Female Sexual Dysfunction Assessment and Managment of Vaginismus

Phase 2

Not yet recruiting

• Conditions: Female Sexual Dysfunction
• Interventions: Drug: Botox; Device: Radiofrequency

• Registration Number: NCT06755099
• Lead Sponsor: Assiut University

Brief 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 .

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-12
• Study First Submitted QC: 2024-12-24
• Last Update Submitted: 2024-12-24
• Study Start: 2025-01-01
• Study First Posted: 2025-01-01
• Last Update Posted: 2025-01-01
• Primary Completion: 2026-08-30
• Study Completion: 2026-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• • 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:

1. In first degree (also known as grade 1 vaginismus), the patient has spasm of the pelvic floor that can be relieved with reassurance.
2. In the second degree, the spasm is present throughout the pelvis even with reassurance.
3. In third degree, the patient elevates her buttocks to avoid being examined.
4. In fourth degree vaginismus, the most severe form of vaginismus, the patient elevates the buttocks, retreats, and tightly closes her thighs to avoid examination

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Exclusion Criteria

• 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.
  • 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
botox injection arm	Botox	patients in this group will be treated by Botox injection
radio frequency arm	Radiofrequency	patients in this group will be treated by radio frequency

Primary Outcome Measures

Name	Time	Method
- prevalence of female sexual dysfunction and vaginal penetration pain disorders - prevalence of female sexual dysfunction and vaginal penetration pain disorders.	1 year
Reevaluate female sexual function index score after intervention	6 months after intervention

Trial Locations

Locations (1)

women's health hospital of Assiut University; 🇪🇬 Assiut, Egypt