Superficial DyspareuniaNCT04201041
Pudendal Nerve Fluoroscopic Guided Pulsed Radiofrequency for Treatment of Superficial Dyspareunia
A study testing pudendal nerve pulsed radiofrequency in people with Superficial Dyspareunia, run by South Egypt Cancer Institute at 1 site in Egypt.
Trial summary
Superficial dyspareunia represents a major health problem especially for the newly wed couples. Pulsed radiofrequency for pudendal nerve is a non-neurolytic neuromodulatory method that is effective in relief of this type of pain. Read more about this study
- Who is it for?
- Ages 16 to 46 years
- Conditions the study is for
- Superficial Dyspareunia
- What is being tested?
- pudendal nerve pulsed radiofrequency
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2018to 25 Mar 2020
- 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 16 to 46 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- women aged between 16 and 46 years and from a near vicinity to our facility to make her available for follow-up
Who cannot join
- We had excluded women with any abnormality in the transvaginal US guided imagining, or those with any evidence of local gynecological abnormalities on examination. Meanwhile, we had excluded those women with infection at site of injection, coagulopathy or other bleeding diathesis, pre-existing neurologic deficit in the targeted region, those with history of chronic opioid use and women who refused to participate in the study
Trial locations and contacts
1 site in 1 country.
Egypt1 site
South Egypt Cancer Institute, Assiut University, Arab Republic of Egypt
Asyut, 0020
About this study
Official title: Trans-gluteal Versus Trans-vaginal Pudendal Nerve Fluoroscopic Guided Pulsed Radiofrequency for Treatment of Superficial Dyspareunia: a Prospective Cohort Study
Superficial dyspareunia represents a major health problem especially for the newly wed couples. Pulsed radiofrequency for pudendal nerve is a non-neurolytic neuromodulatory method that is effective in relief of this type of pain. Objectives: to evaluate the efficacy of bilateral pudendal nerve fluoroscopic guided pulsed radiofrequency in treatment of intractable non-organic dyspareunia, and compare between trans-gluteal and transvaginal approaches regarding patient comfort and satisfaction.
- Conditions
- Superficial Dyspareunia
- Being tested
- pudendal nerve pulsed radiofrequency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pudendal nerve pulsed radiofrequencyProcedure or surgery
received pudendal nerve pulsed radiofrequency through trans-vaginal approach or trans-gluteal approach
| Study group | Role | What they receive |
|---|---|---|
| trans-gluteal approach | Active comparator | received pudendal nerve pulsed radiofrequency through trans-gluteal approach Receives: Procedure: pudendal nerve pulsed radiofrequency |
| trans-vaginal approach | Active comparator | received pudendal nerve pulsed radiofrequency through trans-vaginal approach Receives: Procedure: pudendal nerve pulsed radiofrequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in Numerical rating scale
0 no pain and 10 maximum pain
Measured: baseline reading -1 day reading-3 days postoperative reading
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2019
- Study start1 Dec 2018
- Primary completion20 Mar 2020
- Study completion25 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Superficial DyspareuniaStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Egypt Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Ali M. Elzohry, South Egypt Cancer Institute
- Investigators
- Alaa Elzohry, MD, Principal investigator, South Egypt Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04201041
- Sponsor's protocol ID
- PNB
- Status last verified
- Apr 2020
- First submitted
- 11 Dec 2019
- Last updated
- 9 Apr 2020
- 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 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trans-gluteal Versus Trans-vaginal Pudendal Nerve Fluoroscopic Guided Pulsed Radiofrequency for Treatment of Superficial Dyspareunia: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04201041
- Acronym / sponsor ID
- PNB
- Conditions
- Superficial Dyspareunia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- South Egypt Cancer InstituteUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 20 Mar 2020 (actual)
- Study completion
- 25 Mar 2020 (actual)
- First posted
- 16 Dec 2019 (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.
Superficial dyspareunia represents a major health problem especially for the newly wed couples. Pulsed radiofrequency for pudendal nerve is a non-neurolytic neuromodulatory method that is effective in relief of this type of pain. Objectives: to evaluate the efficacy of bilateral pudendal nerve fluoroscopic guided pulsed radiofrequency in treatment of intractable non-organic dyspareunia, and compare between trans-gluteal and transvaginal approaches regarding patient comfort and satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| trans-gluteal approach | Active comparator | Procedure: pudendal nerve pulsed radiofrequencyreceived pudendal nerve pulsed radiofrequency through trans-gluteal approach |
| trans-vaginal approach | Active comparator | Procedure: pudendal nerve pulsed radiofrequencyreceived pudendal nerve pulsed radiofrequency through trans-vaginal approach |
Who may qualify
- Ages
- 16 to 46 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- women aged between 16 and 46 years and from a near vicinity to our facility to make her available for follow-up
Key exclusion criteria (1 listed)
- We had excluded women with any abnormality in the transvaginal US guided imagining, or those with any evidence of local gynecological abnormalities on examination. Meanwhile, we had excluded those women with infection at site of injection, coagulopathy or other bleeding diathesis, pre-existing neurologic deficit in the targeted region, those with history of chronic opioid use and women who refused to participate in the study
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 |
|---|---|---|
| pudendal nerve pulsed radiofrequencyreceived pudendal nerve pulsed radiofrequency through trans-vaginal approach or trans-gluteal approach | Procedure or surgery | trans-gluteal approach, trans-vaginal approach |
Primary outcome
change in Numerical rating scale
Time frame: baseline reading -1 day reading-3 days postoperative reading
0 no pain and 10 maximum pain
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 9 Apr 2020.
- Individual participant dataSharing planned: No
Related trials for Superficial Dyspareunia
Active, not recruiting
Physiotherapeutic Approach to Superficial and Deep Dyspareunia in Women With Chronic Pelvic Pain: Comparison Between In-person and Telehealth Care.
Surface and Deep Dyspareunia
Recruiting
Efficacy of Dry Needling in Reducing Pain During Sexual Intercourse
Provoked Vestibulodynia
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.
Alaa Elzohry, MD principal investigator
South Egypt Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pudendal nerve pulsed radiofrequency in people with Superficial Dyspareunia, run by South Egypt Cancer Institute at 1 site in Egypt.
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 1 inclusion and 1 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 9 Apr 2020. 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 Egypt. 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?
change in Numerical rating scale (time frame: baseline reading -1 day reading-3 days postoperative reading). 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 9 Apr 2020.