15 treatments will be provided over a 12 week period using a protocol developed in collaboration with BioFlexTM Laser. Each treatment will last approximately 45 minutes and will include the laser array first being applied to the skin overlying the sacral spine in a horizontal placement then in oblique placement bilaterally (red and infrared light) while a laser probe is applied over the base of the spine (red and infrared light). Next, the array will be applied to the surface of the perineum (red and infrared light) and the focal probe will be applied to painful sites on the perineum. Finally, the infrared light probe will be applied to the skin overlying branches of the pudendal nerve. All the stages will involve use of the same array and probe placement, but at each stage the dosage will be increased according to the BioFlex protocol. During teach treatment session, women will listen to an audio recording of a mindfulness-based meditation on CD through noise cancelling headphones.

15 treatments will be provided over a 12 week period using the same protocol developed in collaboration with BioFlexTM Laser, but at an intensity of 1% output for all sites and at all stages. Each treatment will last approximately 45 minutes. At each visit, the laser array will first be applied to the skin overlying the sacral spine in a horizontal then oblique placement bilaterally (red and infrared light) concurrently with a laser probe applied over the base of the spine (red and infrared light). Next, the array will be applied to the surface of the perineum (red and infrared light), followed by treatment at specific painful sites using the red light probe. Finally, the infrared light probe will be applied to the skin overlying branches of the pudendal nerve. Participants randomized to this group will listen to an audio recording of a mindfulness-based meditation on CD through noise cancelling headphones while receiving the sham laser treatment.

Provoked Vestibulodynia

Each stage will follow this sequence of applications: (1) spine application (DUO-240 red and infrared array in a horizontal placement and 2 oblique placements bilaterally + LDR-100 laser probe + LDI-200 laser probe), (2) perineum application (DUO-240 red and infrared array in the surface of the perineum + LDR-100 probe) and (3) overlying branches of the pudendal nerve at the lateral perineum (LDI-200 probe). Parameters of frequency and duty cycle will be increased along with intensity as the stages progress.

Low Level Laser Therapy

Each stage will follow this sequence of applications: (1) spine application (DUO-240 red and infrared array in a horizontal placement and 2 oblique placements bilaterally + LDR-100 laser probe + LDI-200 laser probe), (2) perineum application (DUO-240 red and infrared array in the surface of the perineum + LDR-100 probe) and (3) overlying branches of the pudendal nerve at the lateral perineum (LDI-200 probe). Parameters of frequency and duty cycle will be progressed, but power will always be set to 1%..

Sham Low Level Laser Therapy

Is Low Level Laser Therapy (LLLT) Effective in Reducing Pain Experienced by Women With Provoked Vestibulodynia?

This is a 19-item validated questionnaire for assessing the key dimension of sexual function in women, considered a gold standard for evaluation of sexual function. It assesses six domains: desire, arousal , lubrification, orgasm, satisfaction, and pain. All scores are totaled for a maximum of 36. Higher scores represents better sexual function. A score ≤26.55 has been set as a cutoff to identify those at risk for sexual dysfunction.

PPT will be determined using a custom vulvalgesiometer and will be defined as the average pressure at which women first report pain when the cotton swab tip is applied at 6 o' clock position of the vaginal introitus. The vulvalgesiometer will also be used to evaluate TS of pain when the pressure measured before will be applied ten times at a rate of approximately one per second at the same location on the vestibule. Participants will rate their pain level on the initial and final application of this pressure using the same numeric rating scale (0-10).

The Global perception of improvement is a single question through which participants indicate their overall perception of improvement attributed to the intervention.

Global patient satisfaction with treatment is a single question through which participants provide a ordinal rating based on their satisfaction with the intervention.

Transcranial magnetic stimulation outcome will be determined for all participants and compared among groups. A Magstim® 200 system coupled with a double coil (96 mm loops, P/N 9902) will be used to probe the corticospinal projections to PFMs. MEPs will be ensemble averaged to generate estimates of MEP peak to peak amplitude (µV).

Transcranial magnetic stimulation outcome will be determined for all participants and compared among groups. A Magstim® 200 system coupled with a double coil (96 mm loops, P/N 9902) will be used to probe the corticospinal projections to PFMs. MEP cortical silent period (cSP) will be measured from individual trials and then averaged.

The participants will be provided with Original Regular Tampax Tampon and will be instructed to insert and then remove it. After, they will be asked to record the degree of pain during the entire insertion/removal experience on a 0-10 pain numeric rating scale (0 meaning no pain and 10 meaning the worst possible pain).

This questionnaire consists primarily of 3 major classes of word descriptors - sensory, affective and evaluative - that are used by patients to specify subjective pain experience. It also contains an intensity scale and other items to determine the properties of pain experience. This questionnaire is composed of 78 words. Respondents choose those that best describe their experience of pain. Scores are tabulated by summing values associated with each word; scores range from 0 (no pain) to 78 (severe pain). Quantitative differences in pain may be reflected in respondents word choice.

This is a reliable and valid scale to measure of catastrophizing. The scores from this questionnaire is predictors of intensity of physical and emotional distress. It is a self-report measure, consisting of 13 items scored from 0 to 4, resulting in a total possible score of 52. The higher the score, the more catastrophizing thoughts are present.

This is a 42-item self report instrument designed to measure the three related negative emotional states of depression, anxiety and tension/stress. Each one contains 14 items, divided into subscales of 2-5 items with similar content. The DASS have been shown to have high internal consistency and to yield meaningful discriminations in a variety of settings.
A higher score on the DASS indicates greater severity or frequency of these negative emotional symptoms. The maximum score is 126.

