Female Sexual DysfunctionPhase 2/3NCT06755099
Female Sexual Dysfunction Assessment and Managment of Vaginismus
A Phase 2/3 study testing Botox and Radiofrequency in people with Female Sexual Dysfunction, run by Assiut University at 1 site in Egypt.
Trial summary
The study aims at : 1. The extent female sexual dysfunction problem in community through questionnaire . 2. Compare effectiveness of two treatment options for vaginismus . Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Female Sexual Dysfunction
- What is being tested?
- Botox and Radiofrequency
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to 30 Nov 2026
- Phase
- Phase 2/3
- 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
- • Age from 18to 40 years.
- Women diagnosed with primary vaginismus.
- Vaginismus has been classified by Lamont (12) according to its severity into four degrees or grades:
- In first degree (also known as grade 1 vaginismus), the patient has spasm of the pelvic floor that can be relieved with reassurance.
- In the second degree, the spasm is present throughout the pelvis even with reassurance.
- In third degree, the patient elevates her buttocks to avoid being examined.
- In fourth degree vaginismus, the most severe form of vaginismus, the patient elevates the buttocks, retreats, and tightly closes her thighs to avoid examination
Who cannot join
- Refusing to participate in the study
- Women whose husbands have an erectile dysfunction.
- women with secondary vaginismus.
- Women with psychiatric disorders.
- Lacking the appropriate cooperation for treatment and follow-up procedure.
- Having any contraindications to receiving botulinum, including allergies to albumin, botulinum toxin, or its injection components.
Show all 9Show fewer
- Previous history of treatment with botulinum or physiotherapy.
- Infection at the injection site.
- Diseases involving nerves and muscles, such as myasthenia gravis and Lambert-Eaton syndrome, vulvodynia, cutaneous problems at the vulva or perineum, anal fissure, urinary duct or rectum disorders, and coagulation disorders urging them to use anticoagulation drugs
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
women's health hospital of Assiut University
Asyut
Safwat Abdalrady Mohamed, 0100133053, safwatam@aun.edu.eg
About this study
Official title: Experience of Vaginismus in Outpatient Attendants in Assiut University Women's Health Hospital: Prevalence, Impact on Quality of Life and Management
The study aims at :
- The extent female sexual dysfunction problem in community through questionnaire .
- Compare effectiveness of two treatment options for vaginismus .
Read the detailed description
Female sexual dysfunction affects 41% of reproductive-age women worldwide, making it a highly prevalent medical issue. The Diagnostic and Statistical Manual of Mental Disorders (DSM) defines female sexual dysfunction (FSD) as "any sexual complaint or problem resulting from disorders of desire, arousal, orgasm, or sexual pain that causes marked distress or interpersonal difficulty". To qualify as a dysfunction, the problem must be present more than 75% of the time, for more than 6 months, causing significant distress. According to the DSM 5 (5th edition, 2013), female sexual dysfunction entails the following disorders: sexual interest / arousal disorder, female orgasmic disorder and genito-pelvic pain / penetration disorder . Sexual dysfunction has a biopsychosocial etiology, i.e. origin of the dysfunction may stem from a biological or organic condition, a psychological condition and/or asocial condition. it is usually underreported especially in conservative communities necessitating screening in different female populations .
Vaginismus is a sexual dysfunction presented as pain and fear during sexual intercourse which is caused by intermittent and unintentional spasms of the outer one-third muscles of the vagina. Negative attitude toward sex and history of sexual abuse are the predisposing factors for vaginismus which is a culture-dependent disorder. A wide range of factors from fear of pain, bleeding and panic attack to family history and valuing the hymen are among the culture-dependent agents .
Vaginismus is classified as primary, in which the woman has never experienced painless intercourse, or secondary, in which the woman has previously experienced painless intercourse but subsequently experiences dyspareunia. Secondary vaginismus may be due to physical causes such as vaginitis or trauma during childbirth, while in some cases it may be due to psychological causes, or to a combination of causes. The treatment for secondary vaginismus is the same as for primary vaginismus .
