Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To determine the efficacy of intravaginal diazepam for the treatment of pelvic pain associated with pelvic floor hypertonic disorder.
Women who are asked to participate will already be receiving a standard conservative therapy consisting of a psyllium-based bowel regimen, heat therapy, pelvic stretching exercises, and Kegel exercises. Participants will randomly be assigned by a computer-derived random number sequence (after pregnancy is ruled out) to either the treatment group (intravaginal diazepam) or the placebo group Investigators and patients will be blinded to group assignment. The placebo or diazepam tablet will be distributed to the participant in the examining room on the day of allocation. The participant will be instructed to insert the diazepam or placebo tablet into her vagina at home. The treatment group will insert the diazepam 10 mg vaginal tablet 1-2 times daily as needed in addition to the standard conservative therapy. The placebo group will receive the standard conservative therapy, and an intravaginal tablet (visually indistinguishable from diazepam) commercially produced by the university pharmacy. After 4 weeks, patients from either group will have the option of enrolling into a standard routine program (not research) of comprehensive pelvic floor rehabilitation therapy. The Visual Analog Pain Scale, Pelvic Floor Distress Inventory-20 Questionnaire, McGill Pain Questionnaire and Global Response Assessment will be completed by the participant at the initial visit, 4 weeks, 8 weeks and 12 weeks. Participants will be given the option of choosing one or more methods for returning questionnaires: electronic mail, self-addressed home envelope, or telephone call.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diazepam | Active Comparator | Participated will be instructed to insert one 10mg tablet vaginally 1-2 times per day as needed for pain. |
|
| Placebo | Placebo Comparator | Participated will be instructed to insert one 10mg tablet vaginally 1-2 times per day as needed for pain. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diazepam | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale (VAS) for Pain | Ten centimeter (100 mm) linear pain scale where patients mark their self-perceived level of pain on a paper with a 10 cm line indicating that the 0 cm position indicates no pain and the 10 cm position indicates the worst pain imaginable. The score is measured as the distance between the zero position and the patient's mark is measured in cm to the nearest mm. A higher score indicates a worse outcome. The change in pain score is calculated by from the value at baseline minus the value at 4 weeks. Potential range is -100 to 100, with a higher value indicating a better outcome. | Baseline and 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pelvic Floor Distress Inventory-20 (PFDI-20) Questionnaire Score at 4 Weeks. | The Pelvic Floor Distress Inventory-20 is both a symptom inventory and a measure of the degree of bother and distress (quality-of-life) caused by pelvic floor symptoms. Includes 20 questions and 3 scales. Each of the 3 scales is scored from a minimum score of 0 (least distress) to a maximum of 100 (greatest distress), thus a higher score indicates a poorer outcome. The scores from each of the 3 scales are added together to give a summary score (range 0 to 300). The PFDI-20 questionnaire was administered at baseline and at 4 weeks of treatment. The outcome was the score at 4 weeks of treatment. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Raymond T Foster, MD | University of Missouri-Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Missouri Center for Female Continence and Advanced Pelvic Surgery, University of Missouri Health System | Columbia | Missouri | 65201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29280763 | Derived | Holland MA, Joyce JS, Brennaman LM, Drobnis EZ, Starr JA, Foster RT Sr. Intravaginal Diazepam for the Treatment of Pelvic Floor Hypertonic Disorder: A Double-Blind, Randomized, Placebo-Controlled Trial. Female Pelvic Med Reconstr Surg. 2019 Jan/Feb;25(1):76-81. doi: 10.1097/SPV.0000000000000514. |
Not provided
Not provided
Not provided
urogynecology outpatient clinic patients sequentially enrolled September 2013-August 2016. Inclusion: 18+ years of age with primary complaint of acute or chronic pelvic pain, with or without dyspareunia, and hypertonicity of the levator muscles. Exclusion: pregnant, breastfeeding, previous pelvic floor therapy, contraindication to denzodiazepines
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Diazepam | Participated will be instructed to insert one 10mg tablet vaginally 1-2 times per day as needed for pain. Diazepam |
| FG001 | Placebo | Participated will be instructed to insert one 10mg tablet vaginally 1-2 times per day as needed for pain. Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Diazepam | Participated will be instructed to insert one 10mg tablet vaginally 1-2 times per day as needed for pain. Diazepam |
| BG001 | Placebo | Participated will be instructed to insert one 10mg tablet vaginally 1-2 times per day as needed for pain. Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Visual Analog Scale (VAS) for Pain | Ten centimeter (100 mm) linear pain scale where patients mark their self-perceived level of pain on a paper with a 10 cm line indicating that the 0 cm position indicates no pain and the 10 cm position indicates the worst pain imaginable. The score is measured as the distance between the zero position and the patient's mark is measured in cm to the nearest mm. A higher score indicates a worse outcome. The change in pain score is calculated by from the value at baseline minus the value at 4 weeks. Potential range is -100 to 100, with a higher value indicating a better outcome. | After randomization, 25 patients on diazepam treatment and 24 patients on placebo provided baseline values for visual analog score (VAS) for pain. At 4 weeks treatment, 19 patients in the diazepam group and 16 patients in the placebo group provided VAS data for pain. Data from the latter group of 35 patients were analyzed. | Posted | Median | 95% Confidence Interval | score on a scale | Baseline and 4 weeks |
