NCT03139734

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2017

Completed
27 days until next milestone

First Posted

Study publicly available on registry

May 4, 2017

Completed
20 days until next milestone

Study Start

First participant enrolled

May 24, 2017

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

May 17, 2021

Status Verified

May 1, 2021

Enrollment Period

4.9 years

First QC Date

April 7, 2017

Last Update Submit

May 14, 2021

Conditions

Endometriosis

Keywords

Sacral Nerve Modulation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Pelvic pain intensity

    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

    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

    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

    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

    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

  • +1 more secondary outcomes

Other Outcomes (1)

  • The need for sick-leave due to pelvic pain/endometriosis

    Change measures: retrospectively asked at baseline and then every 6 months during the 3 year follow-up

Study Arms (1)

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.

Device: Sacral Neuromodulation

Interventions

Sacral NeuromodulationDEVICE

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.

Also known as: Sacral Nerve Stimulation, Sacral Nerve Modulation
Sacral neuromodulation

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsgender identity
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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..

You may not qualify if:

  • Present or future desire to become pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turku University Hospital (Tyks) Main Hospital

Turku, Southwest Finland, 20521, Finland

RECRUITING

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Teuvo Tammela

    Tampere University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Adrian Zegrea

CONTACT

+35864153405adrian.zegrea@epshp.fi

Tarja Pinta

CONTACT

tarja.pinta@epshp.fi

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 7, 2017

First Posted

May 4, 2017

Study Start

May 24, 2017

Primary Completion

May 1, 2022

Study Completion

May 1, 2022

Last Updated

May 17, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)