Sacral Neuromodulation for Pelvic Pain Associated With Endometriosis

May 14, 2021 updated by: Adrian Zegrea, MD, Seinajoki Central Hospital
The purpose of this study is to find out if sacral neuromodulation is an effective treatment for pelvic pain associated with surgically treated endometriosis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Finland
    • Varsinais-Suomi
      • Turku, Varsinais-Suomi, Finland, 20521
        • Recruiting
        • Turku University Hospital (Tyks) Main Hospital
        • Contact:
          • Emilia Ojala, MD
        • Principal Investigator:
          • Emilia Ojala, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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..

Exclusion Criteria:

  • Present or future desire to become pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Sacral neuromodulation
The purpose of this study is to find out if Sacral Neuromodulation is an effective treatment for pelvic pain associated with endometriosis.
Device: Sacral Neuromodulation
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.
Other Names:
  • Sacral Nerve Stimulation
  • Sacral Nerve Modulation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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"
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Pain is evaluated with Brief Pain Inventory Questionnaire at clinical visits
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
Endometriosis Health Profile Questionnaire (EHP-30)
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
15D-measure
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
McCoy Female Sexuality Questionaire
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
Pelvic Floor Distress Inventory (PFDI-20)
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
Evaluation of satisfaction with sacral neuromodulation treatment evaluated with NRS 0-10 (0= totally dissatisfied and 10= totally satisfied)
Change measures 1-2 months after initiation of the sacral neuromodulation and then every 6 months for 3 years

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The need for sick-leave due to pelvic pain/endometriosis
Time Frame: Change measures: retrospectively asked at baseline and then every 6 months during the 3 year follow-up
Number of sick-leave days/week during 6 months period
Change measures: retrospectively asked at baseline and then every 6 months during the 3 year follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seinajoki Central Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Turku University Hospital
Helsinki University Central Hospital
Oulu University Hospital
Tampere University Hospital
Jyväskylä Central Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Teuvo Tammela, Tampere University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 24, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 7, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 4, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 17, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ENDONEMO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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