According to various potential etiologies, a multidimensional approach should be considered for treatment of vaginismus. Caregivers should take psychological, biological, emotional, and relational factors of women and their partners into account. So far , plenty of psychological, sexual and pharmacological interventions as well as cognitive and behavioral therapy, relaxation therapy and hypnotherapy have been applied for management of vaginismus which had positive effects to some extent.
Radiofrequency has been beingapplied since decades for vaginal rejuvenation and previous researches have proven the efficacy of energy-based minimally invasive radiofrequency devices for vaginal tightening . In addition, this method might offer benefits for women with genitourinary syndrome including female sexual dysfunction (FSD) and stress urinary incontinence (SUI); however, there seems to be a need for robust data and high-quality evidence. A recent study has confirmed the positive effects of temperature controlled dual-mode radiofrequency for management of vaginal laxity and improvement of pelvic floor muscles as well as female sexual function.
More recent approaches may include local injections of botulinum toxin. Type A botulinum toxin proteolytically degrades the synaptosomal-associated protein 25 (SNAP-25), a protein required for vesicle fusion and neurotransmitter release, preventing secretory vesicles from releasing the neurotransmitters, therefore blocking neuromuscular junction .
Botox, (onabotulinumtoxin A) a drug derived from a Botulinum toxin, interferes with the chemical transmitter, acetylcholine, that is responsible for muscle contraction or spasm. Botox has proven to be as safe as aspirin. It has been used for decades to weaken over-active muscles and glands in patients with conditions such as cerebral palsy, stroke , hyper hidrosis, and migraines, as well as for cosmetic purposes .
After thorough research of literature, the studies comparing Botox injection and pulsed radiofrequency in treatment of vaginismus are lacking.
- Conditions
- Female Sexual Dysfunction
- Being tested
- Botox, Radiofrequency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BotoxDrug
The patient will be placed in gynecological position. Subsequently, the patient will be anesthetized with propofol bolus, a total of 270 mg IV sterilization of valval area with antiseptic solution then digital examination to assess the spasm of intriotus and vaginal walls under lowest possible doses then increasing the doses to allow for intra vaginal injection of Botox under full sedation. Pacik technique will be adopted for Botox Injection in the vagina .
. One vial of frozen Botox 100 U will be diluted with 2 mL saline, without foaming or shaking the vial, giving a concentration of 2.5 U/0.05 mL . Using a small sized speculum and after bending the needle to 30° to facilitate injection into sub mucosal area,1 mL (50 U) of Botox will be injected into the right bulbocavernosus then into the left side .
RadiofrequencyDevice
Patients will be placed in prone position. After proper disinfection, the ischial spine (IS) and insertion point of the sacrospinous ligament will be identified using fluoroscopy medial to IS. 5 ml Lidocaine 2 % will be used to apply local anesthesia to the skin at the expected entry point for the radiofrequency cannula. Then a 20 G, 10 cm long and 1 cm active tip radiofrequency cannula will be introduced gradually utilizing 2 Hz motor stimulation until pudendal nerve is identified visually by the occurrence of contraction of the external anal sphincter muscle.
Subsequently, pulsed radiofrequency lesioning at temperature limit of 42 C will be applied bilaterally to the pudendal nerves for 240 s (2 cycles of 120 s) after applying local anesthesia using 2 cm 2% lidocaine in its vicinity.
| Study group | Role | What they receive |
|---|---|---|
| botox injection arm | Experimental | patients in this group will be treated by Botox injection Receives: Drug: Botox |
| radio frequency arm | Experimental | patients in this group will be treated by radio frequency Receives: Device: Radiofrequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
- prevalence of female sexual dysfunction and vaginal penetration pain disorders - prevalence of female sexual dysfunction and vaginal penetration pain disorders.
