Sacral Neuromodulation for Pelvic Pain Associated With Endometriosis

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: Recruiting
• Conditions: Endometriosis
• Intervention / Treatment: Device: Sacral Neuromodulation

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: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adrian Zegrea; Phone Number: +35864153405; Email: adrian.zegrea@epshp.fi
• Study Contact Backup: Name: Tarja Pinta; Email: tarja.pinta@epshp.fi

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

Eligibility Criteria

• Ages Eligible for Study: 16 years to 48 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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"	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

Outcome Measure	Measure Description	Time Frame
Pelvic pain intensity	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	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	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	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	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	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

Outcome Measure	Measure Description	Time Frame
The need for sick-leave due to pelvic pain/endometriosis	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

• Sponsor: Seinajoki Central Hospital
• Collaborators: Turku University Hospital; Helsinki University Central Hospital; Oulu University Hospital; Tampere University Hospital; Jyväskylä Central Hospital
• Investigators: Principal Investigator: Teuvo Tammela, Tampere university Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2017
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): May 1, 2022

Study Registration Dates

• First Submitted: April 7, 2017
• First Submitted That Met QC Criteria: May 1, 2017
• First Posted (Actual): May 4, 2017

Study Record Updates

• Last Update Posted (Actual): May 17, 2021
• Last Update Submitted That Met QC Criteria: May 14, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Sacral Nerve Modulation
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Endometriosis; Pelvic Pain
• Other Study ID 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