Exercise Program in Women With Pudendal Neuralgia

NCT07446556 | Enrolling By Invitation

• 1 other identifier: 6808/2023/ODDZ-2
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Pudendal Neuralgia- Physiotherapy

Keywords

Pudendal neuralgia Chronic pelvic pain Pelvic floor physiotherapy Shear-wave elastography Pelvic floor muscle stiffness

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 6 months (post-intervention)

Secondary Outcomes (3)

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

  Baseline and 6 months (post-intervention)

• Female Sexual Distress Scale-Revised (FSDS-R)

  Baseline and 6 months (post-intervention)

• Pain/discomfort intensity by visual analog scale (VAS)

  Baseline and 6 months (post-intervention)

Study Arms (2)

Pelvic Floor Relaxation Protocol

EXPERIMENTAL

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

Control

NO INTERVENTION

Participants did not receive the structured physiotherapy exercise program.

Interventions

Pelvic Floor Relaxation Protocol BEHAVIORAL

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.

Pelvic Floor Relaxation Protocol

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Yes (if PRS asks whether eligibility is based on sex/gender)
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Comenius University: lead

Study Sites (1)

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

Martin, Slovakia, Slovakia

Location

Study Officials

• Magdalena Hagovska, prof.PhDr.PhD.

  Pavol Jozef Safarik University, Medical Faculty, Kosice Slovakia

  PRINCIPAL INVESTIGATOR

• Jan Svihra, prof.MUDr.PhD.

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 3, 2026
• Study Start: March 2, 2026
• Primary Completion (Estimated): September 2, 2026
• Study Completion (Estimated): September 5, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)