PTNS as a Treatment for Tenesmus
Primary Purpose
Pelvic Floor Disorders
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Percutaneous Tibial Nerve Stimulation (PTNS)
Sponsored by
About this trial
This is an interventional treatment trial for Pelvic Floor Disorders
Eligibility Criteria
Inclusion Criteria:
- Patients that have tenesmus who are post-rectal cancer treatment and have Anterior Resection Syndrome.
- Patients that have tenesmus who have a rectal cancer.
- Patients that have tenesmus due to a gynaecological condition.
Exclusion Criteria:
- Anyone under the age of 18.
- Anyone with a pacemaker or implantable defibrillator.
- Anyone who is prone to excessive bleeding.
- Anyone who is pregnant or is planning on becoming pregnant throughout their time in the trial.
- Anyone with diabetic neuropathy, multiple sclerosis, Parkinson's disease or peripheral neuropathy.
- Inability to provide consent for the research study.
- Anatomical limitations that would prevent successful placement of needle electrode.
- Present evidence of external full thickness rectal prolapse.
- Stoma in situ.
Sites / Locations
- Department of General SurgeryRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
tenesmus patients
Arm Description
Percutaneous Tibial Nerve Stimulation (PTNS) will be applied to all patients in the study
Outcomes
Primary Outcome Measures
improve the symptom of tenesmus in patients with pelvic floor disorders
The degree of success of the PTNS treatment will be measured by comparing the results from the COREFO, e-PAQ and HADS questionnaires before and after the 12 weeks of treatment. The treatment will be deemed successful if the post-treatment score is significantly lower than the pre-treatment score.
Secondary Outcome Measures
Full Information
NCT ID
NCT02270190
First Posted
October 16, 2014
Last Updated
October 16, 2014
Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT02270190
Brief Title
PTNS as a Treatment for Tenesmus
Official Title
Evaluating the Effectivenemss of Percutaneous Tibial Nerve Stimulation as a Treatment for Tenesmus in Patients With Pelvic Floor Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
April 2015 (Anticipated)
Study Completion Date
April 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main research question is to see if Percutaneous Tibial Nerve Stimulation (PTNS) can improve the symptom of tenesmus in patients with pelvic floor disorders. This includes those who have rectal cancer in situ or who are post-rectal cancer treatment and have Anterior Resection Syndrome.
The secondary research questions are to see if other pelvic floor symptoms and quality of life improves for this patient group and if levels of anxiety and depression improve for these patients.
Detailed Description
The aim of the study is to discover if PTNS can be used to reduce the symptoms in those patients with tenesmus due to their pelvic floor disorders. These pelvic floor disorders include rectal cancer in situ, Anterior Resection Syndrome developed after rectal-cancer treatment, or gynaecological problems. Gynaecological problems that can cause tenesmus include radiotherapy for gynaecological cancer, ovarian cysts, pelvic organ prolapse and hysterectomy.
Currently, there is a lack of treatment options available to manage patients with tenesmus and it is hoped that PTNS will provide a simple, non-invasive treatment to this wide patient group with distressing symptoms. Assessment of symptom improvement will be used by analysing the change in scores on the COREFO, e-PAQ and HADS questionnaires, which will be completed pre and post treatment. COREFO is a validated questionnaire which includes questions specifically relating to tenesmus. e-PAQ is a validated questionnaire which looks at all aspects of the pelvic floor (bowel, urinary, vaginal, sexual) along with quality of life. HADS is a validated questionnaire classifying the patient's degree of anxiety and depression as either "normal", "borderline abnormal" or "abnormal".
There have been two pilot studies looking into the effect of PTNS in improving symptoms in Anterior Resection Syndrome patients. However, full papers have not been published of this data. These two studies assessed symptom improvement using questionnaires, but they did not use COREFO, e-PAQ or HADS, or include patients who currently have rectal cancer (i.e. not Anterior Resection Syndrome patients) or gynaecological problems and have the same tenesmus symptoms. Thus this makes this research an original proposal. e-PAQ is widely used in STH to assess pelvic floor symptoms, and thus its use here enables comparison with other patient groups who also have PTNS as a treatment option.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Floor Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
tenesmus patients
Arm Type
Other
Arm Description
Percutaneous Tibial Nerve Stimulation (PTNS) will be applied to all patients in the study
Intervention Type
Device
Intervention Name(s)
Percutaneous Tibial Nerve Stimulation (PTNS)
Primary Outcome Measure Information:
Title
improve the symptom of tenesmus in patients with pelvic floor disorders
Description
The degree of success of the PTNS treatment will be measured by comparing the results from the COREFO, e-PAQ and HADS questionnaires before and after the 12 weeks of treatment. The treatment will be deemed successful if the post-treatment score is significantly lower than the pre-treatment score.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients that have tenesmus who are post-rectal cancer treatment and have Anterior Resection Syndrome.
Patients that have tenesmus who have a rectal cancer.
Patients that have tenesmus due to a gynaecological condition.
Exclusion Criteria:
Anyone under the age of 18.
Anyone with a pacemaker or implantable defibrillator.
Anyone who is prone to excessive bleeding.
Anyone who is pregnant or is planning on becoming pregnant throughout their time in the trial.
Anyone with diabetic neuropathy, multiple sclerosis, Parkinson's disease or peripheral neuropathy.
Inability to provide consent for the research study.
Anatomical limitations that would prevent successful placement of needle electrode.
Present evidence of external full thickness rectal prolapse.
Stoma in situ.
Facility Information:
Facility Name
Department of General Surgery
City
Sheffield
State/Province
South Yorkshire
ZIP/Postal Code
S10 2JF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samantha Morris
Email
Samantha.Morris@sth.nhs.uk
First Name & Middle Initial & Last Name & Degree
Samantha Morris
12. IPD Sharing Statement
Learn more about this trial
PTNS as a Treatment for Tenesmus
We'll reach out to this number within 24 hrs