|
4 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Diazepam | Participated will be instructed to insert one 10mg tablet vaginally 1-2 times per day as needed for pain. Diazepam |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Erma Z. Drobnis, Associate Director, Research Success Center | University of Missouri-Columibia, Dept. Ob/Gyn | 573-817-3124 | drobnise@health.missouri.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 18, 2016 | Apr 14, 2021 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D059952 | Pelvic Floor Disorders |
| D017699 | Pelvic Pain |
| D013035 | Spasm |
| ID | Term |
|---|---|
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D011248 | Pregnancy Complications |
Not provided
Not provided
| ID | Term |
|---|---|
| D003975 | Diazepam |
| ID | Term |
|---|---|
| D001570 | Benzodiazepinones |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
| 4 weeks |
| McGill Pain Questionnaire Score (PRI) at 4 Weeks | The McGilll pain questionnaire is a validated instrument that assigns quantitative value to qualitative descriptions of chosen by the patient. The minimum pain score is 0 (would not be seen in a person with true pain) and the maximum pain score: 78. The higher the pain score the greater the pain and the poorer the outcome. measured at 4 weeks. | 4 weeks |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Body Mass Index | Median | Inter-Quartile Range | kg/m^2 |
|
| Gravida | Median | Inter-Quartile Range | number of pregnancies |
|
| Term Pregnancies | Median | Inter-Quartile Range | number of full-term pregnancies |
|
| Cesarean sections | Median | Inter-Quartile Range | number of cesarean sections |
|
| Vaginal deliveries | Median | Inter-Quartile Range | number of vaginal deliveries |
|
| Largest baby | Median | Inter-Quartile Range | gm |
|
| Symptom duration | Median | Inter-Quartile Range | months |
|
| Post void residual | Median | Inter-Quartile Range | mL |
|
| Prolapse | Prolapse data unavailable for 1 diazepam and 2 placebo participants | Number | participants |
|
| diabetes mellitus | Count of Participants | Participants |
|
| Cardiovascular disease | Count of Participants | Participants |
|
| Lung disease | Count of Participants | Participants |
|
| Low back pain | Count of Participants | Participants |
|
| Gastrointestinal disease | Count of Participants | Participants |
|
| Headache | Count of Participants | Participants |
|
| Neurological disease | Count of Participants | Participants |
|
| Anxiety | Count of Participants | Participants |
|
| Depression | Count of Participants | Participants |
|
| Bipolar disorder | Count of Participants | Participants |
|
| Obsterical trauma | Count of Participants | Participants |
|
| Menopausal | Count of Participants | Participants |
|
| Current hormone replacement therapy | Count of Participants | Participants |
|
| Vaginal estrogen use | Count of Participants | Participants |
|
| Hysterectomy | Count of Participants | Participants |
|
| Mesh surgery | Count of Participants | Participants |
|
| Smoker | Count of Participants | Participants |
|
| Heavy lifting | Count of Participants | Participants |
|
| Diazepam |
Participated will be instructed to insert one 10mg tablet vaginally 1-2 times per day as needed for pain. Diazepam |
| OG001 | Placebo | Participated will be instructed to insert one 10mg tablet vaginally 1-2 times per day as needed for pain. Placebo |
|
|
|
| Secondary | Pelvic Floor Distress Inventory-20 (PFDI-20) Questionnaire Score at 4 Weeks. | The Pelvic Floor Distress Inventory-20 is both a symptom inventory and a measure of the degree of bother and distress (quality-of-life) caused by pelvic floor symptoms. Includes 20 questions and 3 scales. Each of the 3 scales is scored from a minimum score of 0 (least distress) to a maximum of 100 (greatest distress), thus a higher score indicates a poorer outcome. The scores from each of the 3 scales are added together to give a summary score (range 0 to 300). The PFDI-20 questionnaire was administered at baseline and at 4 weeks of treatment. The outcome was the score at 4 weeks of treatment. | After randomization, 25 patients on diazepam treatment and 24 patients on placebo provided baseline values for the pelvic floor distress inventory-20 (PFDI-20) questionnaire. At 4 weeks treatment, 19 patients in the diazepam group and 16 patients in the placebo group provided PFDI-20 questionnaire data. Data from the latter group of 35 patients were analyzed. | Posted | Median | 95% Confidence Interval | score on a scale | 4 weeks |
|
|
|
|
| Secondary | McGill Pain Questionnaire Score (PRI) at 4 Weeks | The McGilll pain questionnaire is a validated instrument that assigns quantitative value to qualitative descriptions of chosen by the patient. The minimum pain score is 0 (would not be seen in a person with true pain) and the maximum pain score: 78. The higher the pain score the greater the pain and the poorer the outcome. measured at 4 weeks. | After randomization, 25 patients on diazepam treatment and 24 patients on placebo provided baseline values for the McGill pain questionnaire. At 4 weeks treatment, 19 patients in the diazepam group and 16 patients in the placebo group provided McGill pain questionnaire data. Data from the latter group of 35 patients were analyzed. | Posted | Median | 95% Confidence Interval | score on a scale | 4 weeks |
|
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 4 |
| 25 |
| EG001 | Placebo | Participated will be instructed to insert one 10mg tablet vaginally 1-2 times per day as needed for pain. Placebo | 0 | 24 | 0 | 24 | 4 | 24 |
| drowsiness | Nervous system disorders | Systematic Assessment |
|
| site irritation | Product Issues | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D052801 | Male Urogenital Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020879 | Neuromuscular Manifestations |
| D009422 | Nervous System Diseases |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|