Measured: 1 year
Reevaluate female sexual function index score after intervention
Measured: 6 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start1 Jan 2025 (estimated)
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Female Sexual DysfunctionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa M. Mostafa, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06755099
- Sponsor's protocol ID
- Treatment trials in vaginismus
- Status last verified
- Dec 2024
- First submitted
- 12 Dec 2024
- Last updated
- 1 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Ferreira JR, Souza RP. Botulinum toxin for vaginismus treatment. Pharmacology. 2012;89(5-6):256-9. doi: 10.1159/000337383.
PubMed 22507920Pacik PT, Geletta S. Vaginismus Treatment: Clinical Trials Follow Up 241 Patients. Sex Med. 2017 Jun;5(2):e114-e123. doi: 10.1016/j.esxm.2017.02.002. Epub 2017 Mar 28.
PubMed 28363809Matak I, Bolcskei K, Bach-Rojecky L, Helyes Z. Mechanisms of Botulinum Toxin Type A Action on Pain. Toxins (Basel). 2019 Aug 5;11(8):459. doi: 10.3390/toxins11080459.
PubMed 31387301Stachowicz AM, Hoover ML, Karram MM. Clinical utility of radiofrequency energy for female genitourinary dysfunction: past, present, and future. Int Urogynecol J. 2021 Jun;32(6):1345-1350. doi: 10.1007/s00192-021-04735-9. Epub 2021 Mar 4.
PubMed 33661319Juhasz MLW, Korta DZ, Mesinkovska NA. Vaginal Rejuvenation: A Retrospective Review of Lasers and Radiofrequency Devices. Dermatol Surg. 2021 Apr 1;47(4):489-494. doi: 10.1097/DSS.0000000000002845.
PubMed 33165070Banaei M, Kariman N, Ozgoli G, Nasiri M. Bio-psychosocial factor of vaginismus in Iranian women. Reprod Health. 2021 Oct 18;18(1):210. doi: 10.1186/s12978-021-01260-2.
PubMed 34663378Fadul R, Garcia R, Zapata-Boluda R, Aranda-Pastor C, Brotto L, Parron-Carreno T, Alarcon-Rodriguez R. Psychosocial Correlates of Vaginismus Diagnosis: A Case-Control Study. J Sex Marital Ther. 2019;45(1):73-83. doi: 10.1080/0092623X.2018.1484401. Epub 2019 Feb 7.
PubMed 30044690McCool-Myers M, Theurich M, Zuelke A, Knuettel H, Apfelbacher C. Predictors of female sexual dysfunction: a systematic review and qualitative analysis through gender inequality paradigms. BMC Womens Health. 2018 Jun 22;18(1):108. doi: 10.1186/s12905-018-0602-4.
PubMed 29929499
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experience of Vaginismus in Outpatient Attendants in Assiut University Women's Health Hospital: Prevalence, Impact on Quality of Life and Management
- ClinicalTrials.gov ID
- NCT06755099
- Acronym / sponsor ID
- Treatment trials in vaginismus
- Conditions
- Female Sexual Dysfunction
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 1 Jan 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 study aims at :
- The extent female sexual dysfunction problem in community through questionnaire .
- Compare effectiveness of two treatment options for vaginismus .
Detailed description
Female sexual dysfunction affects 41% of reproductive-age women worldwide, making it a highly prevalent medical issue. The Diagnostic and Statistical Manual of Mental Disorders (DSM) defines female sexual dysfunction (FSD) as "any sexual complaint or problem resulting from disorders of desire, arousal, orgasm, or sexual pain that causes marked distress or interpersonal difficulty". To qualify as a dysfunction, the problem must be present more than 75% of the time, for more than 6 months, causing significant distress. According to the DSM 5 (5th edition, 2013), female sexual dysfunction entails the following disorders: sexual interest / arousal disorder, female orgasmic disorder and genito-pelvic pain / penetration disorder . Sexual dysfunction has a biopsychosocial etiology, i.e. origin of the dysfunction may stem from a biological or organic condition, a psychological condition and/or asocial condition. it is usually underreported especially in conservative communities necessitating screening in different female populations .
