeedback. | Other | Group B - women without a diagnosis of vaginismus |
| The physiotherapeutic treatmentThe available treatment tools are educational, behavioral and rehabilitating. The physiotherapeutic treatment will consist of the following features: * Kinesiotherapy * Manual therapy * Electrotherapy (electric electrostimulation, ultrasound) * Behavioral therapy | Other | Group A - women diagnosed with vaginismus |
Primary outcome
Quality sex life
Time frame: 3 months
Female Sexual Function Index
Female Sexual Function
Time frame: 3 months
Sex Index - Female Version (QS-F)
Verification of female anxiety
Time frame: 3 months
Hamilton Anxiety Rating Scale (Ham-A)
Verification of female depression
Time frame: 3 months
Beck Depression Inventory (BDI)
Check Muscle Activity
Time frame: 3 months
Electromyographic biofeedback
Evaluation of Pain
Time frame: 3 months
Functional pain scale
Evaluation of Pain
Time frame: 3 months
Algometry
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 7 Oct 2019.
- Background: PubMed 25648245Herbenick D, Schick V, Sanders SA, Reece M, Fortenberry JD. Pain experienced during vaginal and anal intercourse with other-sex partners: findings from a nationally representative probability study in the United States. J Sex Med. 2015 Apr;12(4):1040-51. doi: 10.1111/jsm.12841. Epub 2015 Feb 4.
- Background: PubMed 25293781Edenfield AL, Levin PJ, Dieter AA, Amundsen CL, Siddiqui NY. Sexual activity and vaginal topography in women with symptomatic pelvic floor disorders. J Sex Med. 2015 Feb;12(2):416-23. doi: 10.1111/jsm.12716. Epub 2014 Oct 8.
- Background: PubMed 16020150Rosenbaum TY. Physiotherapy treatment of sexual pain disorders. J Sex Marital Ther. 2005 Jul-Sep;31(4):329-40. doi: 10.1080/00926230590950235.
- Background: PubMed 21400333Rosenbaum T. Addressing anxiety in vivo in physiotherapy treatment of women with severe vaginismus: a clinical approach. J Sex Marital Ther. 2011;37(2):89-93. doi: 10.1080/0092623X.2011.547340.
- Background: PubMed 16551154van Lankveld JJ, ter Kuile MM, de Groot HE, Melles R, Nefs J, Zandbergen M. Cognitive-behavioral therapy for women with lifelong vaginismus: a randomized waiting-list controlled trial of efficacy. J Consult Clin Psychol. 2006 Feb;74(1):168-78. doi: 10.1037/0022-006X.74.1.168.
- Background: PubMed 15672966Addar MH. The unconsummated marriage: causes and management. Clin Exp Obstet Gynecol. 2004;31(4):279-81.
- Background: PubMed 20887170Lahaie MA, Boyer SC, Amsel R, Khalife S, Binik YM. Vaginismus: a review of the literature on the classification/diagnosis, etiology and treatment. Womens Health (Lond). 2010 Sep;6(5):705-19. doi: 10.2217/whe.10.46.
- Background: PubMed 25470078Aydin S, Arioglu Aydin C, Batmaz G, Dansuk R. Effect of vaginal electrical stimulation on female sexual functions: a randomized study. J Sex Med. 2015 Feb;12(2):463-9. doi: 10.1111/jsm.12788. Epub 2014 Dec 3.
- Background: PubMed 13688369BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. doi: 10.1001/archpsyc.1961.01710120031004. No abstract available.
- Background: PubMed 8579326Biswas A, Ratnam SS. Vaginismus and outcome of treatment. Ann Acad Med Singap. 1995 Sep;24(5):755-8.
- Background: PubMed 25855126Bortolami A, Vanti C, Banchelli F, Guccione AA, Pillastrini P. Relationship between female pelvic floor dysfunction and sexual dysfunction: an observational study. J Sex Med. 2015 May;12(5):1233-41. doi: 10.1111/jsm.12882. Epub 2015 Apr 8.
- Background: PubMed 16967145De Lorenzi DR, Saciloto B. [Factors related to frequency of sexual activity of postmenopausal women]. Rev Assoc Med Bras (1992). 2006 Jul-Aug;52(4):256-60. doi: 10.1590/s0104-42302006000400027. Portuguese.
- Individual participant dataSharing planned: No
Related trials for Vaginismus
Enrolling by invitation
Immersive Visual Modulation and Ambient Music Therapy During Transvaginal Ultrasonography in Women With Vaginismus
Vaginismus
Not yet recruiting
Implementing Virtual Reality Exposure Therapy for Vaginismus: From Efficacy to Clinical Integration (VIVID 3)
Vaginismus, Difficulties With Vaginal Penetration
Active, not recruiting
Virtual Reality Exposure for Vaginismus: A Replicated Single-Case Design
Vaginismus
Not yet recruiting
Measuring Pelvic Floor Muscle Fitness Before and After Treatment
Myofacial Pain, Pelvic Pain
Active, not recruiting
Early Psychological Intervention After Rape
Post Traumatic Stress Disorder, Rape Sexual Assault
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 Evaluation and Comparison of women pelvic floor with and without sexual dysfunction and The physiotherapeutic treatment in people with Vaginismus and Sexual Dysfunctions, run by Faculdade de Ciências Médicas da Santa Casa de São Paulo at 1 site in Brazil.
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 7 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: finished, as of the sponsor's last update on 7 Oct 2019. 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 Brazil. 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?
Quality sex life (time frame: 3 months). The study lists 7 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 NCT03176069, which also lists 23 linked publications.
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 7 Oct 2019.