Exercise Program in Women With Pudendal Neuralgia (ELASTIN)

March 12, 2026 updated by: Comenius University

Comparison of Shear-Wave Elastography of Superficial Pelvic Floor Muscles in Healthy Women and Women With Pudendal Neuralgia

This randomized controlled trial compares a 6-month physiotherapy exercise program versus no structured exercise intervention in women with pudendal neuralgia. Outcomes include pelvic floor muscle stiffness measured by shear-wave elastography (SWE), pelvic floor symptom burden (PFIQ-7), sexual distress (FSDS-R), and pain/discomfort scores (VAS).

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

83

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

  • Slovakia
    • Slovakia
      • Martin, Slovakia, Slovakia
        • Comenius University Bratislava, Jessenius Faculty of Medicine in Martin, Slovakia

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
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Female participants aged 18 years or older
  • Confirmed diagnosis of pudendal neuralgia based on all five Nantes diagnostic criteria
  • Duration of symptoms at least 3 months
  • Written informed consent provided

Exclusion Criteria:

  • History of psychiatric, neurological (except pudendal neuralgia), severe internal medical, orthopedic, or oncological disease

    • Botulinum toxin therapy within the previous 12 months
    • Pelvic surgery within the previous 12 months
    • Incomplete or incorrectly completed questionnaires
    • Refusal to participate or withdrawal of informed consent

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pelvic Floor Relaxation Protocol
Participants received a 6-month physiotherapy intervention consisting of 6 individual sessions with a physiotherapist and daily home exercise (30 minutes/day).
Behavioral: Pelvic Floor Relaxation Protocol
A structured 6-month physiotherapy program was implemented, focusing on pelvic floor muscle relaxation, postural correction, and functional movement patterns.The program included 6 individual sessions with a physiotherapist and mandatory daily home exercise (30 minutes/day). Adherence was recorded in participant diaries.
No Intervention: Control
Participants did not receive the structured physiotherapy exercise program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pelvic floor muscle stiffness by shear-wave elastography (SWE)
Time Frame: Baseline and 6 months (post-intervention)
Pelvic floor muscle stiffness (kPa) measured by shear-wave elastography in superficial pelvic floor muscles (bulbospongiosus, ischiocavernosus, and superficial transverse perineal muscles). Measurements were obtained using a 2 mm circular ROI with real-time quality control (RLB > 90%, M-STB 4-5 stars). Shell analysis was used to identify sites of minimum and maximum stiffness within each muscle.
Baseline and 6 months (post-intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pelvic Floor Impact Questionnaire-Short Form 7 (PFIQ-7)
Time Frame: Baseline and 6 months (post-intervention)
PFIQ-7 is a 21-item questionnaire assessing the impact of pelvic floor disorders across urinary, colorectal-anal, and prolapse/vaginal symptom domains. Total score ranges from 0 to 300; higher scores indicate greater negative impact on quality of life.
Baseline and 6 months (post-intervention)
Female Sexual Distress Scale-Revised (FSDS-R)
Time Frame: Baseline and 6 months (post-intervention)
FSDS-R is a 13-item questionnaire measuring sexually related personal distress. Each item is scored on a 5-point Likert scale (0-4). Total score ranges from 0 to 52; higher scores indicate greater sexual distress.
Baseline and 6 months (post-intervention)
Pain/discomfort intensity by visual analog scale (VAS)
Time Frame: Baseline and 6 months (post-intervention)
Pain and discomfort were assessed using VAS in five domains: bladder, vagina, perineum, rectum, and dyspareunia (pain during sexual intercourse).
Baseline and 6 months (post-intervention)

Collaborators and Investigators

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

Sponsor

Comenius University

Investigators

  • Principal Investigator: Magdalena Hagovska, prof.PhDr.PhD., Pavol Jozef Safarik University, Medical Faculty, Kosice Slovakia
  • Study Director: Jan Svihra, prof.MUDr.PhD., Comenius University Bratislava, Jessenius Faculty of Medicine in Martin, Slovakia

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)

March 2, 2026

Primary Completion (Estimated)

September 2, 2026

Study Completion (Estimated)

September 5, 2026

Study Registration Dates

First Submitted

February 26, 2026

First Submitted That Met QC Criteria

February 26, 2026

First Posted (Actual)

March 3, 2026

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 12, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 6808/2023/ODDZ-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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