Vaginismus is a sexual dysfunction presented as pain and fear during sexual intercourse which is caused by intermittent and unintentional spasms of the outer one-third muscles of the vagina. Negative attitude toward sex and history of sexual abuse are the predisposing factors for vaginismus which is a culture-dependent disorder. A wide range of factors from fear of pain, bleeding and panic attack to family history and valuing the hymen are among the culture-dependent agents .
Vaginismus is classified as primary, in which the woman has never experienced painless intercourse, or secondary, in which the woman has previously experienced painless intercourse but subsequently experiences dyspareunia. Secondary vaginismus may be due to physical causes such as vaginitis or trauma during childbirth, while in some cases it may be due to psychological causes, or to a combination of causes. The treatment for secondary vaginismus is the same as for primary vaginismus .
According to various potential etiologies, a multidimensional approach should be considered for treatment of vaginismus. Caregivers should take psychological, biological, emotional, and relational factors of women and their partners into account. So far , plenty of psychological, sexual and pharmacological interventions as well as cognitive and behavioral therapy, relaxation therapy and hypnotherapy have been applied for management of vaginismus which had positive effects to some extent.
Radiofrequency has been beingapplied since decades for vaginal rejuvenation and previous researches have proven the efficacy of energy-based minimally invasive radiofrequency devices for vaginal tightening . In addition, this method might offer benefits for women with genitourinary syndrome including female sexual dysfunction (FSD) and stress urinary incontinence (SUI); however, there seems to be a need for robust data and high-quality evidence. A recent study has confirmed the positive effects of temperature controlled dual-mode radiofrequency for management of vaginal laxity and improvement of pelvic floor muscles as well as female sexual function.
More recent approaches may include local injections of botulinum toxin. Type A botulinum toxin proteolytically degrades the synaptosomal-associated protein 25 (SNAP-25), a protein required for vesicle fusion and neurotransmitter release, preventing secretory vesicles from releasing the neurotransmitters, therefore blocking neuromuscular junction .
Botox, (onabotulinumtoxin A) a drug derived from a Botulinum toxin, interferes with the chemical transmitter, acetylcholine, that is responsible for muscle contraction or spasm. Botox has proven to be as safe as aspirin. It has been used for decades to weaken over-active muscles and glands in patients with conditions such as cerebral palsy, stroke , hyper hidrosis, and migraines, as well as for cosmetic purposes .
After thorough research of literature, the studies comparing Botox injection and pulsed radiofrequency in treatment of vaginismus are lacking.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| botox injection arm | Experimental | Drug: Botoxpatients in this group will be treated by Botox injection |
| radio frequency arm | Experimental | Device: Radiofrequencypatients in this group will be treated by radio frequency |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- • Age from 18to 40 years.
- Vaginismus has been classified by Lamont (12) according to its severity into four degrees or grades:
- In first degree (also known as grade 1 vaginismus), the patient has spasm of the pelvic floor that can be relieved with reassurance.
- In the second degree, the spasm is present throughout the pelvis even with reassurance.
- In third degree, the patient elevates her buttocks to avoid being examined.
Key exclusion criteria (9 listed)
- Refusing to participate in the study
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 |
|---|---|---|
| BotoxThe patient will be placed in gynecological position. Subsequently, the patient will be anesthetized with propofol bolus, a total of 270 mg IV sterilization of valval area with antiseptic solution then digital examination to assess the spasm of intriotus and vaginal walls under lowest possible doses then increasing the doses to allow for intra vaginal injection of Botox under full sedation. Pacik technique will be adopted for Botox Injection in the vagina . . One vial of frozen Botox 100 U will be diluted with 2 mL saline, without foaming or shaking the vial, giving a concentration of 2.5 U/0.05 mL . Using a small sized speculum and after bending the needle to 30° to facilitate injection into sub mucosal area,1 mL (50 U) of Botox will be injected into the right bulbocavernosus then into the left side . | Drug | botox injection arm |
| RadiofrequencyPatients will be placed in prone position. After proper disinfection, the ischial spine (IS) and insertion point of the sacrospinous ligament will be identified using fluoroscopy medial to IS. 5 ml Lidocaine 2 % will be used to apply local anesthesia to the skin at the expected entry point for the radiofrequency cannula. Then a 20 G, 10 cm long and 1 cm active tip radiofrequency cannula will be introduced gradually utilizing 2 Hz motor stimulation until pudendal nerve is identified visually by the occurrence of contraction of the external anal sphincter muscle. Subsequently, pulsed radiofrequency lesioning at temperature limit of 42 C will be applied bilaterally to the pudendal nerves for 240 s (2 cycles of 120 s) after applying local anesthesia using 2 cm 2% lidocaine in its vicinity. | Device | radio frequency arm |
Primary outcome
- prevalence of female sexual dysfunction and vaginal penetration pain disorders - prevalence of female sexual dysfunction and vaginal penetration pain disorders.
