Clinical trial NCT06760767: Pelvic Floor Physiotherapy Combined With Sexual Therapy in Vaginismus Treatment
Official title: Investigation of The Effectiveness of Pelvic Floor Physiotherapy Combined With Sexual Therapy in Vaginismus Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Women Health
Physiotherapy
Exercise
Keywords: Sexual Dysfunction
Sexual Therapy
Electromyography
Pelvic Floor Physiotherapy
Vaginismus
Lead sponsor: Medipol University
Sponsor class: OTHER
First posted: 2025-01-07
Enrollment: 44
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled study
Primary purpose: TREATMENT

Brief summary: Studies on pelvic floor physiotherapy in individuals diagnosed with vaginismus are quite limited in the literature. While current studies have focused on certain physiotherapy modalities, the literature is quite limited in terms of combined rehabilitation programs. There is a need for non-invasive therapy methods that can be an alternative for the patient and client population whose vaginismus problem continues after behavioral therapies. No studies on pelvic floor physiotherapy combined with sexual therapy have been found in the literature. In this context, our study aimed to examine the effectiveness of pelvic floor physiotherapy combined with sexual therapy in individuals diagnosed with vaginismus.

Detailed description: Vaginismus is a sexual dysfunction defined as recurrent or persistent difficulty or impossibility of sexual intercourse due to involuntary contractions of the muscles in the vaginal area in women. This condition is usually associated with excessive tension and spasm of the pelvic floor muscles and adductor muscles when evaluated in terms of these muscle groups.

Sexuual therapy includes the placement of dilators of graduated sizes by the therapist at home or in a clinical setting, guided by both the patient and the partner, for systematic desensitization to vaginal penetration, and sexual education to alleviate the psychological impact of the condition. This method is most frequently used in studies and the reported success rates are quite high.

Various techniques such as breathing and relaxation exercises, local tissue desensitization, vaginal dilators, biofeedback and manual therapy are used within the scope of pelvic floor physiotherapy in the treatment of vaginismus. There are studies in the literature investigating the effectiveness of biofeedback exercises in the treatment of vaginismus with a 100% success rate. It has also been reported that the combined application of pelvic floor exercises with behavioral sexual therapy provides significant improvement. In this study aimed to examine the effectiveness of pelvic floor physiotherapy combined with sexual therapy in individuals diagnosed with vaginismus.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with vaginismus,
* Being between the ages of 20-45,
* Having an active sexual partner in the last 6 months,
* Not being in the accompanying physiotherapy or psychotherapy process.

Exclusion Criteria:

* Diagnosed with or treated for vulvodynia and/or vulvar vestibulitis,
* Having a pacemaker,
* Not being able to give personal consent,
* Having a physical problem that would prevent treatment.

Primary outcomes:
measure: Surface Electromyography (sEMG)
timeFrame: 0-6 weeks
Secondary outcomes:
measure: Female Sexual Function Index (FSFI)
timeFrame: 0-6 weeks
measure: The Vaginal Penetration Cognition Questionnare (VPCQ)
timeFrame: 0-6 weeks
measure: "Does sexual intercourse occur?"
timeFrame: 0-6 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University
Study officials:
affiliation: Medipol University
name: Gülay Aras Bayram, PhD
role: PRINCIPAL_INVESTIGATOR
References: