A total of 40 volunteers women with a diagnosis of interstitial cystitis. Their ages ranged from 25 to 40 years old; their body mass index was > 30 kg/m2 and were randomly assigned to a group (A) received interferential current at the lower abdomen, and also received traditional medicine or group (B) received traditional medicine for 8 successive weeks. Both of the groups received the treatment program for 8 successive weeks. Assessment of pain perception and disability level for all patients in both groups (A&B) were done through Visual analogue scale, O'Leary-Sant Symptom Index or Interstitial Cystitis Index (ICSI) and blood cortisol concentration were done before and after the treatment program.
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Double (Participant, Investigator)
- Study Primary Completion Date: January 1, 2019
Forty volunteers women diagnosed clinically by gynecologist as painful bladder syndrome were participated in this study. They were selected randomly from the gynecological outpatient clinic, at Al-Zahra Universal Hospital, Al Azhar University, their ages ranged from 25 to 40 years and their body mass index was > 30 kg/m2. All participants complain from suprapubic pain related to bladder filling, accompanied by other symptoms such as increased daytime and night-time frequency. Exclusion criteria of the study were as follows: Participant who had acute viral disease, acute tuberculosis and mental disorders, benign or malignant tumors of the pelvic region, Participant who had active endometriosis or having artificial pacemaker or cardiac arrhythmia, Participant who had sensory disturbances. Participants were assigned randomly used sealed envelope into two groups (A&B) equally in number. Group (A): Consisted of twenty patients suffering from painful bladder syndrome. They received interferential current at the lower abdomen, and also received traditional medicine (they were administered anticholinergics (propiverine hydrochloride 20 mg/once per day in the morning) for 8 successive weeks. Group (B): Consisted of twenty patients suffering from painful bladder syndrome. They received traditional medicine (they were administered anticholinergics (propiverine hydrochloride 20 mg/once per day in the morning) for 8 successive weeks
- Device: interferential current
- Treatment was applied using four vacuum electrodes with wet sponge, two of them were put under the patient lumber region on a distance from lumber spinous process by five cm on each side and the other two were applied over the suprapubic region parallel to iliac crest.
- Drug: Propiverine Hydrochloride
- propiverine hydrochloride 20 mg/once per day in the morning
Arms, Groups and Cohorts
- Active Comparator: interferential current
- interferential current with a constant frequency of 100Hz for pain relief, then using rhythmic frequency of 1-100 Hz that help to disperse infiltration and adhesions for 8 successive weeks
- Active Comparator: anticholinergics
- anticholinergics (propiverine hydrochloride 20 mg/once per day in the morning) for 8 successive weeks
Clinical Trial Outcome Measures
- Visual analogue scale
- Time Frame: 8 weeks
- pain was assessed by the visual analogue scale to all participants in both two groups (A, B)
- O’Leary-Sant Symptom Index or Interstitial Cystitis Index (ICSI)
- Time Frame: 8 weeks
- It is useful in assessing baseline symptoms (including pain, frequency, nocturia and impact on activities) and effectiveness of treatments. The Interstitial Cystitis Problem Index (ICPI) documents symptom bother.
- Plasma cortisol concentration
- Time Frame: 8 weeks
- 5 ml of venous blood were drawn from the patient at the morning (at 9 am), put into a tube to measures the level of cortisol in the blood.
Participating in This Clinical Trial
- their ages ranged from 25 to 40 years. – their body mass index was > 30 kg/m2 Exclusion Criteria:
- Participant who had acute viral disease. – acute tuberculosis – mental disorders. – benign or malignant tumors of the pelvic region
Gender Eligibility: Female
Minimum Age: 25 Years
Maximum Age: 40 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- Cairo University
- Provider of Information About this Clinical Study
- Principal Investigator: Ghada Ebrahim El Refaye, assistant professor – Cairo University
- Overall Official(s)
- ghada eb elrefaye, professor, Principal Investigator, Department of Physical Therapy for Women’s Health, Faculty of Physical therapy, Cairo University, Egypt.
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