Pelvic Floor Disorders, Pelvic Pain
Conditions
Keywords
High-tone pelvic floor dysfunction, Spasm, Pelvic pain, Diazepam, Female, Randomized trial
Brief summary
To determine the efficacy of intravaginal diazepam for the treatment of pelvic pain associated with pelvic floor hypertonic disorder.
Detailed description
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.
Interventions
DRUGDiazepam
DRUGPlacebo
Sponsors
Raymond Foster
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years old * Primary complaint of acute or chronic pelvic pain with or without dyspareunia * Physical exam findings consistent with levator muscle spasm * Capable of inserting tablet in vagina without use of applicator.
Exclusion criteria
* Chronic narcotic use * Non-English speaking * Currently serving a prison sentence * Stage III or greater vaginal prolapse * Allergies or contraindications to benzodiazepines * Pregnant or breastfeeding * Currently receiving comprehensive pelvic floor rehabilitation therapy and/or vaginal valium therapy * Unwilling or incapable of inserting tablet in vagina without applicator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) for Pain | Baseline and 4 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pelvic Floor Distress Inventory-20 (PFDI-20) Questionnaire Score at 4 Weeks. | 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. |
| McGill Pain Questionnaire Score (PRI) at 4 Weeks | 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. |
Countries
United States
Participant flow
Recruitment details
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
Participants by arm
| Arm | Count |
|---|---|
| Diazepam Participated will be instructed to insert one 10mg tablet vaginally 1-2 times per day as needed for pain.
Diazepam | 25 |
| Placebo Participated will be instructed to insert one 10mg tablet vaginally 1-2 times per day as needed for pain.
Placebo | 24 |
| Total | 49 |
Baseline characteristics
| Characteristic | Placebo | Total | Diazepam |
|---|---|---|---|
| Age, Continuous | 42 years | 42 years | 36 years |
| Anxiety | 16 Participants | 26 Participants | 10 Participants |
| Bipolar disorder | 3 Participants | 5 Participants | 2 Participants |
| Body Mass Index | 26.99 kg/m^2 | 27.07 kg/m^2 | 27.07 kg/m^2 |
| Cardiovascular disease | 0 Participants | 2 Participants | 2 Participants |
| Cesarean sections | 0 number of cesarean sections | 0 number of cesarean sections | 0 number of cesarean sections |
| Current hormone replacement therapy | 2 Participants | 4 Participants | 2 Participants |
| Depression | 14 Participants | 23 Participants | 9 Participants |
| diabetes mellitus | 1 Participants | 4 Participants | 3 Participants |
| Gastrointestinal disease | 11 Participants | 19 Participants | 8 Participants |
| Gravida | 2 number of pregnancies | 2 number of pregnancies | 2 number of pregnancies |
| Headache | 11 Participants | 22 Participants | 11 Participants |
| Heavy lifting | 7 Participants | 11 Participants | 4 Participants |
| Hysterectomy | 8 Participants | 17 Participants | 9 Participants |
| Largest baby | 3487 gm | 3642 gm | 3713 gm |
| Low back pain | 10 Participants | 23 Participants | 13 Participants |
| Lung disease | 5 Participants | 7 Participants | 2 Participants |
| Menopausal | 11 Participants | 23 Participants | 12 Participants |
| Mesh surgery | 4 Participants | 9 Participants | 5 Participants |
| Neurological disease | 0 Participants | 1 Participants | 1 Participants |
| Obsterical trauma | 12 Participants | 22 Participants | 10 Participants |
| Post void residual | 35 mL | 25 mL | 20 mL |
| Prolapse | 4 participants | 8 participants | 4 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 22 Participants | 45 Participants | 23 Participants |
| Sex: Female, Male Female | 24 Participants | 49 Participants | 25 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Smoker | 8 Participants | 17 Participants | 9 Participants |
| Symptom duration | 30 months | 24 months | 24 months |
| Term Pregnancies | 2 number of full-term pregnancies | 2 number of full-term pregnancies | 2 number of full-term pregnancies |
| Vaginal deliveries | 1 number of vaginal deliveries | 1 number of vaginal deliveries | 1 number of vaginal deliveries |
| Vaginal estrogen use | 3 Participants | 11 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 24 |
| other Total, other adverse events | 4 / 25 | 4 / 24 |
| serious Total, serious adverse events | 0 / 25 | 0 / 24 |
Outcome results
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.
Time frame: Baseline and 4 weeks
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Diazepam | Visual Analog Scale (VAS) for Pain | 50 score on a scale |
| Placebo | Visual Analog Scale (VAS) for Pain | 39 score on a scale |
p-value: 0.62Wilcoxon (Mann-Whitney)
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.
Time frame: 4 weeks
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Diazepam | McGill Pain Questionnaire Score (PRI) at 4 Weeks | 34 score on a scale |
| Placebo | McGill Pain Questionnaire Score (PRI) at 4 Weeks | 33 score on a scale |
p-value: 0.88Wilcoxon (Mann-Whitney)
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.
Time frame: 4 weeks
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Diazepam | Pelvic Floor Distress Inventory-20 (PFDI-20) Questionnaire Score at 4 Weeks. | 96 score on a scale |
| Placebo | Pelvic Floor Distress Inventory-20 (PFDI-20) Questionnaire Score at 4 Weeks. | 107 score on a scale |
p-value: 0.66Wilcoxon (Mann-Whitney)