Comparison of Sacral Nerve Modulation and Pudendal Nerve Stimulation in Treatment of Fecal Incontinence

NCT ID: NCT01069016

Last Updated: 2017-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2015-02-28

Brief Summary

Sacral nerve modulation (SNM) is an established treatment for refractory lower urinary tract and bowel dysfunction (Spinelli 2008). Pudendal nerve stimulation (PNS) has been proposed for patients failing SNM treatment of urinary dysfunction (Spinelli 2005). In this study SNM and PNS are compared for the treatment of fecal incontinence. In a test phase, both treatments will be applied for one week each in a randomized and blinded order (cross-over design). After the test phase the more successful treatment will be determined and applied permanently. If both treatments are equally sufficient, PNS will be chosen for permanent stimulation, since preliminary data indicate that PNS has a lower power consumption than SNM. Lower power consumption results in a longer lifetime of the stimulator, thus requiring less replacement surgeries.

Detailed Description

Primary Surgery:

• Implantation of two electrodes, one placed next to the sacral nerve, one close to the pudendal nerve. Electrode wires are passed through the skin just above the gluteal region and are marked S and P. One of the sub-investigators (not involved in the follow-up) replaces the S and P marks by 1 and 2 marks in absence of the operating surgeon. Assignment of 1 and 2 is carried out in a predefined randomized fashion (computerized block randomization).

Test phase:

• Electrode labeled 1 is connected to a stimulator and the nerve is stimulated for one week, then the other electrode is stimulated for a week.
• Based on bowel habit diary, Wexner score (Jorge 1993) and subjective experience of the patient, the more successful treatment is chosen. If both electrodes were equally successful, the pudendal nerve electrode will be chosen for permanent stimulation.

Secondary surgery:

• After unblinding, the less effective electrode is removed and the remaining electrode is connected to an implanted stimulator (permanent phase). In case both treatments were unsuccessful, both electrodes are removed.

Conditions

Fecal Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Sacral nerve modulation first

Sacral nerve modulation is applied before the pudendal nerve stimulation. There is no "wash-out" period (pause) between the two treatments.

Group Type: EXPERIMENTAL

Sacral nerve modulation

Intervention Type: PROCEDURE

For one week the sacral nerve is continuously stimulated by an external pulse generator. Strength of stimulation can be adjusted by the patient.

Pudendal nerve stimulation

Intervention Type: PROCEDURE

For one week the pudendal nerve is continuously stimulated by an external pulse generator. Strength of stimulation can be adjusted by the patient.

Pudendal nerve stimulation first

Pudendal nerve stimulation is applied before the sacral nerve modulation. There is no "wash-out" period (pause) between the two treatments.

Group Type: EXPERIMENTAL

Sacral nerve modulation

Intervention Type: PROCEDURE

For one week the sacral nerve is continuously stimulated by an external pulse generator. Strength of stimulation can be adjusted by the patient.

Pudendal nerve stimulation

Intervention Type: PROCEDURE

For one week the pudendal nerve is continuously stimulated by an external pulse generator. Strength of stimulation can be adjusted by the patient.

Interventions

Sacral nerve modulation

For one week the sacral nerve is continuously stimulated by an external pulse generator. Strength of stimulation can be adjusted by the patient.

Intervention Type: PROCEDURE

Pudendal nerve stimulation

For one week the pudendal nerve is continuously stimulated by an external pulse generator. Strength of stimulation can be adjusted by the patient.

Intervention Type: PROCEDURE

Other Intervention Names

SNM; Sacral nerve stimulation; SNS; PNS

Eligibility Criteria

Inclusion Criteria

• fecal incontinence nonresponsive to conservative treatment

Exclusion Criteria

• sacral or perineal infection
• sphincter defect larger than 60° (sonography)
• pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cantonal Hospital of St. Gallen

OTHER

Sponsor Role: lead

Responsible Party

Lukas Marti

Leitender Arzt

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lukas Marti, MD

Role: PRINCIPAL_INVESTIGATOR

Dep. of Surgery, Cantonal Hospital St. Gallen

Locations

Department of Surgey, Cantonal Hospital St. Gallen

Sankt Gallen, , Switzerland

Countries

Switzerland

References

Spinelli M, Sievert KD. Latest technologic and surgical developments in using InterStim Therapy for sacral neuromodulation: impact on treatment success and safety. Eur Urol. 2008 Dec;54(6):1287-96. doi: 10.1016/j.eururo.2008.01.076. Epub 2008 Feb 8.

Reference Type: BACKGROUND

PMID: 18336992 (View on PubMed)

Spinelli M, Malaguti S, Giardiello G, Lazzeri M, Tarantola J, Van Den Hombergh U. A new minimally invasive procedure for pudendal nerve stimulation to treat neurogenic bladder: description of the method and preliminary data. Neurourol Urodyn. 2005;24(4):305-9. doi: 10.1002/nau.20118.

Reference Type: BACKGROUND

PMID: 15977260 (View on PubMed)

Jorge JM, Wexner SD. Etiology and management of fecal incontinence. Dis Colon Rectum. 1993 Jan;36(1):77-97. doi: 10.1007/BF02050307.

Reference Type: BACKGROUND

PMID: 8416784 (View on PubMed)

Rockwood TH, Church JM, Fleshman JW, Kane RL, Mavrantonis C, Thorson AG, Wexner SD, Bliss D, Lowry AC. Fecal Incontinence Quality of Life Scale: quality of life instrument for patients with fecal incontinence. Dis Colon Rectum. 2000 Jan;43(1):9-16; discussion 16-7. doi: 10.1007/BF02237236.

Reference Type: BACKGROUND

PMID: 10813117 (View on PubMed)

Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.

Reference Type: BACKGROUND

PMID: 15273542 (View on PubMed)

Related Links

http://www.chirurgie.kssg.ch/home/unsere_klinik/Leistungsangebot_standort_st_gallen/koloproktologie.html

Proctological consultations, Department of Surgery

Other Identifiers

SNS/PNS

Identifier Type: -

Identifier Source: org_study_id