EndometriosisNCT03139734
Sacral Neuromodulation for Pelvic Pain Associated With Endometriosis
A study testing Sacral Neuromodulation in people with Endometriosis, run by Seinajoki Central Hospital at 1 site in Finland.
Trial summary
The purpose of this study is to find out if sacral neuromodulation is an effective treatment for pelvic pain associated with surgically treated endometriosis. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Sacral Neuromodulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFinland
- Study dates
- 24 May 2017to May 2022
- 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Life interfering pelvic pain with no other obvious pathology than endometriosis, that has been histologically confirmed at previous surgery.
- History of radical or fertility sparing endometriosis surgery either without obvious recurrent or residual endometriosis at gynecological examination and pelvic imaging (transvaginal ultrasound examination and/or pelvic MRI) or with recurrent or residual endometriosis, but re-operation is not desirable.
- Other treatment options, i.e. hormonal treatments and pain medications, are in use or have been tested, but they are ineffective or not possible to use due to contraindications or side effects..
Who cannot join
- Present or future desire to become pregnant
Trial locations and contacts
1 site in 1 country.
Tarja Pinta contact
Finland1 site, 1 recruiting
- Recruiting
Turku University Hospital (Tyks) Main Hospital
Turku, Southwest Finland, 20521
Emilia Ojala, MD
Emilia Ojala, MD
About this study
The purpose of this study is to find out if sacral neuromodulation is an effective treatment for pelvic pain associated with surgically treated endometriosis.
Read the detailed description
Endometriosis is typically associated with severe pelvic pain and pain is often combined with dysfunctional symptoms of the urinary bladder and the bowel. Endometriosis impairs the health-related quality of life and pain is the main reason for the decreased quality of life. When the primary endometriosis treatments, i.e. hormonal therapy and surgery, fail to alleviate pain or symptoms recur after successful treatment, the options are often limited. Recurrent or long-lasting endometriosis pain commonly involves neuropathic pain component with periferal or central sensitisation to pain. This kind of pain is likely more resistant to traditional endometriosis treatments and thus neuromodulation offers a logical treatment option.
There are some case series and at least one randomized trial describing the effect of Sacral Neuromodulation in chronic pelvic pain associated with interstitial cystitis and painful bladder syndrome. These reports indicate that Sacral Neuromodulation may be effective in treating chronic pelvic pain but the level of evidence is low. There is one report on long-term pelvic pain with Visual Analogue Scale score dropping from 8.1 to 2.1 and the effect lasting for five years. There are also few case reports on different difficult sacral area pain conditions treated successfully with Sacral Nerve Modulation. The common consensus seems to be that further studies are needed on the effects of Sacral Neuromodulation on chronic pelvic pain.
This study aims to evaluate if sacral neuromodulation alleviates pelvic pain symptoms and related dysfunctional symptoms in surgically treated endometriosis patients and improves their health-related quality of life. The treating gynecologist does the screening for suitable patients and a signed informed consent is needed from the patients prior to entering the study. A test pulse generator is placed uni- or bilaterally under local or general anesthesia and used during a 2-3-week test period. A permanent pulse generator is placed if marked improvement of symptoms is detected, the patient is satisfied with the treatment and willing to continue. Women not responding to sacral neuromodulation will not receive a permanent generator. They are asked to continue in the 3 year follow-up and they serve as the control group if applicable.
- Conditions
- Endometriosis
- Being tested
- Sacral Neuromodulation
- Keywords
- Sacral Nerve Modulation
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacral NeuromodulationDevice
Also called Sacral Nerve Stimulation, Sacral Nerve Modulation
S3 nerve root (sometimes S4) is stimulated with low electrical current via an electrode placed through a sacral foramen. This electrode is connected to a stimulator resembling a cardiac pacemaker.
