Pelvic Floor Physiotherapy Combined With Sexual Therapy in Vaginismus Treatment

January 6, 2025 updated by: Gülay Aras, Medipol University

Investigation of The Effectiveness of 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34810
        • Istanbul Medipol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
Participants in the intervention group received pelvic floor physiotherapy combined with sexual therapy twice a week for 6 weeks.
Behavioral: sexual therapy
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
Behavioral: Pelvic floor physiotherapy combined with sexual therapy
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.
Experimental: Control Group
Participants in the control group received sexual therapy twice a week for 6 weeks.
Behavioral: sexual therapy
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
0-6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0-6 weeks
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.
0-6 weeks
"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".
0-6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medipol University

Investigators

  • Principal Investigator: Gülay Aras Bayram, PhD, Medipol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2024

Primary Completion (Actual)

July 31, 2024

Study Completion (Actual)

August 2, 2024

Study Registration Dates

First Submitted

December 30, 2024

First Submitted That Met QC Criteria

December 30, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 6, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-10840098-202.3.02-222

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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