Comparing the effect of radial extracorporeal shock wave with and without manual penile stretching on Peyronie’s disease: A randomized clinical trial

comparing the effect of radial extracorporeal shock wave with and without manual penile stretching on Peyronie's disease.

A controlled, parallel-group, single-blind, randomized clinical trial of 30 patients. Permutation block randomization is used.

Study will be conducted at the Neuromuscular Rehabilitation Research Center of Semnan University of Medical Sciences, Men with Peyronie's disease will be treated in either of two intervention or control groups. Using a therapist, the evaluator will be blinded to the type of intervention

Inclusion criteria: age older than 18 years; VAS less than 7 in resting and erection; men with full erection Exclusion criteria: Receiving any medication in last three weeks; inability to tolerate pain during treatment; any surgery or disease in the urinary-genital tract; psychiatric diseases or psychogenic erectile dysfunction; neurological disease and lumbar sacral peripheral nerve damage; penile abnormalities

The intervention group will receive radial extracorporeal shock wave and manual stretching simultaneously, the skin covering the plaque is locally anesthetized with lidocaine spray. The therapist stretches the head of the penis between the two fingers of one hand to the maximum amount tolerated by the patient and with the other hand applies mechanical pressure to the concavity of the body of the penis. Mechanical pressure of 4 bar with frequency of 8 Hz and 3000 strokes is given in six sessions and twice a week. The control group will receive radial extracorporeal shock wave in the resting state of the penis with the above method.

Pain with VAS; length of penis with photography and ruler; angle of penile deviation with photography and goniometer; sexual function with IIEF-5 questionnaire; size of the penile plaque with sonography

The sample size in each group is 15 people (30 people in total). Permuted block randomization method will be used for randomization. In this regard, blocks of four with numbers 1 to 6 will be used as follows: (in each block, a means the intervention group and b means the control group): 1-aabb 2-abba 3-abab 4-baba 5-baab 6-bbaa After choosing numbers one to six from the table of random numbers (numbers 0 and 7 to 9 are not taken into account), the block associated with each number is determined and the eligible people are enrolled in the study from left to right in each block and will be assigned in one of a or b group. The numbers will be selected seven times and the first 28 people will be grouped in this way, and the last two people will be entered into the group by assigning a coin. Participants, therapists, and evaluators will be unaware of the grouping. To implement the generated random sequence, the method of hiding the box or coded cans is used. In this method, the cans will be numbered based on a random sequence, and inside the boxes, the desired intervention will be given to the therapist with a sheet on which the random allocation is written, with the condition that the boxes are completely sealedو and the therapist will assign patients to intervention and control groups based on the order of arrival.

A physiotherapist will be in charge of the treatment process of the intervention group, and another physiotherapist and a radiologist will evaluate the desired variables. Therefore, the future study will be a single-blind study.

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