Difference between pain reported on first application of pressure at the vulvar vestibule, delivered through a vulvalgesiometer, and the pain reported after the tenth application of that same pressure

The Central Sensitisation Inventory (CSI) is a self-report outcome measure designed to identify patients who have symptoms that may be related to central sensitisation (CS) or central sensitivity syndromes (CSS). Part A includes 25 questions related to common CSS symptoms.
Part B determines if the patient has been diagnosed with certain CSS disorders or related disorders, such as anxiety and depression. CSI severity levels have been established for part A: subclinical = 0 to 29; mild = 30 to 39; moderate = 40 to 49; severe = 50 to 59; and extreme = 60 to 100.

Mean smoothed, rectified activation amplitude of the PFMs recorded through electromyography while the muscles remain at rest.

Mean smoothed, rectified activation amplitude of the PFMs recorded through electromyography while participants attempt a maximum voluntary activation of their PFMs

Mean smoothed, rectified activation amplitude of the PFMs recorded through electromyography while participants perform a bearing down maneuver

The proportion of women in each group who demonstrate anticipatory responses of the PFMs to impeding pressure applied at the vulvar vestibule will be determined for each group. Participants will be deemed to have anticipatory responses if electromyiographic signals recorded from the PFMs precede the application of pressure. A vulvagesiometer will be employed using a response-dependent methodology. The vulvagesiometer will be used to apply low (25g) and moderate (232g) pressure to the posterior vaginal fourchette or to the posterior thigh.

The proportion of women in each group who demonstrate behavioural responses of the PFMs to pressure applied at the vulvar vestibule will be determined for each group. Participants will be deemed to have behavioural responses if the activation of the PFMs (or other muscles) occurs after the pressure is applied. A vulvagesiometer will be employed using a response-dependent methodology. The vulvagesiometer will be used to apply low (25g) and moderate (232g) pressure to the posterior vaginal fourchette or to the posterior thigh.

Attendance of laser treatment visits will be tracked.

Spreadsheets will be provided by email upon request and based on the planned use of the data.

Dr. Linda McLean

Professor in the School of Rehabilitation Sciences at the University of Ottawa.

University of Ottawa

BioFlexTM Laser Therapy

Six weekly bladder instillations of standard cocktail plus triamcinolone acetonide. Standard cocktail= heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), and 0.5% bupivacaine (10 mL of 5 mg/mL) plus triamcinolone acetonide (1 vial, 40 milligrams (mg)/1 milliliters (mL).

Six weekly bladder instillations of standard cocktail without triamcinolone acetonide. Standard cocktail= heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), and 0.5% bupivacaine (10 mL of 5 mg/mL).

Interstitial Cystitis

Bladder Pain Syndrome

Bladder instillation mixture of heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), 0.5% bupivacaine (10 mL of 5 mg/mL) plus triamcinolone acetonide (1 vial, 40 milligrams (mg)/1 milliliters (mL).

Bladder instillation WITH triamcinolone acetonide

Bladder instillation mixture of heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), and 0.5% bupivacaine (10 mL of 5 mg/mL).

Bladder instillation WITHOUT triamcinolone acetonide

University of Louisville Urogynecology at Springs Medical Center

Clinical Trial Comparing Two Bladder Instillations for IC/BPS

Randomized Controlled Trial Comparing Two Different Bladder Instillation Treatments for Interstitial Cystitis/Bladder Pain Syndrome

Total scores range: 0-36 (0= no symptoms to 36= the most severe symptoms)

Total scores range: 0-35 (0= no symptoms to 35= the most severe symptoms)

Total scores range: 0-100 (higher scores on the symptom-severity scale suggestive of greater severity of symptoms and higher scores on the quality-of-life scale suggestive of better quality of life)

20 question self-administered questionnaire on the presence and abscence of pelvic floor symptoms

Measures sexual function in women with pelvic floor disorders. Queries about arousal, orgasm, partner-related issues, sexual quality, and desire. The tool also takes into account those who are not sexually active

VAS is measured on marking on a 10-centimeter (cm) ruler (measured in cm, 0= no pain and 10= most severe pain possible)

Adverse events will only be those determined to be related to the study drug

De-identified raw data and other supporting materials will be made available to approved investigators. Email requests to olivia.cardenas-trowers@louisville.edu.

Olivia Cardenas-Trowers, M.D.

Sponsor-Investigator

Pelvic Floor Dyssynergia

Vaginal suppository placed once daily, patients will record pelvic pain daily on a VAS scale, sexual satisfaction and quality of life on a standardized questionnaire weekly

Baclofen/diazepam

Vaginal suppository placed once daily, patient will record pelvic pain daily on a VAS scale, sexual satisfaction and quality of life on a standardized questionnaire weeky.

Vaginal placebo

Baclofen/Diazepam Supps for Treatment of Pelvic Floor Myalgia

A Randomized Double Blind Placebo Controlled Cross-over Trial of Baclofen and Diazepam Suppositories for the Management of Pelvic Floor Myalgia

The scale ranges from 0 (no pain) to 10 (worst pain ever experienced)

Self report measure of female sexual dysfunction

Ranks patients overall feeling about health from 1 (very much better) to 7 (very much worse)

vulvodynia/fatigue

Is Low Level Laser Therapy (LLLT) Effective in Reducing Pain Experienced by Women With Provoked Vestibulodynia?

Clinical Trial Comparing Two Bladder Instillations for IC/BPS

Baclofen/Diazepam Supps for Treatment of Pelvic Floor Myalgia

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