Clinical Trials Logo
  1. Home
  2. Sexual Dysfunction
  3. NCT01312259

Clinical Efficacy of Changing the InterStim® Parameters in Patients With Interstitial Cystitis/Painful Bladder Syndrome

Sexual Dysfunction Clinical Trial

Official title:
Clinical Efficacy of Changing the InterStim® Parameters in Patients With Interstitial Cystitis/Painful Bladder Syndrome

Clinical Trial Summary

Purpose:

1. To demonstrate better symptoms control (pain, urinary urgency and frequency) with sacral neuromodulation (SNM) in patients with interstitial cystitis /painful bladder syndrome (IC/PBS) using a stimulation frequency of 40 hertz (experimental) compared to a frequency of 14 hertz (standard).

2. The evaluate the efficacy of the two frequency settings on the other associated conditions that often coexist in patients with IC/PBS, such as female sexual dysfunction (FSD), bowel dysfunction, high tone pelvic floor dysfunction (HTPFD, painful spasm of the pelvic floor muscles), Vulvodynia (pain at the opening of the vagina).

Clinical Trial Description

Purpose:

1. Primary: to demonstrate better symptoms control (pain, urinary urgency and frequency) with sacral neuromodulation (SNM) in patients with interstitial cystitis /painful bladder syndrome (IC/PBS) using a stimulation frequency of 40 hertz (experimental) compared to a frequency of 14 hertz (standard).

2. Secondary: The evaluate the efficacy of the two frequency settings on the other associated conditions that often coexist in patients with IC/PBS, such as female sexual dysfunction (FSD), bowel dysfunction, high tone pelvic floor dysfunction (HTPFD, painful spasm of the pelvic floor muscles), Vulvodynia (pain at the opening of the vagina). ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01312259
Study type Interventional
Source Pelvic and Sexual Health Institute
Contact Elizabeth Elias, CCRP
Phone 267 479 2387
Email InterStimStudy@yahoo.com
Status Recruiting
Phase Phase 4
Start date April 2011
Completion date April 2018
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05039775 - Clitoral Therapy Device in Alleviating Sexual Dysfunction After Genital Mutilation. N/A
Recruiting NCT05380856 - Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction N/A
Not yet recruiting NCT05918770 - Side Effects Screening and Early Intervention to Impact in Quality of Life of Gynaecological Cancer Patients N/A
Completed NCT02096783 - Scripted Sexual Health Informational Intervention in Improving Sexual Function in Patients With Gynecologic Cancer N/A
Completed NCT02430987 - Low Sexual Desire and Metabolic Syndrome N/A
Completed NCT02837796 - Effects of Trans-Obturator Tape outside-in Versus Inside-out Procedure for Stres Urinary Incontinence N/A
Completed NCT01660152 - Vacuum Erection Device in Improving Recovery of Erectile Function in Patients With Prostate Cancer Undergoing Surgery N/A
Completed NCT01434290 - Radiation Therapy in Treating Patients With Prostate Cancer Phase 2
Active, not recruiting NCT00981305 - Impact of Lactate-Containing Vaginal Lubricant on Sexual Dysfunction in Young Breast Cancer Survivors Phase 3
Completed NCT04964895 - Sexual Quality of Patients After Bladder Cancer Cystectomy N/A
Enrolling by invitation NCT05832268 - Pelvic Floor Function After Obstetric Injury to the Anal Sphincter
Completed NCT04066218 - Sexual Function Screening in Childhood Cancer Survivors
Not yet recruiting NCT05530681 - Correlation Pelvic Floor Function and Ultrasound Findings One Year After Childbirth N/A
Recruiting NCT05826691 - Benign Prostate Surgery and QOL and Sexual Function
Completed NCT04560283 - HYDEAL-D® Application for Promoting the Restoration of Sexual Function in the Postpartum Period Phase 4
Completed NCT03232801 - A Mindfulness-based Intervention for Older Women With Low Sexual Desire N/A
Suspended NCT04544735 - Improving Women's Function After Pelvic Radiation N/A
Completed NCT05732844 - Efficacy of the Use of Vaginal Balls for the Improvement of Urinary Incontinence and Sexual Function in Women. N/A
Recruiting NCT05097469 - Carbon Dioxide Acupulse Laser Treatment Versus Sham Treatment and Sexual Dysfunction. N/A
Withdrawn NCT01635543 - Investigation of Sexual Function in Crohn's Disease Patients With Perianal Fistulas N/A