Skip to main content
OpenTrials
Completed

NCT Number: NCT06760767

Pelvic Floor Physiotherapy Combined With Sexual Therapy in Vaginismus Treatment

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Medipol University

Istanbul, 34810, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

sexual therapy

Behavioral

In sexual therapy sessions, sexual education, cognitive restructuring, body awareness exercises, systematic desensitization, relaxation training, individual and partner home exercise training and dilator treatment were applied with the supervision of a physiotherapist. All techniques and stages were not applied in the same session and were used with a certain progression

Pelvic floor physiotherapy combined with sexual therapy

Behavioral

Pelvic floor physiotherapy combined with sexual therapy was applied in the experimental group. Sexual therapy techniques were added appropriately before, during and after the pelvic floor physiotherapy session. In the pelvic floor physiotherapy sessions, pelvic floor muscle training, biofeedback, electrotherapy, manual therapy applications, breathing exercises, stretching and relaxation exercises were applied with the physiotherapist. Pelvic floor physiotherapy techniques and stages were applied in the same session and followed a certain progression.

Primary outcomes

  1. Surface Electromyography (sEMG)

    Time frame: 0-6 weeks

    A 2-channel Neurotrac MyoPlus 4 Pro (Verity Medical, UK) surface electromyography (sEMG) device with testing and biofeedback features was used to measure the activity of the pelvic floor muscles, adductor and muscles

Secondary outcomes

  1. Female Sexual Function Index (FSFI)

    Time frame: 0-6 weeks

    The FSFI consists of 19 questions and aims to determine the ongoing sexual functions of the person in the last four weeks.

  2. The Vaginal Penetration Cognition Questionnare (VPCQ)

    Time frame: 0-6 weeks

    The questions in this questionnaire are aimed at investigating thoughts related to vaginal penetration.

  3. "Does sexual intercourse occur?"

    Time frame: 0-6 weeks

    Before and after the treatment, the participants were asked the question "Does sexual intercourse occur?" and their answers were collected as "Yes" and "No".

Sponsors and collaborators

Lead sponsor

Medipol University

Other

Registry information

Official study title

Investigation of The Effectiveness of Pelvic Floor Physiotherapy Combined With Sexual Therapy in Vaginismus Treatment

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 7, 2025
Registry last updated
Jan 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.