| Study group | Role | What they receive |
|---|---|---|
| Sacral neuromodulation | Other | The purpose of this study is to find out if Sacral Neuromodulation is an effective treatment for pelvic pain associated with endometriosis. Receives: Device: Sacral Neuromodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic pain intensity and frequency
Pain is evaluated with Patient's pain diary: self-reported daily pain intensity (NRS 0-10) for dysmenorrhea, non-cyclic pelvic pain, dyschezia, dysuria and dyspareunia during one month period. NRS= numerical rating scale with 0 meaning "no pain" and 10 meaning "Worst pain one can imagine"
Measured: Change measures at baseline, before and during Sacral neuromodulation test period and 1-2 months after initiation of the modulation and then every 6 months for 3 years
Secondary outcomes (6)
Pelvic pain intensity
Pain is evaluated with Brief Pain Inventory Questionnaire at clinical visits
Measured: Change measures at baseline, before and during Sacral neuromodulation test period and 1-2 months after initiation of the modulation and then every 6 months for 3 years
Disease specific health-related quality of life
Endometriosis Health Profile Questionnaire (EHP-30)
Measured: Change measures at baseline, before and during Sacral neuromodulation test period and 1-2 months after initiation of the modulation and then every 6 months for 3 years
General health-related Quality of life
15D-measure
Measured: Change measures at baseline, before and during Sacral neuromodulation test period and 1-2 months after initiation of the modulation and then every 6 months for 3 years
Sexual health-related quality of life
McCoy Female Sexuality Questionaire
Measured: Change measures at baseline, before and during Sacral neuromodulation test period and 1-2 months after initiation of the modulation and then every 6 months for 3 years
Pelvic organ dysfunction symptoms
Pelvic Floor Distress Inventory (PFDI-20)
Measured: Change measures at baseline, before and during Sacral neuromodulation test period and 1-2 months after initiation of the modulation and then every 6 months for 3 years
Patient satisfaction with sacral neuromodulation treatment
Evaluation of satisfaction with sacral neuromodulation treatment evaluated with NRS 0-10 (0= totally dissatisfied and 10= totally satisfied)
Measured: Change measures 1-2 months after initiation of the sacral neuromodulation and then every 6 months for 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study start24 May 2017
- Primary completionMay 2022 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seinajoki Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Helsinki University Central Hospital, Turku University Hospital, Tampere University Hospital, Oulu University Hospital, Jyväskylä Central Hospital
- Responsible party
- Principal investigator, Adrian Zegrea, MD, Seinajoki Central Hospital
- Investigators
- Teuvo Tammela, Principal investigator, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03139734
- Sponsor's protocol ID
- ENDONEMO
- Status last verified
- May 2021
- First submitted
- 7 Apr 2017
- Last updated
- 17 May 2021
- 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 17 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sacral Neuromodulation for Pelvic Pain Associated With Endometriosis
- ClinicalTrials.gov ID
- NCT03139734
- Acronym / sponsor ID
- ENDONEMO
- Conditions
- Endometriosis
- Keywords
- Sacral Nerve Modulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Seinajoki Central HospitalUniversity, hospital or other
- Collaborators
- Helsinki University Central Hospital, Turku University Hospital, Tampere University Hospital, Oulu University Hospital, Jyväskylä Central Hospital
- Study start
- 24 May 2017 (actual)
- Primary completion
- May 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 4 May 2017 (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.
The purpose of this study is to find out if sacral neuromodulation is an effective treatment for pelvic pain associated with surgically treated endometriosis.
Detailed description
Endometriosis is typically associated with severe pelvic pain and pain is often combined with dysfunctional symptoms of the urinary bladder and the bowel. Endometriosis impairs the health-related quality of life and pain is the main reason for the decreased quality of life. When the primary endometriosis treatments, i.e. hormonal therapy and surgery, fail to alleviate pain or symptoms recur after successful treatment, the options are often limited. Recurrent or long-lasting endometriosis pain commonly involves neuropathic pain component with periferal or central sensitisation to pain. This kind of pain is likely more resistant to traditional endometriosis treatments and thus neuromodulation offers a logical treatment option.
There are some case series and at least one randomized trial describing the effect of Sacral Neuromodulation in chronic pelvic pain associated with interstitial cystitis and painful bladder syndrome. These reports indicate that Sacral Neuromodulation may be effective in treating chronic pelvic pain but the level of evidence is low. There is one report on long-term pelvic pain with Visual Analogue Scale score dropping from 8.1 to 2.1 and the effect lasting for five years. There are also few case reports on different difficult sacral area pain conditions treated successfully with Sacral Nerve Modulation. The common consensus seems to be that further studies are needed on the effects of Sacral Neuromodulation on chronic pelvic pain.
