Pudendal Neuralgia- PhysiotherapyELASTINNCT07446556
Exercise Program in Women With Pudendal Neuralgia
A study testing Pelvic Floor Relaxation Protocol in people with Pudendal Neuralgia- Physiotherapy, run by Comenius University at 1 site in Slovakia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pudendal Neuralgia- Physiotherapy
- What is being tested?
- Pelvic Floor Relaxation Protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteSlovakia
- Study dates
- 2 Mar 2026to 2 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Slovakia1 site
Comenius University Bratislava, Jessenius Faculty of Medicine in Martin, Slovakia
Martin, Slovakia
About this study
Official title: 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).
- Conditions
- Pudendal Neuralgia- Physiotherapy
- Being tested
- Pelvic Floor Relaxation Protocol
- Keywords
- Pudendal neuralgia Chronic pelvic pain Pelvic floor physiotherapy Shear-wave elastography Pelvic floor muscle stiffness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic Floor Relaxation ProtocolBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Pelvic Floor Relaxation Protocol |
| Control | No intervention | Participants did not receive the structured physiotherapy exercise program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 6 months (post-intervention)
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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).
Measured: Baseline and 6 months (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start2 Mar 2026
- Primary completion2 Sep 2026
- Study completion2 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pudendal Neuralgia- PhysiotherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Comenius University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Magdalena Hagovska, prof.PhDr.PhD., Principal investigator, Pavol Jozef Safarik University, Medical Faculty, Kosice SlovakiaJan Svihra, prof.MUDr.PhD., Study director, Comenius University Bratislava, Jessenius Faculty of Medicine in Martin, Slovakia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07446556
- Sponsor's protocol ID
- 6808/2023/ODDZ-2
- Acronym
- ELASTIN
- Status last verified
- Sep 2026
- First submitted
- 26 Feb 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Shear-Wave Elastography of Superficial Pelvic Floor Muscles in Healthy Women and Women With Pudendal Neuralgia
- ClinicalTrials.gov ID
- NCT07446556
- Acronym / sponsor ID
- ELASTIN / 6808/2023/ODDZ-2
- Conditions
- Pudendal Neuralgia- Physiotherapy
- Keywords
- Pudendal neuralgia Chronic pelvic pain Pelvic floor physiotherapy Shear-wave elastography Pelvic floor muscle stiffness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Comenius UniversityUniversity, hospital or other
- Study start
- 2 Mar 2026 (actual)
- Primary completion
- 2 Sep 2026 (actual)
- Study completion
- 2 Sep 2026 (actual)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pelvic Floor Relaxation Protocol | Experimental | Behavioral: Pelvic Floor Relaxation ProtocolParticipants received a 6-month physiotherapy intervention consisting of 6 individual sessions with a physiotherapist and daily home exercise (30 minutes/day). |
| Control | No intervention | –Participants did not receive the structured physiotherapy exercise program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- History of psychiatric, neurological (except pudendal neuralgia), severe internal medical, orthopedic, or oncological disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic Floor Relaxation ProtocolA 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. | Behavioural | Pelvic Floor Relaxation Protocol |
Primary outcome
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.
3 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Magdalena Hagovska, prof.PhDr.PhD. principal investigator
Pavol Jozef Safarik University, Medical Faculty, Kosice Slovakia
Jan Svihra, prof.MUDr.PhD. study director
Comenius University Bratislava, Jessenius Faculty of Medicine in Martin, Slovakia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic Floor Relaxation Protocol in people with Pudendal Neuralgia- Physiotherapy, run by Comenius University at 1 site in Slovakia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic floor muscle stiffness by shear-wave elastography (SWE) (time frame: Baseline and 6 months (post-intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.