Time frame: 1 year
Reevaluate female sexual function index score after intervention
Time frame: 6 months after intervention
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 1 Jan 2025.
- Background: PubMed 22507920Ferreira JR, Souza RP. Botulinum toxin for vaginismus treatment. Pharmacology. 2012;89(5-6):256-9. doi: 10.1159/000337383.
- Background: PubMed 28363809Pacik PT, Geletta S. Vaginismus Treatment: Clinical Trials Follow Up 241 Patients. Sex Med. 2017 Jun;5(2):e114-e123. doi: 10.1016/j.esxm.2017.02.002. Epub 2017 Mar 28.
- Background: PubMed 31387301Matak I, Bolcskei K, Bach-Rojecky L, Helyes Z. Mechanisms of Botulinum Toxin Type A Action on Pain. Toxins (Basel). 2019 Aug 5;11(8):459. doi: 10.3390/toxins11080459.
- Background: PubMed 33661319Stachowicz AM, Hoover ML, Karram MM. Clinical utility of radiofrequency energy for female genitourinary dysfunction: past, present, and future. Int Urogynecol J. 2021 Jun;32(6):1345-1350. doi: 10.1007/s00192-021-04735-9. Epub 2021 Mar 4.
- Background: PubMed 33165070Juhasz MLW, Korta DZ, Mesinkovska NA. Vaginal Rejuvenation: A Retrospective Review of Lasers and Radiofrequency Devices. Dermatol Surg. 2021 Apr 1;47(4):489-494. doi: 10.1097/DSS.0000000000002845.
- Background: PubMed 34663378Banaei M, Kariman N, Ozgoli G, Nasiri M. Bio-psychosocial factor of vaginismus in Iranian women. Reprod Health. 2021 Oct 18;18(1):210. doi: 10.1186/s12978-021-01260-2.
- Background: PubMed 30044690Fadul R, Garcia R, Zapata-Boluda R, Aranda-Pastor C, Brotto L, Parron-Carreno T, Alarcon-Rodriguez R. Psychosocial Correlates of Vaginismus Diagnosis: A Case-Control Study. J Sex Marital Ther. 2019;45(1):73-83. doi: 10.1080/0092623X.2018.1484401. Epub 2019 Feb 7.
- Background: PubMed 29929499McCool-Myers M, Theurich M, Zuelke A, Knuettel H, Apfelbacher C. Predictors of female sexual dysfunction: a systematic review and qualitative analysis through gender inequality paradigms. BMC Womens Health. 2018 Jun 22;18(1):108. doi: 10.1186/s12905-018-0602-4.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Botox and Radiofrequency in people with Female Sexual Dysfunction, run by Assiut University at 1 site in Egypt.
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 9 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: opening soon, as of the sponsor's last update on 1 Jan 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 Egypt. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Doaa Mostafa Mahmoud (+0201061699727, doaa21122@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
- prevalence of female sexual dysfunction and vaginal penetration pain disorders - prevalence of female sexual dysfunction and vaginal penetration pain disorders. (time frame: 1 year). The study lists 2 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 NCT06755099, which also lists 8 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 1 Jan 2025.