PTNS as a Treatment for Tenesmus

Sponsor

Sheffield Teaching Hospitals NHS Foundation Trust (Other)

Overall Status

Unknown status

CT.gov ID

NCT02270190

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Floor Disorders	Device: Percutaneous Tibial Nerve Stimulation (PTNS)	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Evaluating the Effectivenemss of Percutaneous Tibial Nerve Stimulation as a Treatment for Tenesmus in Patients With Pelvic Floor Disorders

Study Start Date :

Aug 1, 2014

Anticipated Primary Completion Date :

Apr 1, 2015

Anticipated Study Completion Date :

Apr 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Other: tenesmus patients Percutaneous Tibial Nerve Stimulation (PTNS) will be applied to all patients in the study	Device: Percutaneous Tibial Nerve Stimulation (PTNS)

Arm

Intervention/Treatment

Other: tenesmus patients

Percutaneous Tibial Nerve Stimulation (PTNS) will be applied to all patients in the study

Device: Percutaneous Tibial Nerve Stimulation (PTNS)

Outcome Measures

Primary Outcome Measures

improve the symptom of tenesmus in patients with pelvic floor disorders [12 weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of General Surgery	Sheffield	South Yorkshire	United Kingdom	S10 2JF

Sponsors and Collaborators

Sheffield Teaching Hospitals NHS Foundation Trust

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sheffield Teaching Hospitals NHS Foundation Trust

ClinicalTrials.gov Identifier:

NCT02270190

Other Study ID Numbers:

STH18418
152830

First Posted:

Oct 21, 2014

Last Update Posted:

Oct 21, 2014

Last Verified:

Oct 1, 2014

Additional relevant MeSH terms:

Pelvic Floor Disorders

Study Results

No Results Posted as of Oct 21, 2014