Vibrator for Pelvic Floor Disorders

1
Effectiveness
1
Safety
Cedars Sinai Medical Center, Los Angeles, CA
Pelvic Floor Disorders+16 More
Vibrator - Behavioral
Eligibility
18+
Female
Eligible conditions
Pelvic Floor Disorders

Study Summary

This study is evaluating whether a vibrator may help improve sexual health and quality of life for women.

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Eligible Conditions

  • Pelvic Floor Disorders
  • Frigidity
  • Pelvic Organ Prolapse
  • Prolapse
  • Enuresis
  • Cystitis, Interstitial
  • Cystitis
  • Hypokinesia
  • Disease
  • Urinary Incontinence
  • Sexual Dysfunctions, Psychological
  • Sexual Desire Disorder
  • Hypoactive Sexual Desire Disorder (HSDD)
  • Female Sexual Dysfunction (FSD)
  • Sexual Dysfunctions
  • Interstitial Cystitis
  • Sexuality
  • Orgasmic Disorder

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Vibrator will improve 3 primary outcomes in patients with Pelvic Floor Disorders. Measurement will happen over the course of baseline, post intervention at 3 months.

Month 3
To assess the change from baseline degree of pelvic organ prolapse at 3 month
To assess the change from baseline overall health and quality of life at 3 month
To assess the change from baseline sexual function at 3 month

Trial Safety

Trial Design

2 Treatment Groups

Control
Vibrator

This trial requires 100 total participants across 2 different treatment groups

This trial involves 2 different treatments. Vibrator is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Vibrator
Behavioral
Participants will be using commercially available genital vibrator for at least 5 minutes and/or reaching an orgasm three times a week for 3-4 months.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vibrator
2008
Completed Phase 1
~10

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, post intervention at 3 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline, post intervention at 3 months for reporting.

Who is running the study

Principal Investigator
K. E.
Prof. Karyn Eilber, Female Pelvic Medicine & Reconstructive Surgery Chair, Cedars-Sinai Medical Group Department of Surgery Associate Professor, Urology and Obstetrics & Gynecology
Cedars-Sinai Medical Center

Closest Location

Cedars Sinai Medical Center - Los Angeles, CA

Eligibility Criteria

This trial is for female patients aged 18 and older. There are 2 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
English speaking
Diagnosis of female sexual dysfunction, pelvic floor dysfunction, genito-urologic issues (stress urinary incontinence, urge urinary incontinence, pelvic organ prolapse, interstitial cystitis, pelvic pain, dyspareunia, lichen sclerosis)

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can pelvic floor disorders be cured?

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Almost half of rectocele patients present with a concurrent urge sensation. An operation is often performed for rectocele. The findings in this study have led to the conclusion that it is possible to objectively diagnose rectocele using magnetic resonance imaging. Patients undergoing SUI surgery had higher rectocele severity scores and subjective scores for urinary symptoms. However, no correlation was detectable between rectocele scores and objective bladder capacity. A statistically significant decline was only detected in rectocele scores and maximal bladder capacity at 1 year. Therefore, no objective evidence can be drawn to the conclusion that rectocele can be treated.

Unverified Answer

How many people get pelvic floor disorders a year in the United States?

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around 25 million Americans are affected by pelvic floor disorders each year. These disorders occur most frequently in middle-aged Americans. Nearly 75% of all women and girls report that a gynecologist or OB/GYN is where they get the treatment they need for pelvic floor disorders.

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What are common treatments for pelvic floor disorders?

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Women and pelvic floor surgeons have a unique knowledge base regarding pelvic floor disorders. For some patients with pelvic floor disorders, conservative treatment can relieve symptoms while avoiding unnecessary surgery for others. The patient's physical presentation, medical history, and history of pelvic floor dysfunction should be used in the design of treatment algorithms.

Unverified Answer

What are the signs of pelvic floor disorders?

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The presence of fecal incontinence or constipation is more than four times more likely than the absence of these symptoms to be accompanied with other pelvic floor disorders or stress urinary incontinence. Patients with constipation should not be ignored. In patients with urinary symptoms, a complete history and physical examination should be performed before a diagnosis of stress urinary incontinence is made, even in patients without other pelvic floor symptoms.

Unverified Answer

What causes pelvic floor disorders?

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Patients with pelvic floor disorders need to be informed of the importance of pelvic floor education in order to decrease the occurrence of pelvic organ prolapse.

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What is pelvic floor disorders?

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Pelvic floor disorders are defined as disorders of pelvic floor muscles and connective tissues. The most common pelvic floor disorders include stress urinary incontinence and fecal incontinence. They are associated with aging, pregnancy, menopause, and chronic disease. However, the most accurate diagnosis of pelvic floor disorders should be made by the pelvic floor disorders specialist. The management of pelvic floor syndromes include pelvic floor physical therapy, lifestyle modification, drug intervention, and surgery. The surgical management of stress urinary incontinence consists of transvaginal adjustable implant or suburethral mesh repair of the urinary sphincter muscles.

Unverified Answer

Is vibrator typically used in combination with any other treatments?

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Vibrator use appears to improve patients' compliance with their recommended pelvic floor muscle exercises, with consequent improvement of urinary symptoms. However, one recent study showed that use of vibrator does not seem to improve patients' compliance with pelvic floor muscle exercises and patients' pain perception. Further research is needed to compare use of vibrator with different techniques (involvulus) with other pelvic floor exercises.

Unverified Answer

What is the average age someone gets pelvic floor disorders?

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Women tend to develop PFDs as they get older, but it is unknown what is the average age people get PFDs. As the prevalence of PFDs continue to increase, it is important to understand the onset, natural course and treatment for this disorder. Also, the development of new treatments should be encouraged.

Unverified Answer

What is the primary cause of pelvic floor disorders?

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More than 85% of women had a primary cause of pelvic floor dysfunction which included aging, pregnancy, and childbirth history, whereas 3.5% had a secondary cause.

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What are the common side effects of vibrator?

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Vibrators have side effects which include burning, irritation, redness of the vagina, and vaginal tearing. These side effects are caused by rubbing against vaginal walls. Vibrators should be used by [women under the age of 25] in order to [avoid irritation of vaginal walls] and [increase the enjoyment of vibrators]. However, some [women of reproductive age] [might] use vibrators as well. Thus, it is a matter of [women's choice] about whether they [will] use vibrators, which can [increase vaginal lubrication] and make [them] feel more comfortable [during intercourse].

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What are the latest developments in vibrator for therapeutic use?

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Vibrator is an attractive adjunct therapy and seems to be well received by the majority of women undergoing pelvic floor disorder. The advantages are minimal pain, minimal side effects and ease of use.

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Have there been other clinical trials involving vibrator?

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The first vibrator clinical trial was undertaken by H.L. in 1987. A number of other clinical trials regarding the vibrator have been reported, some of which were published in refereed scientific journals. These trials represent the preliminary results of the use of the vibrator in various situations in relation to women's health. The first published article on the use of the vibrator for women experiencing pelvic pain or discomfort was reported in 2003. Results from a recent paper from both these studies, however, are still highly controversial.

Unverified Answer
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