Pelvic Floor Physiotherapy Combined With Sexual Therapy in Vaginismus Treatment

NCT06760767 | Completed

• 1 other identifier: E-10840098-202.3.02-222
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Women Health; Physiotherapy; Exercise

Keywords

Sexual Dysfunction; Sexual Therapy; Electromyography; Pelvic Floor Physiotherapy; Vaginismus

Outcome Measures

Primary Outcomes (1)

• Surface Electromyography (sEMG)

  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 Outcomes (3)

• Female Sexual Function Index (FSFI)

  0-6 weeks

• The Vaginal Penetration Cognition Questionnare (VPCQ)

  0-6 weeks

• "Does sexual intercourse occur?"

  0-6 weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants in the intervention group received pelvic floor physiotherapy combined with sexual therapy twice a week for 6 weeks.

Behavioral: sexual therapy; Behavioral: Pelvic floor physiotherapy combined with sexual therapy

Control Group

EXPERIMENTAL

Participants in the control group received sexual therapy twice a week for 6 weeks.

Behavioral: sexual therapy

Interventions

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

Control Group; Intervention Group

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.

Intervention Group

Eligibility Criteria

• Age: 20 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Istanbul Medipol University

Istanbul, 34810, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity; Sexual Dysfunction, Physiological; Vaginismus

Condition Hierarchy (Ancestors)

Behavior; Genital Diseases; Urogenital Diseases; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Gülay Aras Bayram, PhD

  Medipol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Randomized controlled study

Study Record Dates

• First Submitted: December 30, 2024
• First Posted: January 7, 2025
• Study Start: January 15, 2024
• Primary Completion: July 31, 2024
• Study Completion: August 2, 2024
• Last Updated: January 8, 2025

Record last verified: 2025-01

Locations

TU (1)