Exercise Program in Women With Pudendal Neuralgia

N/AEnrolling By InvitationNCT07446556

Comenius University83 enrolled

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Pudendal Neuralgia- Physiotherapy

Interventions

Pelvic Floor Relaxation ProtocolBEHAVIORAL

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.

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

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

Martin, Slovakia, Slovakia

Outcomes

Primary Outcomes

Pelvic floor muscle stiffness by shear-wave elastography (SWE)

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.

Time frame: Baseline and 6 months (post-intervention)

Secondary Outcomes

Pelvic Floor Impact Questionnaire-Short Form 7 (PFIQ-7)

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.

Time frame: Baseline and 6 months (post-intervention)

Female Sexual Distress Scale-Revised (FSDS-R)

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.

Time frame: Baseline and 6 months (post-intervention)

Pain/discomfort intensity by visual analog scale (VAS)

Pain and discomfort were assessed using VAS in five domains: bladder, vagina, perineum, rectum, and dyspareunia (pain during sexual intercourse).

Time frame: Baseline and 6 months (post-intervention)

Data from ClinicalTrials.gov

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