This study aims to evaluate if sacral neuromodulation alleviates pelvic pain symptoms and related dysfunctional symptoms in surgically treated endometriosis patients and improves their health-related quality of life. The treating gynecologist does the screening for suitable patients and a signed informed consent is needed from the patients prior to entering the study. A test pulse generator is placed uni- or bilaterally under local or general anesthesia and used during a 2-3-week test period. A permanent pulse generator is placed if marked improvement of symptoms is detected, the patient is satisfied with the treatment and willing to continue. Women not responding to sacral neuromodulation will not receive a permanent generator. They are asked to continue in the 3 year follow-up and they serve as the control group if applicable.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sacral neuromodulation | Other | Device: Sacral NeuromodulationThe purpose of this study is to find out if Sacral Neuromodulation is an effective treatment for pelvic pain associated with endometriosis. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Life interfering pelvic pain with no other obvious pathology than endometriosis, that has been histologically confirmed at previous surgery.
- History of radical or fertility sparing endometriosis surgery either without obvious recurrent or residual endometriosis at gynecological examination and pelvic imaging (transvaginal ultrasound examination and/or pelvic MRI) or with recurrent or residual endometriosis, but re-operation is not desirable.
- Other treatment options, i.e. hormonal treatments and pain medications, are in use or have been tested, but they are ineffective or not possible to use due to contraindications or side effects..
Key exclusion criteria (1 listed)
- Present or future desire to become pregnant
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 |
|---|---|---|
| Sacral NeuromodulationAlso: Sacral Nerve Stimulation, Sacral Nerve ModulationS3 nerve root (sometimes S4) is stimulated with low electrical current via an electrode placed through a sacral foramen. This electrode is connected to a stimulator resembling a cardiac pacemaker. | Device | Sacral neuromodulation |
Primary outcome
Pelvic pain intensity and frequency
Time frame: Change measures at baseline, before and during Sacral neuromodulation test period and 1-2 months after initiation of the modulation and then every 6 months for 3 years
Pain is evaluated with Patient's pain diary: self-reported daily pain intensity (NRS 0-10) for dysmenorrhea, non-cyclic pelvic pain, dyschezia, dysuria and dyspareunia during one month period. NRS= numerical rating scale with 0 meaning "no pain" and 10 meaning "Worst pain one can imagine"
6 secondary outcomes
Pelvic pain intensity
Time frame: Change measures at baseline, before and during Sacral neuromodulation test period and 1-2 months after initiation of the modulation and then every 6 months for 3 years
Disease specific health-related quality of life
Time frame: Change measures at baseline, before and during Sacral neuromodulation test period and 1-2 months after initiation of the modulation and then every 6 months for 3 years
General health-related Quality of life
Time frame: Change measures at baseline, before and during Sacral neuromodulation test period and 1-2 months after initiation of the modulation and then every 6 months for 3 years
Sexual health-related quality of life
Time frame: Change measures at baseline, before and during Sacral neuromodulation test period and 1-2 months after initiation of the modulation and then every 6 months for 3 years
Pelvic organ dysfunction symptoms
Time frame: Change measures at baseline, before and during Sacral neuromodulation test period and 1-2 months after initiation of the modulation and then every 6 months for 3 years
Patient satisfaction with sacral neuromodulation treatment
Time frame: Change measures 1-2 months after initiation of the sacral neuromodulation and then every 6 months for 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2021.
- Individual participant dataSharing planned: No
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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.
Tarja Pinta contact
Teuvo Tammela principal investigator
Tampere University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sacral Neuromodulation in people with Endometriosis, run by Seinajoki Central Hospital at 1 site in Finland.
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 3 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: status not confirmed, as of the sponsor's last update on 17 May 2021. 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 Finland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adrian Zegrea (+35864153405, adrian.zegrea@epshp.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic pain intensity and frequency (time frame: Change measures at baseline, before and during Sacral neuromodulation test period and 1-2 months after initiation of the modulation and then every 6 months for 3 years). 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 17 May 2021.