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Enrolling by invitation NCT07446556

Exercise Program in Women With Pudendal Neuralgia

No phase Interventional Pudendal Neuralgia- Physiotherapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pelvic Floor Relaxation Protocol.
Who it may be relevant to
Registry conditions: Pudendal Neuralgia- Physiotherapy. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Slovakia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Interventions

  • 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.

Primary outcome measures

  • Pelvic floor muscle stiffness by shear-wave elastography (SWE) [Time frame: Baseline and 6 months (post-intervention)]
Secondary outcome measures (3)
  • Pelvic Floor Impact Questionnaire-Short Form 7 (PFIQ-7) [Time frame: Baseline and 6 months (post-intervention)]
  • Female Sexual Distress Scale-Revised (FSDS-R) [Time frame: Baseline and 6 months (post-intervention)]
  • Pain/discomfort intensity by visual analog scale (VAS) [Time frame: Baseline and 6 months (post-intervention)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Slovakia · 1 center
  • Comenius University Bratislava, Jessenius Faculty of Medicine in Martin, Slovakia — Martin

Identifiers

NCT: NCT07446556 · 6808/2023/ODDZ-2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