Sacral Neuromodulation in Patients With IC

NCT00590473 | Completed

• 1 other identifier: 71692
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The hypothesis for this study is that bilateral sacral neuromodulation will improve symptoms of interstitial cystitis by at least 25% when compared to unilateral sacral neuromodulation as reported by patient's responses to the Interstitial Cystitis Symptom and Problem Indices. This study will be a prospective randomized study comparing bilateral to unilateral sacral neuromodulation. The study population will include all patients diagnosed with interstitial cystitis, using the NIDDK criteria, having staged sacral neuromodulator stimulators placed at Hahnemann University Hospital.

Conditions

Interstitial Cystitis

Keywords

Interstitial Cystitis; IC; Neuromodulation; Interstim Therapy

Outcome Measures

Primary Outcomes (1)

• To determine if bilateral sacral neuromodulation will reduce the patient's score on the Interstitial Cystitis Symptom and Problem Questionnaire by at least 25% when compared to unilateral sacral neuromodulation in patients with interstitial cystitis.

  Post-op, at 6 weeks and at 3 months post-surgery

Secondary Outcomes (1)

• To determine if bilateral sacral neuromodulation will improve the patient's voiding diary defined as reduction in urinary frequency by 25% from baseline when compared to unilateral sacral neuromodulation in patients with interstitial cystitis

  Post-op, at 6 weeks and 3 months post-surgery

Study Arms (2)

1

ACTIVE COMPARATOR

Unilateral Placement of Interstim IPG

Device: Interstim

2

ACTIVE COMPARATOR

Bilateral Placement of Interstim IPG

Device: Interstim

Interventions

Interstim DEVICE

Unilateral vs. Bilateral Placement of Interstim IPG

1; 2

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• Diagnosis of interstitial cystitis for at least 6 months.
• At least 18yrs old and less than 80.
• Symptoms of urgency (\>4 on the visual analog scale).
• Symptoms of urinary frequency (\>8 episodes/day as recorded on a voiding diary)
• Symptoms of pelvic pain (\>4 on the visual analog scale for pelvic pain).
• Interstitial Cystitis refractory to more conservative treatments such as behavioral modification, dietary intervention, or medical therapy for at least 6 months.
• Able to make medical decisions for herself.
• Presence of either glomerulations of Hunner's ulcer on cystoscopic examination.
• Participant must agree to use a medically acceptable method of contraception throughout the entire study period, and for 7 days after the study period. Medically acceptable methods of contraception include abstinence, birth control pills or patches, diaphragm with spermicide, IUD, condom with vaginal spermicide, surgical sterilization, post menopausal for at least 1 year, implants or injections, or vasectomized partner.
• Must give written informed consent to participate in this study.

You may not qualify if:

• Prior sacral neuromodulation.
• Participant is currently pregnant or breastfeeding.
• Male.
• Urinary retention (defined by post void residual greater than 100cc).
• Neurologic deficit.
• Need for future MRI surveillance.
• Involved in any study within the past thirty days or currently enrolled.
• Presence of bladder or ureteral calculi.
• Active genital herpes.
• Uterine, cervical, vaginal, or urethral cancer.
• Urethral diverticulum.
• Cyclophosphamide cystitis.
• Vaginitis.
• Tuberculous cystitis.
• Foreign body within the bladder (indwelling catheter- foley or suprapubic tube, or ureteral stent).

Sponsors & Collaborators

• Drexel University College of Medicine: lead
• Medtronic: collaborator

Study Sites (1)

Pelvic and Sexual Health Institute

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Cystitis, Interstitial

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Kristene E. Whitmore, M.D.

  Drexel University College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2007
• First Posted: January 10, 2008
• Study Start: April 1, 2007
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: April 10, 2017

Record last verified: 2017-04

Locations

US (1)